Phase 3
N=1
CU Programme of Idarucizumab for Japanese Patients
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02831660 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Percentage of Subjects With Drug-related Adverse Events — 0.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- idarucizumab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events |
0.0 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- Currently taking dabigatran etexilate.
- Age >= 20 years at entry.
- Written Informed consent
- Group A:
-- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
- Group B:
- A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Exclusion criteria
- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
- Group A:
- Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
- Patients with no clinical signs of bleeding.
- Group B:
- surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Data sourced from ClinicalTrials.gov (NCT02831660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.