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Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

NCT05115942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-12-20

No results posted yet for this study

Summary

This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study.

The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.

Conditions

  • Liver Fibrosis

Interventions

DRUG

Hydronidone capsules

After randomization, the experimental group were orally received hydronidone capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d,30 min before meals for 52 weeks.

DRUG

The placebo capsules

After randomization, The control group were orally received placebo capsules at a daily dose of 270 mg, 3 capsules each time, t.i.d, 30 min before meals for 52 weeks.

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
2021-12-30
Primary Completion
2024-10-22
Completion
2024-10-22

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 NCT05115942 on ClinicalTrials.gov