Back to resultsA Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
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 trial for Haemophilia B
Eligibility Criteria
Inclusion Criteria:
- Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.
Exclusion Criteria:
-
Sites / Locations
- Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
- Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
- Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
- Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Replenine®-VF
Arm Description
Outcomes
Primary Outcome Measures
Amount of Factor IX Administered per Month (IU/KG)
Secondary Outcome Measures
Full Information
NCT ID
NCT02263469
First Posted
September 2, 2014
Last Updated
October 9, 2014
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02263469
Brief Title
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Under the Age of 6 Years
Official Title
An Open Multi-centre Phase III Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients Under the Age of 6 Years
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 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 objective of this study was to assess the safety and efficacy of Replenine®-VF in children enrolled in the study, under the age of six years, with severe haemophilia B.
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
Amount of Factor IX Administered per Month (IU/KG)
Time Frame
26 Weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients under six years of age at the time of entry with severe Haemophilia B at the time of diagnosis without inhibitors to FIX and requiring Factor IX therapy.
Exclusion Criteria:
-
Facility Information:
Facility Name
Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Oddzial Pediatrii, Hematologii I Onkologii, ul. Marszalkowska 24, 00-576
City
Warsaw
Country
Poland
Facility Name
Institute of Urgent and Recovery Surgery, Academy of Medical Science of Ukraine, Leninski Avenue
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Institute of Haematology and Transfusiology, Academy of Medical Science of Ukrainem Berlynskogo Str.
City
Kiev
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine, Academy of Medical Science of Ukraine, Gen. Chuprynkea Str.
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
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 Under the Age of 6 Years
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