Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

Octapharma

Status and phase: Completed; Phase 2

Conditions: Hemophilia A

Treatments: Biological: Kogenate FS; Biological: Human-cl rhFVIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989196

GENA-01

Details and patient eligibility

About

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Enrollment: 22 patients

Sex: Male

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe hemophilia A (FVIII:C <= 1%)
• Male subjects between 12 and 65 years of age
• Body weight 25 kg to 110 kg
• Previously treated with FVIII concentrate for at least 150 EDs

Exclusion criteria

• Other coagulation disorder than hemophilia A
• Present or past FVIII inhibitor activity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Human-cl rhFVIII

Experimental group

Treatment:

Biological: Human-cl rhFVIII

Kogenate FS

Active Comparator group

Treatment:

Biological: Kogenate FS