Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.

Official Title
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An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir
* Drug: Telbivudine
* Drug: Tenofovir plus Telbivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBeAg negative at screening Documented chronic Hepatitis B Treatment naive Compensated liver disease Exclusion Criteria: Chronic Hepatitis B with Child Pugh B & C HBeAg positive Decompensated liver disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenofovir<br> | Drug: Tenofovir<br>* 300 mg of Tenofovir daily<br>|
| Active Comparator: Telbivudine<br> | Drug: Telbivudine<br>* 600 mg of Telbivudine daily<br>|
| Experimental: Tenofovir plus Telbivudine<br> | Drug: Tenofovir plus Telbivudine<br>* Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone |  | 6 Months and 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in serum HBV DNA levels |  | Baseline and 2 Years | 
| Percentage of patients with ALT normalization |  | Baseline and 2 Years | 
| Percentage of patients with reduction in HBsAg concentration by >50% |  | Baseline and 2 Years | 
| Percentage of patients with virological breakthrough |  | 24 weeks | 
| Percentage of patients with primary treatment failure |  | 12 weeks | 
| Occurrence of adverse events |  | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, Tenofovir, Telbivudine