Trials / Completed
CompletedNCT02250573
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery
An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replenine®-VF (High Purity Factor IX) |
Timeline
- Start date
- 2005-12-01
- Primary completion
- 2006-04-01
- First posted
- 2014-09-26
- Last updated
- 2018-02-22
Locations
5 sites across 3 countries: Poland, Romania, Russia
Source: ClinicalTrials.gov record NCT02250573. Inclusion in this directory is not an endorsement.