Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

October 15, 2008 updated by: GlaxoSmithKline

A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)

This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

Study Overview

Study Type

Interventional

Enrollment

160

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

      • Shatin, Hong Kong
        • GSK Investigational Site

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
  • Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion criteria:

  • Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients with HBeAg seroconversion to anti-HBe

Secondary Outcome Measures

Outcome Measure
Normalization of alanine aminotransferase (ALT)
Undetectable HBV DNA
Histologic improvement
Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment

Collaborators and Investigators

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

Sponsor

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

April 1, 2000

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 15, 2008

Last Verified

October 1, 2008

More Information

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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