Non-invasive approach to assess liver fibrosis in chronic 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 observational study enrolls 1000 patients with chronic hepatitis B who have undergone liver biopsy at least one year after receiving antiviral therapy. It collects various health metrics, including liver stiffness measurements and blood tests, to develop a predictive model for liver fibrosis regression. The study aims to validate this model using an independent cohort of patients with similar criteria. The focus is on understanding the relationship between liver stiffness and fibrosis regression in patients treated with nucleos(t)ide analogs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yameng Sun
• Email: sunyamenggo@163.com
• Phone: 0086-13810643902

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• Umbilical cord stem cells added during Kasai to help biliary atresia

  This early-stage trial tests whether injecting umbilical cord mesenchymal stem cells during Kasai portoenterostomy is safe and helpful for infants with biliary atresia.

  Recruiting Phase 1 Dr Cipto Mangunkusumo General Hospital · Jakarta Pusat, DKI Jakarta · NCT07797673

• Automated Passive Case-Finding for Advanced Liver Fibrosis in MASLD

  This program automatically screens high‑risk adults aged 50–75 in primary care to see if they have advanced liver fibrosis and possible MASLD, using routine blood tests and reflex lab tests without extra work for clinicians.

  Recruiting Hospital General Universitario Gregorio Marañon · Madrid, Madrid · NCT07658755

• AZD2389 safety and dosing in adults with fatty liver disease and advanced liver scarring

  This study tests whether AZD2389 is safe and how it behaves in adults with steatotic liver disease and advanced fibrosis, comparing it to placebo over about six months.

  Recruiting at 22 sites Phase 2 AstraZeneca · Chandler, Arizona and 21 other locations · NCT07610837

• See if EUS-SWQ can accurately detect and grade liver fibrosis in adults with chronic liver disease

  This study tests whether the endoscopic ultrasound shear wave quantification (EUS-SWQ) can match liver biopsy results in adults with chronic liver disease to diagnose and stage fibrosis, and whether it offers safety and measurement advantages over FibroScan.

  Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07588854

• Non-invasive liver fibrosis testing in children and young adults with type III glycogen storage disease

  This project tries to see if non-invasive liver stiffness measurements (like elastography) can monitor liver fibrosis in children and young adults with type III glycogen storage disease.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07303140

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.