Trials / Completed
CompletedNCT02263456
A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, 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
The purpose of this study is: * to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg. * to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches. * to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Replenine®-VF (High Purity Factor IX) |
Timeline
- Start date
- 1997-07-01
- Primary completion
- 2001-09-01
- First posted
- 2014-10-13
- Last updated
- 2014-10-13
Locations
7 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02263456. Inclusion in this directory is not an endorsement.