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RECRUITING
NCT05905172
PHASE3

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

Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2023-08-12

Completion Date

2028-10-20

Last Updated

2025-06-04

Healthy Volunteers

No

Conditions

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.

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