Trials / Completed
CompletedNCT02231944
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replenine®-VF (High Purity Factor IX) |
Timeline
- Start date
- 1997-07-01
- Primary completion
- 2003-10-01
- First posted
- 2014-09-04
- Last updated
- 2018-02-22
Locations
7 sites across 2 countries: Poland, United Kingdom
Source: ClinicalTrials.gov record NCT02231944. Inclusion in this directory is not an endorsement.