Australian Trial in Acute Hepatitis C Recall Study | NCT02000063

Studies
Australian Trial in Acute Hepatitis C Recall Study

NCT02000063

Sponsor

Kirby Institute

Status

Completed

Last Update Posted

Oct 1, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Acute Hepatitis C

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
VHCRP1105	Other Identifier	Kirby-VHCRP

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Nov 12, 2013

First Submission Date that Met QC Criteria

Nov 26, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2014

Last Update Posted Date

Oct 1, 2014Estimated

Name	Class
The University of New South Wales	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.
To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Measure	Description	Time Frame
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
Incidence and predictors of HCV mixed and superinfections in those with persistent viraemia.

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gail Matthews, MBChB, MRCP (UK), FRACP, PhD	University of New South Wales, Syndey Australia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Hospital		Sydney	New South Wales	2010	Australia
Royal Adelaide Hospital

References Module

Citations

Not provided

ID	Term
D006526	Hepatitis C
D000092122	Bronchiolitis Obliterans Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human