Status:
COMPLETED
Australian Trial in Acute Hepatitis C
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
National Institutes of Health (NIH)
Conditions:
Hepatitis C
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
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 follo...
Detailed Description
The main purposes of the study are: * To enrol and follow-up a large group of people with acute hepatitis C infection to examine why some people naturally clear hepatitis C and some don't. * To exami...
Eligibility Criteria
Inclusion
- Male and female patients \>16 years of age; Anti-HCV antibody positive within the previous 6 months; Anti-HCV antibody negative in the two years prior to the anti-HCV antibody positive result OR acute hepatitis (jaundice or ALT \> 10 XULN) within the 12 months prior to the anti-HCV antibody results (where other causes of acute hepatitis are excluded); HCV RNA positive (for treatment group); Negative urine or blood pregnancy test (for women of childbearing potential; treated arm only); Informed consent
Exclusion
- Women with ongoing pregnancy or breast feeding;Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<6 months prior to the first dose of study drug; Any investigational drug \<6 weeks prior to the first dose of study drug; Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab; History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures); History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease; Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening; Serum creatinine level \>1.5 times the upper limit of normal at screening; Hgb\< 12g/dL in women or \< 13g/dL in men at screening (for patients who receive combination therapy with Pegylated interferon and ribavirin only); Male partners of women who are pregnant (for patients who receive combination therapy with Pegylated interferon and ribavirin only); History of a severe seizure disorder or current anticonvulsant use; History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study; History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease; Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration); Inability or unwillingness to provide informed consent or abide by the requirements of the study
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00192569
Start Date
July 1 2004
End Date
June 1 2010
Last Update
April 15 2011
Active Locations (18)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
407 Doctors
Darlinghurst, New South Wales, Australia, 2010
3
Holdsworth House GP Practice
Darlinghurst, New South Wales, Australia, 2010
4
Kirketon Road Centre
Darlinghurst, New South Wales, Australia, 2010