Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00606099

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

A 26 Week Randomized, Open Label, Multi-center Study of the Efficacy and Safety of Telbivudine 600 mg Once Daily Versus Adefovir Dipivoxil 10mg Once Daily in Subjects With Compensated Chronic Hepatitis B and Sub-optimal Response to at Least 48 Weeks of Adefovir Dipivoxil 10 mg

Status
Withdrawn
Phase
Phase 4
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Novartis · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.

Conditions

Interventions

TypeNameDescription
DRUGtelbivudineTo compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
DRUGadefovir dipivoxilActive Comparator

Timeline

Start date
2007-11-01
Primary completion
2009-11-01
First posted
2008-02-01
Last updated
2012-05-02

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00606099. Inclusion in this directory is not an endorsement.