Clinical trial NCT02000063: Australian Trial in Acute Hepatitis C Recall Study
Official title: Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hepatitis C
Keywords: Hepatitis C
acute
early chronic
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: The University of New South Wales
First posted: 2013-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Long-term effects of HCV clearance
timeFrame: 4 to 8 years from initial infection
Secondary outcomes:
measure: Incidence of HCV re-infection
timeFrame: 4 to 8 years from initial infection
Other outcomes:
measure: Predictors of HCV re-infection
timeFrame: 4 to 8 years from initial infection
measure: Incidence and predictors of HCV mixed and superinfections in those with persistent viraemia.
timeFrame: 4 to 8 years from initial infection
measure: Collection of specimens for future immunological or virological research.
timeFrame: 4 to 8 years from initial infection
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: University of New South Wales, Syndey Australia
name: Gail Matthews, MBChB, MRCP (UK), FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References: