Long-term Study With Clevudine

Study Overview
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Brief Summary
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A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

Official Title
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A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Clevudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline. Patient is documented to be HBsAg positive for > 6 months. Patient has ALT levels >=80 IU/L Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy. Exclusion Criteria. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. Patients previously treated with interferon within the previous 6 months. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma Patient is pregnant or breast-feeding. Patient is unwilling to use an effective method of contraception during the study and for up to 3 months after the use of study drug ceases. Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clevudine|clevudine 30 mg qd|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR |  | Screening, day1,every 12 weeks during treatment period(96weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation |  | Screening, day1, every 12 weeks during treatment period(96 weeks) |