Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000435684
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Trial in Acute Hepatitis C
Scientific title
A prospective non-randomised dual arm longitudinal cohort of people with acute or newly acquired Hepatitis C within which all subjects will be given the option of undergoing treatment involving a 24 week course of pegylated interferon monotherapy (180mcg/wk) at entry to study
Secondary ID [1] 299813 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ATAHC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Hepatitis C 547 0
Condition category
Condition code
Inflammatory and Immune System 624 624 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
pegylated interferon alfa 2a
ribavirin (HIV coinfected patients only)
Intervention code [1] 476 0
Treatment: Drugs
Comparator / control treatment
There is no comparator treatment group for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 730 0
To define the natural history of newly acquired HCV infection, including time course and predictors for HCV clearance among untreated individuals
Timepoint [1] 730 0
Proportion of patients achieving HCV clearance as defined by two consecutive negative qualitative HCV-RNA assessments during follow-up (untreated group).
Primary outcome [2] 731 0
To assess the safety and efficacy of pegylated interferon alfa-2a (PEG-IFN) monotherapy given for 24 weeks in newly acquired HCV infection
Timepoint [2] 731 0
Proportion of patients with SVR defined as undetectable HCV RNA in serum 24 weeks post therapy (treated group).
Primary outcome [3] 732 0
To assess incidence and predictors of reinfection after HCV clearance in treated and untreated IDUs
Timepoint [3] 732 0
Proportion of patients with undetectable HCV RNA at study end ie.144 weeks (all subjects).
Secondary outcome [1] 1495 0
To compare patterns and levels of HCV clearance in newly acquired HCV infection between treated and untreated individuals.
Timepoint [1] 1495 0
Comparison of proportion of subjects with negative HCV RNA at weeks 48, 96 and 144 between treated and untreated groups adjusted for baseline differences.
Secondary outcome [2] 1496 0
To examine the impact of treatment adherence on efficacy of PEG-IFN monotherapy in newly acquired infection.
Timepoint [2] 1496 0
At the end of treatment (week 24).
Secondary outcome [3] 1497 0
To monitor the level of injection risk behaviour, including the impact of enrolment into the therapeutic study and drug treatment strategies, among IDUs with newly acquired HCV infection.
Timepoint [3] 1497 0
To look at the changes in levels of injecting risk behaviour (treated and untreated groups) from screening to the end of follow-up (Week 144).
Secondary outcome [4] 1498 0
To identify factors that influence recruitment and uptake of treatment in individuals with newly acquired HCV infection.
Timepoint [4] 1498 0
At the end of treatment (week 24).
Secondary outcome [5] 1499 0
To develop recommendations for treatment of newly acquired HCV infection among IDUs.
Timepoint [5] 1499 0
Week 144

Eligibility
Key inclusion criteria
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.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2004
Actual
24/06/2004
Date of last participant enrolment
Anticipated
Actual
2/02/2008
Date of last data collection
Anticipated
Actual
2/02/2009
Sample size
Target
240
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 15153 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 28448 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 682 0
Government body
Name [1] 682 0
National Institutes of Health
Country [1] 682 0
United States of America
Primary sponsor type
Government body
Name
National Centre in HIV Epidemiology and Clinical Research
Address
The Kirby Institute (formerly known as National Centre in HIV Epidemiology and Clinical Research), University of New South Wales Australia, Wallace Wurth Building, Sydney, NSW 2052, Australia.
