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A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

NCT02499562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-06-23

No results posted yet for this study

Summary

To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Hydronidone

The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.

DRUG

Placebo

DRUG

Entecavir

Sponsors & Collaborators

  • Shanghai Genomics, Inc.

    lead INDUSTRY

Principal Investigators

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

  • Jun Cheng · 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
2015-06-25
Primary Completion
2020-11-20
Completion
2020-11-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT02499562 on ClinicalTrials.gov