Status:
TERMINATED
Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Severe Hemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this pilot R34 trial is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly recombinant factor V...
Detailed Description
The purpose of this 52-week pilot R34 randomized, open-label, non-inferiority, cross-over study is to determine the feasibility of a large single dose Phase III study of hemophilia adult prophylaxis. ...
Eligibility Criteria
Inclusion
- Adult males 18 years or older
- Severe hemophilia A (F.VIII \< 0.01 U/ml)
- At least 150 exposure days to F.VIII products
- No detectable inhibitor
- No history of allergic reaction
- Platelets at least 150,000/ul
- If HIV(+), CD4 at least 200/ul, HIV-VL \<48 copies/ml,and cART compliant
- If HCV(+), no splenomegaly,varices,GI bleed,ascites,edema,encephalopathy
- Willingness to comply with cross-over design, randomization schema
- Willingness to keep a personal diary of bleeding frequency and factor use
- Willingness to make every 3 month visits, coagulation testing at wks 2, 28
Exclusion
- Acquired hemophilia
- Any bleeding disorder other than hemophilia A
- Presence of an inhibitor to factor VIII
- Historic platelet count \< 100,000
- Use of experimental drugs
- Surgery anticipate in the next 52 weeks
- Symptomatic HCV(splenomegaly,varices,GI bleed,ascites,edema,encephalopathy)
- Symptomatic HIV(CD4\<200/ul or HIV VL 48 or more copy/ml,cART noncompliant)
- Life expectancy less than 5 years
- Investigational drug or study within 4 weeks prior to study
- Inability to comply with study requirements
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01405742
Start Date
July 1 2012
End Date
November 1 2013
Last Update
October 7 2016
Active Locations (6)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20057-1168
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4206
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
4
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213-4306