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
236 participants
OBSERVATIONAL
2013-06-01
2019-12-31
Brief Summary
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Detailed Description
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Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (\<20 IU/mL) at month 36.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. documented HBsAg positivity at least 6 months before enrollment
2. age \>18 years old,
3. confirmed genotypic resistance to more than two classes of NAs
4. HBV DNA level ≥ 200 IU/mL
5. compensated liver diseases (defined by Child-Pugh-Turcotte score \<7; prothrombin time \<3 seconds above upper limit of normal or international normalized ratio \<1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)
6. willingness to give an informed consent.
Exclusion Criteria
2. no definite evidence of genotypic resistance
3. positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
4. HCC
5. a proof of pregnant or lactating women
6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
7. any untreated malignancy.
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
CHA University
OTHER
Soon Chun Hyang University
OTHER
Chonbuk National University
OTHER
Hallym University
OTHER
Inje University
OTHER
The Catholic University of Korea
OTHER
Korea University
OTHER
Responsible Party
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Hyung Joon Yim
Professor
Locations
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Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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MDRCHB
Identifier Type: -
Identifier Source: org_study_id
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