Tenofovir Combination or Mono-therapy for MDR CHB
Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
1 other identifier
observational
236
1 country
1
Brief Summary
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJuly 24, 2018
July 1, 2018
5.6 years
July 16, 2018
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Virologic Response
undetectable HBV DNA (\<20 IU/mL)
36 months
Secondary Outcomes (6)
Virologic Response
60 months
mean HBV DNA
36 months, 60 months
ALT normalization
36 months, 60 months
Hepatitis B e antigen (HBeAg) seroconversion
36 months, 60 months
virologic breakthrough
36 months, 60 months
- +1 more secondary outcomes
Other Outcomes (1)
Adverse event
36 months, 60 months
Eligibility Criteria
Chronic hepatitis B patients with multiple drug resistance.
You may qualify if:
- CHB patients with:
- documented HBsAg positivity at least 6 months before enrollment
- age \>18 years old,
- confirmed genotypic resistance to more than two classes of NAs
- HBV DNA level ≥ 200 IU/mL
- 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)
- willingness to give an informed consent.
You may not qualify if:
- laboratory abnormalities of low serum phosphorous level \<2.0 mEq/dL, elevated serum creatinine \>1.5 mg/dL, decreased creatinine clearance rate \<50 mL/min, absolute neutrophil count \<1000 cell/mL, or low hemoglobin level \<10 g/dL (if female, \<9 g/dL)
- no definite evidence of genotypic resistance
- positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
- HCC
- a proof of pregnant or lactating women
- evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
- any untreated malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
- Yonsei Universitycollaborator
- CHA Universitycollaborator
- Soon Chun Hyang Universitycollaborator
- Chonbuk National Universitycollaborator
- Hallym Universitycollaborator
- Inje Universitycollaborator
- The Catholic University of Koreacollaborator
Study Sites (1)
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355, South Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2018
First Posted
July 24, 2018
Study Start
June 1, 2013
Primary Completion
December 31, 2018
Study Completion
December 31, 2019
Last Updated
July 24, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share
Confidential