Australian Trial in Acute Hepatitis C Recall Study (ATAHC Recall)

September 29, 2014 updated by: Kirby Institute

Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.

A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.

Study Overview

Status

Completed

Conditions

Detailed Description

The study aims are:

  1. To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, injecting behaviour, mental health and liver health.
  2. To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
  3. To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
  4. To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
  5. To add to a tissue repository of serum and PBMCs from well-characterised patients treated for recently acquired HCV infection to allow future examination of the role of other variables that may potentially impact on the prognosis and outcomes of early HCV treatment.

Study Type

Observational

Enrollment (Actual)

50

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
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3005
        • The Alfred 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

Sampling Method

Non-Probability Sample

Study Population

An anticipated 60 participants will be recruited from 3 study sites: St Vincent's Hospital, Sydney; The Alfred Hospital, Melbourne; Royal Adelaide Hospital, Adelaide.

Description

Inclusion Criteria:

  • Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
  • Provision of written, informed consent.

Exclusion Criteria:

  • In the opinion of the investigator that the patient is not able to provide informed consent.
  • Inability or unwillingness to comply with study collection requirements.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term effects of HCV clearance
Time Frame: 4 to 8 years from initial infection
Health related quality of life (measured by SF-12) Social functioning (measured by OTI survey) Injecting behaviour Mental health (measured by DASS and MINI) Liver health (measured by FibroScan and biochemical markers)
4 to 8 years from initial infection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of HCV re-infection
Time Frame: 4 to 8 years from initial infection
Rate of HCV RNA positivity in patients previously HCV RNA negative.
4 to 8 years from initial infection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of HCV re-infection
Time Frame: 4 to 8 years from initial infection
Associations of HCV re-infection in those with HCV RNA positivity who were previously HCV RNA negative.
4 to 8 years from initial infection
Incidence and predictors of HCV mixed and superinfections in those with persistent viraemia.
Time Frame: 4 to 8 years from initial infection
Rate (or proportion over average years of follow-up) of new mixed HCV RNA infections in those with persistent viraemia and no prior evidence of multiple HCV infection.
4 to 8 years from initial infection
Collection of specimens for future immunological or virological research.
Time Frame: 4 to 8 years from initial infection
Stored serum and peripheral blood mononuclear cells.
4 to 8 years from initial infection

Collaborators and Investigators

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

Sponsor

Kirby Institute

Collaborators

The University of New South Wales

Investigators

  • Principal Investigator: Gail Matthews, MBChB, MRCP (UK), FRACP, PhD, University of New South Wales, Syndey Australia

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.

Helpful Links

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, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 3, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2014

Last Update Submitted That Met QC Criteria

September 29, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP1105 (Other Identifier: Kirby-VHCRP)

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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