Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01
- Conditions
- Severe haemophilia A (FVIII:C <1%)MedDRA version: 12.1Level: LLTClassification code 10018937Term: Haemophilia A
- Registration Number
- EUCTR2010-023242-69-DE
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 25
Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrolment into GENA-11.
Voluntarily given, fully informed written and signed consent obtained before any study-related procedures are conducted.
Patient must be capable to understand and comply with the relevant aspects of the study protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Development of FVIII inhibitors (=0.6 BU), during the course of the GENA-01 study.
Development of any severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L) during the course of the GENA-01 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