Actively Recruiting
A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-04-02
200
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
B
Beijing Continent Pharmaceutical Co, Ltd.
Lead Sponsor
T
The First Hospital of Jilin University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single-arm study designed to collect safety data on hydronidone capsules in patients with chronic hepatitis B virus infection accompanied by liver fibrosis or fatty liver disease accompanied by liver fibrosis . Approximately 200 subjects will be enrolled, all of whom will receive hydronidone capsules three times daily, with three capsules per dose, resulting in a total daily treatment dose of 270 mg. The medication will be administered orally half an hour before meals for a total of 28 days.
CONDITIONS
Official Title
A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing the informed consent form
- Diagnosed with chronic hepatitis B with hepatic fibrosis or fatty liver disease with fibrosis (including compensated cirrhosis) confirmed by histology, imaging, or lab markers
- Histological diagnosis of hepatic fibrosis stage F2 or higher
- Presence of esophageal or gastric varices or ectopic gastrointestinal varices confirmed by endoscopy, excluding non-cirrhotic portal hypertension
- For chronic hepatitis B: liver stiffness measurement (LSM) ≥ 8.5 kPa or Fibrosis-4 Index (FIB-4) ≥ 1.45
- For non-alcoholic fatty liver disease: LSM ≥ 8.5 kPa or FIB-4 ≥ 1.3
- For alcoholic liver disease: LSM ≥ 8.5 kPa
- Male participants must use highly effective contraception from consent until 6 months after last dose
- Female participants must not be pregnant or lactating and either be non-childbearing potential or use highly effective contraception from consent until 6 months after last dose
- Agree to participate voluntarily, comply with the study, and able to understand and sign consent
You will not qualify if you...
- Total bilirubin (TBIL) greater than 3 times upper limit of normal (ULN), or direct bilirubin (DBIL) greater than 2 times ULN, or alanine aminotransferase (ALT) greater than 3 times ULN at screening
- Alpha-fetoprotein (AFP) over 20 µg/L at screening
- Platelet count (PLT) 75 × 10⁹/L or less, or international normalized ratio (INR) above 1.5 at screening
- History or current diagnosis of decompensated cirrhosis, or liver imaging showing significant lesions larger than 10 mm, or possible malignancy
- Diagnosis of other cancers within 5 years prior to screening except certain treated skin, bladder, cervical, or prostate cancers
- Use of interferon within 3 months before screening
- Severe diseases of cardiovascular, pulmonary, renal, endocrine, neurological, digestive, hematopoietic systems, or psychiatric disorders
- Planned participation in other interventional clinical trials during this study
- Participation in any clinical trial within 3 months prior to screening
- Pregnant or breastfeeding women
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jilin University First Hospital
Jilin, Changchun, China
Actively Recruiting
Research Team
L
Ling Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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