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OpenTrials
Completed

NCT Number: NCT02831660

CU Programme of Idarucizumab for Japanese Patients

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fukuoka Tokushukai Medical Center

Fukuoka, Kasuga, 816-0864, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

idarucizumab

Drug

Primary outcomes

  1. 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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