Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Novartis Pharmaceuticals

Overview

The purpose of this study is to find out if taking a combination of telbivudine and adefovir or tenofovir and telbivudine can lower the amount of Hepatitis B virus in patients that have been taking adefovir alone for at least 5 months and have had less than optimal responses. The safety of taking telbivudine and adefovir together or tenofovir and telbivudine together will also be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Chronic Hepatitis B

Interventions

TelbivudineDRUG

Study cancelled: Withdrawn before enrollment of any participants

AdefovirDRUG

TenofovirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented compensated chronic hepatitis B defined by clinical history compatible with chronic hepatitis B * Patient is currently receiving Hepsera (adefovir dipivoxil) and has received treatment continuously for a minimum of 5 months prior to screening. Other inclusion criteria may apply. Exclusion Criteria: * Patient is pregnant or breastfeeding * Patient is co-infected with hepatitis C, hepatitis D or HIV * Patient previously received nucleoside(tide) therapy other than adefovir * Patient previously received an interferon-based treatment or an investigational agent for hepatitis B in the preceding 12 months Other exclusion criteria may apply.

Data from ClinicalTrials.gov

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