An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
NCT02250573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2018-02-22
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.
Conditions
- Haemophilia B
Interventions
- BIOLOGICAL
-
Replenine®-VF (High Purity Factor IX)
Sponsors & Collaborators
-
Bio Products Laboratory
lead OTHER
Study Design
- Purpose
- TREATMENT
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-12-31
- Primary Completion
- 2006-04-30
Countries
- Poland
- Romania
- Russia
Study Locations
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