Hepatitis CPhase 4NCT00192569
Australian Trial in Acute Hepatitis C
A Phase 4 study testing Pegylated Interferon alfa 2a and Ribavirin (HIV conifected patients only) in people with Hepatitis C, run by Kirby Institute at 18 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pegylated Interferon alfa 2a and Ribavirin (HIV conifected patients only)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 18 sitesAustralia
- Study dates
- Jul 2004to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Australia18 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
407 Doctors
Darlinghurst, New South Wales, 2010
Holdsworth House GP Practice
Darlinghurst, New South Wales, 2010
Kirketon Road Centre
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Fitzroy, Victoria, 3065
HealthWorks Health Centre
Footscray, Victoria, 3011
Western Hospital
Footscray, Victoria, 3011
Fremantle Hospital
Fremantle, Western Australia, 6160
Austin Hospital
Heidelburg, Victoria, 3084
The Alfred Hospital
Melbourne, Victoria, 3004
John Hunter Hospital
Newcastle, New South Wales, 2310
Royal Melbourne Hospital
Parkville, Victoria, 3050
Nepean Hospital
Penrith, New South Wales, 2751
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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).
Read the 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:
- To examine whether treatment is effective in clearing the virus.
- Conditions
- Hepatitis C
- Being tested
- Pegylated Interferon alfa 2a, Ribavirin (HIV conifected patients only)
- Keywords
- Acute Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon alfa 2aDrug
Also called pegasys
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
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
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)
Measured: 24 weeks
Secondary outcomes (1)
Natural history of acute hepatitis C
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales, National Institutes of Health (NIH)
- Investigators
- John Kaldor, PhD, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.Greg Dore, MB BS FRACP, Principal investigator, National Centre in HIV Epidemiology and Clinical Research.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192569
- Sponsor's protocol ID
- 1R01DA015999-01
- Other IDs
- ATAHC
- Status last verified
- Oct 2009
- First submitted
- 11 Sep 2005
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27355323Lamoury 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.
PubMed 27246604Alavi 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.
PubMed 26115881Applegate 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.
PubMed 25105742Matthews 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.
PubMed 21282185Grebely 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.
PubMed 21145855
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Australian Trial in Acute Hepatitis C
- ClinicalTrials.gov ID
- NCT00192569
- Acronym / sponsor ID
- 1R01DA015999-01
- Conditions
- Hepatitis C
- Keywords
- Acute Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales, National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine whether treatment is effective in clearing the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Drug: Pegylated Interferon alfa 2a, Drug: Ribavirin (HIV conifected patients only)Subjects will be treated for 24 weeks with PEG-IFN (HIV coinfected subjects will received RBV) |
| Untreated | No intervention | –Subjects will be followed for natural history of newly acquired HCV |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferon alfa 2aAlso: pegasysPEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly | Drug | Treated |
| 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 | Drug | Treated |
Primary outcome
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)
Time frame: 24 weeks
1 secondary outcome
Natural history of acute hepatitis C
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
- Derived from this study: PubMed 27355323Doyle 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.
- Derived from this study: PubMed 27246604Lamoury 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.
- Derived from this study: PubMed 26115881Alavi 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.
- Derived from this study: PubMed 25105742Applegate 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.
- Derived from this study: PubMed 21282185Matthews 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.
- Derived from this study: PubMed 21145855Grebely 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.
- National Centre in HIV Epidemiology and Clinical ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kaldor, PhD principal investigator
National Centre in HIV Epidemiology and Clinical Research.
Greg Dore, MB BS FRACP principal investigator
National Centre in HIV Epidemiology and Clinical Research.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated Interferon alfa 2a and Ribavirin (HIV conifected patients only) in people with Hepatitis C, run by Kirby Institute at 18 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192569, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011; AzTrials last refreshed its copy on 29 Oct 2026.