This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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Los Angeles, California, United States
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Orange, California, United States
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San Diego, California, United States
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Hackensack, New Jersey, United States
Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.
Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.
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Houston, Texas, United States
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Seoul, South Korea
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Barcelona, Spain
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Valencia, Spain
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Bangkok, Thailand
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Istanbul, Turkey (Türkiye)
...and 1 more locations