Australian Trial in Acute Hepatitis C Recall Study

Completed

• Conditions: Acute Hepatitis C

• Registration Number: NCT02000063
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

St Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia