Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Octapharma

Status and phase: Completed; Phase 3

Conditions: Severe Hemophilia A

Treatments: Biological: Human cl rhFVIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712438

2012-002554-23 (EudraCT Number)

GENA-05

Details and patient eligibility

About

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

Enrollment: 110 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients
• Severe Hemophilia A (FVIII:C <1%)
• No previous treatment with FVIII concentrates or other blood products containing FVIII

Exclusion criteria

• Diagnosis with a coagulation disorder other than Hemophilia A
• Severe liver or kidney disease
• Concomitant treatment with any systemic immunosuppressive drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

Human cl rhFVIII

Experimental group

Treatment:

Biological: Human cl rhFVIII