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
Date results information 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
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.
Trial website
Trial related presentations / publications
Quality of Life and Social Functioning during Treatment of Recent Hepatitis C Infection: A Multi-Centre Prospective Cohort. Doyle JS, Grebely J, Spelman T, Alavi M, Matthews GV, Thompson AJ, Dore GJ, Hellard ME; ATAHC Study Group. PLoS One. 2016 Jun 29;11(6):e0150655. doi: 10.1371/journal.pone.0150655. eCollection 2016. PMID: 27355323

HIV infection is associated with higher levels of monocyte chemoattractant protein-1 and eotaxin among people with recent hepatitis C virus infection. Lamoury FM, Hajarizadeh B, Keoshkerian E, Feld JJ, Amin J, Teutsch S, Matthews GV, Hellard M, Dore GJ, Lloyd AR, Applegate TL, Grebely J; ATAHC Study Group. BMC Infect Dis. 2016 Jun 1;16:241. doi: 10.1186/s12879-016-1567-2. PMID: 27246604

Alanine aminotransferase, HCV RNA levels and pro-inflammatory and pro-fibrogenic cytokines/chemokines during acute hepatitis C virus infection. Hajarizadeh B, Lamoury FM, Feld JJ, Amin J, Keoshkerian E, Matthews GV, Hellard M, Dore GJ, Lloyd AR, Grebely J, Applegate TL; ATAHC Study Group. Virol J. 2016 Feb 24;13:32. doi: 10.1186/s12985-016-0482-x.
PMID: 26911712

Injecting risk behaviours following treatment for hepatitis C virus infection among people who inject drugs: The Australian Trial in Acute Hepatitis C. Alavi M, Spelman T, Matthews GV, Haber PS, Day C, van Beek I, Walsh N, Yeung B, Bruneau J, Petoumenos K, Dolan K, Kaldor JM, Dore GJ, Hellard M, Grebely J; ATAHC Study Group. Int J Drug Policy. 2015 Oct;26(10):976-83. doi: 10.1016/j.drugpo.2015.05.003. Epub 2015 May 21. PMID: 26115881

Dynamics of HCV RNA levels during acute hepatitis C virus infection. Hajarizadeh B, Grebely J, Applegate T, Matthews GV, Amin J, Petoumenos K, Hellard M, Rawlinson W, Lloyd A, Kaldor J, Dore GJ; ATAHC study group. J Med Virol. 2014 Oct;86(10):1722-9. doi: 10.1002/jmv.24010. Epub 2014 Jul 8. PMID: 25042465

Maintenance of Th1 hepatitis C virus (HCV)-specific responses in individuals with acute HCV who achieve sustained virological clearance after treatment. Flynn JK, Dore GJ, Hellard M, Yeung B, Rawlinson WD, White PA, Kaldor JM, Lloyd AR, Ffrench RA; ATAHC Study Group. J Gastroenterol Hepatol. 2013 Nov;28(11):1770-81. doi: 10.1111/jgh.12265. PMID: 23663030

Impaired hepatitis C virus (HCV)-specific interferon-? responses in individuals with HIV who acquire HCV infection: correlation with CD4(+) T-cell counts. Flynn JK, Dore GJ, Matthews G, Hellard M, Yeung B, Rawlinson WD, White PA, Kaldor JM, Lloyd AR, Ffrench RA; ATAHC Study Group. J Infect Dis. 2012 Nov 15;206(10):1568-76. doi: 10.1093/infdis/jis544. Epub 2012 Sep 4.
PMID: 22949308

Virological responses during treatment for recent hepatitis C virus: potential benefit for ribavirin use in HCV/HIV co-infection. Grebely J, Hellard M, Applegate T, Petoumenos K, Yeung B, Feld JJ, Rawlinson W, Lloyd AR, George J, Kaldor JM, Dore GJ, Matthews GV; ATAHC Study Group. AIDS. 2012 Aug 24;26(13):1653-61. PMID: 22555168

