At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1 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.
Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism.
In Brief
A Phase 3 clinical trial evaluating Idarucizumab for Hemorrhage. Completed, enrolled 1 participant across 2 sites.
Detailed Summary
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoagulant effect of dabigatran is needed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartSep 2016
Primary CompletionOct 2019
TodayJul 2026
First PostedJun 28, 2016
Enrollment StartSep 7, 2016
Primary CompletionOct 19, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.0 years ago
Interventions
Idarucizumabdrug