Actively Recruiting
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2026-03-31
300
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, multicenter, open-label Phase III clinical trial to evaluate the safety and tolerability of high-dose hydronidone capsules in patients with hepatic fibrosis and cirrhosis. Eligible participants will be sequentially enrolled to receive hydronidone capsules 120 mg three times daily (TID) for 28 consecutive days. Participants will return to the hospital on Day 28 after the first dose for a follow-up safety assessment. All adverse events (AEs) and concomitant medications must be recorded during the study period. Participants who complete the Day 28 follow-up visit are considered to have completed the study.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
- Aged 18 years or older, regardless of gender.
- Confirmed diagnosis of hepatic fibrosis or cirrhosis by liver biopsy within 1 year or imaging (Fibroscan, Fibrotouch, or ultrasound) within 3 months prior to enrollment.
- Alanine aminotransferase (ALT) less than 8 times the upper limit of normal (ULN).
- Female participants of childbearing potential must have a negative serum pregnancy test and agree to use highly effective contraception from the start of the trial until 6 months after the last dose.
You will not qualify if you...
- History of major upper gastrointestinal hemorrhage within 3 months prior to enrollment or presence of gastrointestinal disorders affecting drug absorption at screening.
- Total bilirubin (TBIL) greater than 3 times ULN, or ALT greater than 3 times ULN but less than 8 times ULN with TBIL greater than 2 times ULN.
- Alpha-Fetoprotein (AFP) level greater than 100 bcg/L, regardless of hepatocellular carcinoma signs.
- Platelet count less than or equal to 50 d7 10 9/L; Prothrombin activity less than 50% or INR greater than 1.5.
- Active bacterial, viral (excluding chronic hepatitis B or C), fungal, or parasitic infection within 4 weeks before screening, or infection requiring systemic anti-infective treatment.
- Positive test for HIV antibody.
- History of malignant tumors or significant dysfunction of major organs including heart, lungs, or kidneys, or severe liver dysfunction not caused by underlying liver disease.
- Pregnant or lactating women.
- Participation in another clinical trial or use of investigational drugs within 3 months prior to screening.
- Any other condition judged by the investigator as unsuitable or likely to prevent study completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Sixth People's Hospital of Zhengzhou City
Zhengzhou, 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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