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Active Not RecruitingNCT03777969

Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
2,000 (estimated)
Sponsor
Beijing Friendship Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Detailed description

No.

Conditions

Timeline

Start date
2018-06-29
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2018-12-19
Last updated
2022-09-06

Locations

7 sites across 1 country: China

Source: ClinicalTrials.gov record NCT03777969. Inclusion in this directory is not an endorsement.