A Study to Investigate the Safety and Efficacy of Replenine�-VF in Haemophilia B Patients Undergoing Major Surgery.
Information source: Bio Products Laboratory
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Haemophilia B
Intervention: Replenine®-VF (High Purity Factor IX) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Bio Products Laboratory
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.
Clinical Details
Official title: An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
Study design: N/A
Primary outcome: Assessment of control of prevention of bleeding
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
-
Locations and Contacts
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road, Basingstoke RG24 9NA, United Kingdom
Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street, London NW3 2QG, United Kingdom
Haemophilia Centre, The Royal London Hospital, White Chapel, London E1 1BB, United Kingdom
Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, United Kingdom
Haemophilia Centre, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, United Kingdom
Additional Information
Starting date: April 2000
Last updated: September 24, 2014
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