NCT00879541

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

A Phase II, Multicentre, Double-blinded, Randomised, Cross-over Study to Evaluate Efficacy, Safety and Pharmacokinetics of Biostate® in Subjects With Haemophilia A.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

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® \[SP\].

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Biostate® [SP]	Single bolus intravenous dose of 50 IU/kg
BIOLOGICAL	Biostate® [SP]	The dose is dependent on the reason for use and may consist of repeated bolus doses as required to manage haemophilia condition.
BIOLOGICAL	Biostate® [RP]	Single bolus intravenous dose of 50 IU/kg.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-04-10
• Last updated: 2011-02-11

Locations

14 sites across 4 countries: Bulgaria, North Macedonia, Poland, Russia