Safety of hydronidone capsules for people with liver fibrosis

An Open-label, Single-arm Clinical Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

This trial tests whether taking hydronidone capsules three times daily for 28 days is safe for adults with chronic hepatitis B or fatty liver disease who have liver fibrosis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (Industry-sponsored)
• Locations: 1 site (Jilin, Changchun)
• Trial ID: NCT07364448 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase 2 trial enrolling about 200 adults with chronic hepatitis B–related or fatty liver–related hepatic fibrosis, including compensated cirrhosis. All participants will receive hydronidone capsules orally three times a day (three capsules per dose) for a total daily dose of 270 mg, taken 30 minutes before meals for 28 days. The study is designed to collect safety and tolerability data during and after the 28-day dosing period. The trial is sponsored by Beijing Continent Pharmaceutical Co., Ltd. with site(s) at The First Hospital of Jilin University in Changchun, China.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic hepatitis B or fatty/alcoholic liver disease who have hepatic fibrosis documented by histology (F2+), imaging, or fibrosis markers (e.g., LSM ≥ 8.5 kPa or FIB-4 thresholds) and who can take oral medication and use effective contraception are ideal candidates.

Not a fit: People without liver fibrosis, those with decompensated liver disease or serious uncontrolled comorbidities, and pregnant or breastfeeding individuals are unlikely to benefit from participation.

Why it matters

Potential benefit: If hydronidone is shown to be safe, it could enable larger trials to test whether the drug helps people with liver fibrosis and eventually expand treatment options.

How similar studies have performed: Early-phase safety studies of investigational oral drugs for liver fibrosis are common, but published clinical results specifically for hydronidone are limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years at the time of signing the informed consent form (ICF), male or female.
* Patients assessed by the investigator as having chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) based on histology, imaging, or laboratory markers, meeting any of the following criteria:

Histologically confirmed diagnosis of hepatic fibrosis (F2 or above);

Endoscopy showing esophageal or gastric varices or ectopic gastrointestinal varices, excluding non-cirrhotic portal hypertension;

For chronic hepatitis B patients: liver imaging suggestive of fibrotic features, with liver stiffness measurement (LSM) ≥ 8.5 kPa, or Fibrosis-4 Index (FIB-4) ≥ 1.45; Or for non-alcoholic fatty liver disease patients: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3; Or for alcoholic liver disease patients: LSM ≥ 8.5 kPa.

* Subjects who agree to use effective contraception measures as specified below during their participation in the trial:

Male subjects must consistently employ highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product.

Female subjects participating in this trial must not be pregnant or lactating and must meet at least one of the following conditions:

1. Be a woman of non-childbearing potential (WONCBP), as defined in Appendix 1;
2. Be a woman of childbearing potential (WOCBP) who consistently uses highly effective contraception methods as described in Appendix 1 from the time of signing the informed consent form until at least 6 months after the last dose of the investigational product, and agrees not to donate eggs for reproductive purposes during this period.

   * The patient voluntarily agrees to participate in this trial, demonstrates good compliance, and has the capacity to understand and sign the informed consent form prior to the study.

Exclusion Criteria:

* At screening, total bilirubin (TBIL) \> 3 × upper limit of normal (ULN), or direct bilirubin (DBIL) \> 2 × ULN, or alanine aminotransferase (ALT) \> 3 × ULN.
* At screening, alpha-fetoprotein (AFP) \> 20 μg/L.
* At screening, platelet count (PLT) ≤ 75 × 10⁹/L, or international normalized ratio (INR) \> 1.5.
* History of or current clinical diagnosis of decompensated cirrhosis at screening, or imaging showing significant space-occupying lesions in the liver (intrahepatic nodules \> 10 mm), or findings suggestive of malignancy.
* Diagnosis of any other malignancy within the past 5 years prior to screening, except for radically resected and non-recurrent skin basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix (excluding the cervical cancer cohort), localized prostate cancer, or other carcinomas in situ.
* Use of interferon within 3 months prior to screening.
* Concurrent severe diseases of the cardiovascular, pulmonary, renal, endocrine, neurological, digestive, or hematopoietic systems, or psychiatric disorders.
* Planned participation in other interventional clinical trials during the study period.
* Participation in any other clinical trials within 3 months prior to screening.
* Pregnant and/or lactating women.
* Other conditions deemed unsuitable for inclusion by the investigator.

Where this trial is running

Jilin, Changchun

• Jilin University First Hospital — Jilin, Changchun, China (Recruiting)

Study contacts

• Study coordinator: Ling Zhang

Conditions Chronic Hepatitis B With Hepatic Fibrosis; Chronic Hepatitis B with Hepatic Fibrosis; Hydronidone