Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)

Octapharma

Status and phase: Completed; Phase 3

Conditions: Severe Hemophilia A

Treatments: Biological: Human-cl rhFVIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01341912

GENA-11

Details and patient eligibility

About

The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.

Enrollment: 3 patients

Sex: Male

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of GENA-01 study with at least 50 Exposure Days (EDs) and at least 6 months study participation and immediate enrollment into GENA-11

Exclusion criteria

• Development of FVIII inhibitors (<=0.6 BU), during the course of the GENA-01 study
• Development of any severe liver or kidney disease (ALT and AST level > 5 times of upper limit of normal, creatine >120 micro mol/L) during the course of the GENA-01 study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Human-cl rhFVIII

Experimental group

Description:

Recombinant FVIII derived from a human cell line.

Treatment:

Biological: Human-cl rhFVIII