Status:
COMPLETED
Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A
Lead Sponsor:
Octapharma
Conditions:
Severe Haemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Hu...
Detailed Description
There were 3 phases in this study: (1) An initial pharmacokinetic (PK) assessment in which participants received a single infusion of 60±5 IU/kg of Human-cl rhFVIII; blood samples were collected for 7...
Eligibility Criteria
Inclusion
- Severe haemophilia A (FVIII:C \< 1%) according to medical history.
- Male patients ≥ 18 years old.
- Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 exposure days (EDs).
- Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start.
- Immunocompetence (CD4+ count \> 200/microliter).
- HIV-negative, if positive, viral load \< 200 particles/microliter or \< 400,000 copies/mL.
- Freely given written informed consent
Exclusion
- Any coagulation disorder other than haemophilia A.
- Present or past FVIII inhibitor activity (\> 0.6 Bethesda Unit \[BU\])
- Severe liver or kidney disease.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01863758
Start Date
August 1 2013
End Date
January 1 2015
Last Update
January 30 2018
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University Vienna
Vienna, Austria
2
University Multiprofile Hospital for Active Treatment
Plovdiv, Bulgaria
3
Specialized Hospital for Active Treatment
Sofia, Bulgaria
4
Multiprofile Hospital for Active Treatment
Varna, Bulgaria