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Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis

NCT05905172 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-06-04

No results posted yet for this study

Summary

This study is a Phase IIIb extension trial following the "A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B".

The main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.

Conditions

  • Liver Fibrosis

Interventions

DRUG

Hydronidone capsules

After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.

DRUG

The placebo capsules

After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Principal Investigators

  • Lungen Lu, Dr · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Jun Cheng, Dr · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-12
Primary Completion
2028-06-20
Completion
2028-10-20

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 NCT05905172 on ClinicalTrials.gov