Back to resultsCU Programme of Idarucizumab for Japanese Patients
Primary Purpose
Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
idarucizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage
Eligibility Criteria
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.
Sites / Locations
- Fukuoka Tokushukai Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
idarucizumab
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events is presented
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02831660
Brief Title
CU Programme of Idarucizumab for Japanese Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
September 16, 2016 (Actual)
Study Completion Date
September 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
idarucizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
idarucizumab
Primary Outcome Measure Information:
Title
Percentage of Subjects With Drug-related Adverse Events
Description
Percentage of subjects with drug-related adverse events is presented
Time Frame
from first drug administration until 5 days after last drug administration, up to 6 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Fukuoka Tokushukai Medical Center
City
Fukuoka, Kasuga
ZIP/Postal Code
816-0864
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
CU Programme of Idarucizumab for Japanese Patients
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