Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis
Recruiting · NCT05905172 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Continent Pharmaceutical Co, Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Hydronidone capsulesThe placebo capsules
What this trial is about
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 can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
23 locations listed.
- 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
- Beijing Ditan Hospital Capital Medical University - Beijing, Beijing Municipality, China
- Shanghai General Hospital,Shanghai Jiao Tong University - Shanghai, Shanghai Municipality, China