CU Programme of Idarucizumab for Japanese Patients
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
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Start
First participant enrolled
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2016
CompletedResults Posted
Study results publicly available
March 20, 2018
CompletedMarch 20, 2018
March 1, 2018
2 months
July 11, 2016
August 18, 2017
March 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
idarucizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fukuoka Tokushukai Medical Center
Fukuoka, Kasuga, 816-0864, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because of the trial design and backgrounds, only 1 patient was entered in the trial. Because of the limited number of patients, it was difficult to draw general conclusion regarding safety or tolerability of idarucizumab
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
July 22, 2016
Primary Completion
September 16, 2016
Study Completion
September 16, 2016
Last Updated
March 20, 2018
Results First Posted
March 20, 2018
Record last verified: 2018-03