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

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

NCT02250482

8VWF02

Details and patient eligibility

About

The main objective of the study is to investigate the safety and efficacy of Optivate®, administered in appropriate dosage to present bleeding and achieve haemostasis in patients with Haemophilia A undergoing surgery.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Haemophilia A, at least 12 years of age, due to undergo surgery and have a lifetime exposure of at least 20 exposures to a FVIII concentrate.

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)