Expanded Access for Apixaban
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Available
CT.gov ID
NCT05187286
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
This is an expanded access designed to provide access to apixaban for eligible participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Expanded Access
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
28 Days
to 17 Years
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Pre-Approval Access (PAA) Healthcare Practitioner Requests
- BMS Clinical Trial Information
- FDA Safety Alerts and Recalls
- BMS Clinical Trial Patient Recruiting
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT05187286
Other Study ID Numbers:
- CV185-826
First Posted:
Jan 11, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Additional relevant MeSH terms: