Status:
COMPLETED
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
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 recruite...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
788 Patients enrolled
Trial Details
Trial ID
NCT00645736
Start Date
February 1 2008
End Date
November 1 2008
Last Update
November 22 2011
Active Locations (1)
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1
Gilead Sciences Pty Ltd
East Melbourne, Victoria, Australia, 3002