---
title: CU Programme of Idarucizumab for Japanese Patients
nct_id: NCT02831660
overall_status: COMPLETED
phase: PHASE3
sponsor: Boehringer Ingelheim
study_type: INTERVENTIONAL
primary_condition: Hemorrhage
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02831660.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02831660"
ct_last_update_post_date: 2018-03-20
last_seen_at: "2026-05-12T06:09:38.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# CU Programme of Idarucizumab for Japanese Patients

**Official Title:** A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures

**NCT ID:** [NCT02831660](https://clinicaltrials.gov/study/NCT02831660)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1
- **Lead Sponsor:** Boehringer Ingelheim
- **Conditions:** Hemorrhage
- **Start Date:** 2016-07-22
- **Completion Date:** 2016-09-16
- **CT.gov Last Update:** 2018-03-20

## Brief 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

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **idarucizumab** (EXPERIMENTAL)

## Interventions

- **idarucizumab** (DRUG)

## Primary Outcomes

- **Percentage of Subjects With Drug-related Adverse Events** _(time frame: from first drug administration until 5 days after last drug administration, up to 6 days.)_ — Percentage of subjects with drug-related adverse events is presented

## Locations (1)

- Fukuoka Tokushukai Medical Center, Fukuoka, Kasuga, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fukuoka tokushukai medical center|fukuoka, kasuga||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02831660.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02831660*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*