The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2,200
600 mg/day, oral tablets, once daily, 52 weeks
Novartis Investigative Site
Beijing, China
HBV DNA PCR negativity rate
Time frame: at 52 weeks
HBV DNA PCR negativity rate
Time frame: at week 24
DNA reduction
Time frame: from baseline to Weeks 12, 24, 36, 52
HBeAg loss rate
Time frame: at week 52
HBeAg seroconversion rate
Time frame: at week 52
ALT normalization rate
Time frame: at weeks 24 and 52
Incidence of AE (SAE,etc), Graded lab abnormalities
Time frame: at week 52
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