Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

Asan Medical Center90 enrolled

Overview

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

LamivudineDRUG

Lamivudine 100mg/day orally

AdefovirDRUG

Adefovir 10mg/day orally

EntecavirDRUG

Entecavir 1mg/day orally

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic hepatitis B * Age ≥ 20 year old * Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks * Proven Lamivudine resistant mutation * HBV DNA levels at screening ≥ 15 IU/mL * Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test * Patient is able to give written informed consent prior to study start and to comply with the study requirements Exclusion Criteria: * A history or current of decompensated cirrhosis or hepatocellular carcinoma * Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy * Co-infected with HCV or HIV * A history of organ transplantation * Pregnant or breast-feeding * Current clinically relevant of abuse of alcohol or drugs. * Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy * malignancy in previous 5 years

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients with HBV DNA<15IU/mL

Time frame: week 48

Secondary Outcomes

Proportion of patients with HBV DNA<15IU/mL

Time frame: Day1, week12, week 24, week 36, week 48

The change of HBV DNA from the baseline

Time frame: week 48

Proportion of patients with ALT normalization

Time frame: Day1, week12, week 24, week 36, week 48

Proportion of patients with HBeAg loss and/or seroconversion

Time frame: Day1, week12, week 24, week 36, week 48

The change of HBsAg from the baseline

Time frame: week 48

Proportion of patients with HBsAg loss and/or seroconversion

Time frame: week 24, week 48

Proportion of patients who experienced virologic breakthrough

Time frame: week 48

Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)

Composite outcome measure consisting of multiple measures, including: 1. Number of patients with Adverse events( including SAEs) 2. Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time 3. Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other 4. Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)

Central Contacts

Danbi Lee

CONTACT

82)2-3010-3907 leighdb@hanmail.net

Data from ClinicalTrials.gov

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