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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00645736 |
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
Condition | Intervention |
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Chronic Hepatitis B |
Other: No intervention |
Study Type: | Observational |
Study Design: | Cohort, Cross-Sectional |
Official Title: | Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy |
Estimated Enrollment: | 800 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Single cohort
|
Other: No intervention
No intervention
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Gilead Sciences Pty Ltd ( Howard Wraight, Medical Director ) |
Study ID Numbers: | GS-AU-103-0185 |
Study First Received: | March 25, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00645736 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council |
Chronic Hepatitis B |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Hepadnaviridae Infections |