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

Liver Fibrosis Clinical Trial

Official title:

A Clinical Study to Evaluate the Efficacy and Safety of Hydroxynidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905172
• Other study ID #: KDN-F351-202201
• Status: Recruiting
• Phase: Phase 3
• Start date: August 12, 2023
• Est. completion date: October 20, 2028

Study information

• Verified date: January 2024
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Contact: Ling Zhang, Dr
• Phone: +86-13501209210
• Email: zhangling[@]bjcontinent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Phase IIIb extension trial following the "randomized, double-blind, placebo-controlled, entecavir basic treatment, multi-center Phase III clinical trial of hydroxnidone capsules in the treatment of liver fibrosis of chronic viral hepatitis B".

The main objective of this study is to evaluate the effectiveness and the safety of hydroxyeidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.

Description:

Nowadays, there is no satisfactory treatment and drug for liver fibrosis, so the etiology treatment of liver fibrosis and cirrhosis is the most important treatment. However, the etiology and treatment can not completely prevent the progression of liver fibrosis, and liver cirrhosis and liver cancer still occur after antiviral treatment. Although some drugs in domestic and foreign clinical trials have reported the effect of treating liver fibrosis, there is no recognized effective chemical drugs or biological agents against liver fibrosis. According to the available evidence, hydroxnidone capsules can effectively reduce the severity of liver fibrosis, which is expected to further reduce the risk of clinical endpoint events. Since the clinical benefit from the improvement of liver fibrosis usually takes a long time to observe, this trial takes an extended treatment approach to continuously evaluate the clinical benefit of subjects undergoing long-term treatment with hydroxylnidone capsules in patients with liver fibrosis.

This study is a Phase IIIb extension trial following the "randomized, double-blind, placebo-controlled, entecavir basic treatment, multi-center Phase III clinical trial of hydroxnidone capsules in the treatment of liver fibrosis of chronic viral 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 hydroxyeidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.

The test group received hydroxnidone 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: October 20, 2028
• Est. primary completion date: June 20, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis B
• Hepatitis B, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
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	Chongqing Public health medical treatment Center	Chongqing
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	The Fourth Affiliated Hospital of Harbin Medical University	Harbin
China	The First Hospital of Hebei Medical University	Hebei
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei
China	Henan Provincial People's Hospital	Henan
China	The First Affiliated Hospital of Hunan University of Chinese Medicine	Hunan
China	Lanzhou university first hospital	Lanzhou
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	The Second Hospital of Ningbo	Ningbo
China	Huashan Hospital affiliated to Fudan University	Shanghai
China	Shanghai General Hospital,Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai
China	Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai
China	Shenzhen Third People's Hospital	Shenzhen
China	Taizhou People's Hospital	Taizhou
China	Wuxi Fifth People's Hospital	Wuxi
China	Xiamen Hospital of Traditional Chinese Medicine	Xiamen
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang
China	Yanbian University Affiliated Hospital	Yanbian
China	Zhengzhou Sixth People's Hospital	Zhengzhou
China	Zhenjiang Third People's Hospita	Zhenjiang
China	Affiliated Hospital of Zunyi Medical University	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Continent Pharmaceutical Co, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event).	For non-cirrhotic patients, clinical endpoints include progression to cirrhosis, decompensated cirrhosis complications [ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy, etc.], hepatocellular carcinoma, liver transplantation or liver disease-related death / all-cause death; for patients with cirrhosis, clinical endpoints include occurrence of decompensated cirrhosis complications, hepatocellular carcinoma, liver transplantation or liver disease-related death or all-cause death.	5years