TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA
NCT ID: NCT01732367
Last Updated: 2016-10-28
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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COMPLETED
PHASE4
171 participants
INTERVENTIONAL
2012-11-30
2016-04-30
Brief Summary
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Detailed Description
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In particular, the annual resistance rate to lamivudine currently widely being used in Korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years.
The guidelines by the American Association for the Study of Liver Disease (AASLD) and the European Association for the Study of the Liver (EASL) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant HBV .
In Korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions.
Tenofovir that has been developed most recently and will be placed on sale sooner or later in Korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir.
In particular, several papers reported that tenofovir has effective and sustaining antiviral effects in patients who had other antiviral agents resistant HBV as well as those who received initial treatment. This shows that patients only with lamivudine resistant HBV can be treated only with tenofovir without a combination therapy and when they have low levels of HBV DNA, treatment is relatively effective despite their resistance to adefovir.
Therefore, it is considered that tenofovir switching therapy in patients with undetectable HBV DNA after lamivudine plus adefovir combination therapy to maintain their virus response.
The results of this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in such patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lamivudine plus adefovir
Continue lamivudine/adefovir add on treatment (standard treatment)
Lamivudine plus adefovir
Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks
Tenofovir
Switch from lamivudine/adefovir add on treatment to tenofovir monotherapy
Tenofovir
Tenofovir 300mg QD for 96 weeks
Interventions
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Lamivudine plus adefovir
Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks
Tenofovir
Tenofovir 300mg QD for 96 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.
Exclusion Criteria
* Patients with HCV, HDV or HIV
* Patients with HCC
* Serum ALT \> 2x ULN level
* Serum creatinine \> 2.0mg/dL
* Pregnant or lactating women
* Women who have a plan for pregnancy within the three coming years
* Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection
* Those who have no capabilities to understand and sign an informed consent
18 Years
ALL
No
Sponsors
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Kyungpook National University Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
DongGuk University
OTHER
Pusan National University Hospital
OTHER
Yeungnam University Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Responsible Party
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Jang Byoung Kuk
Keimyung University Dongsan Medical Center
Principal Investigators
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Byoung Kuk Jang, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Keimyung University Dongsan Medical Center
Locations
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Department of Internal Medicine, Keimyung University Dongsan Medical Center
Daegu, , South Korea
Countries
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References
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Lee HJ, Kim SJ, Kweon YO, Park SY, Heo J, Woo HY, Hwang JS, Chung WJ, Lee CH, Kim BS, Suh JI, Tak WY, Jang BK. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. PLoS One. 2018 Jan 12;13(1):e0190581. doi: 10.1371/journal.pone.0190581. eCollection 2018.
Other Identifiers
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TDF0001
Identifier Type: -
Identifier Source: org_study_id