Study 17 of 929 for search of: Australia, Victoria
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Australian Trial in Acute Hepatitis C
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: The National Centre in HIV Epidemiology and Clinical Research
The University of New South Wales
National Institutes of Health (NIH)
Information provided by: The National Centre in HIV Epidemiology and Clinical Research
ClinicalTrials.gov Identifier: NCT00192569
  Purpose

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
Hepatitis C
Drug: Pegylated Interferon alfa 2a
Drug: Ribavirin (HIV conifected patients only)
Phase IV

MedlinePlus related topics: AIDS Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Australian Trial in Acute Hepatitis C

Further study details as provided by The National Centre in HIV Epidemiology and Clinical Research:

Primary Outcome Measures:
  • Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Natural history of acute hepatitis C [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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)
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 examine how many people become re-infected after having cleared hepatitis C and to look at why this happened.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192569

Locations
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
Sponsors and Collaborators
The National Centre in HIV Epidemiology and Clinical Research
The University of New South Wales
Investigators
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
  More Information

National Centre in HIV Epidemiology and Clinical Research  This link exits the ClinicalTrials.gov site

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

Keywords provided by The National Centre in HIV Epidemiology and Clinical Research:
Acute Hepatitis C

Study placed in the following topic categories:
Interferon-alpha
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Interferons
Ribavirin
Peginterferon alfa-2a
Hepatitis, Viral, Human
Hepatitis C
Interferon Alfa-2a

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009