Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.

Official Title
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A 26 Week Randomized, Open Label, Multi-center Study of the Efficacy and Safety of Telbivudine 600 mg Once Daily Versus Adefovir Dipivoxil 10mg Once Daily in Subjects With Compensated Chronic Hepatitis B and Sub-optimal Response to at Least 48 Weeks of Adefovir Dipivoxil 10 mg

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: telbivudine
* Drug: adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, at least 18 years of age. Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily. Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL). Patient is willing to comply with all study requirements. Patient is willing and able to provide written informed consent. Exclusion Criteria: Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit. Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide). Patient is co-infected with hepatitis C virus or HIV. Patient has previously taken lamivudine. Patient is currently abusing illicit drugs or alcohol. Patient is using any investigational drugs or with in the last 30 days. Patient is enrolled or plans to enroll in a clinical study involving investigational drug. Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir. Other protocol-defined inclusion/exclusion criteria may apply.

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>telbivudine | Drug: telbivudine<br>* To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.<br>|
| Active Comparator: 2<br>adefovir dipivoxil | Drug: adefovir dipivoxil<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at 24 weeks of treatment. |  | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare biochemical response at week 24 of treatment. To compare changes in viral load at week 24 of treatment. To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment. |  | 1yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adults, compensated chronic hepatitis B, telbivudin, aedevofir dipivoxil