At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 9 enrolled
Drug / intervention
FACTOR Xbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating FACTOR X for Factor X Deficiency. Completed, enrolled 9 participants across 3 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFactor X Deficiency
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartApr 2015
Primary CompletionOct 2016
TodayJul 2026
First PostedNov 6, 2012
Enrollment StartApr 1, 2015
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.7 years ago
Interventions
FACTOR Xbiological