Back to resultsAn Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
Primary Purpose
Haemophilia B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Replenine®-VF (High Purity Factor IX)
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia B
Eligibility Criteria
Inclusion Criteria:
- Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.
Exclusion Criteria:
-
Sites / Locations
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
- Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
- Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
- Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
- Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Replenine®-VF
Arm Description
Outcomes
Primary Outcome Measures
Incremental recovery for Factor IX
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
Secondary Outcome Measures
Full Information
NCT ID
NCT02250573
First Posted
September 2, 2014
Last Updated
February 20, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02250573
Brief Title
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
Official Title
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2006 (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 objectives of this study were to investigate the safety and efficacy of Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and achieve haemostasis in subjects with haemophilia B undergoing 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
Primary Purpose
Treatment
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
Incremental recovery for Factor IX
Description
Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
Time Frame
90 min post-dose
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with moderate to severe haemophilia B undergoing major surgery requiring an in-patient stay of generally 5 to 10 days.
Exclusion Criteria:
-
Facility Information:
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.
City
Poznan
ZIP/Postal Code
61-825
Country
Poland
Facility Name
Institutul National de Haemtologie, 2-8 Constantin Caracas Str.
City
Bucharest
Country
Romania
Facility Name
Spitalul de urgenta pentru copii "Louis Turcana", Str. losef Nemoianu 2.
City
Timisoara
Country
Romania
Facility Name
Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
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