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

NCT ID: NCT07343778

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2026-10-30

Brief Summary

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

Chronic Hepatitis B With Hepatic Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydronitone Capsules group

Eligible subjects who passed screening were enrolled sequentially in this study and received Hydronidone Capsules 120mg TID for 28 consecutive days.

Group Type: EXPERIMENTAL

Hydronidone Capsules

Intervention Type: DRUG

120mg TID for 28 consecutive days

Interventions

Hydronidone Capsules

120mg TID for 28 consecutive days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Continent Pharmaceutical Co, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Sixth People's Hospital of Zhengzhou City

Zhengzhou, , China

Countries

China

Central Contacts

Ling Zhang

Role: CONTACT

zhangling@bjcontinent.com

+86-13501209210

Facility Contacts

Guangming Li

Role: primary

li36918@163.com

13603715881

Other Identifiers

KDN-F351-202508

Identifier Type: -

Identifier Source: org_study_id