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A Study to Evaluate the Safety of Hydronidone Capsules in Patients With Liver Fibrosis

NCT07364448 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-02

No results posted yet for this study

Summary

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

  • Chronic Hepatitis B With Hepatic Fibrosis

Interventions

DRUG

Hydronidone capsules

three times a day, 3 capsules each time,

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

  • The First Hospital of Jilin University

    collaborator OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2026-07-30
Completion
2026-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07364448 on ClinicalTrials.gov