Trials / Completed
CompletedNCT02250560
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF administered by continuous infusion in appropriate dosage to prevent bleeding and achieve haemostasis in patients with haemophilia B undergoing major surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replenine®-VF (High Purity Factor IX) |
Timeline
- Start date
- 2000-04-01
- Primary completion
- 2003-11-01
- First posted
- 2014-09-26
- Last updated
- 2018-02-22
Locations
5 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02250560. Inclusion in this directory is not an endorsement.