CLINICAL TRIALS PROFILE FOR IDARUCIZUMAB
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All Clinical Trials for idarucizumab
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT02028780 ↗ | Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects | Completed | Boehringer Ingelheim | Phase 1 | 2014-01-01 | The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran. |
NCT02104947 ↗ | Reversal of Dabigatran Anticoagulant Effect With Idarucizumab | Completed | Boehringer Ingelheim | Phase 3 | 2014-05-06 | Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. |
NCT02798107 ↗ | Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients | Withdrawn | Boehringer Ingelheim | 2019-05-20 | Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required. | |
NCT02815670 ↗ | Reversal Dabigatran Anticoagulant Effect With Idarucizumab | Completed | Boehringer Ingelheim | Phase 3 | 2016-09-07 | 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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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