HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
NCT ID: NCT03405597
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
97 participants
INTERVENTIONAL
2017-03-30
2018-06-30
Brief Summary
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There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy control
Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Chronic hepatitis B with vaccination
Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
Chronic hepatitis B without vaccination
Standard treatment
Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
Interventions
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Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Principal Investigators
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Tawesak Tanwandee
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University
Locations
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Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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Chairat Shayakul
Role: primary
References
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Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22.
Other Identifiers
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13/2560(EC1)
Identifier Type: -
Identifier Source: org_study_id
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