CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
NCT ID: NCT00645736
Last Updated: 2011-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
788 participants
OBSERVATIONAL
2008-02-29
2008-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1
Single cohort
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Wraight
Role: STUDY_DIRECTOR
Gilead Sciences Pty Ltd
Locations
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Gilead Sciences Pty Ltd
East Melbourne, Victoria, Australia
Countries
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Other Identifiers
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GS-AU-103-0185
Identifier Type: -
Identifier Source: org_study_id