Clinical Trial: Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL's High Purity FACTOR X in the Treatment of Factor X Deficient Subjects Undergoing Surgery
Brief Summary:
To primary efficacy variable is to assess the presence or absence of excessive blood loss during and after surgery.
The secondary efficacy endpoints are as follows:
- A subjective overall assessment by the investigator of FACTOR X in the control of bleeding during surgery.
- The incidence of bleeding episodes during treatment with FACTOR X while the subject is at risk of post-operative bleeding, including location and duration.
- Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.
- Assessment of FX:C and FX:Ag levels on each day post-surgery.
- Assessment of the cumulative weight-adjusted doses of FACTOR X as measured by FX:C (IU/kg body weight) administered to each subject to maintain haemostasis.
- Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to each subject to maintain haemostasis.
- Amount of weight-adjusted FACTOR X as measured by FX:C (IU/kg body weight) administered daily (day of surgery and each post-operative day) to maintain haemostasis.