CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study (CHARM)

November 21, 2011 updated by: Gilead Sciences

Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy.

It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

Study Type

Observational

Enrollment (Actual)

788

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

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Gilead Sciences Pty Ltd

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

Sampling Method

Non-Probability Sample

Study Population

Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.

Description

Inclusion Criteria:

  • Aged 18 years and over
  • Provided informed consent
  • Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)
  • Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management
  • Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
  • Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years

Exclusion Criteria:

  • Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D
  • Concomitant immunosuppression / immunomodulatory therapies
  • Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
  • Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
  • Current Child Pugh class C classification (current Child Pugh score > 9)
  • Other known or suspected cause of chronic liver disease
  • Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Single cohort
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptive statistics for clinical and viral characteristics of the study population
Time Frame: Single timepoint (blood draw)
Single timepoint (blood draw)

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: Howard Wraight, Gilead Sciences Pty Ltd

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, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-AU-103-0185

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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