EUCTR2008-001563-11-BGActive, not recruitingNot Applicable
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A.
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Octapharma AG
- Enrollment
- 22
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •Must have severe hemophilia A (FVIII:C <1%).
- •Male subjects greater/equal 12 and less or equal than 65 years of age.
- •Body weight 25 kg to 110 kg.
- •Previously treated with FVIII concentrate, at least 150 EDs.
- •Immunocompetent (CD4+ count >200/µL)
- •Negative for anti-HIV; if positive, viral load <200 particles/µL or <400,000 copies/mL.
- •Freely given written informed consent.
- •Are the trial subjects under 18? no
- •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 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Other coagulation disorder than hemophilia A.
- •Present or past FVIII inhibitor activity (>0.6 BU).
- •Severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L).
- •Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs.
- •Participation in another interventional clinical study currently or during the past month.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2016-003681-34-PLOctapharma AG55
Active, not recruiting
Phase 1
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2016-003681-34-BGOctapharma AG55
Active, not recruiting
Phase 1
Study to Investigate the product Wilate in Patients with Severe Hemophilia ASevere hemophilia A (<1% FVIII:C)MedDRA version: 19.1Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850EUCTR2016-003681-34-HUOctapharma AG55
Active, not recruiting
Not Applicable
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A.Severe hemophilia A (FVIII:C <1%)EUCTR2008-001563-11-DEOctapharma AG25
Completed
Not Applicable
Clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII in previously treated patients with severe haemophilia ASevere haemophilia AHaematological DisordersHereditary factor VIII deficiencyISRCTN87293301Octapharma AG (Switzerland)20