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

Octapharma

Status and phase: Completed; Phase 3

Conditions: Severe Hemophilia A

Treatments: Biological: recombinant Factor VIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125813

GENA-08

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe hemophilia A ((FVIII:C <= 1%)
• Male subjects >= 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

human cl-rhFVIII

Experimental group

Treatment:

Biological: recombinant Factor VIII