Reversal of diluted thrombin time (dTT), ecarin clotting time (ECT), activated partial thromboplastin time (aPTT), and thrombin time (TT) were secondary endpoints assessed by measuring the area under the effect curve from 2 h to 12 h (AUEC2-12) after dabigatran etexilate ingestion on days 3 and 4. The primary endpoint was incidence of drug-related adverse events, analysed in all randomly assigned participants who received at least one dose of dabigatran etexilate. Idarucizumab (1 g, 2 g, or 4 g 5-min infusion, or 5 g plus 2♵ g in two 5-min infusions given 1 h apart) was administered about 2 h after the final dabigatran etexilate dose. All participants received oral dabigatran etexilate 220 mg twice daily for 3 days and a final dose on day 4. Participants and care providers were masked to treatment assignment. Participants were randomly assigned within groups in a 3:1 ratio to idarucizumab or placebo using a pseudorandom number generator and a supplied seed number. In this randomised, placebo-controlled, double-blind, proof-of-concept phase 1 study, we enrolled healthy volunteers (aged 18-45 years) with a body-mass index of 18♵-29♹ kg/m(2) into one of four dose groups at SGS Life Sciences Clinical Research Services, Belgium. ![]() Here we present the results of the proof-of-concept part of the study. We investigated the safety, tolerability, and efficacy of increasing doses of idarucizumab for the reversal of anticoagulant effects of dabigatran in a two-part phase 1 study (rising-dose assessment and dose-finding, proof-of-concept investigation). Idarucizumab is a monoclonal antibody fragment that binds dabigatran with high affinity in a 1:1 molar ratio.
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