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) (ADAPT)
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- STATUS
- Recruiting
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- End date
- Dec 25, 2024
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- participants needed
- 140
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- sponsor
- Asan Medical Center
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: 700 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 Identifier | NCT04782375 |
| Sponsor | Asan Medical Center |
| Last Modified on | 25 October 2022 |
Eligibility
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