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Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research The University of New South Wales National Institutes of Health (NIH) |
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Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00192569 |
Australian Trial in Acute Hepatitis C (ATAHC)
A prospective non-randomised dual arm longitudinal cohort of newly acquired hepatitis C infection into which participants will be enrolled and then followed at 3 monthly intervals over a 3 year period.
All participants will be offered a 24 week course of pegylated interferon alfa 2a which will be commenced within 12 weeks of screening (patients coinfected with HIV will be offered 24 weeks with pegylated interferon alfa 2a plus ribavirin).
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Pegylated Interferon alfa 2a Drug: Ribavirin (HIV conifected patients only) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Australian Trial in Acute Hepatitis C |
Estimated Enrollment: | 240 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
The main purposes of the study are:
The study will also offer everyone taking part the option of undergoing a 6 month course of pegylated interferon alfa 2a (plus ribavirin if HIV coinfected) as treatment for hepatitis C. The purpose of this part of the study is:
1. To examine whether treatment is effective in clearing the virus.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, New South Wales | |
St Vincent's Hospital | |
Darlinghurst, New South Wales, Australia, 2010 | |
Kirketon Road Centre | |
Darlinghurst, New South Wales, Australia, 2010 | |
Royal Prince Alfred Hospital | |
Camperdown, New South Wales, Australia, 2050 | |
Nepean Hospital | |
Penrith, New South Wales, Australia, 2751 | |
Westmead Hospital | |
Westmead, New South Wales, Australia, 2145 | |
Holdsworth House GP Practice | |
Darlinghurst, New South Wales, Australia, 2010 | |
407 Doctors | |
Darlinghurst, New South Wales, Australia, 2010 | |
John Hunter Hospital | |
Newcastle, New South Wales, Australia, 2310 | |
Australia, Queensland | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
HealthWorks Health Centre | |
Footscray, Victoria, Australia, 3011 | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
St Vincent's Hospital | |
Fitzroy, Victoria, Australia, 3065 | |
Royal Melbourne Hospital | |
Parkville, Victoria, Australia, 3050 | |
Western Hospital | |
Footscray, Victoria, Australia, 3011 | |
Austin Hospital | |
Heidelburg, Victoria, Australia, 3084 | |
Monash Medical Centre | |
Clayton, Victoria, Australia, 3168 | |
Australia, Western Australia | |
Fremantle Hospital | |
Fremantle, Western Australia, Australia, 6160 |
Principal Investigator: | John Kaldor, PhD | National Centre in HIV Epidemiology and Clinical Research |
Principal Investigator: | Greg Dore, MB BS FRACP | National Centre in HIV Epidemiology and Clinical Research |
Responsible Party: | National Centre in HIV Epidemiology and Clincial Research. University of New South Wales ( Professor John Kaldor ) |
Study ID Numbers: | 1R01DA 15999-01, ATAHC |
Study First Received: | September 11, 2005 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00192569 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; United States: Federal Government |
Acute Hepatitis C |
Interferon-alpha Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Interferons |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Interferon Alfa-2a |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |