Changeflow GovPing Pharma & Drug Safety Apixaban-PK Trial for Portal Hypertension, Cirr...
Routine Notice Added Final

Apixaban-PK Trial for Portal Hypertension, Cirrhosis

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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

  1. Monitor for trial updates on ClinicalTrials.gov
  2. Ensure clinical trial disclosure compliance under FDAAA 801

Archived snapshot

Apr 13, 2026

GovPing 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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Last updated

Classification

Agency
NLM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07521332

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Pharmacokinetic study Clinical research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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