Trials / Completed
CompletedNCT02815670
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idarucizumab |
Timeline
- Start date
- 2016-09-07
- Primary completion
- 2019-10-19
- Completion
- 2019-10-19
- First posted
- 2016-06-28
- Last updated
- 2020-04-14
- Results posted
- 2020-04-14
Locations
2 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT02815670. Inclusion in this directory is not an endorsement.