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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00192569
Registration number
NCT00192569
Ethics application status
Date submitted
11/09/2005
Date registered
19/09/2005
Date last updated
15/04/2011
Titles & IDs
Public title
Australian Trial in Acute Hepatitis C
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Scientific title
Australian Trial in Acute Hepatitis C
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Secondary ID [1]
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ATAHC
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Secondary ID [2]
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1R01DA015999-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pegylated Interferon alfa 2a
Treatment: Drugs - Ribavirin (HIV conifected patients only)
Experimental: Treated - Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV)
No Intervention: Untreated - Subjects will be followed for natural history of newly acquired HCV
Treatment: Drugs: Pegylated Interferon alfa 2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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Natural history of acute hepatitis C
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Assessment method [1]
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Timepoint [1]
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5 years
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Eligibility
Key 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
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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407 Doctors - Darlinghurst
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Recruitment hospital [3]
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Holdsworth House GP Practice - Darlinghurst
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Recruitment hospital [4]
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Kirketon Road Centre - Darlinghurst
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Recruitment hospital [5]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [6]
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John Hunter Hospital - Newcastle
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Recruitment hospital [7]
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Nepean Hospital - Penrith
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Recruitment hospital [8]
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Westmead Hospital - Westmead
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Recruitment hospital [9]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [10]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [11]
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Monash Medical Centre - Clayton
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Recruitment hospital [12]
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St Vincent's Hospital - Fitzroy
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Recruitment hospital [13]
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HealthWorks Health Centre - Footscray
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Recruitment hospital [14]
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Western Hospital - Footscray
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Recruitment hospital [15]
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Austin Hospital - Heidelburg
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Recruitment hospital [16]
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The Alfred Hospital - Melbourne
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Recruitment hospital [17]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [18]
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Fremantle Hospital - Fremantle
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2310 - Newcastle
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Recruitment postcode(s) [4]
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2751 - Penrith
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Recruitment postcode(s) [10]
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3011 - Footscray
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Recruitment postcode(s) [11]
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3084 - Heidelburg
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Recruitment postcode(s) [12]
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3004 - Melbourne
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Recruitment postcode(s) [13]
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3050 - Parkville
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Recruitment postcode(s) [14]
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Other collaborator category [2]
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Government body
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Name [2]
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National Institutes of Health (NIH)
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Address [2]
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Ethics approval
Ethics application status
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Summary
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 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00192569
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Kaldor, PhD
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Address
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National Centre in HIV Epidemiology and Clinical Research.
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00192569
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