Phase 3
N=36
Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A
Severe Hemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT01125813 ↗Enrolled (actual)
36
Serious AEs
6.3%
Results posted
Apr 2013
Primary outcome: Primary: Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months — 0.188 Bleeds per month
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- recombinant Factor VIII (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Male
- Sponsor
- Octapharma
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months |
0.188 | — |
| PRIMARY Efficacy of Treating Bleeding Episodes |
71.4; 28.6 | — |
Summary
This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.
Eligibility Criteria
Inclusion Criteria
- Severe hemophilia A ((FVIII: C = 12 years of age
- Previously treated with FVIII concentrate, at least 50 EDs
- Immunocompetent (CD4+ count > 200/ul)
- Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL
Exclusion Criteria
- Other coagulation disorder than hemophilia A
- Present of past FVIII inhibitor activity (.= 0.6 BU)
- Severe liver and kidney disease
- Receiving of scheduled to receive immuno-modulating drugs
Data sourced from ClinicalTrials.gov (NCT01125813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.