Australian Trial in Acute Hepatitis C Recall Study

NCT ID: NCT02000063

Last Updated: 2014-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail Matthews, MBChB, MRCP (UK), FRACP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales, Syndey Australia

Locations

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St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Related Links

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http://www.kirby.unsw.edu.au

UNSW Kirby Institute for infection and immunity in society Homepage

Other Identifiers

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VHCRP1105

Identifier Type: OTHER

Identifier Source: secondary_id

VHCRP1105

Identifier Type: -

Identifier Source: org_study_id

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