Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
NCT ID: NCT05905172
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
248 participants
INTERVENTIONAL
2023-08-12
2028-10-20
Brief Summary
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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.
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Detailed Description
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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". Subjects who have completed the Phase III, placebo-controlled design, double-blind, can enter the study and continue treatment according to the original treatment protocol.The aim is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.
The test group received hydronidone capsules three times a day at a daily dose of 270 mg and oral medication half an hour before the meal. The control group received placebo capsules three times a day, half an hour before the meal.Both the test and control groups received entecavir antiviral therapy as basic treatment, once daily at 0.5 mg each, by fasting oral administration. If the subject is not suitable for entecavir, the investigator will decide on the corresponding antiviral treatment according to the subject's specific condition. Discontinuation criteria for entecavir: According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition), the American Association for the Study of Liver Disease (AASLD) and the European Association for Liver Disease (EASL) management guidelines.
Visit examination items: clinical laboratory tests (routine ALT) every 6 months (for ALT and AST, additional tests as appropriate), HBVDNA, hepatitis B, transient elastography examination, etc. In order to improve subject compliance, the investigator may increase or reduce the examination frequency or items, and at least 1 year to reducing the frequency. Additional according to the actual situation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Control group: placebo capsules, three times a day, 3 capsules each time，oral，half an hour before the meal.
Basic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, oral.
In case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately.
TREATMENT
QUADRUPLE
Study Groups
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Hydronidone group
Patients were given three capsules of hydronidone three times a day for 5 years.
Hydronidone capsules
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
The placebo group
Patients were given three capsules of placebo three times a day 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.
Exclusion Criteria
* Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;
* Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial may affect the trial results or their own safety.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Continent Pharmaceutical Co, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lungen Lu, Dr
Role: PRINCIPAL_INVESTIGATOR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jun Cheng, Dr
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Wen Xie
Role: primary
Sujun Zheng
Role: primary
Yuan Huang
Role: primary
Wei Li
Role: primary
Yongfang Jiang
Role: primary
Yan Huang
Role: primary
Yongguo Li
Role: primary
Xuan An
Role: primary
Xinhua Luo
Role: primary
Jianfeng Bao
Role: primary
Jia Shang
Role: primary
Jing Wang
Role: primary
Long Xu
Role: primary
Xiaoping Wu
Role: primary
Jun Li
Role: primary
Liyun Fu
Role: primary
Jiming Zhang
Role: primary
Qingxian Cai
Role: primary
Xinwen Song
Role: primary
Ning Chen
Role: primary
Youwen Tan
Role: primary
Yawen Luo
Role: primary
Other Identifiers
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KDN-F351-202201
Identifier Type: -
Identifier Source: org_study_id
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