Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000846921
Ethics application status
Approved
Date submitted
10/08/2011
Date registered
10/08/2011
Date last updated
26/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The correlation of IL28B genotypes with patient demographics and disease characteristics in patients with Genotype 1 chronic hepatitis C
Scientific title
The correlation of IL28B genotypes with patient demographics and disease characteristics in patients with Genotype 1 chronic hepatitis C
Secondary ID [1] 262722 0
nil
Universal Trial Number (UTN)
U1111-1123-2199
Trial acronym
Predict
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatitis C 270430 0
genotype 1 270431 0
antiviral treatment naive 270432 0
Condition category
Condition code
Infection 270578 270578 0 0
Other infectious diseases
Human Genetics and Inherited Disorders 270691 270691 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A single blood sample taken for IL28B testing
Intervention code [1] 267070 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269320 0
National distribution of the IL28B genotypes for both the rs12979860 and rs8099917 SNPs.

Both SNPs will be tested through blood testing.
Timepoint [1] 269320 0
At the end of recruitment
Secondary outcome [1] 279369 0
To see if there is any correlation between the IL28B genotype and pre-treatment factors such as the extent of liver fibrosis, viral load and HCV genotype 1, Self reported ethnicity years of infection and fibrosis staging ,treatment initiation status post testing and 6 and 12 months post genotyping.
All the above parameters will be collected from patients and their medical records and entered into a database.
Timepoint [1] 279369 0
12 months after recruitment

Eligibility
Key inclusion criteria
hepatitis C (HCV)
genotype 1
evidence of hepatitis C infection for at least 6 months
Serological evidence of HCV infection by an anti-HCV antibody test (current or historical)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infection with any HCV genotype other than genotype 1. Patients with indeterminate or mixed subtypes will be allowed.
2. Patients currently treated, or a history of having received any interferon or ribavirin based therapy or investigational anti-HCV agents at any previous time.
3. Patients co-infected with hepatitis B, or HIV

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
31/05/2011
Date of last participant enrolment
Anticipated
Actual
29/06/2012
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
2000
Accrual to date
Final
1131
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 4335 0
2000
Recruitment postcode(s) [2] 4336 0
3000
Recruitment postcode(s) [3] 4337 0
4000
Recruitment postcode(s) [4] 4338 0
5000
Recruitment postcode(s) [5] 4339 0
6000
Recruitment postcode(s) [6] 4340 0
7000

Funding & Sponsors
Funding source category [1] 269580 0
Commercial sector/Industry
Name [1] 269580 0
Roche Products Pty Ltd
Country [1] 269580 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Liver Association Clinical Trial Network
Address
GESA
PO Box 508
MULGRAVE 3170
VICTORIA
Country
Australia
Secondary sponsor category [1] 266614 0
None
Name [1] 266614 0
Address [1] 266614 0
Country [1] 266614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269504 0
WSLHN HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 269504 0
(Westmead Campus)
Westmead Hospital
Westmead, 2145
NSW
Ethics committee country [1] 269504 0
Australia
Date submitted for ethics approval [1] 269504 0
Approval date [1] 269504 0
16/12/2010
Ethics approval number [1] 269504 0
HREC/10WMEAD/255HREC2010/12/4.18(3260)
Ethics committee name [2] 269505 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 269505 0
The Alfred
Commercial Road
Melbourne, 3004
Victoria
Ethics committee country [2] 269505 0
Australia
Date submitted for ethics approval [2] 269505 0
28/03/2011
Approval date [2] 269505 0
14/07/2011
Ethics approval number [2] 269505 0
HREC/11/Alfred/23 (Local Reference: Project No 110/11)

Summary
Brief summary
This is a prospective, multicentre, single arm observational non-interventional investigator initiated study by members of the Australian Liver Association Clinical Trials Network.
This study will examine the distribution of the known IL28B polymorphisms (rs12979860 and rs8099917 SNPs) in patients with treatment naive genotype 1 chronic hepatitis C being considered for treatment in Australian clinics.
In addition to describing the IL28B distribution in the Australian cohort, we will investigate if there is any correlation between the IL28B genotype and pre-treatment factors such as the extent of liver fibrosis, viral load and HCV genotype 1 subtype.
Trial website
http://fmstorr.sydney.edu.au/fmi/iwp/res/iwp_home.html
Trial related presentations / publications
Oral Presentation at Australian Gastroenterology Week, Adelaide October 2012

Roberts S, Mitchell J, Leung RC, Booth D, McCaughan G, Crawford DH, Thompson A, Sievert W, Dore G, George J. The distribution of polymorphisms in the IL28B gene in previously untreated Australian patients with genotype 1 CHC: the PREDICT study. Journal of Gastroenterology and Hepatology 2012 Oct;27:178.
Public notes

Contacts
Principal investigator
Name 32940 0
Prof Jacob George
Address 32940 0
Storr Liver Unit, Westmead Hospital,
Darcy Road, Westmead, NSW, 2145
Country 32940 0
Australia
Phone 32940 0
+61 2 9845 7705
Fax 32940 0
Email 32940 0
[email protected]
Contact person for public queries
Name 16187 0
Prof Professor Jacob George
Address 16187 0
Storr Liver Unit
Westmead Hospital
Westmead
NSW, 2145
Country 16187 0
Australia
Phone 16187 0
+61 2 9845 7705
Fax 16187 0
Email 16187 0
[email protected]
Contact person for scientific queries
Name 7115 0
Prof Professor Jacob George
Address 7115 0
Storr Liver Unit
Westmead Hospital
Westmead
NSW, 2145
Country 7115 0
Australia
Phone 7115 0
+ 61 2 9845 7705
Fax 7115 0
Email 7115 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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