A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

Bio Products Laboratory

Status and phase: Completed; Phase 2

Conditions: vonWillebrand's Disease

Treatments: Biological: Optivate® (Human Coagulation Factor VIII); Biological: Haemate P® (Human Coagulation Factor VIII)

Study type: Interventional

Funder types: Other

Identifiers

NCT02250508

8VWF04

Details and patient eligibility

About

The main objectives of the study were

• to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
• to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.

Exclusion criteria

Trial design

0 participants in 2 patient groups

Optivate®

Experimental group

Treatment:

Biological: Optivate® (Human Coagulation Factor VIII)

Haemate P®

Active Comparator group

Treatment:

Biological: Haemate P® (Human Coagulation Factor VIII)