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Trial record 40 of 2126 for:    Hepatitis C

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

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ClinicalTrials.gov Identifier: NCT02000063
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : October 1, 2014
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:
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.

Condition or disease
Acute Hepatitis C

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Stored serum and peripheral blood mononuclear cells.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000063


Locations
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Australia, New South Wales
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3005
Sponsors and Collaborators
Kirby Institute
The University of New South Wales
Investigators
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Principal Investigator: Gail Matthews, MBChB, MRCP (UK), FRACP, PhD University of New South Wales, Syndey Australia

Additional Information:
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02000063     History of Changes
Other Study ID Numbers: VHCRP1105
VHCRP1105 ( Other Identifier: Kirby-VHCRP )
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Kirby Institute:
Hepatitis C
acute
early chronic

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections