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Completed

NCT Number: NCT02000063

Australian Trial in Acute Hepatitis C Recall Study

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.

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Key information

Conditions

Acute Hepatitis C Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Communicable Diseases Digestive System Diseases Flaviviridae Infections Graft vs Host Disease Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital, Sydney, New South Wales, Australia

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About this study

The study aims are:

  • 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.
  • To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
  • To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
  • To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • The University of New South Wales

Registry information

Official study title

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

Acronym: ATAHC Recall

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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