Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

Study Overview
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Brief Summary
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This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.

Official Title
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Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study)

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Lamivudine
* Drug: Telbivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented compensated HBeAg-positive or negative chronic hepatitis B Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification) Negative urine pregnancy test with fertile women Willingness to use a recognized method of contraception Able to comply with study regimen and provide written informed consent Exclusion Criteria: Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations Pregnant or breastfeeding women or women Simultaneous participation in other clinical trials or in the past three months Co-infected with HCV, HDV, HIV Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml) Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination Lack of willingness or inability to consent in writing Concurrent condition likely to preclude compliance with schedule of evaluations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: A<br> | Drug: Lamivudine<br>* 100 mg/day<br>* Other names: 73339;|
| Experimental: B<br> | Drug: Telbivudine<br>* 600 mg/day<br>* Other names: 159269;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml). |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy |  | 12 weeks | 
| Influence of HBeAg status to the decrease in viral load |  | 12 weeks | 
| Influence of HBV genotype to the decrease in viral load |  | 12 weeks | 
| Change in ALT and AST levels from Baseline to Week 12 |  | 12 weeks | 
| Development of viral resistance and treatment failure during the study and subsequent course of observation |  | 6 month | 
| Safety assessed by adverse events and laboratory values |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viral kinetics, Viral dynamics, Telbivudine, Lamivudine