Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Adefovir; Adefovir dipivoxil; Telbivudine

Criteria

Inclusion Criteria:

• Male or female, at least 18 years of age.

• Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria:

• Co-infection with HCV, HDV, or HIV.

• Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.

• History of hepatic decompensation

• History of malignancy

• Patient has one or more additional known primary or secondary causes of liver disease