Status:
COMPLETED
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
Lead Sponsor:
Bio Products Laboratory
Conditions:
Haemophilia B
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in pati...
Eligibility Criteria
Inclusion
- Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to undergo major surgery, previously treated patients, at least 16 years of age without inhibitors, currently receiving Factor IX concentrate.
Exclusion
- \-
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02250560
Start Date
April 1 2000
Last Update
February 22 2018
Active Locations (5)
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1
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
Basingstoke, United Kingdom, RG24 9NA
2
Haemophilia Centre, The Royal London Hospital, White Chapel
London, United Kingdom, E1 1BB
3
Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
London, United Kingdom, NW3 2QG
4
Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
Manchester, United Kingdom, M13 9WL