Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV

Study Overview
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Brief Summary
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The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative

Official Title
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A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Clevudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were between 18 and 60, inclusive Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline. Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening). Patients who were HBeAg negative and HBeAb positive. Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL. Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy. Patients who were able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patients coinfected with HCV, HDV or HIV. Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL Patients who were pregnant or breast-feeding. Patients who were unwilling to use an effective method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence) Patients with a clinically relevant history of abuse of alcohol or drugs. Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor. Patients with 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clevudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: |  |  | 
| Antiviral activity (change from baseline in HBV DNA (log 10)) |  |  | 
| Safety: |  |  | 
| Laboratory tests |  |  | 
| Adverse Events |  |  | 
| Vital signs |  |  | 
| ECG |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay) |  |  | 
| Biochemical improvement (e.g. ALT normalization ) |  |  |