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Search Results Within Category "Digestive Systems & Liver Disease"

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20 Study Matches

A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous(SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease

The primary objective and primary endpoint in this study is to assess clinical remission. To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction. To evaluate the safety profile of ustekinumab. To evaluate ustekinumab exposure (pharmacokinetics [PK]). To evaluate the efficacy of IV ustekinumab during the induction period. To evaluate the efficacy of SC ustekinumab during the maintenance period among participants who were in clinical response in induction.

Participants who meet inclusion criteria will receive ustekinumab through an IntraVenous infusion during the induction period. And then will be randomized either every 8weeks or 12weeks to receive ustekinumab through a SubCutaneous injection.

Yes
 

Marc Schaefer
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Gastroenterology and Nutrition (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04673357
STUDY00016344
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have been diagnosed with moderately to severely active Crohn's Disease prior to screening

Exclusion Criteria:
Has had any kind of bowel resection within 6months
Currently has or is suspected to have an abscess
Digestive Systems & Liver Disease
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Hershey, PA ,

The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis

NASH is associated with increased risk of mortality. Currently, there are few treatment options. Therefore, there is a need for an effective and safe medication treatment options. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), can address certain aspects of NASH and is therefore considered a strong candidate for the treatment of NASH.

If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, vital signs, waist circumference, height, and weight measurements, questionnaires, COVID-19 screening and test, a liver biopsy, blood draws, eye examination, and pregnancy test, if applicable. You will be randomized to either Semaglutide 2.4 mg once weekly or placebo (an inactive substance of no medical value). For treatment, you will be asked to inject yourself once a week for with the study medicine. You will be asked to come in for 21 study visits to evaluate your health and the effect of the study medicine at week 0, week 2, week 8, week 12, week 16, week 24, week 36, week 48, week 60, week 72, week 78, week 96, week 108, week 120, week 144, week 156, week 168, week 192, week 204, week 216, week 240 and week 247. There will be up to 9 phone calls with the study staff.

1,050.00

Yes
 

Jonathan Stine
Nataliya Smith - at stinelaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04822181
STUDY00017043
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Inclusion Criteria:
Biopsy consistent with NASH and presence of fibrosis stage 2 or 3
able to provide consent
18 years or older

Exclusion Criteria:
previous participation in this trial
known/suspected allergic reaction to study drug
pregnancy
cirrhosis
hepatocellular carcinoma
Digestive Systems & Liver Disease
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Hershey, PA ,

Seamless, Adaptive, Phase2b/3, Double-blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirhosis

This trial will evaluate the study drug Belapectin in patients with NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The purpose of this voluntary research study is to find out about the safety and efficacy of the study drug and for the prevention of esophageal varices in NASH Cirrhosis..

If you consent to participate, you will be asked to have some screening tests and procedures, as described in the table below. This period of up to 3 visits within 2 months is called Screening Period. Based upon results of tests and procedures completed during these visits, your study doctorwill be able to decide if you meet the requirements to participate in this study. If you meet the study requirements to participate in this study, your study doctor will discuss with you when you should start the study treatment.

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04365868
STUDY00018518
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Inclusion Criteria:
Adults age >18-75 years old
early stage cirrhosis
diagnosis of NASH

Exclusion Criteria:
end stage cirrhosis
substance abuse
other liver disease
history of organ transplant
Digestive Systems & Liver Disease
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Hershey, PA ,

Visceral Pain Sensation and Nav1.8

We wish to investigate the role of a specific gene in visceral pain sensation and perception. This gene, Nav1.8 has a known change present in 10% of the population which may affect the way we feel inflammatory pain in the gut. This is an important symptom in inflammatory bowel disease (IBD). Some patients feel high levels of pain we would like to control, other patients feel little to no pain in the presence of very active disease, which can lead to dangerously under-treated disease. In this study, we will use healthy volunteers of a known genotype for Nav1.8, and test their sensitivity using rectal balloon dilation.Research subjects will be asked to fast, skipping solid foods and opaque liquids for 6 hours before the testing. Usually this means skipping 1 meal. At the beginning of the study visit. they will use an over the counter enema to clear their rectum of any stool. Then. a trained physician on the research team will insert a thin, lubricated tube into the rectum, which will be inflated to specific pressures. Most of these tests will be designed to measure any change in sensation, then the need to use the toilet, followed by urgent need or discomfort, and lastly the lower threshold of pain. Patients will be able to stop testing at any time, should they become too uncomfortable. The testing takes between 1 and 1 and a half hours, and volunteers are compensated $200 for their time.

To simulate abdominal pain, we use a thin tube placed in the rectum that inflates a small balloon to very precise and safe pressures. Our bodies interpret these pressures (in ascending order) as the need to go to the bathroom; first just a little, then with increasing urgency and eventually discomfort and pain. During these experiments, we only measure the lower threshold of pain, and stop immediately when you tell us to stop. We have significant experience using this approach and we have found it consistently informative while causing the least amount of discomfort possible. The whole thing takes about an hour and we’re paying volunteers $200 for participating. We'll ask that you skip a meal before the study visit, and perform an over-the-counter enema at the start of the visit.

$200

Yes
 

Matthew Coates
August Stuart - at astuart@pennstatehealth.psu.edu or 717-531-0003, ext=281928
Medicine: General Internal Medicine (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00010688
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Inclusion Criteria:
Have a diagnosis of ulcerative colitis, Crohn's disease, or no lower GI diseases (healthy control)
Had a colonoscopy in HMC health record within the past 6 months (UC or Crhon's) or 5 years (healthy control)

Exclusion Criteria:
UC and Crohn's patients: moderate to severe disease activity on your recent colonoscopy
Healthy control: any diagnosed lower GI disease (such as IBS or active diverticulitis) or significant abdominal pain in the last 12 months.
Any peripheral neuropathy or neuromodulating/opioid medications
Any Autoimmune disease (except Crohn's disease or ulcerative colitis)
Infectious Diseases & Immune System, Digestive Systems & Liver Disease, Pain Management
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Hershey, PA ,
State College, PA ,

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous (SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective and primary endpoint in this study is to assess clinical remission.participants who were in clinical response in induction. To evaluate the safety profile of ustekinumab (study drug).Participants who meet inclusion criteria will receive ustekinumab through and IntraVenous infusion during the induction period. And then will be randomized either every 8weeks or 12weeks to receive ustekinumab through a SubCutaneous injection.

You will be asked to complete patient diary and questionnaires, provide blood, stool samples and urine samples, receive at least 3 endoscopy with biopsies, chest x-rays. If you pass screening, you will receive an IV dose of the study medication and then be randomized to receive a subcutaneous injection of study medication every 8weeks or every 12 weeks.

Yes
 

Marc Schaefer
Erica Miller - at emiller25@pennstatehealth.psu.edu or 717-531-5656
Pediatrics: Gastroenterology and Nutrition (HERSHEY)
 

All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04630028
STUDY00016342
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have Ulcerative Colitis diagnosed prior to screening
Must have moderately to severely active Ulcerative Colitis

Exclusion Criteria:
Have severe extensive colitis
Have Ulcerative Colitis limited to the rectum only
Presence of a stoma
Presence or history of a fistula
Digestive Systems & Liver Disease
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Hershey, PA ,

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

To evaluate the effect of Saroglitazar Magnesium compared with Placebo on liver scarring in patients with NASH.

There will be 11 in person visits, various procedures will be completed such as a fibroscan, liver biopsy, blood draws and DXA scan. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or Saroglitazar 2 mg or placebo (inactive substance).

1,325

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05011305
STUDY00020176
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Inclusion Criteria:
Age 18-75
NASH diagnosis
Stage 2 or 3 fibrosis

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC).

this is a phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with Primary Sclerosing Cholangitis (PSC), and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period (no placebo) to assess long-term safety and maintenance of effects of elafibranor.After the first dose of the study intervention on Day 1, the participants will have study visits every 4 weeks through Week 12 of the DBP to assess efficacy and safety. In the OLE period, the study visits for each participant will occur after 4 weeks of entering the OLE, then every 12 weeks up to Week 52, followed by every 22 weeks up to Week 96 which will be the end of treatment (EOT). All participants will have a safety follow-up 4 weeks after the last dose of study intervention.

There will be 2 screening visits followed by 4 visits during the double blind/placebo part of the trial, followed by visits every 3 months for the open label part of the study. All visits will be in person. Blood will be drawn at every visit. Urine will be collected at most visits. ECG's (recording of your heart activity) will be done on a regular basis. Additional procedures include fibroscans (scan of your liver to determine liver stiffness) and ultrasound exams of your abdomen and bladder. Multiple questionnaires will be competed throughout the trial period.

Yes
 

Karen Krok
Laurie Peiffer - at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05627362
STUDY00021989
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Inclusion Criteria:
Diagnosis of PSC
Elevated ALP

Exclusion Criteria:
Chronic Liver Disease
percutaneous drain or bile duct stent
cholangiocarcinoma
bacterial cholangitis within 60 days
hepatic decompensation
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 1, Double Blind, Randomized, Placebo-Controlled, Multi-Center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2693 in Patients with Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Stage 0-3 and Carriers of the PNPLA3 148M Risk Allele

The purpose of this voluntary research study is to test the safety and ability to tolerate of the an injection treatment of the study drug AZD2693 in patients with Non-alcoholic Steatohepatitis (NASH).

If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, height, and weight measurements, an electrocardiogram, questionnaires, COVID-19 screening and test, an MRI, a liver biopsy, an elastography, telemetry, blood draws, urine drug testing and a pregnancy test if applicable. For treatment, you will be asked to administer study drug or placebo (a substance that has no therapeutic effect) at week 1, week 5 and week 9. There will be 13 other study visits that will occur biweekly.

2,000

Yes
 

Jonathan Stine
Gloriany Rivas - at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04483947
STUDY00016898
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Inclusion Criteria:
BMI within the range 25 to 45 kg/m2
NASH diagnosis

Exclusion Criteria:
history of liver transplant
pre-existing renal disease
Digestive Systems & Liver Disease
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Hershey, PA ,

CC-93538-EE-001 – A PHASE 3, MULTI-CENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS

The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction and inflammation in subjects with Eosinophilic esophagitis (EoE).The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. The phase 3 program will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance, and Open-Label Extension study.

The participants are required to sign the consent form. If you decide to participate, you will be required to attend study visits, follow doctor's instructions and take the study drug as instructed. You will be required to complete electronic questionnsires, and tell you doctor about any health problems, symptoms and drugs that you are taking. There are two visits during screening, including EGD procedure with biopsies. All the procedures during screening are done to determine if you are qualified to participate in the study. If the screening tests show that you can take part in this study, a computer program will make the assignment of which study drug you are to receive. You will be assigned to start the study by receiving either active drug (360 mg of CC-93538), or placebo. Both active drug and placebo will be given weekly by subcutaneous injection.You will be asked to have blood test done for serum and for biomarkers at most of your visits (except week 20). Physical exam and pregnancy's tests will be done at screening visit, and every visit during the induction after week 4. the ECG test will be done at screening. Similarly, the blood work and pregnancy's tests will be done at every visit during the maintenance. urinalysis and physical exam will also be done at some visits in the maintenance. Your vital signs will be monitored throughout the study.

$750 induction, $565 Maintenance max

Yes
 

Kofi Clarke
Zvjezdana "Stella" Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-0003, ext=322136
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04753697
STUDY00017625
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Inclusion Criteria:
Adults with body weight more than 40 kg
Histologic evidence of EoE
Symptoms of dysphagia
Previous therapy with PPI medications, intolerant or inadequate corticosteroid response, or steroid responders/naive
Must agree to maintain stable diet

Exclusion Criteria:
Active, ongoing infections
Liver function impairment, structural abnormality of esophagus
Receiving concurrent treatment with another IP, or the same drug previously
Currently is succesfully treated for EoE with dietary modifications
Currently receiving corticosteroids
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

This is a phase 2/3, multi-center, randomized, double-blind, study for patients with moderate to severe Crohn's disease. Subjects with refractory CD or who are intolerant to at least one current therapy will be considered. The study consists of four substudies. They are designed to investigate efficacy, safety, tolerability of etrasimod as therapy for CD.

The study consists of a screening period, a 14-week induction period, a 6-week extended induction period (if applicable), and a follow-up period. •The subject will have to go to the study center for the visits and follow the instructions the study doctor and the study team give them, and take the study medication, as directed.They are required to bring all unused study medication and packaging to each study visit. The subject should complete their eDiary every day and bring it with you to all visits. They also must remember to return your Holter monitor to the study clinic.Other tests that the subject is required to complete will include ECG, drug test, TB test at screening. Also urine and blood tests at all induction visits except day 1 extension, vital signs and physical at every visit, eye and pulmonary function tests will be done at screening.

$600

Yes
 

Kofi Clarke
Zvjezdana (stella) Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04173273
STUDY00017209
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Inclusion Criteria:
Age 18-80 years
Crohn's disease >3 months
Inadequate response, LOR or intolerance to more than one therapies
Females must not be/intent to be pregnant

Exclusion Criteria:
History of inadequate response to more than two biologics
Use of certain therapies less than 2 weeks prior to randomization
Hypersensitivity to Entrasimod
Have UC diagnosis
Has infection
Digestive Systems & Liver Disease
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Hershey, PA ,

A Phase 2A, Double-blind, Randomized, Placebo-ControlledClinical Trial to Evaluate the Efficacy and Safety ofSaroglitazar Magnesium 4 mg Tablets for Treating NonalcoholicFatty Liver Disease (NAFLD) in Women WithPolycystic Ovary Syndrome (PCOS)

The purpose of this study is to evaluate the efficacy and safety of Saroglitazar Magnesium 4 mg Tablets once-daily in women with well characterized Polycystic ovary syndrome (PCOS) diagnosed with nonalcoholic fatty liver disease (NAFLD).

There will be 9 in person visits, various procedures will be completed such as a fibroscan, endometrial biopsy, blood draws and surveys. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or placebo (inactive substance).

Yes
 

Jonathan Stine
Gloriany Rivas - at grivas@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03617263
STUDY00020411
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Inclusion Criteria:
Adults age >18-75 years old
NAFLD diagnosis
Stage 2 or 3 fibrosis

Exclusion Criteria:
causes of chronic liver disease other than NAFLD
pregnancy
Cirrhosis
Inability to provide informed consent
history of liver transplant
Digestive Systems & Liver Disease, Women's Health
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

NASH AMPK Exercise Dosing (AMPED) Trial

The purpose of this trial is to test different levels of exercise needed to reduce liver fat in patients with NASH.

If you take part in this research, your major responsibilities will include: •Completing exercise sessions (if randomized to exercise group). A typical exercise session will include a 5 minutes warm-up with stretching, 15-45 minutes of brisk walking, jogging or recumbent bike and a 5-minute cool-down.

250.00

Yes
 

Jonathan Stine
Breianna Hummer-Bair - at stinelab@pennstatehealth.psu.edu or 717-531-0003, ext=320222
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987879
STUDY00018280
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Inclusion Criteria:
Adults age >18 years
NASH diagnosis
BMI 25-45 kg/m2
sedentary lifestyle

Exclusion Criteria:
pregnancy
Active cardiac symptoms
Cancer that is active
Inability to provide informed consent
Other liver disease
Food & Nutrition, Digestive Systems & Liver Disease, Sports Medicine
Not applicable
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Hershey, PA ,

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.

Patients will have to sign the consent form to participate in the trial

Yes
 

Matthew Moyer
Matthew Moyer - at mmoyer@pennstatehealth.psu.edu or 717-531-0003, ext=287992
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
STUDY00005206
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.

Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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Hershey, PA ,

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis

-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.

Yes
 

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05677971
STUDY00021539
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Inclusion Criteria:
The participant, of any sex, is aged 18 to 75 years, inclusive
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD

Exclusion Criteria:
The participant is receiving long-term around-the-clock oxygen (O2) supplementation or supplemental O2 with continuous positive airway pressure (CPAP), or bi-level positive airway pressure (BiPAP) for acute respiratory failure.
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
Allergies, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROL, PARALLEL GROUP STUDY TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND SAFETY OF INBRX-101 COMPARED TO PLASMA DERIVED ALPHA1-PROTEINASE INHIBITOR (A1PI) AUGMENTATION THERAPY IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA

Voluntary research study is to test INBRX-101 as an experimental drug to treat patients with alpha-1 antitrypsin deficiency. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in AATD emphysema patients when compared with current approved AATD therapy with A1PI.

You will visit the study site up to a total of 37 times for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion.

Unknown at this time

Yes
 

Timothy Craig
Kara Grim - at kgrim@pennstatehealth.psu.edu or 717-531-4513
Medicine: Pulmonary, Allergy and Critical Care (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05856331
STUDY00022890
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Inclusion Criteria:
Males or females 18-80 years of age and Ability to understand and the willingness to sign a written informed consent document
Confirmed diagnosis of alpha-1 antitrypsin deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Available to participate for duration of study and willingness to commit to all requirements of the study, including study visits

Exclusion Criteria:
Known selective or severe Immunoglobulin A (IgA) deficiency
On waiting list for lung or liver transplant
Known or suspected diagnosis of type 1 diabetes or diagnosed uncontrolled type 2 diabetes
Active cancers or has a history of cancer within 5 years prior to screening
Females who are pregnant or breastfeeding or females of childbearing potential unwilling to practice highly effective contraception during the study
Infectious Diseases & Immune System, Lung Disease & Asthma, Digestive Systems & Liver Disease
Experimental drug compared to an approved drug
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Hershey, PA ,

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The “EvolvE” Study)

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety profile of barzolvolimab (CDX-0159) in patients with active EoE. The study will enroll approximately 60 patients.This study consists of four distinct phases lasting approximately a year. Each patient will receive four doses of study treatments spread out every eight weeks; two in the placebo-controlled phase and two in the active study phase. The participants will be required to sign the informed consent before any procedures are performed. If eligible for screening, they will need to have standard lab tests (blood and urine), EKG, pregnancy test if applicable, and tests for COVID-19. They will also be required to have EGD with biopsies done during the screening period and at weeks 12 and 28. If eligible to continue, the participants will be randomized on day 1, when they will receive their first treatment. They will be required to come back to the clinic in two weeks and four weeks after that. They will have to complete the e-diary questionnaires at home.

There will be ten in person visits, including screening, placebo-controlled treatment and active (open label) treatment. In addition, there are four follow up visits every 4 weeks. The participants must sign the informed consent. There are going to have vital signs checked at every visit. Some visits have a physical exam. There are blood tests, urine tests, ECG, and COVID -19 tests done. The participants will have EGD procedure with biopsies at screening, and at 12 and 28 weeks of treatment. There will be four study treatments administered in the clinic. The concomitant medications, and adverse events will be monitored and documented. Serum and urine pregnancy tests will be performed if applicable. Participants will be asked to complete electronic diary daily.

