Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reversal Dabigatran Anticoagulant Effect With Idarucizumab

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: NCT02815670
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoagulant effect of dabigatran is needed.

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

Layout table for study information
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: Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism.
Actual Study Start Date : September 7, 2016
Actual Primary Completion Date : October 19, 2019
Actual Study Completion Date : October 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Idarucizumab Drug: Idarucizumab



Primary Outcome Measures :
  1. Number of Participants With Drug-related Adverse Events (AEs) [ Time Frame: From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days ]
    Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial.


Secondary Outcome Measures :
  1. Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose [ Time Frame: At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration. ]
    Percent change of coagulation time for diluted thrombin time (dTT) and ecarin clotting time (ECT) at 30 minutes (min) post-dose compared with pre-dose. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h.

  2. Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT) [ Time Frame: From end of vial 2 of Idarucizumab up to 24h. ]

    Idarucizumab administration resulted in normalisation of dTT and ECT. Time to achieve reversal of anticoagulant effect of dabigatran based on the coagulation time for dTT and ECT, at any time point from the end of the second injection (vial 2) up to 24 hours (h). Reversal of the dabigatran effect at time t was defined as the 100 percent (%) *(pre-dose coagulation time - post-dose coagulation time at time t)/(pre-dose coagulation test - upper limit of normal).

    Values equal to or higher than 100% were interpreted as reversal. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h.


  3. Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT) [ Time Frame: From end of vial 2 of Idarucizumab up to 24h. ]
    Duration of reversal, defined as the time period a patient remained completely reversed based on dTT and ECT, up to 24 hours post-dose or restarting the treatment of anticoagulation. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of idarucizumab and post-dose at 30min, 4h, 12h and 24h.

  4. Number of Participants With Cessation of Bleeding [ Time Frame: From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min. ]
  5. Number of Participants Per Bleeding Status During the Trial [ Time Frame: From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days ]
    Numbers of participants whose bleeding had stopped, reduced, unchanged, worsened or not applicable during the trial were characterized.

  6. Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial [ Time Frame: From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days ]
    Number of participants with clinical conditions (trauma, surgery and use of antiplatelet) contributing to bleeding during the trial were characterized.

  7. Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab [ Time Frame: At day 25 post vial 2 of Idarucizumab administration, up to 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients taking dabigatran etexilate in the paediatric trials 1160.106 or 1160.108 are eligible for this trial if they meet the following criteria:

Group A:

  • Overt bleeding judged by the treating physician to require a reversal agent.
  • Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran etexilate (1160.106 or 1160.108).
  • Male or female patients from 0 to less than 18 years of age at the time of informed consent/assent for participation in trial 1160.106 or in trial 1160.108.
  • Female patients of childbearing potential (defined as having experienced menarche) must have followed the contraception requirements according to the dabigatran trial 1160.106 or trial 1160.108 in which they are enrolled.
  • Written informed consent provided by the patient (and/or the patient's legally accepted representative) and assent provided by the patient (if applicable) at the time of informed consent signature in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial. If the child is unable to give assent at the time of the emergency, the assent, when applicable will be obtained as soon as feasible.

Group B:

  • A condition requiring an emergency surgery or invasive procedure where adequate haemostasis is required. Emergency is defined as need for surgery or intervention within the following 8 hours.
  • Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran etexilate (1160.106 or 1160.108).
  • Male or female patients from 0 to less than 18 years of age at the time of informed consent/assent for participation in trial 1160.106 or in trial 1160.108.
  • Female patients of childbearing potential (defined as having experienced menarche) must have followed the contraception requirements according to the dabigatran trial 1160.106 or trial 1160.108 in which they are enrolled.
  • Written informed consent provided by the patient (and/or the patient's legally accepted representative) and assent provided by the patient (if applicable) at the time of informed consent signature in accordance with GCP and local legislation prior to admission to the trial. If the child is unable to give assent at the time of the emergency, the assent, when applicable will be obtained as soon as feasible.

Exclusion criteria:

Group A:

  • Patients with minor bleeding (e.g. epistaxis, haematuria) who can be managed with standard supportive care.
  • Patients with no clinical signs of bleeding.
  • Patients with body weight < 2.5 kg
  • Contraindications to trial medication including known hypersensitivity to the drug or its excipients; i.e. patients with hereditary fructose intolerance who may react to sorbitol.
  • Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.

Group B:

  • A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
  • Patients with body weight < 2.5 kg
  • Contraindications to trial medication including known hypersensitivity to the drug or its excipients; i.e. patients with hereditary fructose intolerance who may react to sorbitol.
  • Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.

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): NCT02815670


Locations
Layout table for location information
Russian Federation
Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan
Kazan, Russian Federation, 420138
Regional Clin.Hosp.1,Congen.heart defects&child.Cardiol.dept
Tyumen, Russian Federation, 625021
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] February 4, 2016
Statistical Analysis Plan  [PDF] July 31, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02815670    
Other Study ID Numbers: 1321.7
2015-002177-37 ( EudraCT Number )
First Posted: June 28, 2016    Key Record Dates
Results First Posted: April 14, 2020
Last Update Posted: April 14, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes