Australian Trial in Acute Hepatitis C

This study has been completed.
Sponsor:
Collaborators:
The University of New South Wales
Information provided by:
Kirby Institute
ClinicalTrials.gov Identifier:
NCT00192569
First received: September 11, 2005
Last updated: April 13, 2011
Last verified: October 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Australian Trial in Acute Hepatitis C

Resource links provided by NLM:


Further study details as provided by Kirby Institute:

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 ]

Enrollment: 167
Study Start Date: July 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192569

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

Additional Information:
No publications provided by Kirby Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor John Kaldor, National Centre in HIV Epidemiology and Clincial Research. University of New South Wales
ClinicalTrials.gov Identifier: NCT00192569     History of Changes
Other Study ID Numbers: 1R01DA 15999-01, ATAHC
Study First Received: September 11, 2005
Last Updated: April 13, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Federal Government

Keywords provided by Kirby Institute:
Acute Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014