None listed
Conditions
Interventions
Drug : his 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
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. Patien
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion 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 <3,000 IU/mL at the time of screening 4. Antiviral treatment continued at least 2 years and HBeAg (-) at the time of screening 5. Undetectable HBV DNA level at the time of screening 6. Serum ALT level <80 IU/mL at the time of screening 7. Estimated creatinine clearance =30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation) 8. Ability to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1) Confirmed known co-infection with HCV, HIV, or HDV 2) Evidence of liver cirrhosis defined as meeting any of the following criteria: (1) Splenomegaly (>12 cm) assessed by ultrasound, CT, or MRI (2) Fibroscan =9.0 kPa (3) Platelet count 40 mg/day for >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 a-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of virological relapse defined as HBV DNA =2,000 IU/mL at 6months and 12months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of liver-related unexpected hospital admission;Proportion of clinical relapse (HBV DNA =2,000 IU/mL and ALT =80 IU/mL) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyangki Lee
Asan Medical Center
Outcome results
None listed