Brief Title
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
Official Title
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Assessment of control of prevention of bleeding
Condition
Haemophilia B
Intervention
Replenine®-VF (High Purity Factor IX)
Study Arms / Comparison Groups
Replenine®-VF
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
April 2000
Primary Completion Date
November 2003
Eligibility 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: -
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02250560
Organization ID
R9VFCIMS
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
August 2014