At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
Octafibrindrug
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.
Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Subjects With Congenital Fibrinogen Deficiency
In Brief
A Phase 3 clinical trial evaluating Octafibrin for Congenital Fibrinogen Deficiency. Completed, enrolled 25 participants across 12 sites in 9 countries.
Detailed Summary
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Fibrinogen Deficiency
CountriesBulgaria, India, Iran, Lebanon, Russia, Saudi Arabia, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionFeb 2018
TodayJul 2026
First PostedOct 17, 2014
Enrollment StartSep 1, 2014
Primary CompletionFeb 14, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.7 years ago
Interventions
Octafibrindrug