Status:
COMPLETED
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Lead Sponsor:
Octapharma
Conditions:
Severe Haemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between dose...
Eligibility Criteria
Inclusion
- Severe Haemophilia A (FVIII:C \< 1%)
- Male patients \>= 18 years of age
- Previous treatment with a FVIII concentrate for at least 150 EDs
- Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
- Immunocompetence (CD4+ count \> 200/uL)
Exclusion
- Any coagulation disorder other than Haemophilia A
- Present of past FVIII inhibitor activity
- Severe liver or kidney disease
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02256917
Start Date
May 1 2015
End Date
September 1 2018
Last Update
January 19 2021
Active Locations (30)
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1
Octapharma Research Site
Sacramento, California, United States, 95817
2
Octapharma Research Site
Aurora, Colorado, United States, 80045
3
Octapharma Research Site
Washington D.C., District of Columbia, United States, 20057
4
Octapharma Research Site
Miami, Florida, United States, 33136