A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.

Bio Products Laboratory

Status and phase

Completed

Phase 3

Conditions

Von Willebrand Disease

Treatments

Biological: Optivate® (Human Coagulation Factor VIII)

Study type

Interventional

Funder types

Other

Identifiers

NCT02246881

8VWFPK

Details and patient eligibility

About

The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Previously treated subjects with severe Haemophilia A (<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.

Exclusion criteria