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
|Condition or disease|
|Acute Hepatitis C|
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.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|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|
- 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)
- 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.
- 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.
- 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.
- 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
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
|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|
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3005|
|Principal Investigator:||Gail Matthews, MBChB, MRCP (UK), FRACP, PhD||University of New South Wales, Syndey Australia|