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NCT05905172RecruitingPhase 3

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

A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B

Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
248 (estimated)
First submitted
7 Jun 2023
Start date
12 Aug 2023
Primary completion date
20 Jun 2028
Lead sponsor
Beijing Continent Pharmaceutical Co, Ltd.
Diseases
Hepatitis B
NCT number
NCT05905172

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 248
  • From 12 Aug 2023 to the primary completion date, 20 Jun 2028
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing youan hospital, the capital of the capital
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BeijingChinaRecruiting
Tsinghua Changgeng Hospital, Beijing
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BeijingChinaRecruiting
Beijing Ditan Hospital, Capital Medical University
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BeijingChinaRecruiting
The First Affiliated Hospital of Bengbu Medical University
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BengbuChinaRecruiting
The Second Xiangya Hospital, Central South University
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ChangshaChinaRecruiting
Xiangya Hospital Central South University
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ChangshaChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
Three Gorges Hospital Affiliated to Chongqing University
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ChongqingChinaRecruiting
Guizhou Provincial People's Hospital
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GuizhouChinaRecruiting
Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital)
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HangzhouChinaRecruiting
Henan Provincial People's Hospital
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HenanChinaRecruiting
Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
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LuzhouChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
Nanchang Ninth Hospital (Nanchang Central Hospital)
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NanchangChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
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NanjingChinaRecruiting
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
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NingboChinaRecruiting
Shanghai General Hospital, Shanghai Jiao Tong University
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ShanghaiChinaRecruiting
Huashan Hospital Affiliated to Fudan University
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ShanghaiChinaRecruiting
Shenzhen Third People's Hospital
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ShenzhenChinaRecruiting
The First Affiliated Hospital of Xinxiang Medical College
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XinxiangChinaRecruiting
Yanbian University Affiliated Hospital
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YanbianChinaRecruiting
Zhenjiang Third People's Hospita
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ZhenjiangChinaRecruiting
Affiliated Hospital of Zunyi Medical University
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ZunyiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.