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Reversal Dabigatran Anticoagulant Effect With Idarucizumab

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ClinicalTrials.gov Identifier: NCT02815670
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : March 6, 2019
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 anticoalugant effect of dabigatran is needed.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
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
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Idarucizumab Drug: Idarucizumab



Primary Outcome Measures :
  1. Safety of idarucizumab in a paediatric population as assessed by the occurrence of drug-related adverse events (including immune reactions) and all-cause mortality during the trial. [ Time Frame: 30 days post-dose ]

Secondary Outcome Measures :
  1. Cessation of bleeding (Group A patients only). [ Time Frame: Up to 24 hours post-dose ]
  2. Bleeding status and other clinical conditions that may contribute to bleeding (Group A patients only) during the trial. [ Time Frame: 30 days post-dose ]
  3. Percent change of coagulation tests (diluted thrombin time, ecarin clotting time) at 30 minutes post-dose compared to pre-dose. [ Time Frame: 30 minutes post-dose ]
  4. Time to achieve complete reversal of dabigatran effect, based on coagulation tests (diluted thrombin time, ecarin clotting time). [ Time Frame: Up to 24 hours post-dose ]
  5. Duration of complete reversal of dabigatran effect sustained at 24 hours post-dose, based on coagulation tests (diluted thrombin time, ecarin clotting time). [ Time Frame: Up to 24 hours post-dose ]
  6. Development of treatment-emergent anti drug antibodies with cross reactivity to idarucizumab at 30 days post-dose of idarucizumab. [ Time Frame: 30 days post-dose ]


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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


Contacts
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Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02815670     History of Changes
Other Study ID Numbers: 1321.7
2015-002177-37 ( EudraCT Number )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants