Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery (Ten03)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The primary efficacy variable is the presence or absence of excessive blood loss during surgery. [ Time Frame: After surgery for each subject. ] [ Designated as safety issue: Yes ]
- A subjective overall assessment by the investigator of FACTOR X in the control of bleeding due to surgery throughout the whole study. [ Time Frame: This will assessed througout the study until discharge of the patient. ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: FACTOR X
Human Coagulation Factor X
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.
Other Name: FACTOR X
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.
|Contact: Miranda Norton, Dr||+44 (0)208 957 firstname.lastname@example.org|
|Contact: Kate Gillanders||+44 (0)208 957 email@example.com|
|United States, Texas|
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|Houston, Texas, United States, 77030|
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|Principal Investigator: Dr Miguel Escobar|
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|Madrid, Spain, 28046|
|Contact: Dr Theresa Alvarez + 34-91-207-1945 email@example.com|
|Principal Investigator: Dr Theresa Alvarez|
|Ege University School of Medicine, Departmant of Pediatric Hematology||Not yet recruiting|
|Bornova, Izmir, Turkey, 35100|
|Contact: Prof Kaan Kavakli + 90 232 390 10 17 firstname.lastname@example.org|
|Principal Investigator: Prof Kaan Kavakli|
|Istanbul University Cerrahpasa Medicine Faculty Department of Pediatric Hematology||Not yet recruiting|
|Istanbul, Turkey, 34098|
|Contact: Prof Tulin T Celkan + 90 212 414 3000 ext 21956 email@example.com|
|Principal Investigator: Prof Tulin Celkan|
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|Truro, Cornwall, United Kingdom, TR1 3LJ|
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|Principal Investigator: Dr Desmond Creagh|
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|Hampstead, London, United Kingdom, NW3 2QG|
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|Principal Investigator: Dr Carolyn Millar, MBBS, BSc, MD,FRCPath, MRCP|
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