An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
Phase 1
- Conditions
- Hemophilia ASevere hemophilia AMedDRA version: 17.0Level: 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-ES
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 246
Inclusion Criteria
? 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
Exclusion Criteria
? 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
- Secondary Outcome Measures
Name Time Method