Clinical trial NCT00192569: Australian Trial in Acute Hepatitis C
Official title: Australian Trial in Acute Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Acute Hepatitis C
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
name: National Institutes of Health (NIH)
First posted: 2005-09-19
Enrollment: 167
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)
timeFrame: 24 weeks
Secondary outcomes:
measure: Natural history of acute hepatitis C
timeFrame: 5 years
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: 407 Doctors
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House GP Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: Kirketon Road Centre
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Footscray
country: Australia
facility: HealthWorks Health Centre
state: Victoria
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Heidelburg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
Study officials:
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: John Kaldor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre in HIV Epidemiology and Clinical Research.
name: Greg Dore, MB BS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doyle JS, Grebely J, Spelman T, Alavi M, Matthews GV, Thompson AJ, Dore GJ, Hellard ME; ATAHC Study Group. Quality of Life and Social Functioning during Treatment of Recent Hepatitis C Infection: A Multi-Centre Prospective Cohort. PLoS One. 2016 Jun 29;11(6):e0150655. doi: 10.1371/journal.pone.0150655. eCollection 2016.
citation: 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. HIV infection is associated with higher levels of monocyte chemoattractant protein-1 and eotaxin among people with recent hepatitis C virus infection. BMC Infect Dis. 2016 Jun 1;16:241. doi: 10.1186/s12879-016-1567-2.
citation: 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. Injecting risk behaviours following treatment for hepatitis C virus infection among people who inject drugs: The Australian Trial in Acute Hepatitis C. Int J Drug Policy. 2015 Oct;26(10):976-83. doi: 10.1016/j.drugpo.2015.05.003. Epub 2015 May 21.
citation: Applegate TL, Gaudieri S, Plauzolles A, Chopra A, Grebely J, Lucas M, Hellard M, Luciani F, Dore GJ, Matthews GV. Naturally occurring dominant drug resistance mutations occur infrequently in the setting of recently acquired hepatitis C. Antivir Ther. 2015;20(2):199-208. doi: 10.3851/IMP2821. Epub 2014 Aug 8.
citation: 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. Patterns and characteristics of hepatitis C transmission clusters among HIV-positive and HIV-negative individuals in the Australian trial in acute hepatitis C. Clin Infect Dis. 2011 Mar 15;52(6):803-11. doi: 10.1093/cid/ciq200. Epub 2011 Jan 31.
citation: 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. Adherence to treatment for recently acquired hepatitis C virus (HCV) infection among injecting drug users. J Hepatol. 2011 Jul;55(1):76-85. doi: 10.1016/j.jhep.2010.10.033. Epub 2010 Nov 23.