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

A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250508

Enrollment

Unknown

Registered

2014-09-26

Start date

2004-12-31

Completion date

Unknown

Last updated

2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vonWillebrand's Disease

Brief summary

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.

Interventions

BIOLOGICALOptivate® (Human Coagulation Factor VIII)

BIOLOGICALHaemate P® (Human Coagulation Factor VIII)

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
AUC (0-48h) for VWF: RCo	Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026