Reversal Dabigatran Anticoagulant Effect With Idarucizumab

NCT02815670 | Completed Phase 3 Results

• 2 other identifiers: 1321.72015-002177-37
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Drug-related Adverse Events (AEs)

  Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial.

  From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days

Secondary Outcomes (7)

• Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose

  At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration.

• Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT)

  From end of vial 2 of Idarucizumab up to 24h.

• Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT)

  From end of vial 2 of Idarucizumab up to 24h.

• Number of Participants With Cessation of Bleeding

  From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min.

• Number of Participants Per Bleeding Status During the Trial

  From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days

Study Arms (1)

Idarucizumab

EXPERIMENTAL

Drug: Idarucizumab

Interventions

Idarucizumab DRUG

Idarucizumab

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

Kazan', 420138, Russia

Location

Regional Clin.Hosp.1,Congen.heart defects&child.Cardiol.dept

Tyumen, 625021, Russia

Location

Related Publications (1)

• Albisetti M, Schlosser A, Brueckmann M, Gropper S, Glund S, Tartakovsky I, Brandao LR, Reilly PA. Rationale and design of a phase III safety trial of idarucizumab in children receiving dabigatran etexilate for venous thromboembolism. Res Pract Thromb Haemost. 2017 Nov 17;2(1):69-76. doi: 10.1002/rth2.12053. eCollection 2018 Jan.

  PMID: 30046708 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hemorrhage

Interventions

idarucizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The patient completed the treatment period, but the end-of-trial visit was by mistake scheduled 5 days earlier. Thus, the patient was formally considered as having prematurely discontinued the trial although all planned visits were performed.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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: June 24, 2016
• First Posted: June 28, 2016
• Study Start: September 7, 2016
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: April 14, 2020
• Results First Posted: April 14, 2020

Record last verified: 2020-03

Locations

RU (2)