$75 per visit; you may receive travel reimbursement $50, and $50 meal compensation for visit 1, 2, 5, 7, and 9

Yes
 

Kofi Clarke
Z. Stella Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05774184
STUDY00022619
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Inclusion Criteria:
Read, understood, and provided written informed consent
Male or female, ≥ 18 years of age
Documented diagnosis of EoE by endoscopy
Must be symptomatic, with dysphagia twice a week
Must have been on a stable diet

Exclusion Criteria:
Diagnosis of hypereosinophilic syndrome
Known active Helicobacter pylori infection
History of achalasia, Crohn’s disease, ulcerative colitis or celiac disease.
Esophageal dilation within 3 months prior to screening visit
Women who are pregnant or nursing.
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE 1B OPEN-LABEL/ PHASE 2 DOUBLE-BLIND PLACEBO-CONTROLLED STUDY FOR PHARMACODYNAMIC ACTIVITY, PHARMACOKINETICS, SAFETY AND TOLERABILITY OF KAN-101 IN PATIENTS WITH CELIAC DISEASE-A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

At this time, there is no treatment available for celiac disease diagnosis. The study is designed to test safety, tolerability and pharmacokinetics of KAN-101 to treat celiac disease diagnosis. We will participate only in the Part B study portion. Part B is a Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response (plasma IL-2) in peripheral blood following gluten challenge, safety, tolerability, and pharmacokinetics (how does drug move in the body) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed celiac disease. Participants will be randomized 1:1:1:1, where one arm is placebo, and other arms are different drug doses. The study consists of a screening period to determine eligibility to participate, a run-in phase where participants are gluten-challenged for one day, a treatment phase where participants will receive a seven-days treatment, and observation period lasting 358 days where participants will have a post-dose gluten challenge on Day 15, and three other time-points. The study aims to enroll 120 subjects across all sites. Participants will be asked to come for the clinic visit, to have gluten challenged done in the clinic, and treatment infusions in the clinic. There are two follow-up visits planned. The participants will have required EGD w/biopsy, and will be offered optional EGD biopsy study, that collects specimens at two time points. All participants will have a blood work done to access eligibility for participation, and to test for drug PK and biomarkers in the response of the treatment. They will also have EKG and physical examinations, vital signs checked during the clinic visits. They will complete questions for patient reported symptoms. Eligible women participants will be tested for pregnancy, and contraception will be discussed for both male and female participants.

Participants will be asked to come to the clinic visits for the screening, gluten challenge, treatment visits and follow up. During the visits, participants will have blood tests done to determine eligibility for the study, or the test how the drug moves through the body and whether it works to dampen the celiac disease symptoms. The patients will have EGD with biopsies procedure done in the endoscopy suite, and they will be offered optional biopsies study. The gluten challenge will consist of drinking a glass of water containing 9g pre-prepared gluten challenge mix. The participants will be observed for four hours. The treatment is done via infusion in the clinic over 30-minutes,and observed for four hours after that. The participants will have to come in for three treatment visits within seven days (days 1, 4, and 7).

$975

Yes
 

Kofi Clarke
Zvjezdana (Stella) Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05574010
STUDY00022990
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Inclusion Criteria:
subject is aged 18 to 70 years
positive celiac serology and histology
followed gluten free diet for more than a year

Exclusion Criteria:
have refractory celiac
have wheat allergy
have hypersensitivity to gluten
active GI disease
have Type 1 diabetes
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

Feasibility, Safety and Acceptability of a Mobile Health Delivered Exercise Training Program in Patients with Nonalcoholic Steatohepatitis

This study will be a pilot study to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously confirmed in patients with cirrhosis,(1) in patients with Nonalcoholic Steatohepatitis (NASH)

El-Fit NASH (Nonalcoholic Steatohepatitis) is a 9-week intervention trial for patients with NASH. Our goal is to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program. The El-FIT application allows for participants to access to a library of guided workouts. All patients will be asked to complete a screening visit that includes a physical exam, height, and weight measurements & surveys. Participants will be asked to download the EL-Fit NASH application and use it for 8 weeks. In addition to using the application, participants will be asked to complete 3 check-in phone calls through-out the 8 weeks.

