Trials / Completed
CompletedNCT01721681
A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years
A Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL's High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Bio Products Laboratory · Academic / Other
- Sex
- All
- Age
- 11 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months. The secondary objectives of the study are: 1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg. 2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | FACTOR X |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2012-11-06
- Last updated
- 2018-04-02
- Results posted
- 2018-03-07
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01721681. Inclusion in this directory is not an endorsement.