Hydronidone capsules for hepatic fibrosis and liver cirrhosis

A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

This trial tries high-dose hydronidone capsules to see if they are safe and tolerable for adults with chronic hepatitis B who have hepatic fibrosis or cirrhosis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (Industry-sponsored)
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT07343778 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter, open-label Phase III safety trial in which eligible adults receive hydronidone 120 mg three times daily for 28 consecutive days. Participants are sequentially enrolled and return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events and concomitant medications are recorded during the study period, and completion is defined by attending the Day 28 follow-up visit. Eligibility requires confirmed hepatic fibrosis or cirrhosis by recent biopsy or imaging and liver enzyme limits, with exclusions including recent major upper gastrointestinal hemorrhage.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with chronic hepatitis B and confirmed hepatic fibrosis or cirrhosis, ALT below 8×ULN, able to give informed consent, and women of childbearing potential willing to use effective contraception.

Not a fit: People with recent major upper gastrointestinal bleeding, pregnancy, or other serious uncontrolled medical conditions are unlikely to benefit or be eligible for the trial.

Why it matters

Potential benefit: If successful, this could show hydronidone has an acceptable short-term safety profile in people with hepatic fibrosis or cirrhosis and justify further efficacy trials.

How similar studies have performed: Hydronidone has limited prior phase III safety data in this population, so this short high-dose safety approach is relatively novel while comparable short-term safety studies of other liver-directed drugs have shown mixed results.

Eligibility criteria

Inclusion Criteria:

* Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
* Aged ≥18 years, regardless of gender.
* Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:

A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or

Imaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).

* Alanine aminotransferase (ALT) \< 8 × upper limit of normal (ULN).
* Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the trial until 6 months after the last dose of the study drug.

Exclusion Criteria:

* History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
* Total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or ALT \> 3 × ULN but \< 8 × ULN and TBIL \> 2 × ULN.
* Alpha-Fetoprotein (AFP) \> 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
* Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) \< 50% or International Normalized Ratio (INR) \> 1.5.
* Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
* Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
* History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying liver disease (e.g., manifestations of decompensated cirrhosis).
* Pregnant or lactating women.
* Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.
* Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.

Where this trial is running

Zhengzhou

• The Sixth People's Hospital of Zhengzhou City — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Ling Zhang

Conditions Chronic Hepatitis B With Hepatic Fibrosis; Chronic hepatitis B with hepatic fibrosis