Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

NCT03777969 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-09-06

No results posted yet for this study

Summary

A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.

Conditions

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • ShuGuang Hospital

    collaborator OTHER
  • Beijing Ditan Hospital

    collaborator OTHER
  • Hangzhou Choutu Technology Co.,Ltd.

    collaborator UNKNOWN
  • Wuxi Hisky Medical Technologies Co., Ltd.

    collaborator UNKNOWN
  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Hong You, Doctor · Beijing Friendship Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777969 on ClinicalTrials.gov