Clinical Trial: Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Multicentre, Double-blinded, Randomised, Cross-over Study to Evaluate Efficacy, Safety and Pharmacokinetics of Biostate® in Subjects With Haemophilia A.
Brief 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].
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome:
- Haemostatic efficacy [ Time Frame: Monthly, until final study visit ]
- Number of treatments/units required to resolve any bleeding event [ Time Frame: From Day 1 until final study visit ]
- FVIII concentrate usage (number of infusions, IU/kg per event, per month, and per year) [ Time Frame: From Day 1 until final study visit ]
- Assessment of blood loss during any surgical procedure [ Time Frame: From Day 1 until final study visit ]
- Pharmacokinetics of FVIII activity [ Time Frame: Up to 48 hours following infusions (Part 1 and Part 3 only) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The nature, frequency and incidence of adverse events [ Time Frame: From Day 1 until final study visit ]
- Development of FVIII inhibitors [ Time Frame: From Day 1 until final study visit ]
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: April 9, 2009
Date Started: February 2009
Date Completion:
Last Updated: February 10, 2011
Last Verified: February 2011