Status:
UNKNOWN
Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
Lead Sponsor:
Korea University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1...
Detailed Description
This study is a prospective single-arm open-label trial. The primary endpoint is virological response (\<20 IU/mL) at 12 months after switching treatment. Patients who satisfy the inclusion and exclu...
Eligibility Criteria
Inclusion
- Age \>19 years old CHB patients
- Confirmed antiviral resistance
- Taking brand entecavir 1 mg for more than 1 year
- HBV DNA \< 20 IU/mL
- Compensated liver cirrhosis
- Willing to participate
Exclusion
- Failure to meet the inclusion criteria
- Cr\>1.5 mg/dL
- Postive HCV Ab
- Decompensated cirrhosis
- Pregnant women
- HCC
- Alcoholics
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04069858
Start Date
December 1 2016
End Date
December 31 2020
Last Update
February 17 2020
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 15355