Data Collection to Investigate compassionate use with FACTOR X
Research type
Research Study
Full title
A Multicenter, Retrospective Data Collection Study on the Use of BPL’s High Purity Factor X in the Treatment of Patients with Hereditary Factor X Deficiency: Ten05
IRAS ID
185865
Contact name
Lisa Wilson
Contact email
Sponsor organisation
Bio Products Labarotory Limited
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Retrospective data will be collected from patients who have received Factor X on a compassionate use basis in patients with hereditary factor X deficiency. Some of these patients have been on Factor X compassionate use for over 3 years and data from such long term use will add significantly to the clinical knowledge of FACTOR X and may enhance the knowledge pertaining to the clinical effectiveness and safety of FACTOR X use in relation preventing bleeding episodes, use during routine prophylaxis or usefulness in the management of routine surgery or in the short term prevention prior to increased physical activity.
The primary reason for the retrospective data collection is for publication purposes on the long term prophylaxis use of Factor X.
Patients who have received at least one dose of FACTOR X on compassionate use and who have not used other concurrent factor x treatment will be eligible. Patients enrolled into the study may have been treated with FACTOR X on a compassionate use basis having completed a BPL FACTOR X study. Following consent, no additional patient visits will be required.
REC name
Wales REC 7
REC reference
15/WA/0408
Date of REC Opinion
4 Nov 2015
REC opinion
Favourable Opinion