Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

Octapharma

Status and phase: Completed; Phase 3

Conditions: Severe Hemophilia A

Treatments: Biological: Human-cl rhFVIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992549

GENA-15

Details and patient eligibility

About

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

Enrollment: 48 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who completed GENA-05 in accordance with the study protocol

Exclusion criteria

1. Severe liver or kidney disease
2. Concomitant treatment with any systemic immunosuppressive drug;
3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Human-cl rhFVIII

Experimental group

Treatment:

Biological: Human-cl rhFVIII