Expanded Access for Apixaban


Study First Submitted Date 2021-11-16
Study First Posted Date 2022-01-11
Last Update Posted Date 2022-03-18
Verification Month Year March 2022
Verification Date 2022-03-31
Last Update Posted Date 2022-03-18


Sequence: 201060440
Status Available
Name Childrens Hospital Of Philadelphia
City Philadelphia
State Pennsylvania
Zip 19104
Country United States

Facility Contacts

Sequence: 28253369
Facility Id 201060440
Contact Type primary
Name Andrew Glatz, Site 0001

Browse Interventions

Sequence: 96472880 Sequence: 96472881 Sequence: 96472882 Sequence: 96472883 Sequence: 96472884 Sequence: 96472885 Sequence: 96472886 Sequence: 96472887
Mesh Term Apixaban Mesh Term Factor Xa Inhibitors Mesh Term Antithrombins Mesh Term Serine Proteinase Inhibitors Mesh Term Protease Inhibitors Mesh Term Enzyme Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Anticoagulants
Downcase Mesh Term apixaban Downcase Mesh Term factor xa inhibitors Downcase Mesh Term antithrombins Downcase Mesh Term serine proteinase inhibitors Downcase Mesh Term protease inhibitors Downcase Mesh Term enzyme inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term anticoagulants
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Id Information

Sequence: 40347778
Id Source org_study_id
Id Value CV185-826


Sequence: 42780815
Name United States
Removed False


Sequence: 52746122
Intervention Type Drug
Name Apixaban
Description Administered as directed by treating physician


Sequence: 48565090
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Bristol-Myers Squibb

Overall Officials

Sequence: 29423367
Role Study Director
Name Bristol-Myers Squibb
Affiliation Bristol-Myers Squibb

Central Contacts

Sequence: 12078323 Sequence: 12078324
Contact Type primary Contact Type backup
Name Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, Name First line of the email MUST contain NCT # and Site #.
Phone please email:
Email Clinical.Trials@bms.com
Role Contact Role Contact


Sequence: 30917404
Gender All
Minimum Age 28 Days
Maximum Age 17 Years
Criteria 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
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254184542
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 28
Maximum Age Num 17
Minimum Age Unit Days
Maximum Age Unit Years

Intervention Other Names

Sequence: 26805230
Intervention Id 52746122
Name Eliquis


Sequence: 4408329 Sequence: 4408330 Sequence: 4408331 Sequence: 4408332
Url https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine/investigational-drugs-available.html Url https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html Url https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm Url https://www.bmsstudyconnect.com/s/US/English/USenHome
Description Pre-Approval Access (PAA) Healthcare Practitioner Requests Description BMS Clinical Trial Information Description FDA Safety Alerts and Recalls Description BMS Clinical Trial Patient Recruiting

Responsible Parties

Sequence: 29029773
Responsible Party Type Sponsor