Treatment of Recently Acquired Hepatitis C Virus Infection
ATAHC-II
1 other identifier
interventional
82
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 15, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 2, 2015
August 1, 2015
3.8 years
April 13, 2011
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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);
8-48 weeks
Study Arms (6)
Group A - 8 weeks therapy
EXPERIMENTAL8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy.
Group B - 16 weeks therapy
EXPERIMENTAL16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy.
Group C - 24 weeks therapy
EXPERIMENTAL24 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)
EXPERIMENTAL32 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)
EXPERIMENTAL48 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 INTERVENTIONObservation 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.
Interventions
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
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
Eligibility Criteria
You may qualify if:
- Male and female patients ≥ 16 years of age
- Recent hepatitis C infection with an estimated duration of Infection ≤ 18 months defined as
- 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
- 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.
You may not qualify if:
- 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
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Study Sites (8)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Kirketon Road Centre
Darlinghurst, New South Wales, 2010, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
St Vincent's Hospital Melbourne
Melbourne, New South Wales, 3065, Australia
Nepean Hospital
Penrith, New South Wales, 2751, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3065, Australia
Related Publications (1)
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.
PMID: 26867206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory J Dore, MBBS, PhD
University of New South Wales
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 15, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 2, 2015
Record last verified: 2015-08