An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Study Overview
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Brief Summary
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This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.

Official Title
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An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Clevudine 30mg
* Drug: Clevudine 20mg+Adefovir dipivoxil 10mg
* Drug: Clevudine 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years and older. Patient is documented to be HBsAg positive for > 6 months. Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline. Patient has ALT levels ≥ 1×ULN Patient who is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection. Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL) Patient is coinfected with HCV, HDV or HIV. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient with clinical evidence of hepatocellular carcinoma Patient with previous liver transplantation Patient is pregnant or breast-feeding. 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

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: 1<br>Clevudine 30mg | Drug: Clevudine 30mg<br>* Clevudine 30mg<br>* Other names: Levovir 30mg;|
| Experimental: 2<br>Clevudine 20mg+Adefovir dipivoxil 10mg | Drug: Clevudine 20mg+Adefovir dipivoxil 10mg<br>* Clevudine 20mg+ Adefovir 10mg<br>* Other names: Levovir 20mg+Adefovir 10mg;|
| Experimental: 3<br>Clevudine 20mg | Drug: Clevudine 20mg<br>* Clevudine 20mg<br>* Other names: Levovir 20mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBV DNA levels < 300 copies/mL |  | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HBV DNA form the baseline | (log copies/mL) | 24week, 48week, 96week | 
| Proportion of patients with HBV DNA < 300 copies/mL |  | 48week, 96week | 
| Proportion of patients with ALT normalization |  | 24week, 48week, 96week | 
| Proportion of patients with HBeAg loss and/or seroconversion |  | 96 Week |