Chronic Hepatitis B
Conditions
Keywords
Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine
Brief summary
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.
Interventions
DRUGTelbivudine
600 mg/day, oral tablets, once daily, 52 weeks
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 16 to 65 year of age * Documented CHB defined by detectable serum HBsAg and serum HBV DNA level * Willing and able to comply with the study drug regimen * Written informed consent before any assessment
Exclusion criteria
* Patient has a history of/or clinical signs/symptoms of hepatic decompensation * Patient has a history of HCC or findings suggestive of possible HCC * Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time * History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes * Patient has received IFN or other immunomodulatory treatment with 12 months before screening * Previous treatment history with NRTIs Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA PCR negativity rate | at 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg seroconversion rate | at week 52 |
| ALT normalization rate | at weeks 24 and 52 |
| HBeAg loss rate | at week 52 |
| HBV DNA PCR negativity rate | at week 24 |
| DNA reduction | from baseline to Weeks 12, 24, 36, 52 |
| Incidence of AE (SAE,etc), Graded lab abnormalities | at week 52 |
Countries
China
Outcome results
None listed