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

Phase 3CompletedNCT00640588

Novartis Pharmaceuticals30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

TelbivudineDRUG

Arm 1: 600 mg/day, oral telbivudina for 24 weeks

oral adefovirDRUG

Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigative Site

Barcelona, Spain

Outcomes

Primary Outcomes

HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Secondary Outcomes

Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline

Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Data from ClinicalTrials.gov

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