Haemophilia B Clinical Trial
Official title:
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
| NCT number | NCT02250560 |
| Other study ID # | R9VFCIMS |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | February 19, 2018 |
| Start date | April 2000 |
| Verified date | August 2014 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | November 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road | Basingstoke | |
| United Kingdom | Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street | London | |
| United Kingdom | Haemophilia Centre, The Royal London Hospital, White Chapel | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of control of prevention of bleeding | Investigator's assessment as excellent, good, moderate or none. | End of study (Day 5 to Day 10) |
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