Hydronidone treatment for chronic hepatitis B-related liver fibrosis

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

We will try Hydronidone capsules for adults with chronic hepatitis B-related liver fibrosis to see if four weeks of treatment is safe and tolerated.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (Industry-sponsored)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07417553 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicenter Phase 2 trial in which eligible adults with chronic hepatitis B-related liver fibrosis will receive Hydronidone 270 mg three times daily for 28 consecutive days after a screening period of up to 21 days. Eligibility is confirmed by prior biopsy, liver stiffness measurement, or imaging showing fibrosis or cirrhotic features, and participants must be on stable antiviral therapy. Safety will be monitored with a Day 28 (±3 days) visit and a follow-up period to capture delayed adverse events, with all adverse events and concomitant medications recorded. The trial is conducted at the Second Affiliated Hospital of Chongqing Medical University under sponsorship from Beijing Continent Pharmaceutical Co., Ltd.

Who should consider this trial

Good fit: Adults aged 18–70 with chronic hepatitis B (HBsAg ≥6 months) and evidence of liver fibrosis by biopsy, elastography, or imaging who are on stable antiviral therapy are the intended participants.

Not a fit: People outside the 18–70 age range, those not on stable antiviral therapy, or patients with other uncontrolled or decompensated liver conditions are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, Hydronidone could become a new oral option to help slow or improve liver fibrosis related to chronic hepatitis B.

How similar studies have performed: Targeted antifibrotic approaches for HBV-related fibrosis remain experimental, with mixed early signals from other agents and no broadly proven oral antifibrotic therapy in this setting.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Liver biopsy histopathological examination (results from within 12 months prior to screening are acceptable) with an Ishak score ≥3 or Metavir score ≥F2;
  2. 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;
  3. 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.

Exclusion Criteria:

* Individuals with a history of specific allergies (e.g., asthma, urticaria, eczema), an allergic constitution (e.g., allergy to drugs or food), or known allergy to Hydroxynidone, pirfenidone, any of their components, or excipients.
* Individuals currently suffering from the following serious concurrent diseases:

  1. Cardiovascular System: Uncontrolled heart failure (NYHA Class III-IV), unstable angina, myocardial infarction within the past 6 months, uncontrolled hypertension, etc.
  2. Renal Diseases: Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²), end-stage renal disease, acute kidney injury, etc.
  3. Endocrine and Metabolic Diseases: Poorly controlled diabetes (HbA1c \>8.5%), thyroid crisis, etc.
  4. Other Chronic Liver Diseases: Alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or severe hepatic steatosis (CAP ≥295 dB/m).
  5. Individuals currently receiving anti-tuberculosis treatment or diagnosed with active tuberculosis.
* Individuals with a history of decompensated liver cirrhosis (e.g., ascites, hepatic encephalopathy, history of esophageal and gastric variceal bleeding) within 12 months prior to screening, patients with clinically diagnosed liver malignancy, or those with other confirmed malignancies.
* Individuals with a history of major upper gastrointestinal bleeding within 6 months prior to screening; those scheduled or requiring immediate upper gastrointestinal endoscopy (gastroscopy) during the trial due to portal hypertension; or cACLD patients with liver stiffness measurement ≥20 kPa and/or platelet count ≤150×10⁹/L.
* Individuals with abnormal laboratory test results or clinically significant abnormalities as judged by the investigator:

Total bilirubin (TBIL) \>3 × ULN, or 3 × ULN \< ALT \<8 × ULN and TBIL \>2 × ULN.

ALT ≥8 × ULN.

Platelet count (PLT) ≤50 × 10⁹/L.

Prothrombin activity (PTA) \<40% or International Normalized Ratio (INR) \>1.5.

* Individuals with a body mass index (BMI) \>32 kg/m².
* Individuals with alpha-fetoprotein (AFP) \>100 μg/L in the absence of indicators suggesting hepatocellular carcinoma.
* Concurrent users of the following medications:

  1. Currently using interferon.
  2. 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.
  3. Use of complex traditional Chinese herbal formulations, herbal medicines, or health supplements with unclear interaction profiles.
* Individuals with a history of or currently suffering from severe depression, post-traumatic stress disorder (PTSD), other serious mental disorders (e.g., schizophrenia, bipolar disorder, etc.), or cognitive impairment, who are unable to cooperate with medication administration and follow-up.
* Individuals with dysphagia, swallowing disorders, or diseases affecting digestion and absorption, such as inflammatory bowel disease, short bowel syndrome, etc.
* Individuals testing positive for human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus (HCV) antibody.
* Individuals with a history of drug abuse, alcohol abuse, or drug dependence (including methadone maintenance therapy) within 12 months prior to screening.
* Pregnant or lactating women.
* Individuals who do not agree, from the time of signing the informed consent until 6 months after the last dose of the study drug, to voluntarily adopt effective contraception for themselves and their partner, and have no plans for pregnancy, sperm donation, or egg donation during this period.
* Individuals who have participated in other clinical trials and used investigational drugs or medical devices within 3 months prior to screening.
* Individuals unable to complete the trial for other reasons, or those deemed unsuitable for participation by the investigator due to other factors.

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing Medical University Second Affiliated Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ling Zhang, Dr

Conditions Chronic Hepatitis B-related Liver Fibrosis; Chronic Hepatitis B-related liver fibrosis