Australian Trial in Acute Hepatitis C Recall Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02000063

Acronym

ATAHC Recall

Enrollment

Registered

2013-12-03

Start date

2012-08-31

Completion date

2014-03-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hepatitis C

Keywords

Hepatitis C, acute, early chronic

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Long-term effects of HCV clearance	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

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

Other

Measure	Time frame	Description
Predictors of HCV re-infection	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.	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.	4 to 8 years from initial infection	Stored serum and peripheral blood mononuclear cells.

Countries

Australia

Outcome results