Australian Trial in Acute Hepatitis C Recall Study

NCT02000063 | Completed

• 1 other identifier: VHCRP1105
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Hepatitis C

Keywords

Hepatitis C; acute; early chronic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Incidence of HCV re-infection

  4 to 8 years from initial infection

Other Outcomes (3)

• Predictors of HCV re-infection

  4 to 8 years from initial infection

• Incidence and predictors of HCV mixed and superinfections in those with persistent viraemia.

  4 to 8 years from initial infection

• Collection of specimens for future immunological or virological research.

  4 to 8 years from initial infection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
• Provision of written, informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirby Institute: lead
• The University of New South Wales: collaborator

Study Sites (3)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3005, Australia

Location

Related Links

• UNSW Kirby Institute for infection and immunity in society Homepage

Biospecimen

Retention: SAMPLES WITH DNA

Stored serum and peripheral blood mononuclear cells.

MeSH Terms

Conditions

Hepatitis C; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Gail Matthews, MBChB, MRCP (UK), FRACP, PhD

  University of New South Wales, Syndey Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: December 3, 2013
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

AU (3)