Yes
 

Jonathan Stine
Stine Laboratory at StineLaboratory@pennstatehealth.psu.edu or 717-531-0003, ext=320222
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06195943
STUDY00022771
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Inclusion Criteria:
18 years or older
Evidence of NASH
Posission of a Smart Phone

Exclusion Criteria:
Active cardiac Symptoms
Active or recent participation in exercise training program within the last 90 years
Active or recent weight-loss supplement use within the last 90 days
Active illicit substance use
Cancer that is active
Digestive Systems & Liver Disease, Sports Medicine
Not applicable
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

Hepatic encephalopathy (HE) is a complication of liver cirrhosis (liver damage). It affects nearly half of people with cirrhosis. Because of the damage, the liver doesn’t work as well as it should, and some toxins stay in the body. HE occurs when too many toxins build up in the bloodstream and reach the brain. It can cause symptoms like confusion, personality changes, lack of energy, inappropriate behavior, sleep problems, loss of small hand movements and tremors in hands and arms.This study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE. Adults who have been diagnosed with liver cirrhosis, but who don’t have yet HE may be eligible to join.•Participants will be in the study will up to 80 weeks. They will attend up to 21 study visits, including 14 visits to the clinic and 7 telephone check-ins.•If participants are eligible and choose to participate, they will be randomly (like a flip of a coin) assigned to one of two treatment groups: the study medicine or placebo (which contains no active ingredients). This means participants have a 50/50 chance of receiving the study medicine.•Both study groups will take their assigned study medicine study medicine as a pill twice a day.•The study is double-blind, which means neither the participant nor the study team will know which treatment they are receiving.

There will be 14 in person visits. Safety assessments will be done at each visit including blood tests and urine tests. Participants will need to take study drug as directed.

$1050.00

Yes
 

Karen Krok
Laurie Peiffer - at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05297448
STUDY00022899
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Inclusion Criteria:
liver cirrhosis
Conn score <2
Mini Mental State Exam score >24

Exclusion Criteria:
active COVID-19
allergic to rifaximin
history of Spontaneous bacterial peritonitis (SBP)
history of neurological disorder
substance abuse
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A PHASE 2, MULTICENTER, PLACEBO-CONTROLLED,RANDOMIZED, DOUBLE-BLIND, 48-WEEK STUDY TOEVALUATE THE EFFICACY AND SAFETY OF COMBINATIONTHERAPY OF K-877-ER AND CSG452 IN PATIENTS WITHNONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)WITH LIVER FIBROSIS

This is a Phase 2, multicenter, double-blind, randomized, 52-week study to assess the efficacy and safety of K-001 medication compared with placebo in subjects with noncirrhotic NASH with liver fibrosis. This study will look at a study drug, called K-001, for participants with a liver condition called noncirrhotic nonalcoholic steatohepatitis (NASH). This condition is defined by a build-up of fat in the liver, which causes liver damage and inflammation. Due to this damage, the liver does not work as well. If left untreated, NASH can lead to liver fibrosis (scarring of the liver), liver cancer, or liver failure. K-001 is a once daily pill that contains combination of two medicines: K-877-ER and CSG452. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with NASH with liver fibrosis. To answer these questions, the study drug will be compared with a placebo.

There will be 10 in person visits over 52-week study period. Various procedures will be completed such as a fibroscan, ECG, liver MRI, liver biopsy, blood draws. You will be randomly assigned by chance (like the flip of a coin) to receive the study drugs or placebo (inactive substance). You will be taking a pill once daily.

$1310

Yes
 

Jonathan Stine
Nataliya Smith - at nsmith9@pennstatehealth.psu.edu or 717-531-0003, ext=320223
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05327127
STUDY00023757
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Inclusion Criteria:
Age ≥18 years
NASH diagnosis
Stage 1, 2 or 3 fibrosis

Exclusion Criteria:
Causes of liver disease other than NAFLD
Chronic alcohol or drug abuse
Cirrhosis
History of liver transplant, or subjects listed for liver transplantation
Inability to provide informed consent
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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Hershey, PA ,