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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incremental recovery for Factor IX
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
December 2005
Primary Completion Date
April 2006
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: -
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT02250573
Organization ID
R9VFSUR
Responsible Party
Sponsor
Study Sponsor
Bio Products Laboratory
Study Sponsor
, ,
Verification Date
February 2018