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Trial registered on ANZCTR


Registration number
ACTRN12619000023156
Ethics application status
Approved
Date submitted
4/01/2019
Date registered
10/01/2019
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Platform in the use of medicines to treat hepatitis C
Scientific title
A registry of adults with active hepatitis C infection to assess the comparative effectiveness of interventions for achieving virological cure.
Secondary ID [1] 296818 0
CVID/2016-08
Universal Trial Number (UTN)
U1111-1225-1592
Trial acronym
PLATINUM C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic hepatitis C infection 310713 0
Condition category
Condition code
Infection 309412 309412 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
This study will enrol participants with hepatitis C virus (HCV) infection from participating sites. Active HCV infection will be established by confirming the presence of HCV RNA in blood. Those enrolled will agree to allow the systematic collection of their demographic, lifestyle, treatment, outcome, and other relevant clinical data to better inform the future management of the condition. The primary outcome is virological cure, as evidenced by a sustained virological response (SVR) defined as a negative HCV PCR result 6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment. Participants within the study will have the option to participate in medication adherence monitoring and a quality of life assessment (EQ-5L-5D).
Intervention code [1] 313109 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308362 0
The primary outcome is virological cure, as evidenced by a sustained virological response (SVR) defined as a negative HCV RNA (in plasma) PCR result 6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment.
Timepoint [1] 308362 0
6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment
Secondary outcome [1] 354732 0
Self-reported quality of life (QoL) measured during and for up to 24 months after initiation of treatment, as measured by the EQ-5D-5L questionnaire
Timepoint [1] 354732 0
0, 3, 6, 12 and 24 months after initiation of therapy
Secondary outcome [2] 354733 0
Self-reported adherence of study participants to antiviral treatment (the proportion of prescribed doses taken) collected via either a weekly SMS (short message service) text message or phone message questioning the number of pills taken per week.
Timepoint [2] 354733 0
Weekly within the treatment period prescribed (approximately 8-12 weeks)

Eligibility
Key inclusion criteria
To be eligible, a participant must meet the following criteria:
1. Evidence of active HCV infection (HCV RNA detected) within the preceding 3 months
2. Adult 18 years of age or above
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A potentially eligible individual will be excluded from participation if either of the following criteria are met:
1. Already receiving direct-acting antiviral medication for HCV infection
2. Unable or unwilling to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Individual demographic and baseline variables will be reported by viral genotype, liver cirrhosis status, previous hepatitis C treatment and clinician prescribed treatment. Continuous variables will be summarised as mean and standard deviation for symmetric distributions and median and interquartile range (IQR) for asymmetric distributions. Categorical variables will be summarised at each level as frequency and percentage. Frequencies below five will be reported as “<5” to ensure individual confidentiality.
Self-reported adherence of study participants to antiviral treatment will be summarised as the median (and IQR) proportion of prescribed doses taken in weeks 1 to 12 by viral genotype, liver cirrhosis status and clinician prescribed treatment.
Self-reported quality of life (QoL) measured during and for up to 24 months after initiation of treatment, as measured by the EQ-5L-5D, will be summarised by median (and IQR) by viral genotype, liver cirrhosis status and clinician prescribed treatment.
All summary statistics will be calculated in R version 3.4.3 (2017-11-30), or a later version as the platform evolves open time, which is provided open-source by the R Foundation for Statistical Computing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301391 0
Government body
Name [1] 301391 0
The Government of Western Australia, Department of Health
Address [1] 301391 0
189 Royal Street
East Perth WA 6004
Australia
Country [1] 301391 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 301077 0
None
Name [1] 301077 0
Address [1] 301077 0
Country [1] 301077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302128 0
Monash Health Human Research Ethics Committee [EC00382]
Ethics committee address [1] 302128 0
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 302128 0
Australia
Date submitted for ethics approval [1] 302128 0
06/09/2018
Approval date [1] 302128 0
24/09/2018
Ethics approval number [1] 302128 0
HREC/45334/MonH-2018-152902
Ethics committee name [2] 302137 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 302137 0
450 Beaufort Street
Highgate
Western Australia
6003
Ethics committee country [2] 302137 0
Australia
Date submitted for ethics approval [2] 302137 0
14/11/2018
Approval date [2] 302137 0
30/11/2018
Ethics approval number [2] 302137 0
868

Summary
Brief summary
Platinum C will collect information on people who have hepatitis C virus infection and the effects of hepatitis C treatment. We aim to work out how effective new hepatitis C treatments are, and to find out what things influence their outcomes, including the type of treatment they have, how well they adhere to treatment, and major life disruptions. We aim to understand which people are unlikely to take all of their hepatitis C medications and if and how this affects their response to treatment. We will ask some additional questions about general well-being before, during and after treatment. We expect this information will help researchers find ways to help more people to get tested, treated and cured of hepatitis C infection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89214 0
A/Prof Tom Snelling
Address 89214 0
Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872
Country 89214 0
Australia
Phone 89214 0
+61 8 63191817
Fax 89214 0
Email 89214 0
tom.snelling@telethonkids.org.au
Contact person for public queries
Name 89215 0
A/Prof Tom Snelling
Address 89215 0
Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872
Country 89215 0
Australia
Phone 89215 0
+61 8 63191817
Fax 89215 0
Email 89215 0
tom.snelling@telethonkids.org.au
Contact person for scientific queries
Name 89216 0
A/Prof Tom Snelling
Address 89216 0
Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872
Country 89216 0
Australia
Phone 89216 0
+61 8 63191817
Fax 89216 0
Email 89216 0
tom.snelling@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Subject to necessary approvals
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Summary results
No Results