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Last Updated: September 28, 2020

DrugPatentWatch Database Preview

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 2014-05-01 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 Not yet recruiting Boehringer Ingelheim N/A 2016-06-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for idarucizumab

Condition Name

Condition Name for idarucizumab
Intervention Trials
Hemorrhage 4
Healthy Volunteers 1
Healthy 1
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Condition MeSH

Condition MeSH for idarucizumab
Intervention Trials
Hemorrhage 4
Emergencies 1
Atrial Fibrillation 1
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Clinical Trial Locations for idarucizumab

Trials by Country

Trials by Country for idarucizumab
Location Trials
United States 27
Australia 3
Japan 3
Canada 3
Italy 2
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Trials by US State

Trials by US State for idarucizumab
Location Trials
Massachusetts 2
California 2
North Carolina 2
Missouri 2
Florida 2
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Clinical Trial Progress for idarucizumab

Clinical Trial Phase

Clinical Trial Phase for idarucizumab
Clinical Trial Phase Trials
Phase 3 3
Phase 1 2
N/A 2
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Clinical Trial Status

Clinical Trial Status for idarucizumab
Clinical Trial Phase Trials
Not yet recruiting 3
Completed 2
Recruiting 2
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Clinical Trial Sponsors for idarucizumab

Sponsor Name

Sponsor Name for idarucizumab
Sponsor Trials
Boehringer Ingelheim 7
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Sponsor Type

Sponsor Type for idarucizumab
Sponsor Trials
Industry 7
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