NCT07412236

A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,208 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening/Baseline Period (4 weeks) and a Dosing/Observation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).

Conditions

• Liver Fibrosis
• Liver Fibrosis in Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Hydronidone (270mg)	Dosage: 30 mg/capsule, three capsules taken three times daily, resulting in a total daily therapeutic dose of 270 mg. The medication is administered orally half an hour before meals.
DRUG	Hydronidone (Placebo Group)	Dosage: three capsules taken three times daily.The medication is administered orally half an hour before meals.

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: China