Long-term treatment with hydronidone capsules for liver fibrosis in hepatitis B patients

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

This study is testing if taking hydronidone capsules for a longer time can help people with liver fibrosis caused by hepatitis B feel better and improve their liver health.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. (industry)
• Locations: 23 sites (Beijing, Beijing Municipality and 22 other locations)
• Trial ID: NCT05905172 on ClinicalTrials.gov

What this trial studies

This Phase IIIb extension trial evaluates the long-term effectiveness and safety of hydronidone capsules in patients with chronic viral hepatitis B liver fibrosis. Following a previous Phase III trial, participants who completed the initial study can continue treatment with hydronidone to assess its impact on liver fibrosis over an extended period. The study aims to provide insights into the potential benefits of hydronidone in reducing liver fibrosis severity and associated clinical risks. Given the lack of effective treatments for liver fibrosis, this trial is crucial for understanding the long-term outcomes of hydronidone therapy.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed the initial Phase III trial of hydronidone and are experiencing liver fibrosis due to chronic hepatitis B.

Not a fit: Patients who have experienced clinical endpoints such as progression to cirrhosis or hepatocellular carcinoma during the previous trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of liver fibrosis in patients with chronic hepatitis B.

How similar studies have performed: While some studies have reported effects of other drugs on liver fibrosis, hydronidone's specific approach in this context is novel and has not been widely tested.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 22 other locations

• Beijing Ditan Hospital Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Shanghai General Hospital,Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, 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)

Study contacts

• Principal investigator: Lungen Lu, Dr — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ling Zhang, Dr

Conditions: Liver Fibrosis