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

NCT05905172 | Recruiting Phase 3

• 1 other identifier: KDN-F351-202201
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hydronidone group

EXPERIMENTAL

Patients were given three capsules of hydronidone three times a day for 5 years.

Drug: Hydronidone capsules

The placebo group

PLACEBO COMPARATOR

Patients were given three capsules of placebo three times a day for 5 years.

Drug: The placebo capsules

Interventions

Hydronidone capsules DRUG

After randomization, the experimental group received hydronidone capsules three times a day, 3 capsules each time, for 5 years.

Also known as: F351

Hydronidone group

The placebo capsules DRUG

After randomization, The control group received three placebo capsules three times a day. 3 capsules each time, for 5 years.

Also known as: N

The placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (23)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

Shanghai General Hospital,Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201620, China

RECRUITING

Beijing youan hospital, the capital of the capital

Beijing, China

RECRUITING

Tsinghua Changgeng Hospital, Beijing

Beijing, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

RECRUITING

The Second Xiangya Hospital, Central South University

Changsha, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Three Gorges Hospital affiliated to Chongqing University

Chongqing, China

RECRUITING

Guizhou Provincial People's Hospital

Guizhou, China

RECRUITING

Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)

Hangzhou, China

RECRUITING

Henan Provincial People's Hospital

Henan, China

RECRUITING

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

Luzhou, China

RECRUITING

Nanchang Ninth Hospital (Nanchang Central Hospital)

Nanchang, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Nanjing, China

RECRUITING

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, China

RECRUITING

Huashan Hospital affiliated to Fudan University

Shanghai, China

RECRUITING

Shenzhen Third People's Hospital

Shenzhen, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China

RECRUITING

Yanbian University Affiliated Hospital

Yanbian, China

RECRUITING

Zhenjiang Third People's Hospita

Zhenjiang, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

hydronidone; 5-methyl-1-(4-hydroxylphenyl)-2-(1H)-pyridone

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lungen Lu, Dr

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jun Cheng, Dr

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Zhang, Dr

CONTACT

+86-13501209210; zhangling@bjcontinent.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Test group: hydronidone capsules, three times a day, 3 capsules each time，oral，daily therapeutic dose of 270 mg, half an hour before the meal Control group: placebo capsules, three times a day, 3 capsules each time，oral，half an hour before the meal. Basic treatment: Both test and control groups were treated with entecavir antiviral therapy, once daily, 0.5 mg per time, oral. In case of drug resistance or other conditions requiring dose adjustment, the investigator may adjust the dose and type of basic treatment drug appropriately.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: August 12, 2023
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): October 20, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)