Treatment of Recently Acquired Hepatitis C Virus Infection (ATAHC-II)

August 31, 2015 updated by: Kirby Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Kirketon Road Centre
      • Melbourne, New South Wales, Australia, 3065
        • St Vincent's Hospital Melbourne
      • Penrith, New South Wales, Australia, 2751
        • Nepean Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3065
        • Royal Melbourne Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

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.

Exclusion Criteria:

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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - 8 weeks therapy
8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy.
Drug: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • Pegasys
Drug: Ribavirin
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
Experimental: Group B - 16 weeks therapy
16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy.
Drug: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • Pegasys
Drug: Ribavirin
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
Experimental: Group C - 24 weeks therapy
24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy.
Drug: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • Pegasys
Drug: Ribavirin
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
Experimental: Group D - 32 weeks (gt1) or 24 weeks (gt 2/3)
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.
Drug: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • Pegasys
Drug: Ribavirin
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
Experimental: Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3)
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).
Drug: Peginterferon alfa-2a
PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
Other Names:
  • Pegasys
Drug: Ribavirin
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
No Intervention: Untreated Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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);
8-48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Gregory J Dore, MBBS, PhD, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01DA015999-07 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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