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

KDN-F351-202201

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.

2023-08-12

2028-06-20

2028-10-20

Recruiting

Early phase I

248

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Test group: hydroxylidone capsules, three times a day, 3 doses, daily therapeutic dose of 270 mg, half an hour before the meal Oral medicine. Control group: placebo capsules, three times a day, half an hour before the meal.\n\nBasic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, fasting oral administration.\n\nIn case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Before the clinical trial begins, the test drug and placebo are packaged in the same way, and the drug number is marked on the packaging according to the random table. The subjects take the drugs according to the randomly assigned drug number.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 248, 'type': 'ESTIMATED'}}

2024-01-17