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

Status Recruiting

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT05905172
• Study type: Interventional
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Contact: Ling Zhang, Dr
• Phone: +86-13501209210
• Email: zhangling@bjcontinent.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 12, 2023
• Completion date: October 20, 2028