Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B (ADAPT)

  • STATUS
    Recruiting
  • End date
    Dec 27, 2024
  • participants needed
    140
  • sponsor
    Asan Medical Center
Updated on 27 May 2022

Summary

Multicenter, Prospective Open-label Single Arm Trial Chronic hepatitis B male and female adults on antiviral treatment for hepatitis B, without cirrhosis who are currently HBV DNA (-) and HBeAg (-) To evaluate the safety and efficacy of stopping long-term antiviral therapy in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-)

Description

This clinical trial is a multicenter, Prospective Open-label Single Arm Trial to compare the short-term clinical outcome between stopping and continuing antiviral treatment in chronic hepatitis B patients without cirrhosis who are currently HBV DNA (-) and HBeAg (-) Approximately 140 subjects meeting eligibility criteria will be enrolled a Intervention Arm as below;

  • Intervention Arm: 140 subjects, discontinue antiviral treatment (stop group)
  • Historical cohort: 140 subjects, continue antiviral treatment

Stop group is scheduled to be followed up to 6months. Patients in the stop group were retreated with nucleos(t)ide analogues that had been prescribed previously if they fulfill one of the following criteria: 1) HBV DNA >2,000 IU/mL, 2) progression to liver cirrhosis, or 3) development of hepatocellular carcinoma.

Details
Condition Hepatitis B, Chronic
Treatment Stop group, Continue group
Clinical Study IdentifierNCT04782375
SponsorAsan Medical Center
Last Modified on27 May 2022

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