An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
- Conditions
- Hemophilia ASevere hemophilia AMedDRA version: 16.1Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2013-003262-13-IT
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 200
• Males of any age who have been diagnosed with severe hemophilia A (FVIII activity levels < 1%)
• Participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
• Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
• Currently receiving a therapy not permitted during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the safety of long term use of rVIII-SingleChain;Secondary Objective: The secondary objectives of the study are:<br>• To measure the incidence rate of inhibitor formation to FVIII after 10 EDs and after 50 EDs<br>• To collect and evaluate additional efficacy information on the prophylaxis and treatment of bleeding events<br>• To assess the hemostatic efficacy of rVIII-SingleChain for subjects who undergo surgery<br>• To characterize the safety profile of rVIII-SingleChain;Primary end point(s): The primary outcome measure is the incidence rate of inhibitor formation to FVIII over 100 EDs.;Timepoint(s) of evaluation of this end point: At the closest visit after 100 EDs (up to three years). <br>
- Secondary Outcome Measures
Name Time Method
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