An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

Bio Products Laboratory

Status and phase: Completed; Phase 3

Conditions: Haemophilia A

Treatments: Biological: Optivate® (Human Coagulation Factor VIII)

Study type: Interventional

Funder types: Other

Identifiers

NCT02246868

8VWFSE

Details and patient eligibility

About

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion criteria

Trial design

0 participants in 1 patient group

Optivate®

Experimental group

Description:

Optivate® (Human Coagulation Factor VIII)

Treatment:

Biological: Optivate® (Human Coagulation Factor VIII)