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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

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE July 13, 2016
Results First Submitted Date  ICMJE August 18, 2017
Results First Posted Date  ICMJE March 20, 2018
Last Update Posted Date March 20, 2018
Actual Study Start Date  ICMJE July 22, 2016
Actual Primary Completion Date September 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CU Programme of Idarucizumab for Japanese Patients
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhage
Intervention  ICMJE Drug: idarucizumab
Study Arms  ICMJE Experimental: idarucizumab
Intervention: Drug: idarucizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
1
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 16, 2016
Actual Primary Completion Date September 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02831660
Other Study ID Numbers  ICMJE 1321.14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP