drugset / Trial / NCT07364448

A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

NCT07364448

NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.

Timeline

Start
2026-03-12
Primary completion
2026-07-30
Completion
2026-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydronidone Small molecule 90 mg Oral