This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir
monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B
patients with Undetectable Hepatitis B Virus DNA
Drug: Lamivudine plus adefovir
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Full eligibility criteria for NCT01732367
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Male and female patients aged 18 or older
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.
Patients with decompensated liver disease
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
All locations for NCT01732367
Korea, Republic of (1)
Department of Internal Medicine, Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, ASI|KR|KS002|TAEGU
View full eligibility
Tris trial is registered with FDA with number: NCT01732367. The sponsor of the trial is Keimyung University Dongsan Medical Center and it is looking for 171 volunteers for the current phase.
Official trial title: Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA.
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