Overview

This trial is active, not recruiting.

Condition severe hemophilia a
Treatment human cl rhfviii
Phase phase 3
Sponsor Octapharma
Start date February 2013
End date December 2018
Trial size 110 participants
Trial identifier NCT01712438, 2012-002554-23, GENA-05

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
human cl rhfviii

Primary Outcomes

Measure
Immunogenicity
time frame: maximum 5 years (100 exposure days)

Secondary Outcomes

Measure
Efficacy
time frame: Maximum 5 years (100 exposure days)

Eligibility Criteria

Male participants of any age.

Inclusion Criteria: - Male patients - Severe Hemophilia A (FVIII:C <1%) - No previous treatment with with FVIII concentrates or other blood prodcuts 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

Additional Information

Official title Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Octapharma.