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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Amount of Factor IX Administered per Month (IU/KG)
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
August 2005
Primary Completion Date
July 2006
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: -
Gender
All
Ages
N/A - 6 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT02263469
Organization ID
R9VF03
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
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Verification Date
August 2014