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

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ClinicalTrials.gov Identifier: NCT00645736
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment
Chronic Hepatitis B Other: 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.


Study Type : Observational
Actual Enrollment : 788 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
Study Start Date : February 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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


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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.
Criteria

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.

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


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

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

Keywords provided by Gilead Sciences:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
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