Efficacy Study of Telbivudine in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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This study is designed to support the optimal use of telbivudine by providing data to refine our understanding of telbivudine efficacy and resistance in real life clinical setting in patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR negativity.

Detailed Description
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This study will be multicenter, open-label and observational data collection of patients on telbivudine who meet baseline characteristics defined as the majority of patients seen in the clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and 104 for efficacy assessments. In patients who discontinue observational drug earlier, clinical information would be kept following for assessment as well. Study purpose: This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings with the use of the Roadmap Concept in chronic hepatitis B treatment. Objectives: Primary: To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis. Secondary: To observe the treatment outcomes. To validate the result of super-responder trial. To validate the Roadmap Concept. Population: The study population will consist of a representative group of 500 chronic hepatitis B patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on investigators' judgment in 16 medical centers located in Taiwan.

Official Title
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A Multicenter Open-label, Observational Study of Telbivudine Treatment Outcome in Patients With Chronic B Virus Infection

Conditions
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Chronic Hepatitis B, Roadmap Concept in Chronic Hepatitis B Treatment, 24-week PCR Negativity of Telbivudine, PCR Negativity at 52 and 104 Week, HBeAg Seroconversion Rate at 52 and 104 Week

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 to 65 years of age Documented chronic hepatitis B defined by ALL of following: Clinical history compatible with compensated chronic hepatitis B Detectable serum hepatitis B surface antigen (HBsAg)> 6 months and at the screening visit. Exclusion Criteria: Pregnant or nursing co-infection with hepatitis C virus (HCV) or HIV Clinical or imaging diagnosis of cirrhosis Evidence of decreased renal function of creatinine >(=)2x ULN

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHB patients without cirrhosis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR negativity |  | week 52 | 
| HBeAg seroconversion rate |  | week 52 | 
| PCR negativity |  | week 104 | 
| HBeAg seroconversion rate |  | week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ALT normalization |  | week 52 | 
| Genotypic resistance |  | week 52 | 
| Rate of ALT normalization |  | week 104 | 
| Genotypic resistance |  | week 104 |