Factor X Deficiency Clinical Trial
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
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:
1. A subjective overall assessment by the investigator of FACTOR X in the control of
bleeding during surgery.
2. The incidence of bleeding episodes during treatment with FACTOR X while the subject is
at risk of post-operative bleeding, including location and duration.
3. Incremental recovery of FX:C and FX:Ag after the pre-surgery bolus infusion.
4. Assessment of FX:C and FX:Ag levels on each day post-surgery.
5. 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.
6. Assessment of the cumulative doses of FACTOR X as measured by FX:C (IU) administered to
each subject to maintain haemostasis.
7. 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.
To investigate the safety and efficacy of FACTOR X administered by bolus infusion to prevent bleeding and achieve haemostasis in factor X deficient subjects undergoing surgery. ;
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