Brief Title
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
Official Title
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
Brief Summary
To compare the first and second recovery assessments on Replenine®-VF and to evaluate recovery of different batches if patients changed batches during the study. To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
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
July 1997
Primary Completion Date
October 2003
Eligibility Criteria
Inclusion Criteria: - Previously treated patients - At least 12 years of age - Severe Haemophilia B and without inhibitor to factor IX Exclusion Criteria: -
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT02231944
Organization ID
R9VFSE
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
February 2018