Effect of pegylated interferon-a-2a treatment on mental health during recent hepatitis C virus infection. Alavi M, Grebely J, Matthews GV, Petoumenos K, Yeung B, Day C, Lloyd AR, Van Beek I, Kaldor JM, Hellard M, Dore GJ, Haber PS; ATAHC Study Group. J Gastroenterol Hepatol. 2012 May;27(5):957-65. doi: 10.1111/j.1440-1746.2011.07035.x. PMID: 22142332

Hepatitis C virus reinfection and superinfection among treated and untreated participants with recent infection. Grebely J, Pham ST, Matthews GV, Petoumenos K, Bull RA, Yeung B, Rawlinson W, Kaldor J, Lloyd A, Hellard M, Dore GJ, White PA; ATAHC Study Group.
Hepatology. 2012 Apr;55(4):1058-69. doi: 10.1002/hep.24754. Epub 2012 Feb 29. PMID: 22031335

Patterns and characteristics of hepatitis C transmission clusters among HIV-positive and HIV-negative individuals in the Australian trial in acute hepatitis C. Matthews GV, Pham ST, Hellard M, Grebely J, Zhang L, Oon A, Marks P, van Beek I, Rawlinson W, Kaldor JM, Lloyd A, Dore GJ, White PA; ATAHC Study Group. Clin Infect Dis. 2011 Mar 15;52(6):803-11. doi: 10.1093/cid/ciq200. Epub 2011 Jan 31. PMID: 21282185

Adherence to treatment for recently acquired hepatitis C virus (HCV) infection among injecting drug users. Grebely J, Matthews GV, Hellard M, Shaw D, van Beek I, Petoumenos K, Alavi M, Yeung B, Haber PS, Lloyd AR, Kaldor JM, Dore GJ; ATAHC Study Group. J Hepatol. 2011 Jul;55(1):76-85. doi: 10.1016/j.jhep.2010.10.033. Epub 2010 Nov 23. PMID: 21145855

Potential role for interleukin-28B genotype in treatment decision-making in recent hepatitis C virus infection. Grebely J, Petoumenos K, Hellard M, Matthews GV, Suppiah V, Applegate T, Yeung B, Marks P, Rawlinson W, Lloyd AR, Booth D, Kaldor JM, George J, Dore GJ; ATAHC Study Group. Hepatology. 2010 Oct;52(4):1216-24. doi: 10.1002/hep.23850. PMID: 20803561

Early IL-10 predominant responses are associated with progression to chronic hepatitis C virus infection in injecting drug users. Flynn JK, Dore GJ, Hellard M, Yeung B, Rawlinson WD, White PA, Kaldor JM, Lloyd AR, Ffrench RA; ATAHC Study Group. J Viral Hepat. 2011 Aug;18(8):549-61. doi: 10.1111/j.1365-2893.2010.01335.x. Epub 2010 Jul 5. PMID: 20626625

Factors associated with uptake of treatment for recent hepatitis C virus infection in a predominantly injecting drug user cohort: The ATAHC Study. Grebely J, Petoumenos K, Matthews GV, Haber P, Marks P, Lloyd AR, Kaldor JM, Dore GJ, Hellard M; ATAHC Study Group.
Drug Alcohol Depend. 2010 Mar 1;107(2-3):244-9. doi: 10.1016/j.drugalcdep.2009.09.015.
PMID: 19926405

Characteristics and treatment outcomes among HIV-infected individuals in the Australian Trial in Acute Hepatitis C. Matthews GV, Hellard M, Haber P, Yeung B, Marks P, Baker D, McCaughan G, Sasadeusz J, White P, Rawlinson W, Lloyd A, Kaldor J, Dore GJ; Australian Trial in Acute Hepatitis C Study Group. Clin Infect Dis. 2009 Mar 1;48(5):650-8. doi: 10.1086/596770.
PMID: 19191653

Recruitment and follow-up of injecting drug users in the setting of early hepatitis C treatment: insights from the ATAHC study. Nguyen OK, Dore GJ, Kaldor JM, Hellard ME; ATAHC Protocol Steering Committee. Int J Drug Policy. 2007 Oct;18(5):447-51. Epub 2007 Feb 21. PMID: 17854736
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
Ms 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
Prof 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.