PraxbindTM India PMS Program

Completed

• Conditions: Thromboembolism
• Interventions: Drug: PraxbindTM

• Registration Number: NCT03359889
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-02
• Study Start: 2018-12-26
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Results First Submitted: 2021-01-13
• Results First Submitted QC: 2021-02-08
• Results First Posted: 2021-02-16
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding

• Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Read More

Exclusion Criteria

-Participation in a PraxbindTM clinical trial

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients administered with PraxbindTM	PraxbindTM	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)	Up to 7 days following treatment.	Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding	Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.	Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.

Trial Locations

Locations (3)

Mazumdar Shaw Medical centre; 🇮🇳 Bangalore, India

Care Hospital; 🇮🇳 Hyderabad, India

Columbia Asia Referral Hospital; 🇮🇳 Bengaluru, India