Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02000063




Registration number
NCT02000063
Ethics application status
Date submitted
12/11/2013
Date registered
3/12/2013
Date last updated
1/10/2014

Titles & IDs
Public title
Australian Trial in Acute Hepatitis C Recall Study
Scientific title
Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
Secondary ID [1] 0 0
VHCRP1105
Secondary ID [2] 0 0
VHCRP1105
Universal Trial Number (UTN)
Trial acronym
ATAHC Recall
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term effects of HCV clearance
Timepoint [1] 0 0
4 to 8 years from initial infection
Secondary outcome [1] 0 0
Incidence of HCV re-infection
Timepoint [1] 0 0
4 to 8 years from initial infection

Eligibility
Key inclusion criteria
* Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
* Provision of written, informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3005 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02000063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MBChB, MRCP (UK), FRACP, PhD
Address 0 0
University of New South Wales, Syndey Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02000063