A Phase 3 interventional study of idarucizumab in Hemorrhage, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 1 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Group A:
-- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
Group B:
Exclusion criteria:
Group A:
Group B:
Drug: idarucizumab
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events is presented
Time frame: from first drug administration until 5 days after last drug administration, up to 6 days.
| Milestone | Idarucizumab 5 g |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Percentage of subjects with drug-related adverse events is presented
| Percentage of participants | Idarucizumab 5 g |
|---|---|
| Percentage of Subjects With Drug-related Adverse Events | 0.0 |
Collected over From first drug administration until 5 days after last drug administration, up to 6 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Idarucizumab 5 g | — | 0/1 (0%) | 1/1 (100%) |
| Event | Idarucizumab 5 g |
|---|---|
| Platelet count decreasedInvestigations | 1/1 |
Treated set (TS) comprised all patients who had been received at least 1 dose of the study medication.
| Age, Continuous(years) | Idarucizumab 5 g |
|---|---|
| Mean | 82 |
| Sex: Female, Male(Participants) | Idarucizumab 5 g |
|---|---|
| Female | 0 |
| Male | 1 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim