Australian Trial in Acute Hepatitis C

April 13, 2011 updated by: Kirby Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Kirketon Road Centre
      • Darlinghurst, New South Wales, Australia, 2010
        • 407 Doctors
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House GP Practice
      • Newcastle, New South Wales, Australia, 2310
        • John Hunter Hospital
      • Penrith, New South Wales, Australia, 2751
        • Nepean Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Footscray, Victoria, Australia, 3011
        • Western Hospital
      • Footscray, Victoria, Australia, 3011
        • HealthWorks Health Centre
      • Heidelburg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated
Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV)
Drug: Pegylated Interferon alfa 2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • pegasys
Drug: Ribavirin (HIV conifected patients only)
  • genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg)
  • Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients
No Intervention: Untreated
Subjects will be followed for natural history of newly acquired HCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Natural history of acute hepatitis C
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

National Institutes of Health (NIH)
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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA015999-01 (U.S. NIH Grant/Contract)
  • ATAHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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