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Search Results Within Category "Blood Disorders"

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5 Study Matches

Efficacy and Safety of Concizumab prophylaxis in patients withhaemophilia A or B without inhibitors

To establish the effect and investigate safety of daily subcutaneous treatment with concizumab prophylaxis when given to adult and adolescent haemophilia patients without inhibitors.

There will be approximate 28 in person visits with blood drawn at 27of these.

Yes
 

M. Elaine Eyster
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
All
This study is NOT accepting healthy volunteers
NCT04082429
STUDY00013127
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Inclusion Criteria:
Male aged ≥12 years
Body weight >25 kg at screening
Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%)
Documented treatment with coagulation factor containing product in the last 24 weeks

Exclusion Criteria:
Treatment with emicizumab within 180 days before screening
Participation in any clinical trial of an approved or non-approved investigational product within 5 half-lives or 30 days from screening
Known or suspected hypersensitivity to monoclonal antibodies
History of thromboembolic disease
inhibitors ≥0.6 BU in the last 5 years
Blood Disorders
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Hershey, PA ,

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.

Yes
 

Robert Greiner
Suzanne Treadway - at streadway@pennstatehealth.psu.edu or 717-531-3097
Pediatrics: Hematology/Oncology (HERSHEY)
 

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This study is NOT accepting healthy volunteers
NCT01656603
STUDY00015052
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Inclusion Criteria:
You have a disorder affecting your hematopoietic system (the organs and tissues that produce your blood) that is inherited, acquired, or from previous chemotherapy

Exclusion Criteria:
You are receiving licensed cord blood products
You are receiving unlicensed CB products from other CB banks
Blood Disorders, Cancer
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Hershey, PA ,

Study of Angelica gigas dietary supplements (Cogni.Q) and potential effects on human immune cells

This human study will test the impact of dietary supplement vegicaps containing Korean Angelica root extract on 2 types of human immune cells: neutrophils that kill bacteria and other germs and natural killer (NK) cells that kill virus-infected cells and cancers. We had done an earlier study with Korean Angelica supplement and discovered even a single dose of it increased blood neutrophils and NK cells within 24 h. In the new study, Korean Angelica capsules (Cogni.Q) will be compared head-to-head with dummy (placebo) capsules. This is to make sure the immune boosting actions are really from the Korean Angelica supplement.Approximately 40 men will take part in this research study at Hershey Medical Center.

Yes
 

Junxuan Lu
Deepkamal Karelia - at dkarelia@pennstatehealth.psu.edu or 717-531-0003, ext=285476
Pharmacology (HERSHEY)
 

Male
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00008009
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Inclusion Criteria:
Male subjects 21 to 65 years of age
Subjects weighing between 110 to 240 pounds; their body mass index (BMI) should be in the range of 19=< BMI >=30
Subjects having normal hepatic, renal function as assessed by history, physical and clinical chemistry analysis (CMP eGFR).
Subjects with normal blood pressure (systolic below 120 mm Hg and diastolic below 80 mm Hg)

Exclusion Criteria:
Subjects positive for HIV, HBV and HCV (self-reported)
Subjects taking any kind of prescription medications regularly or within 10 days of the study will be excluded.
Subjects taking dietary or herbal supplements that contain AGN (e.g. Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) within 10 days of the study.
Non-English-speaking subjects
Infectious Diseases & Immune System, Blood Disorders, Food & Nutrition
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Hershey, PA ,

ATHN 10: Leveraging the ATHNdataset to Document the State of RareCoagulation Disorders in the United States

This is a multi-center project in which the American Thrombosis &amp; Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).

One tube of blood will be collected during a routine clinic visit.

Yes
 

M. Elaine Eyster
Lisa Baker - at lbaker@pennstatehealth.psu.edu or 717-531-7468
Medicine: Hematology and Medical Oncology (HERSHEY)
 

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This study is NOT accepting healthy volunteers
SITE00000669
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Inclusion Criteria:
Subject must have an established Rare Coagulation Disorder diagnosis (
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset

Exclusion Criteria:
Subject is unwilling to sign informed consent form
Blood Disorders
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Hershey, PA ,

Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis

A research study looking at how safe it is to switch from emicizumab (Hemlibra) to Mim8 in people with haemophilia A.

The study will last for about 6-12 months. Subjects will have between 6 and 27 Mim8 injections depending on dosing frequency. There will be 9 clinic visits. Blood will be drawn at all 9 of the visits.

$75 per visit to cover travel expenses

Yes
 

M. Elaine Eyster
Bree Kelly - at jhawthorne@pennstatehealth.psu.edu or 717-531-0003, ext=281498
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
All
This study is NOT accepting healthy volunteers
NCT05878938
STUDY00022172
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Inclusion Criteria:
Congenital haemophilia A of any severity based on medical records
Treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
Age 12 years or above at the time of signing the informed consent.
Patients choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or QM treatment for 26 weeks from start of treatment.
Willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires.

Exclusion Criteria:
Participation in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks before screening
Previous or current thromboembolic disease or events or risk of thromboembolic disease, as evaluated by investigator or risk of thromboembolic disease, as evaluated by investigator.
Receipt of FVIII gene therapy at any time.
Ongoing or planned immune tolerance induction therapy.
Minor or major surgery planned to take place after screening and during the 26-week treatment period.
Blood Disorders
Not applicable
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Hershey, PA ,