Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4

Details

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

Criteria

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.