clinical trial · NCT07412236
A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.
Beijing Continent Pharmaceutical Co, Ltd.·phase3·not yet recruiting·n = 1,208
Liver FibrosisLiver Fibrosis in Chronic Hepatitis BHydronidone (270mg)Hydronidone (Placebo Group)
brief 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).
started
Jan 30, 2026
primary completion
Dec 30, 2028
completion
Dec 30, 2028
last updated
Feb 17, 2026
official title
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol