A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

March 19, 2015 updated by: Novartis
This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking Lamivudine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Spain
      • Barcelona, Spain
      • Valencia, Spain
  • Thailand
      • Bangkok, Thailand
  • Turkey
      • Istanbul, Turkey
  • United Kingdom
      • London, United Kingdom
  • United States
    • California
      • Los Angeles, California, United States
      • Orange, California, United States
      • San Diego, California, United States
    • New Jersey
      • Hackensack, New Jersey, United States
    • Texas
      • Houston, Texas, United States

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

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2.
  • Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time
  • Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

Other protocol defined 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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary efficacy endpoint: "therapeutic response", defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.

Secondary Outcome Measures

Outcome Measure
Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.

Collaborators and Investigators

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

Sponsor

Novartis

Collaborators

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

March 28, 2003

First Submitted That Met QC Criteria

March 28, 2003

First Posted (Estimate)

March 31, 2003

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV-02B-007

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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