Australian Trial in Acute Hepatitis C

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Pegylated Interferon alfa 2a; Drug: Ribavirin (HIV conifected patients only)

• Registration Number: NCT00192569
• Lead Sponsor: Kirby Institute

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Status Verified: 2009-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated	Pegylated Interferon alfa 2a	Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV)
Treated	Ribavirin (HIV conifected patients only)	Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV)

Primary Outcome Measures

Name	Time	Method
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Natural history of acute hepatitis C	5 years

Trial Locations

Locations (17)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Western Hospital; 🇦🇺 Footscray, Victoria, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

407 Doctors; 🇦🇺 Darlinghurst, New South Wales, Australia

Austin Hospital; 🇦🇺 Heidelburg, Victoria, Australia

Fremantle Hospital; 🇦🇺 Fremantle, Western Australia, Australia

St Vincent's Hospital; 🇦🇺 Fitzroy, Victoria, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

HealthWorks Health Centre; 🇦🇺 Footscray, Victoria, Australia

Nepean Hospital; 🇦🇺 Penrith, New South Wales, Australia

John Hunter Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Kirketon Road Centre; 🇦🇺 Darlinghurst, New South Wales, Australia

Holdsworth House GP Practice; 🇦🇺 Darlinghurst, New South Wales, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia