Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

Study Overview
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Brief Summary
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Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

Detailed Description
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The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.

Official Title
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PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Cavir
* Drug: Baraclude


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening. Exclusion Criteria: Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC) Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV) Patient had documented resistance mutations at any time before or at screening Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease. Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study. Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks. Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3 Patient is pregnant or breastfeeding or willing to be pregnant Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavir<br>entecavir/0.5mg/day | Drug: Cavir<br>* 0.5mg/day<br>* Other names: entecavir;|
| Active Comparator: Baraclude<br>entecavir/0.5mg/day | Drug: Baraclude<br>* 0.5mg/day<br>* Other names: entecavir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with maintenance of HBV DNA undetectability | analysis | 48weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with HBeAg seroconversion | analysis | at week 12, 24, 36 and 48 of treatment | 
| The proportion of patients with HBeAg seroclearance | analysis | at week 12, 24, 36 and 48 of treatment | 
| The proportion with HBsAg seroclearance | analysis | at week 48 of treatment | 
| The proportion with HBeAg seroconversion and HBsAb positive | analysis | at week 48 of treatment | 
| Changes in serum HBV DNA levels | analysis | at week 48 of treatment | 
| Changes in HBsAg titer | analysis | at week 48 of treatment | 
| Changes in ALanine amino Transferase (ALT) | analysis | at week 48 of treatment | 
| Proportion of patients with virologic breakthrough | virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment | at week 48 of treatment | 
| Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L) | questionnaire | at week 48 of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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entecavir