Back to resultsA Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
Primary Purpose
Haemophilia B
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Replenine®-VF (High Purity Factor IX)
Sponsored by
About this trial
This is an interventional trial for Haemophilia B
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:
-
Sites / Locations
- North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
- Haemophilia Centre, The Royal London Hospital, White Chapel
- Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
- Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
- Haemophilia Centre, Southampton General Hospital, Tremona Road
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Replenine®-VF
Arm Description
Outcomes
Primary Outcome Measures
Assessment of control of prevention of bleeding
Investigator's assessment as excellent, good, moderate or none.
Secondary Outcome Measures
Full Information
NCT ID
NCT02250560
First Posted
September 2, 2014
Last Updated
February 19, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02250560
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia B
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Replenine®-VF
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Replenine®-VF (High Purity Factor IX)
Primary Outcome Measure Information:
Title
Assessment of control of prevention of bleeding
Description
Investigator's assessment as excellent, good, moderate or none.
Time Frame
End of study (Day 5 to Day 10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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:
-
Facility Information:
Facility Name
North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Haemophilia Centre, The Royal London Hospital, White Chapel
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Haemophilia Centre, Southampton General Hospital, Tremona Road
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
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