A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.

Bio Products Laboratory

Overview

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.

Study Type

INTERVENTIONAL

Conditions

Haemophilia B

Interventions

Replenine®-VF (High Purity Factor IX)BIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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 (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

Outcomes

Primary Outcomes

Assessment of control of prevention of bleeding

Investigator's assessment as excellent, good, moderate or none.

Time frame: End of study (Day 5 to Day 10)

Data from ClinicalTrials.gov

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