A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

March 25, 2026 updated by: Beijing Continent Pharmaceutical Co, Ltd.

A Single-Arm, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver Cirrhosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Zhengzhou, China
        • Recruiting
        • The Sixth People's Hospital of Zhengzhou City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants fully understand the study, voluntarily participate, and have signed the informed consent form (ICF).
  • Aged ≥18 years, regardless of gender.
  • Have a confirmed diagnosis of hepatic fibrosis or cirrhosis based on either:

A prior percutaneous liver biopsy (results within 1 year prior to enrollment are acceptable); or

Imaging findings (Fibroscan, Fibrotouch, or ultrasound, with results within 3 months prior to enrollment acceptable).

  • Alanine aminotransferase (ALT) < 8 × upper limit of normal (ULN).
  • Female participants of childbearing potential must have a negative serum pregnancy test. Furthermore, the participant or their partner must agree to employ highly effective contraceptive methods from the start of the trial until 6 months after the last dose of the study drug.

Exclusion Criteria:

  • History of major upper gastrointestinal hemorrhage within the past 3 months prior to enrollment, or the presence of gastrointestinal disorders affecting drug absorption at the time of screening.
  • Total bilirubin (TBIL) > 3 × upper limit of normal (ULN), or ALT > 3 × ULN but < 8 × ULN and TBIL > 2 × ULN.
  • Alpha-Fetoprotein (AFP) > 100 μg/L, even in the absence of clinical indications of hepatocellular carcinoma.
  • Platelet count (PLT) ≤ 50 × 10⁹/L; Prothrombin activity (PTA) < 50% or International Normalized Ratio (INR) > 1.5.
  • Active bacterial, viral (excluding chronic viral hepatitis B or C), fungal, or parasitic infection within 4 weeks prior to screening, or any infectious event requiring systemic anti-infective therapy.
  • Positive test for Human Immunodeficiency Virus antibody (HIV-Ab).
  • History of definite malignant tumors, or clinically significant dysfunction of major organs including heart, lungs, or kidneys, as well as clinically significant severe hepatic dysfunction unrelated to the underlying liver disease (e.g., manifestations of decompensated cirrhosis).
  • Pregnant or lactating women.
  • Participation in any other clinical trial and receipt of investigational drugs within 3 months prior to screening.
  • Any other condition deemed by the investigator as unsuitable for enrollment or likely to prevent completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydronitone Capsules group
Eligible subjects who passed screening were enrolled sequentially in this study and received Hydronidone Capsules 120mg TID for 28 consecutive days.
Drug: Hydronidone Capsules
120mg TID for 28 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Any adverse events occurring in study participants following drug administration.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDN-F351-202508

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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