CLINICAL TRIALS PROFILE FOR IDARUCIZUMAB
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All Clinical Trials for idarucizumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| 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| NCT02798107 ↗ | Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients | Withdrawn | Boehringer Ingelheim | 2019-05-20 | Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity.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. |
| NCT02831660 ↗ | CU Programme of Idarucizumab for Japanese Patients | Completed | Boehringer Ingelheim | Phase 3 | 2016-07-22 | The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required. |
| NCT03086356 ↗ | Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State | Completed | Boehringer Ingelheim | Phase 1 | 2017-05-10 | The primary objective of the trial is to investigate the pharmacokinetics and pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following intravenous administration of idarucizumab followed by idarucizumab with 15 minutes interval when administered at or close to the steady state of dabigatran. Another objective of this trial is to explore the effect idarucizumab on the PK (pharmacokinetic(s)) and PD (pharmacodynamic) parameters of dabigatran. |
| NCT03343704 ↗ | This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding | Completed | Boehringer Ingelheim | Phase 3 | 2018-03-26 | The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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