NCT07343778
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
Registry fields
- Overall status
- COMPLETED
- Conditions
- Chronic Hepatitis B With Hepatic Fibrosis
- Study type
- INTERVENTIONAL
- Phase
- PHASE3
- Primary purpose
- TREATMENT
- Intervention type
- DRUG
- Interventions
- Hydronidone Capsules
- Lead sponsor
- Beijing Continent Pharmaceutical Co, Ltd. (INDUSTRY)
Cached at: 2026-08-15 00:34:28
Brief summary
This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.
Contact
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