At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 16 enrolled
Drug / intervention
Human Coagulation FACTOR Xbiological
Likely dose
Human Coagulation FACTOR X 25IUfrom 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 Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.
In Brief
A Phase 3 clinical trial evaluating Human Coagulation FACTOR X for Factor X Deficiency. Completed, enrolled 16 participants across 14 sites in 5 countries.
Detailed Summary
The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFactor X Deficiency
CountriesGermany, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJan 2010
Primary CompletionNov 2013
TodayJul 2026
First PostedJun 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.0 years ago
Interventions
Human Coagulation FACTOR Xbiological
Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.