Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT05905172

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

Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2025-06-04

248

Participants Needed

23

Research Sites

270 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participated in the Phase III trial of this study, completed the main treatment course and last visit
  • Understand the trial, its possible benefits and risks, and volunteer to participate
  • Able to communicate well with the investigator and comply with study requirements
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Experienced any clinical endpoint events during the Phase III trial, including progression to cirrhosis or liver cancer
  • Have malignant tumors other than hepatocellular carcinoma with expected survival less than 1 year
  • Any condition that affects ability to give informed consent or follow the trial protocol, or may affect trial results or safety

AI-Screening

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Trial Site Locations

Total: 23 locations

1

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

2

Shanghai General Hospital,Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China, 201620

Actively Recruiting

3

Beijing youan hospital, the capital of the capital

Beijing, China

Actively Recruiting

4

Tsinghua Changgeng Hospital, Beijing

Beijing, China

Actively Recruiting

5

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Actively Recruiting

6

The Second Xiangya Hospital, Central South University

Changsha, China

Actively Recruiting

7

Xiangya Hospital, Central South University

Changsha, China

Actively Recruiting

8

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Actively Recruiting

9

Three Gorges Hospital affiliated to Chongqing University

Chongqing, China

Actively Recruiting

10

Guizhou Provincial People's Hospital

Guizhou, China

Actively Recruiting

11

Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)

Hangzhou, China

Actively Recruiting

12

Henan Provincial People's Hospital

Henan, China

Actively Recruiting

13

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Luzhou, China

Actively Recruiting

14

Nanchang Ninth Hospital (Nanchang Central Hospital)

Nanchang, China

Actively Recruiting

15

The First Affiliated Hospital of Nanchang University

Nanchang, China

Actively Recruiting

16

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

Nanjing, China

Actively Recruiting

17

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, China

Actively Recruiting

18

Huashan Hospital affiliated to Fudan University

Shanghai, China

Actively Recruiting

19

Shenzhen Third People's Hospital

Shenzhen, China

Actively Recruiting

20

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China

Actively Recruiting

21

Yanbian University Affiliated Hospital

Yanbian, China

Actively Recruiting

22

Zhenjiang Third People's Hospita

Zhenjiang, China

Actively Recruiting

23

Affiliated Hospital of Zunyi Medical University

Zunyi, China

Actively Recruiting

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Research Team

L

Ling Zhang, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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