An Study of Efficacy and Safety of Clevudine

Study Overview
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Brief Summary
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Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B

Official Title
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A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Clevudine
* Drug: Adefovir


Participation Criteria
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Eligibility Criteria
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Patients are between 18 and 65, inclusive. All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study. Hepatitis B virus Early Antigen (HBeAg) positive patient with HBV DNA >1 x 105 copies/ml, HBeAg negative patient with HBV DNA >1 x 104 copies/ml within 30 days of baseline. Absolute neutrophil count > 1500 /mm3. Alpha fetoprotein within normal laboratory limit at screening. Normal electrocardiogram (ECG) or clinically non-significant changes at screening. Able to participate and willing to give written informed consent before starting therapy. Able and willing to comply with study assessments and restrictions. Normal renal function to take Adefovir without any dose modifications; Creatinine clearance must be >50 ml/min (based on the Cockcroft-Gault equation. Exclusion criteria Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease. Poorly controlled type I or type 2 diabetes mellitus Donation or loss more than 400 ml blood within 60 days of baseline. Known serious allergies to nucleoside/nucleotide analogs. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Clevudine<br>* Clevudine flexible dosages of 30 mg/day<br>|
| Active Comparator: 2<br> | Drug: Adefovir<br>* Adefovir flexible dosages of 10 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. |  | 48 weeks | 
| Histological response |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay. |  | 48 weeks | 
| Percent of patients with normalization of alanine aminotransferase (ALT) at week 48 |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clevudine, efficacy, safety, chronic hepatitis B