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

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

vonWillebrand's Disease

Interventions

Optivate® (Human Coagulation Factor VIII)BIOLOGICAL

Haemate P® (Human Coagulation Factor VIII)BIOLOGICAL

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Hematology Dept., Sackler School of Medicine, Tel Aviv University

Tel Aviv, Israel

Outcomes

Primary Outcomes

AUC (0-48h) for VWF: RCo

Time frame: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose

Data from ClinicalTrials.gov

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