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.
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.
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Withdrawn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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
