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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 28, 2008
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

Condition Intervention
Chronic Hepatitis B Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Descriptive statistics for clinical and viral characteristics of the study population [ Time Frame: Single timepoint (blood draw) ]

Enrollment: 788
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single cohort
Other: No intervention
No intervention

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645736

Australia, Victoria
Gilead Sciences Pty Ltd
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Gilead Sciences
Study Director: Howard Wraight Gilead Sciences Pty Ltd
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00645736     History of Changes
Other Study ID Numbers: GS-AU-103-0185
First Submitted: March 25, 2008
First Posted: March 28, 2008
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Gilead Sciences:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections