Phase 3 Completed N=36 Prevention

Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A

Source: ClinicalTrials.gov NCT01125813 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Apr 2013

Primary outcomePrimary: 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

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.