PROSPECTIVE CLINICAL STUDY IN CHILDREN WITH SEVERE HAEMOPHILIA A TO INVESTIGATE CLINICAL EFFICACY, IMMUNOGENICITY, PHARMACOKINETICS, AND SAFETY OF HUMAN-CL RHFVIII
- Conditions
- Severe Haemophilia AMedDRA version: 12.1Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)
- Registration Number
- EUCTR2010-018644-14-CZ
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 60
? Severe haemophilia A (FVIII:C < 1%)
? Age >= 2 and < 13
? Previously treated with FVIII concentrate, at least 50 EDs
? Immunocompetence (CD4+ count >200/ µL)
? HIV negative or respective viral load < 200 particles/µL or <400,000 copies/ml
? Freely given written informed consent by parents or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
? Other coagulation disorder than haemophilia A
? Present or past FVIII inhibitor activity (= 0.6 BU)
? Target joints
? Severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L)
? Receipt or scheduled receipt of immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (>10 mg/day), or comparable drugs
? Current participation in another clinical study
? Participation in another interventional clinical study with administration of investigational medical product (IMP) in the course of the past 3 months, except studies investigating already registered FVIII products
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