Status:
UNKNOWN
HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
Lead Sponsor:
Mahidol University
Conditions:
Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there ...
Eligibility Criteria
Inclusion
- Chronic Hepatitis B infection group
- 18-80 year-old
- Compensated liver disease
- Chronic HBV infection with or without NUCs treatment
- History of HBsAg positive \> 6 months
- HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart
- HBsAb negative
- HBV DNA \< 20 IU/mL
- Healthy group
- Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)
Exclusion
- History of previous HBV vaccination
- Anti-HCV and/or anti-HIV positive
- Decompensated cirrhosis
- History of previous malignancies
- History or currently receive immunotherapy, cytotoxic or immunosuppressive agents
- Patient with immunodeficiency disease
- Creatinine \> 1.5 mg/dL
- Pregnancy or lactating woman
- Unable to consent
Key Trial Info
Start Date :
March 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2018
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03405597
Start Date
March 30 2017
End Date
June 30 2018
Last Update
January 23 2018
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700