NCT00930176

A Study Investigating Treatment Factor X in People With Factor X Deficiency

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 Deficiency.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Factor X Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Human Coagulation FACTOR X	Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-06-30
• Last updated: 2014-12-12
• Results posted: 2014-12-12

Locations

14 sites across 5 countries: United States, Germany, Spain, Turkey (Türkiye), United Kingdom