CU Programme of Idarucizumab for Japanese Patients

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hemorrhage

Treatments

Drug: idarucizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02831660

1321.14

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.