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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

Page last updated: August 20, 2015

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