Reversal Dabigatran Anticoagulant Effect With Idarucizumab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02815670
• Date of registration: 24/06/2016
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: Reversal Dabigatran Anticoagulant Effect With Idarucizumab
• Scientific 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.
• Date of first enrolment: September 7, 2016
• Target sample size: 1
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02815670
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russian Federation, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hemorrhage

Intervention(s)

Drug: Idarucizumab

Primary Outcome(s)

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]

Secondary Outcome(s)

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.]

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]

Number of Participants With Cessation of Bleeding [Time Frame: From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min.]

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]

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.]

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]

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.]

Secondary ID(s)

2015-002177-37

1321.7

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02815670