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Completed
NCT04782375
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
Conditions: Hepatitis B, Chronic
Sex: All
Ages: 19 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 140
Sponsor: Asan Medical Center
Location: Asan Medical Center Seoul
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 (-)
Eligibility Criteria
Inclusion Criteria:
1. Willing and able to provide written informed consent prior to study entry
2. Age ≥19 years and ≤65 years at the time of screening
3. HBsAg titer \2 weeks), azathioprine, or monoclonal antibodies
7. Received solid organ or bone marrow transplant
8. Any other clinical conditions (cardiovascular, respiratory, neurologic, or renal conditions) or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
9. History or current evidence of hepatocellular carcinoma (HCC), or high α-fetoprotein (AFP) \> 20 ng/mL. (But, the patients with AFP \> 20 ng/mL can be enrolled and there is no evidence of HCC by dynamic CT or MRI perfomred within 4 months prior to the screening)
10. Malignancy other than hepatocellular carcinoma within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (within 2 years prior to screening with confirmation of no evidence of disease). Subjects under evaluation for possible malignancy are not eligible.
11. Concurrent enrollment in another clinical study for other type of antiviral treatment for CHB or immune modulatory drug within 3 months prior to Screening, participation to an observational (non-interventional) clinical studies or interventional studies not using anti-HBV or immune modulatory drugs, or during the follow-up period of an interventional study are not exclusion criteria.
12. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
Source: ClinicalTrials.gov (NCT04782375). StuddyBuddy aggregates publicly available trial information.