CU Programme of Idarucizumab for Japanese Patients

Phase 3

Completed

• Conditions: Hemorrhage
• Interventions: Drug: idarucizumab

• Registration Number: NCT02831660
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Study Start: 2016-07-22
• Primary Completion: 2016-09-16
• Study Completion: 2016-09-16
• Results First Submitted: 2017-08-18
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-19
• Results First Posted: 2018-03-20
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
idarucizumab	idarucizumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug-related Adverse Events	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

Trial Locations

Locations (1)

Fukuoka Tokushukai Medical Center; 🇯🇵 Fukuoka, Kasuga, Japan