CU Programme of Idarucizumab for Japanese Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-22

Study Completion Date

2016-09-16

Brief Summary

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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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Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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idarucizumab

Group Type EXPERIMENTAL

idarucizumab

Intervention Type DRUG

Interventions

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idarucizumab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No