Status:
COMPLETED
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Hemophilia A
Eligibility:
MALE
12-24 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we ...
Detailed Description
Hemophilia is an important and costly disorder; if left untreated, it may have serious consequences. The greatest impact of hemophilia occurs from recurrent bleeding into joints. The consequences of j...
Eligibility Criteria
Inclusion
- Severe hemophilia A (\<1% factor VIII)
- Age 12 to 24 years inclusive
- Male
- No current factor VIII inhibitor (an inhibitor will be defined as ≥ 0.6 Bethesda Units) within the past year
- Able to participate in a home infusion program with adequate peripheral venous access as assessed ny the treating investigator
Exclusion
- Important co-morbidities (Acquired Immunodeficiency Syndrome or symptomatic HIV infection, symptomatic hepatitis B or C infection)
- Other concomitant acquired or congenital bleeding disorder (e.g. von Willebrand's Disease)
- Receiving factor VIII replacement through central venous catheter
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00717626
Start Date
July 1 2008
End Date
April 1 2011
Last Update
October 8 2020
Active Locations (3)
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1
St. Michael's Hospital
Toronto, Ontario, Canada
2
The Hospital for Sick Children
Toronto, Ontario, Canada
3
Hospital Sainte-Justine
Montreal, Quebec, Canada