RecruitingPhase 3NCT05905172

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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B


Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Enrollment

248 participants

Start Date

Aug 12, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hydronidone capsules and a drug called The placebo capsules for people with liver fibrosis. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHydronidone capsules

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

DRUGThe placebo capsules

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


Locations(23)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Shanghai General Hospital,Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Beijing youan hospital, the capital of the capital

Beijing, China

Tsinghua Changgeng Hospital, Beijing

Beijing, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

The Second Xiangya Hospital, Central South University

Changsha, China

Xiangya Hospital, Central South University

Changsha, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Three Gorges Hospital affiliated to Chongqing University

Chongqing, China

Guizhou Provincial People's Hospital

Guizhou, China

Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)

Hangzhou, China

Henan Provincial People's Hospital

Henan, China

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Luzhou, China

Nanchang Ninth Hospital (Nanchang Central Hospital)

Nanchang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, China

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, China

Huashan Hospital affiliated to Fudan University

Shanghai, China

Shenzhen Third People's Hospital

Shenzhen, China

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China

Yanbian University Affiliated Hospital

Yanbian, China

Zhenjiang Third People's Hospita

Zhenjiang, China

Affiliated Hospital of Zunyi Medical University

Zunyi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05905172


Related Trials