EUCTR2010-018644-14-AT
Active, Not Recruiting
N/A
PROSPECTIVE CLINICAL STUDY IN CHILDREN WITH SEVERE HAEMOPHILIA A TO INVESTIGATE CLINICAL EFFICACY, IMMUNOGENICITY, PHARMACOKINETICS, AND SAFETY OF HUMAN-CL RHFVIII
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Severe Haemophilia A
- Sponsor
- Octapharma AG
- Enrollment
- 60
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified
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