Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A

Status Completed

Clinical Trial Summary

The aim of this study are to

- assess the efficacy of Biostate® [Study Product (SP)] in subjects with Haemophilia A

- compare the pharmacokinetics of Biostate® [SP] with the previously marketed product Biostate® (here referred to as Biostate® [Reference Product (RP)]).

This study is divided into 3 parts:

Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to determine the order in which they receive the two study products. This part of the study is double-blinded.

Part 2: Efficacy component. All subjects will receive Biostate® [SP] as required to manage their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure days) to assess efficacy and safety of the product. This part of the study is open-label.

Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component) will undergo a repeat PK assessment on Day 180 following administration of Biostate® [SP].

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Hemophilia A

Clinical Trial Details

NCT number	NCT00879541
Study type	Interventional
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 2
Start date	February 2009
Completion date	October 2010

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