NCT01086852

Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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: 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.

Detailed description

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.

Conditions

• Factor X Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	FACTOR X	Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg. Post surgery- FX trough levels of 50% should be achieved. Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-03-15
• Last updated: 2019-02-05
• Results posted: 2015-07-03

Locations

7 sites across 4 countries: United States, Spain, Turkey (Türkiye), United Kingdom