Australian Trial in Acute Hepatitis C

NCT00192569 | Completed Phase 4 DMC

• 2 other identifiers: 1R01DA015999-01ATAHC
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 18

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).

Conditions

Hepatitis C

Keywords

Acute Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)

  24 weeks

Secondary Outcomes (1)

• Natural history of acute hepatitis C

  5 years

Study Arms (2)

Treated

EXPERIMENTAL

Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV)

Drug: Pegylated Interferon alfa 2a; Drug: Ribavirin (HIV conifected patients only)

Untreated

NO INTERVENTION

Subjects will be followed for natural history of newly acquired HCV

Interventions

Pegylated Interferon alfa 2a DRUG

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

Also known as: pegasys

Treated

Ribavirin (HIV conifected patients only) DRUG

* 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

Treated

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirby Institute: lead
• The University of New South Wales: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (18)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

407 Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

Holdsworth House GP Practice

Darlinghurst, New South Wales, 2010, Australia

Location

Kirketon Road Centre

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

John Hunter Hospital

Newcastle, New South Wales, 2310, Australia

Location

Nepean Hospital

Penrith, New South Wales, 2751, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

HealthWorks Health Centre

Footscray, Victoria, 3011, Australia

Location

Western Hospital

Footscray, Victoria, 3011, Australia

Location

Austin Hospital

Heidelburg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Related Publications (6)

• 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.

  PMID: 27355323 DERIVED

• 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.

  PMID: 27246604 DERIVED

• 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.

  PMID: 26115881 DERIVED

• 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.

  PMID: 25105742 DERIVED

• 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.

  PMID: 21282185 DERIVED

• 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.

  PMID: 21145855 DERIVED

Related Links

• National Centre in HIV Epidemiology and Clinical Research

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 15, 2011

Record last verified: 2009-10

Locations

AU (18)