Non-Invasive Model for Fibrosis Regression in HBV Patients
Launched by BEIJING FRIENDSHIP HOSPITAL · Mar 11, 2025
Trial Information
Current as of April 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to predict the improvement of liver health in patients with chronic Hepatitis B virus (HBV) infection who have already received antiviral treatment. The researchers are looking at 1,000 patients who had liver biopsies at least one year after their treatment. They will gather various health information, including blood tests and imaging results, to create a model that can help estimate how well the liver is healing over time. The goal is to better understand liver fibrosis, which is the scarring of the liver, and to find ways to tell if patients are getting better.
To participate in this trial, patients need to have had a liver biopsy done at least a year after they started antiviral therapy. They should not have serious liver complications or other severe health issues, and they cannot have certain other liver diseases or conditions. If eligible, participants can expect to provide health information and have their liver condition monitored, which may help improve care for others with similar conditions in the future. This research is important because it aims to develop a simple way to assess liver health that can benefit many patients with chronic HBV.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with liver biopsy performed at least 1 year after antiviral therapy;
- • Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.
- Exclusion Criteria:
- • Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
- • Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
- • Patients with malignant lesion on liver image;
- • Patients with other uncured malignant tumors;
- • Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
- • Pregnant or lactating women;
- • Patients with any other reasons not suitable for the study.
About Beijing Friendship Hospital
Beijing Friendship Hospital, affiliated with Capital Medical University, is a leading comprehensive medical institution located in Beijing, China. Renowned for its advanced clinical services and cutting-edge research, the hospital plays a pivotal role in promoting healthcare innovation and improving patient outcomes. As a prominent clinical trial sponsor, Beijing Friendship Hospital is committed to conducting high-quality, ethical research that adheres to international standards. The hospital's multidisciplinary teams leverage their expertise across various medical fields to facilitate the development of new therapies and interventions, ultimately contributing to the advancement of medical science and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported