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

RecruitingPhase 3Ages 18 Years - 65 YearsAllBeijing Continent Pharmaceutical Co, Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Hydronidone capsules
  • The placebo capsules
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Where

23 sites
Beijing Ditan Hospital Capital Medical University
Beijing, China
Shanghai General Hospital,Shanghai Jiao Tong University
Shanghai, 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

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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