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CU Programme of Idarucizumab for Japanese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831660
Recruitment Status : Completed
First Posted : July 13, 2016
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: idarucizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 22, 2016
Actual Primary Completion Date : September 16, 2016
Actual Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: idarucizumab Drug: idarucizumab


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Drug-related Adverse Events [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831660


Locations
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Japan
Fukuoka Tokushukai Medical Center
Fukuoka, Kasuga, Japan, 816-0864
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02831660    
Other Study ID Numbers: 1321.14
First Posted: July 13, 2016    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes