Australian Trial in Acute Hepatitis C

Hepatitis C Clinical Trial

Official title:

Australian Trial in Acute Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192569
• Other study ID #: 1R01DA015999-01
• Secondary ID: ATAHC
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: April 13, 2011
• Start date: July 2004
• Est. completion date: June 2010

Study information

• Verified date: October 2009
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Pegylated Interferon alfa 2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
• Ribavirin (HIV conifected patients only)
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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	407 Doctors	Darlinghurst	New South Wales
Australia	Holdsworth House GP Practice	Darlinghurst	New South Wales
Australia	Kirketon Road Centre	Darlinghurst	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	HealthWorks Health Centre	Footscray	Victoria
Australia	Western Hospital	Footscray	Victoria
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Austin Hospital	Heidelburg	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Nepean Hospital	Penrith	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Kirby Institute	National Institutes of Health (NIH), The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)		24 weeks	Yes
Secondary	Natural history of acute hepatitis C		5 years	No

External Links

•   National Centre in HIV Epidemiology and Clinical Research