Clinical Trial: A Study Investigating Treatment Factor X in People With Factor X Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Defici

Brief Summary:

The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg.

The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.

Detailed Summary:
Sponsor: Bio Products Laboratory

Current Primary Outcome:

• FX:C Incremental Recovery [ Time Frame: At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose) ]

  Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).

  Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment

• FX:C Half-life [ Time Frame: At Baseline and at 6 months post-Baseline ]
  Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment

Original Primary Outcome: Pharmacokinetic parameters for FACTOR X:Concentrate at the Baseline Visit and the repeat Pharmacokinetic assessment (usually at the 6 month visit) [ Time Frame: maximum study duration of study treatment (excluding the screening period) for each subject is 2 years. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bio Products Laboratory

Dates:
Date Received: June 10, 2009
Date Started: January 2010
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014