Country
Australia
Secondary sponsor category [1] 571 0
Commercial sector/Industry
Name [1] 571 0
Roche Products Pty Ltd
Address [1] 571 0
F. Hoffmann-La Roche AG
Group headquarters
Grenzacherstrasse 124
CH-4070 Basel
Switzerland
Country [1] 571 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1860 0
Westmead Hospital
Ethics committee address [1] 1860 0
Ethics committee country [1] 1860 0
Australia
Date submitted for ethics approval [1] 1860 0
Approval date [1] 1860 0
22/11/2004
Ethics approval number [1] 1860 0
Ethics committee name [2] 1861 0
Fremantle Hospital
Ethics committee address [2] 1861 0
Ethics committee country [2] 1861 0
Australia
Date submitted for ethics approval [2] 1861 0
Approval date [2] 1861 0
21/10/2004
Ethics approval number [2] 1861 0
Ethics committee name [3] 1862 0
Princess Alexandra Hospital
Ethics committee address [3] 1862 0
Ethics committee country [3] 1862 0
Australia
Date submitted for ethics approval [3] 1862 0
Approval date [3] 1862 0
02/11/2004
Ethics approval number [3] 1862 0
Ethics committee name [4] 1863 0
Royal Adelaide Hospital
Ethics committee address [4] 1863 0
Ethics committee country [4] 1863 0
Australia
Date submitted for ethics approval [4] 1863 0
Approval date [4] 1863 0
20/12/2004
Ethics approval number [4] 1863 0
Ethics committee name [5] 1864 0
Royal Melbourne Hospital
Ethics committee address [5] 1864 0
Ethics committee country [5] 1864 0
Australia
Date submitted for ethics approval [5] 1864 0
Approval date [5] 1864 0
20/10/2004
Ethics approval number [5] 1864 0
Ethics committee name [6] 1865 0
Royal Prince Alfred Hospital
Ethics committee address [6] 1865 0
Ethics committee country [6] 1865 0
Australia
Date submitted for ethics approval [6] 1865 0
Approval date [6] 1865 0
29/04/2004
Ethics approval number [6] 1865 0
Ethics committee name [7] 1866 0
St Vincent's Hospital Victoria
Ethics committee address [7] 1866 0
Ethics committee country [7] 1866 0
Australia
Date submitted for ethics approval [7] 1866 0
Approval date [7] 1866 0
16/06/2004
Ethics approval number [7] 1866 0
Ethics committee name [8] 1867 0
St Vincent's Hospital NSW
Ethics committee address [8] 1867 0
Ethics committee country [8] 1867 0
Australia
Date submitted for ethics approval [8] 1867 0
Approval date [8] 1867 0
04/09/2003
Ethics approval number [8] 1867 0
Ethics committee name [9] 1868 0
The Alfred Hospital
Ethics committee address [9] 1868 0
Ethics committee country [9] 1868 0
Australia
Date submitted for ethics approval [9] 1868 0
Approval date [9] 1868 0
12/05/2004
Ethics approval number [9] 1868 0
Ethics committee name [10] 1869 0
Western Hospital
Ethics committee address [10] 1869 0
Ethics committee country [10] 1869 0
Australia
Date submitted for ethics approval [10] 1869 0
Approval date [10] 1869 0
20/10/2004
Ethics approval number [10] 1869 0
Ethics committee name [11] 1870 0
Monash Medical Centre
Ethics committee address [11] 1870 0
Ethics committee country [11] 1870 0
Australia
Date submitted for ethics approval [11] 1870 0
Approval date [11] 1870 0
08/07/2005
Ethics approval number [11] 1870 0
Ethics committee name [12] 1871 0
407 Bourke
Ethics committee address [12] 1871 0
Ethics committee country [12] 1871 0
Australia
Date submitted for ethics approval [12] 1871 0
Approval date [12] 1871 0
04/09/2003
Ethics approval number [12] 1871 0
Ethics committee name [13] 1872 0
Kirketon Road Clinic
Ethics committee address [13] 1872 0
Ethics committee country [13] 1872 0
Australia
Date submitted for ethics approval [13] 1872 0
Approval date [13] 1872 0
04/06/2004
Ethics approval number [13] 1872 0
Ethics committee name [14] 1873 0
Healthworks
Ethics committee address [14] 1873 0
Ethics committee country [14] 1873 0
Australia
Date submitted for ethics approval [14] 1873 0
Approval date [14] 1873 0
29/03/2004
Ethics approval number [14] 1873 0
Ethics committee name [15] 1874 0
Nepean Hospital
Ethics committee address [15] 1874 0
Ethics committee country [15] 1874 0
Australia
Date submitted for ethics approval [15] 1874 0
Approval date [15] 1874 0
18/03/2005
Ethics approval number [15] 1874 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36212 0
Prof Professor Greg Dore
Address 36212 0
The Kirby Institute (formerly known as National Centre in HIV Epidemiology and Clinical Research), University of New South Wales, Wallace Wurth Building, Sydney, NSW 2052, Australia.
Country 36212 0
Australia
Phone 36212 0
+612 9385 0900
Fax 36212 0
Email 36212 0
[email protected]
Contact person for public queries
Name 9665 0
Barbara Yeung
Address 9665 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 9665 0
Australia
Phone 9665 0
+61 2 93850900
Fax 9665 0
Email 9665 0
[email protected]
Contact person for scientific queries
Name 593 0
Professor Greg Dore
Address 593 0
National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
Country 593 0
Australia
Phone 593 0
+61 2 93850900
Fax 593 0
Email 593 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.