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Suggestions within category "Blood Disorders"


Study matches: 5

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.


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
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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.
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NCT02851407
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Location
Hershey, PA

A Phase 1/2a, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics Profile of a Long-Acting Recombinant Factor VIIa (MOD-5014) in Adult Men with Hemophilia A or B

Dose escalation study of a MOD-5014, an extended half life recombinant factor VIIa, in adult males with hemophilia A or B
Bree Kelly at jhawthorne@pennstatehealth.psu.edu or 717-531-0003 (Ext 281498)
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Men, 18-65 years of age, inclusive, at the screening visit
Moderate or severe congenital Hemophilia A or B, </= 3% FVIII or FIX levels, with or without inhibitors
Body Mass Index (BMI) less than 35.0 kg/m2
Adequate venous access
Exclusion Criteria:
Participated in any study with investigation product within the last 3 months
Coagulation disorder other than Hemophilia A or B.
History of arterial and/or venous thromboembolic events
History or current drug/alcohol abuse
Treated with long-acting Factor VIII or IX with >3% normal factor levels prior to study entery
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NCT02418793
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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
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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
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NCT03003533
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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%)
Bree Kelly at jhawthorne@pennstatehealth.psu.edu or 717-531-0003 (Ext 281498)
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
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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
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NCT02615691
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Location
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
Not specified
This study is NOT accepting healthy volunteers
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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.
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NCT02918292
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Location
Hershey, PA