A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis (NCT07417553) | Clinical Trial Compass
RecruitingPhase 2
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
China150 participantsStarted 2026-04-14
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.).
Exclusion criteria
✕. Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled hypertension, etc.
✕. Renal Diseases: Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²), end-stage renal disease, acute kidney injury, etc.
✕. Endocrine and Metabolic Diseases: Poorly controlled diabetes (HbA1c \>8.5%), thyroid crisis, etc.
✕. Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295 dB/m).
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Timeframe: Within 28 days
2
Severity of adverse events (AEs) and serious adverse events (SAEs).
✕. Individuals currently receiving anti-tuberculosis treatment or diagnosed with active tuberculosis.
✕. Currently using interferon.
✕. Use of known CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) or inducers (e.g., rifampicin, omeprazole) prior to screening, with a washout period less than 7 half-lives of the respective drug.
✕. Use of complex traditional Chinese herbal formulations, herbal medicines, or health supplements with unclear interaction profiles.