Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
- Registration Number
- NCT00781105
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2200
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/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Telbivudine -
- Primary Outcome Measures
Name Time Method HBV DNA PCR negativity rate at 52 weeks
- Secondary Outcome Measures
Name Time Method HBV DNA PCR negativity rate at week 24 DNA reduction from baseline to Weeks 12, 24, 36, 52 HBeAg loss rate at week 52 HBeAg seroconversion rate at week 52 ALT normalization rate at weeks 24 and 52 Incidence of AE (SAE,etc), Graded lab abnormalities at week 52
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇳Beijing, China