A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks. The study includes a screening period (up to 21 days) to assess the eligibility of participants. Eligible participants will enter the treatment period and receive Hydronidone capsules at a dosage of 270 mg TID (30 mg/capsule, 3 capsules each time, three times daily, taken orally half an hour before meals) for 28 consecutive days. Participants will return for a follow-up visit on Day 28 (±3 days) after the first dose for safety assessments. All adverse events (AEs) and concomitant medications occurring during the study period must be recorded. After the treatment period, participants will enter a follow-up period to monitor any delayed adverse events. Participants who complete the final follow-up visit are considered to have completed the study. Throughout the study, participants must maintain the stability of all their pre-existing treatment regimens, including antiviral therapy and medications for other comorbid conditions.
• Age 18 to 70 years (inclusive of 18 and 70 years old, based on the date of signing the informed consent form), regardless of gender.
• History of chronic hepatitis B and/or Hepatitis B surface antigen (HBsAg) positive for ≥6 months.
• Diagnosed with chronic hepatitis B-related fibrosis by the investigator, meeting any of the following criteria:
‣ Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2;
⁃ Liver stiffness measurement (Fibroscan, Fibrotouch, or ILivTouch; results from within 1 month prior to screening are acceptable) with a liver stiffness value ≥9.0 kPa;
⁃ Imaging examination (results from within 12 months prior to screening are acceptable), such as abdominal ultrasound, CT, or MRI, indicating morphological features of cirrhosis (e.g., irregular liver surface, liver lobe disproportion, etc.).
• Currently receiving stable antiviral therapy with one or two drugs such as ETV (Entecavir), TAF (Tenofovir Alafenamide), TDF (Tenofovir Disoproxil Fumarate), or TMF (Tenofovir Mefenamide) for ≥6 months.
• The study participant agrees, from the time of signing the informed consent form until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, with no plans for pregnancy, sperm donation, or egg donation during this period.
• Prior to the trial, the participant has fully understood the nature, significance, potential benefits, possible inconveniences, and risks of the study, voluntarily agrees to participate in this clinical trial, can communicate well with the investigator, adheres to all study requirements, and has signed a written informed consent form.