Reversal Dabigatran Anticoagulant Effect With Idarucizumab

Phase 3

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Idarucizumab

• Registration Number: NCT02815670
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Study Start: 2016-09-07
• Primary Completion: 2019-10-19
• Study Completion: 2019-10-19
• Status Verified: 2020-03
• Results First Submitted: 2020-03-31
• Results First Submitted QC: 2020-03-31
• Last Update Submitted: 2020-03-31
• Results First Posted: 2020-04-14
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idarucizumab	Idarucizumab	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Drug-related Adverse Events (AEs)	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

Name	Time	Method
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.	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.
Number of Participants Per Bleeding Status During the Trial	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.
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.	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.
Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial	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.
Number of Participants With Cessation of Bleeding	From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min.
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.	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.
Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab	At day 25 post vial 2 of Idarucizumab administration, up to 1 day

Trial Locations

Locations (2)

Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan; 🇷🇺 Kazan, Russian Federation

Regional Clin.Hosp.1,Congen.heart defects&child.Cardiol.dept; 🇷🇺 Tyumen, Russian Federation