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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form or follow the trial protocol, or participation in the trial may affect the trial results or their own safety. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Hydronidone capsules

After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.

DRUG

The placebo capsules

After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.

Locations (20)

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