A Phase 2 Study to Evaluate the Safety of Hydronidone Capsules in Adults With Chronic Hepatitis B or Fatty Liver Disease and Liver Fibrosis

What this Trial Is About

Researchers are evaluating the safety of hydronidone capsules in patients who have chronic hepatitis B infection with liver fibrosis or fatty liver disease with liver fibrosis. This open-label, single-arm Phase 2 study aims to collect information on any adverse effects that may occur during treatment. Approximately 200 participants will be involved, focusing on conditions related to liver fibrosis, including compensated cirrhosis, diagnosed through histology, imaging, or laboratory markers. All participants will receive hydronidone capsules taken orally three times daily, with three capsules per dose, totaling 270 mg each day. The medication is taken half an hour before meals for 28 days. This study does not include a comparison group and is designed to observe the effects of the drug over this fixed treatment period. During the study, participants will be monitored for any adverse events that occur following drug administration. Safety assessments will be conducted throughout the 28-day treatment period. Participants will be required to use effective contraception during the study and for six months after treatment if applicable. The study aims to gather detailed safety data to better understand the tolerability of hydronidone capsules in this patient population.

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