Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

May 1, 2012 updated by: Novartis

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Novartis
    • New York
      • Flushing, New York, United States, 11355
        • Novartis
    • Virginia
      • Sterling, Virginia, United States, 20166
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
telbivudine
Drug: telbivudine
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
Active Comparator: 2
adefovir dipivoxil
Drug: adefovir dipivoxil
Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy at 24 weeks of treatment.
Time Frame: 1 yr
1 yr

Secondary Outcome Measures

Outcome 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.
Time Frame: 1yr
1yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 1, 2008

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600AUS03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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