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Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
Sponsor: Beijing Continent Pharmaceutical Co, Ltd.
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
Hydronidone capsules
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
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