A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
- Conditions
- Haemophilia B
- Registration Number
- NCT02250560
- Lead Sponsor
- Bio Products Laboratory
- 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 patients with haemophilia B undergoing major surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of control of prevention of bleeding End of study (Day 5 to Day 10) Investigator's assessment as excellent, good, moderate or none.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
🇬🇧Basingstoke, United Kingdom
Haemophilia Centre, The Royal London Hospital, White Chapel
🇬🇧London, United Kingdom
Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
🇬🇧London, United Kingdom
Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
🇬🇧Manchester, United Kingdom
Haemophilia Centre, Southampton General Hospital, Tremona Road
🇬🇧Southampton, United Kingdom
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road🇬🇧Basingstoke, United Kingdom