Expanded Access for Apixaban

• Registration Number: NCT05187286
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This is an expanded access designed to provide access to apixaban for eligible participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
• Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required

Exclusion Criteria

• Weight less than 5 kg or greater than 35 kg

Other inclusion/exclusion criteria apply

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Childrens Hospital Of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States