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Search Results within category "Blood Disorders"

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Suggestions within category "Blood Disorders"


12 Study Matches

A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

A study to confirm and expand information on safety and effectiveness of defibrotide compared to best standard care to prevent veno-occlusive disease of the liver in adult and pediatric transplant patients. This is a randomized study so patients will be selected by chance to be in either the group that receives defibrotide or the group that does not receive defibrotide.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02851407
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Inclusion Criteria:
Must be older than 1 month of age.
Scheduled for a stem cell transplant and be at high risk of veno-occlusive disease.
Be at high risk of veno-occlusive disease.
Exclusion Criteria:
Unstable blood pressure.
Episodes of bleeding.
Blood Disorders, Children's Health, Cancer
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Hershey, PA

Site for ATHN 10: Leveraging the ATHNdataset to Document the State of Rare Coagulation Disorders in the United States

This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).
Lisa Baker at lbaker@pennstatehealth.psu.edu or 717-531-7468
All
All
This study is NOT accepting healthy volunteers
N/A
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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

Gene-transfer, open-label, dose-escalation study of SPK-8011 [recombinant adeno-associated viral vector with B-domain deleted human factor VIII gene] in individuals with hemophilia A

Gene-transfer, open-label, dose-escalation study of SPK-8011 in individuals with hemophilia A. Primary Objective to evaluate the safety, tolerability and efficacy of SPK-8011 a recombinant adeno-associated viral vector with B-domain deleted human factor VIII gene.
Cynthia Campbell-Baird at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03003533
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Inclusion Criteria:
Hemophilia A
FVIII Level <1% or 1-2% with> 10 bleeds past 52 weeks or 1-2% on prophy treatment
Greater than 150 exposure days to Factor VIII concentrate or cryo
No evidence of Factor VIII Inhibitor
Acceptable lab values as defined by protocol
Exclusion Criteria:
Active Hep B or C &/or current antiviral therapy for Hep B or C
Significant underlying liver disease
HIV-1 or HIV-2 with CD4 count </=l to 200
Other investigational product in the past 12 weeks or gene therapy research within the past 52 weeks
Any other significant condition/disease that in the opinion of the investigator would make the subject unsuuitable
Blood Disorders
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Hershey, PA

Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) &lt; 6 years with severe hemophilia A (FVIII &lt; 1%)

Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) &lt; 6 years with severe hemophilia A (FVIII &lt; 1%)
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02615691
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Inclusion Criteria:
< 6 years old at the time of screening
previously untreated with < 3 EDs to ADVATE, BAX 855 or FFP any time prior to screening
severe hemophilia A (FVIII < 1%)
Exclusion Criteria:
History or current FVIII inhibitory antibodies (≥ 0.6 BU
Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A
Previously treated with cryo, PRBC, platelets or any type of FVIII concentrate other than ADVATE, BAX 855v or FFP
weight is < 5 kg
Platelet count < 100,000/mL; severe chronic hepatic dysfunction or severe renal impairment
Blood Disorders
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Hershey, PA

Optimizing Cord Blood and Haploidentical Aplastic Anemia Transplantation (CHAMP)

A study of the safety and effectiveness of an unrelated cord blood transplantation versus haploidentical transplantation for severe aplastic anemia.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02918292
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Inclusion Criteria:
A diagnosis of severe aplastic anemia.
Less than 75 years of age at time of enrollment.
Failed at least one trial of immunosuppressive therapy.
Exclusion Criteria:
Inherited bone marrow failure syndromes.
Diagnosis of myelodysplastic syndrome.
Prior allogeneic stem cell transplant or solid organ transplant.
Blood Disorders, Children's Health
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Hershey, PA

A prospective, multi-national, non-interventional study in haemophilia A and B patients with or without inhibitors treated according to routine clinical treatment practice (explorer™6)

