Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B (Chinese PAC)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781105

CLDT600ACN03

Details and patient eligibility

About

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.

Enrollment: 2,200 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,200 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Telbivudine