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

January 15, 2024 updated by: Beijing Continent Pharmaceutical Co, Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

248

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing youan hospital, the capital of the capital
        • Contact:
          • Sujun Zheng
      • Beijing, China
        • Recruiting
        • Tsinghua Changgeng Hospital, Beijing
        • Contact:
          • Yuan Huang
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
          • Wei Li
      • Changsha, China
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:
          • Yan Huang
      • Changsha, China
        • Recruiting
        • The Second Xiangya Hospital, Central South University
        • Contact:
          • Yongfang Jiang
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Yongguo Li
      • Chongqing, China
        • Recruiting
        • Three Gorges Hospital Affiliated to Chongqing University
        • Contact:
          • Xuan An
      • Chongqing, China
        • Recruiting
        • Chongqing Public health medical treatment Center
        • Contact:
          • Yuming Wang
      • Guizhou, China
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
          • Xinhua Luo
      • Hangzhou, China
        • Recruiting
        • Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)
        • Contact:
          • Jianfeng Bao
      • Harbin, China
        • Recruiting
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
          • Lei Yu
      • Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Liping Liu
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
        • Contact:
          • Lei Li
      • Henan, China
        • Recruiting
        • Henan provincial people's hospital
        • Contact:
          • Jia Shang
      • Hunan, China
        • Recruiting
        • The First Affiliated Hospital of Hunan University of Chinese Medicine
        • Contact:
          • Kewei Sun
      • Lanzhou, China
        • Recruiting
        • Lanzhou University First Hospital
        • Contact:
          • XiaoRong Mao
      • Luzhou, China
        • Recruiting
        • Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
        • Contact:
          • Jing Wang
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Xiaoping Wu
      • Nanchang, China
        • Recruiting
        • Nanchang Ninth Hospital (Nanchang Central Hospital)
        • Contact:
          • Long Xu
      • Nanjing, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
        • Contact:
          • Jun Li
      • Ningbo, China
        • Recruiting
        • The Second Hospital of Ningbo
        • Contact:
          • Liyun Fu
      • Shanghai, China
        • Recruiting
        • Huashan Hospital affiliated to Fudan University
        • Contact:
          • Jiming Zhang
      • Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
          • Zhanqing Zhang
      • Shanghai, China
        • Recruiting
        • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
        • Contact:
          • Xuehua Sun
      • Shenzhen, China
        • Recruiting
        • Shenzhen Third People's Hospital
        • Contact:
          • Qingxian C
      • Taizhou, China
        • Recruiting
        • Taizhou People's Hospital
        • Contact:
          • Jianchun Xian
      • Wuxi, China
        • Recruiting
        • Wuxi Fifth People's Hospital
        • Contact:
          • Hangyuan Wu
      • Xiamen, China
        • Recruiting
        • Xiamen Hospital of Traditional Chinese Medicine
        • Contact:
          • Qingfa Ruan
      • Xinxiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
          • Xinwen Song
      • Yanbian, China
        • Recruiting
        • Yanbian University Affiliated Hospital
        • Contact:
          • Ning Chen
      • Zhengzhou, China
        • Recruiting
        • Zhengzhou Sixth People's Hospital
        • Contact:
          • Anna Zhang
      • Zhenjiang, China
        • Recruiting
        • Zhenjiang Third People's Hospita
        • Contact:
          • Youwen Tan
      • Zunyi, China
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
          • Yawen Luo
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing Ditan Hospital Capital Medical University
        • Contact:
          • Wen Xie
    • Shanghai
      • Shanghai, Shanghai, China, 201620
        • Recruiting
        • Shanghai General Hospital,Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydronidone group
Patients were given three capsules of hydronidone three times a day for 5 years.
Drug: Hydronidone capsules
After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.
Other Names:
  • F351
Placebo Comparator: The placebo group
Patients were given three capsules of placebo three times a day 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.
Other Names:
  • N

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of clinical endpoint events (defined as the occurrence of any clinical endpoint event).
Time Frame: 5years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Investigators

  • Principal Investigator: Lungen Lu, Dr, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Principal Investigator: Jun Cheng, Dr, Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2023

Primary Completion (Estimated)

June 20, 2028

Study Completion (Estimated)

October 20, 2028

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDN-F351-202201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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