CU Programme of Idarucizumab for Japanese Patients

Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831660
• Other study ID #: 1321.14
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2016
• Last updated: March 19, 2018
• Start date: July 22, 2016
• Est. completion date: September 16, 2016

Study information

• Verified date: March 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 16, 2016
• Est. primary completion date: September 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• idarucizumab

Locations

Country	Name	City	State
Japan	Fukuoka Tokushukai Medical Center	Fukuoka, Kasuga

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Drug-related Adverse Events	Percentage of subjects with drug-related adverse events is presented	from first drug administration until 5 days after last drug administration, up to 6 days.

External Links

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