Actively Recruiting
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-04-24
150
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
B
Beijing Continent Pharmaceutical Co, Ltd.
Lead Sponsor
T
The Second Affiliated Hospital of Chongqing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years inclusive
- History of chronic hepatitis B and/or Hepatitis B surface antigen positive for at least 6 months
- Diagnosed with chronic hepatitis B-related liver fibrosis by liver biopsy, liver stiffness measurement, or imaging indicating cirrhosis
- Receiving stable antiviral therapy with one or two drugs such as Entecavir, Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate, or Tenofovir Mefenamide for at least 6 months
- Agree to use effective contraception from signing consent until 6 months after last study drug dose
- Fully understand the study and voluntarily agree to participate with signed informed consent
You will not qualify if you...
- History of allergies to Hydroxynidone, pirfenidone, or their components
- Serious concurrent diseases including uncontrolled heart failure, recent myocardial infarction, uncontrolled hypertension, severe kidney disease, poorly controlled diabetes, thyroid crisis, other chronic liver diseases, or active tuberculosis treatment
- History of decompensated liver cirrhosis or liver malignancy within 12 months
- Recent major upper gastrointestinal bleeding or conditions requiring urgent endoscopy
- Abnormal lab test results or clinically significant abnormalities as judged by investigator
- Body mass index over 32 kg/m2
- Alpha-fetoprotein over 100 mcg/L without signs of liver cancer
- Use of interferon, CYP1A2 inhibitors or inducers without sufficient washout, or complex herbal medicines
- History or current severe mental disorders or cognitive impairment
- Swallowing or digestive disorders like inflammatory bowel disease or short bowel syndrome
- Positive for HIV, syphilis, or hepatitis C antibodies
- History of drug or alcohol abuse within 12 months
- Pregnant or lactating women
- Refusal to use effective contraception until 6 months after last dose
- Participation in other clinical trials using investigational drugs/devices within 3 months
- Unable or unsuitable to complete the trial as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chongqing Medical University Second Affiliated Hospital
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
Research Team
L
Ling Zhang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here