A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.

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

NCT02246894

8VWF05

Details and patient eligibility

About

The main objectives of this study are:

• to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
• to assess clinical outcome when treating a bleed with Optivate®.
• to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
• to assess FVIII inhibitor development during the study.

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.

Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.

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)