A non-interventional study designed to prospectively collect comprehensive data on bleeding episodes and health-related quality of life as well as on physical activity in patients with severe congenital haemophilia A (HA) and B (HB), with or without inhibitors under routine local clinical practice, irrespective of the treatment regimen.
Male
All
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
age ≥ 12 years
Severe (< 1%) congenital hemophilia A or B with or without inhibitors
Pts with inhibitors treated on-demand: ≥ 6 treated (with bypassing agent) bleeding episodes within 24 wks of screening
Pts with severe congenital HA/HB treated on-demand: ≥ 5 treated (with factor product) bleeding episodes within 24 wks of screening
Pts with inhibitors treated with FEIBA prophylaxis: ≥ 2 treated bleeding episodes within 24 wks of screening
Exclusion Criteria:
Known or suspected hypersensitivity to monoclonal antibodies
Previous treatment with concizumabdefined as two or more doses administered.
Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
Current or planned treatment with emicizumab.
Any known congenital or acquired coagulation disorder other than congenital hemophilia.
Blood Disorders
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Hershey, PA

Dose-finding study of SPK-8016 gene therapy in patients with hemophilia A to support future evaluations in individuals with FVIII inhibitors.

SPK-8016-101 is a Phase 1/2a, open-label, non-randomized, dose-finding study designed to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with clinically severe hemophilia A and no measurable inhibitor against FVIII.
Cynthia Campbell-Baird, RN at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03734588
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Inclusion Criteria:
Clinically severe Hemophilia A
Previous exposure to FVIII therapy
Have >150 exposure days to any recombinant and/or plasma-derived FVIII concentrates
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:5
Blood Disorders
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Hershey, PA

A Multi-Center, Observational Study in Males with Hemophilia A

SPK-8011-301 is a prospective, multi-center, observational study to collect efficacy and selected safety data on frequency and type of bleeding episodes and FVIII prophylaxis replacement therapy in the usual care setting of adult males with clinically severe hemophilia A (i.e., ≤ 2% IU/dL FVIII activity level), who are negative for neutralizing antibody (Nab) to AAV-Spark200.
Cynthia Campbell-Baird, RN at cbaird@pennstatehealth.psu.edu or 717-531-5777
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03876301
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Inclusion Criteria:
Clinically severe Hemophilia A
Patients on prophylactic regimen > 2 months
Previous exposure to FVIII therapy
No history of hypersensitivity or anaphylaxis with any FVIII or IV immunoglobulin product
No measurable inhibitor against FVIII
Exclusion Criteria:
Active Hepatitis B or C within past 12 months
Current use of antiviral therapy to treat Hepatitis B or C
Documented significant liver disease
Serological evidence of HIV-1 or HIV-2
Anti-AAV-Spark neutralizing antibody titers >1:1
Blood Disorders
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Hershey, PA

Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia 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.
Male
All
This study is NOT accepting healthy volunteers
NCT04082429
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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

NASH Fitness Intervention for Thrombosis (NASHFit) Trial

Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise. The human genome and regulation of gene expression is influenced by physical activity. NAFLD is a prothrombotic state with derangements in all three phases of hemostasis leading to clinically important clotting events. Exercise can improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to answer the question “Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?” focusing initially on the at-risk population genetically susceptible to advanced disease.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03518294
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Inclusion Criteria:
Nonalcoholic fatty liver disease (NAFLD)
Evidence of hepatic steatosis by imaging
Exclusion Criteria:
>90 minutes/week of at least moderate intensity exercise over the previous three months
Pregnancy
Active cardiac symptoms
Uncontrolled diabetes (changes in medication dosing over the previous three months or hemoglobin A1c >9%)
Blood Disorders, Digestive Systems & Liver Disease, Sports Medicine
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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.
Male
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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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

An open-label, multinational study of fitusiran prophylaxis in male pediatric subjects aged 1 to less than 12 years with hemophilia A or B.

A study to confirm the appropriate dose of fitusiran when given to severe Hemophilia A or B patients with inhibitors between the ages of 1 and &lt;12 years old.
Male
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT03974113
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Inclusion Criteria:
Severe hemophilia A or B (FVIII <1% or FIX ≤2%)
Inhibitory antibodies to FVIII or FIX
Age 1 to <12 years
Exclusion Criteria:
AT activity <60% at screening
Co-existing thrombophilic disorder
Central or peripheral indwelling catheter, with a hx of venous access complications
Anticipated need of surgery during the study
Presence of clinically significant liver disease
Blood Disorders
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Hershey, PA