NCT04782375

Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B

A Multicenter Prospective Open-label Single Arm Trial to Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B With a Comparison to Matched Historical Controls (ADAPT)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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 (-)

Detailed 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: 700 subjects, continue antiviral treatment Stop group is scheduled to be followed up to 12months. 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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Stop group	discontinue antiviral treatment

Timeline

• Start date: 2021-09-01
• Primary completion: 2024-08-19
• Completion: 2026-01-31
• First posted: 2021-03-04
• Last updated: 2025-10-03

Locations

9 sites across 1 country: South Korea