Acute Hepatitis CPhase 4ATAHC-IINCT01336010
Treatment of Recently Acquired Hepatitis C Virus Infection
A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Acute Hepatitis C, run by Kirby Institute at 8 sites in Australia.
Trial summary
To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Hepatitis C
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 8 sitesAustralia
- Study dates
- Aug 2011to Jun 2015
- 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
- Recent hepatitis C infection with an estimated duration of Infection ≤ 18 months defined as
- A)
- i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and
- ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result
- OR
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- B)
- i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and
- ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable and
- Adequate English to provide written, informed consent and to provide reliable responses to the study interview
- Provision of written, informed consent.
Who cannot join
- All patients:
- Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
- Treatment group only:
- Age between 16 and 18 years
- 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
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- 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 PEG-IFN and ribavirin only)
- Male partners of women who are pregnant (for patients who receive combination therapy with PEG-IFN 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, macular degeneration)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Kirketon Road Centre
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
St Vincent's Hospital Melbourne
Melbourne, New South Wales, 3065
Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3065
Nepean Hospital
Penrith, New South Wales, 2751
About this study
To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment.
Read the detailed description
A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.
- Conditions
- Acute Hepatitis C
- Being tested
- Peginterferon alfa-2a, Ribavirin
- Keywords
- Hepatitis C, Acute Hepatitis C, Early chronic Hepatitis C
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
Also called Pegasys
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
RibavirinDrug
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 |
|---|---|---|
| Group A - 8 weeks therapy | Experimental | 8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Group B - 16 weeks therapy | Experimental | 16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Group C - 24 weeks therapy | Experimental | 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Group D - 32 weeks (gt1) or 24 weeks (gt 2/3) | Experimental | 32 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) | Experimental | 48 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 2/3). Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Untreated Group | No intervention | Observation only. No treatment for hepatitis C administered. Subjects who have undetectable HCV RNA at baseline, do not wish to commence treatment or are ineligible for treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment.
Treatment duration will be determined by time to undetectable HCV RNA. Undetectable at week 2=8 weeks of therapy; Undetectable at week 4=16 weeks of therapy; Undetectable at week 6=24 weeks of therapy; Undetectable at week 8=32 weeks of therapy (24 weeks for genotypes 2/3); Undetectable at week 12=48 weeks of therapy (24 weeks for genotypes 2/3);
Measured: 8-48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gregory J Dore, MBBS, PhD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336010
- Sponsor's protocol ID
- 5R01DA015999-07
- Acronym
- ATAHC-II
- Status last verified
- Aug 2015
- First submitted
- 13 Apr 2011
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11.
PubMed 26867206
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recently Acquired Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01336010
- Acronym / sponsor ID
- ATAHC-II / 5R01DA015999-07
- Conditions
- Acute Hepatitis C
- Keywords
- Hepatitis C, Acute Hepatitis C, Early chronic Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Apr 2011 (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.
To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment.
Detailed description
A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A - 8 weeks therapy | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy. |
| Group B - 16 weeks therapy | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy. |
| Group C - 24 weeks therapy | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy. |
| Group D - 32 weeks (gt1) or 24 weeks (gt 2/3) | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin32 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy. |
| Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) | Experimental | Drug: Peginterferon alfa-2a, Drug: Ribavirin48 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 2/3). |
| Untreated Group | No intervention | –Observation only. No treatment for hepatitis C administered. Subjects who have undetectable HCV RNA at baseline, do not wish to commence treatment or are ineligible for treatment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female patients ≥ 16 years of age
- Recent hepatitis C infection with an estimated duration of Infection ≤ 18 months defined as
- A)
- i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and
- ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result
Key exclusion criteria (18 listed)
- Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
- Age between 16 and 18 years
- 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
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysPEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly | Drug | Group A - 8 weeks therapy, Group B - 16 weeks therapy, Group C - 24 weeks therapy, Group D - 32 weeks (gt1) or 24 weeks (gt 2/3), Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) |
| RibavirinGenotype 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 | Group A - 8 weeks therapy, Group B - 16 weeks therapy, Group C - 24 weeks therapy, Group D - 32 weeks (gt1) or 24 weeks (gt 2/3), Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) |
Primary outcome
Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment.
Time frame: 8-48 weeks
Treatment duration will be determined by time to undetectable HCV RNA. Undetectable at week 2=8 weeks of therapy; Undetectable at week 4=16 weeks of therapy; Undetectable at week 6=24 weeks of therapy; Undetectable at week 8=32 weeks of therapy (24 weeks for genotypes 2/3); Undetectable at week 12=48 weeks of therapy (24 weeks for genotypes 2/3);
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 2 Sep 2015.
- Derived from this study: PubMed 26867206Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11.
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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.
Gregory J Dore, MBBS, PhD principal investigator
University of New South Wales
8 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 Peginterferon alfa-2a and Ribavirin in people with Acute Hepatitis C, run by Kirby Institute at 8 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 11 inclusion and 18 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 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment. (time frame: 8-48 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 NCT01336010, which also lists 1 linked publication.
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 2 Sep 2015.