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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing youan hospital, the capital of the capital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Tsinghua Changgeng Hospital, Beijing Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Bengbu Medical University Coordinator of this site? Confirm its status | Bengbu | China | Recruiting |
| The Second Xiangya Hospital, Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Three Gorges Hospital Affiliated to Chongqing University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Guizhou Provincial People's Hospital Coordinator of this site? Confirm its status | Guizhou | China | Recruiting |
| Hangzhou Xixi Hospital (Hangzhou Sixth People's Hospital) Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Henan | China | Recruiting |
| Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University Coordinator of this site? Confirm its status | Luzhou | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Nanchang Ninth Hospital (Nanchang Central Hospital) Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital) Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Ningbo Huamei Hospital, University of Chinese Academy of Sciences Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shanghai General Hospital, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huashan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shenzhen Third People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical College Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| Yanbian University Affiliated Hospital Coordinator of this site? Confirm its status | Yanbian | China | Recruiting |
| Zhenjiang Third People's Hospita Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.