At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
Idarucizumabdrug
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, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
In Brief
A Phase 3 clinical trial evaluating Idarucizumab for Hemorrhage. Completed, enrolled 19 participants across 13 sites.
Detailed Summary
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartMar 2018
Primary CompletionJul 2020
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartMar 26, 2018
Primary CompletionJul 2, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.6 years ago
Interventions
Idarucizumabdrug
Intravenous