Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Telbivudine; Drug: Adefovir; Drug: Tenofovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409019

CLDT600AUS05

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

1

Experimental group

Description:

Study cancelled: Withdrawn before enrollment of any participants

Treatment:

Drug: Telbivudine

2

Experimental group

Description:

Study cancelled: Withdrawn before enrollment of any participants

Treatment:

Drug: Adefovir

3

Experimental group

Description:

Study cancelled: Withdrawn before enrollment of any participants

Treatment:

Drug: Tenofovir