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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01405742 |
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Date of registration:
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25/07/2011 |
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Primary sponsor: |
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Public title:
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Hemophilia Adult Prophylaxis Study
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Scientific title:
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R34 Pilot Feasibility Randomized, Noninferiority, Cross-Over Trial of Once-Weekly vs. Thrice-Weekly Prophylaxis With Recombinant Factor VIII in Adults With Severe Hemophilia A |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01405742 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Margaret V. Ragni, MD, MPH |
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Address:
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Telephone:
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412-209-7288 |
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Email:
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ragni@dom.pitt.edu |
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Affiliation:
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Name:
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Margaret V. Ragni, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Severe Hemophilia A
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Intervention(s)
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Drug: Recombinant factor VIII
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Primary Outcome(s)
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The primary outcome measure is bleeding frequency.
[Time Frame: The time frame is 52 weeks per subject.]
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Secondary Outcome(s)
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A secondary outcome is inter-dose hypocoagulability by thrombin generation.
[Time Frame: The time frame is 52 weeks per subject.]
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A secondary outcome measure is F.VIII and inhibitor formation.
[Time Frame: The time frame is 52 weeks per subject.]
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A secondary outcome measure is factor usage and cost.
[Time Frame: The time frame is 52 weeks per subject.]
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A secondary outcomes is joint range of motion.
[Time Frame: The time frame is 52 weeks per subject.]
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Secondary ID(s)
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PRO10020178
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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