Tests hydronidone capsules for liver scarring from chronic hepatitis B
Tests hydronidone capsules against placebo in adults with hepatitis B liver scarring.
Plain-language title generated from the registry record
Registry title: Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
Key facts
- Where
- Beijing, Bengbu, Changsha, Chongqing, Guizhou, Hangzhou, Henan, Luzhou, Nanchang, Nanjing, Ningbo, Shanghai, Shenzhen, Xinxiang, Yanbian, Zhenjiang, and Zunyi, ChinaSee the 23 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05905172, who can take part
Where in China
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Beijing youan hospital, the capital of the capitalBeijing, ChinaTaking people
- Tsinghua Changgeng Hospital, BeijingBeijing, ChinaTaking people
- The First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaTaking people
- The Second Xiangya Hospital, Central South UniversityChangsha, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Three Gorges Hospital Affiliated to Chongqing UniversityChongqing, ChinaTaking people
- Guizhou Provincial People's HospitalGuizhou, ChinaTaking people
- Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)Hangzhou, ChinaTaking people
- Henan Provincial People's HospitalHenan, ChinaTaking people
- Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical UniversityLuzhou, ChinaTaking people
- Nanchang Ninth Hospital (Nanchang Central Hospital)Nanchang, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)Nanjing, ChinaTaking people
- Ningbo Huamei Hospital, University of Chinese Academy of SciencesNingbo, ChinaTaking people
- Huashan Hospital Affiliated to Fudan UniversityShanghai, ChinaTaking people
- Shanghai General Hospital, Shanghai Jiao Tong UniversityShanghai, ChinaTaking people
- Shenzhen Third People's HospitalShenzhen, ChinaTaking people
- The First Affiliated Hospital of Xinxiang Medical CollegeXinxiang, ChinaTaking people
- Yanbian University Affiliated HospitalYanbian, ChinaTaking people
- Zhenjiang Third People's HospitaZhenjiang, ChinaTaking people
- Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Continent Pharmaceutical Co, Ltd.
- Trial code
- NCT05905172
- Record updated
- 4 June 2025
- Original description
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".Read full original descriptionShow less
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
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.
Inclusion: Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit; 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: One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to cirrhosis,decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy], hepatocellular carcinoma, liver transplantation or liver disease related death / all-cause death; For patients with liver cirrhosis, Clinical endpoints include complications of decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, or liver disease-related death / all-cause death); 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.