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Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606099

Enrollment

Registered

2008-02-01

Start date

2007-11-30

Completion date

Unknown

Last updated

2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Adults, compensated chronic hepatitis B, telbivudin, aedevofir dipivoxil

Brief 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.

Interventions

DRUGtelbivudine

To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.

DRUGadefovir dipivoxil

Active Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, at least 18 years of age. * Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily. * Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL). * Patient is willing to comply with all study requirements. * Patient is willing and able to provide written informed consent.

Exclusion criteria

* Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit. * Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide). * Patient is co-infected with hepatitis C virus or HIV. * Patient has previously taken lamivudine. * Patient is currently abusing illicit drugs or alcohol. * Patient is using any investigational drugs or with in the last 30 days. * Patient is enrolled or plans to enroll in a clinical study involving investigational drug. * Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Efficacy at 24 weeks of treatment.	1 yr

Secondary

Measure	Time frame
To compare biochemical response at week 24 of treatment. To compare changes in viral load at week 24 of treatment. To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.	1yr

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026