Australian Trial in Acute Hepatitis C Recall Study

Acute Hepatitis C Clinical Trial

— ATAHC Recall  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000063
• Other study ID #: VHCRP1105
• Secondary ID: VHCRP1105
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: September 29, 2014
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictors of HCV re-infection	Associations of HCV re-infection in those with HCV RNA positivity who were previously HCV RNA negative.	4 to 8 years from initial infection	No
Other	Incidence and predictors of HCV mixed and superinfections in those with persistent viraemia.	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.	4 to 8 years from initial infection	No
Other	Collection of specimens for future immunological or virological research.	Stored serum and peripheral blood mononuclear cells.	4 to 8 years from initial infection	No
Primary	Long-term effects of HCV clearance	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)	4 to 8 years from initial infection	No
Secondary	Incidence of HCV re-infection	Rate of HCV RNA positivity in patients previously HCV RNA negative.	4 to 8 years from initial infection	No

External Links

•   UNSW Kirby Institute for infection and immunity in society Homepage