Apixaban-PK Trial for Portal Hypertension, Cirrhosis
Summary
ClinicalTrials.gov registered a new observational pharmacokinetic trial NCT07521332 evaluating apixaban in patients with portal hypertension and cirrhosis. The single-center study will collect PK data and assess clinical outcomes without administering study drug. Registration fulfills requirements under the FDA Amendments Act Section 801 for clinical trial disclosure.
What changed
ClinicalTrials.gov published registration details for a new observational pharmacokinetic study (NCT07521332) investigating apixaban in patients with portal hypertension and compensated or decompensated cirrhosis. The trial will collect PK blood samples and follow clinical outcomes without administering investigational drug.
Affected parties including trial sponsors, clinical investigators, and institutional review boards should ensure compliance with ClinicalTrials.gov registration and results posting requirements under the FDA Amendments Act. Healthcare organizations conducting clinical research should verify their active trials are properly registered and updated.
What to do next
- Monitor for trial updates on ClinicalTrials.gov
- Ensure clinical trial disclosure compliance under FDAAA 801
Archived snapshot
Apr 13, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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