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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Lungen Lu, Dr — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Ling Zhang, Dr
• Email: zhangling@bjcontinent.com
• Phone: +86-13501209210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.