ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

20/06/2022

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]

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

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment

Secondary outcome [1]

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]

0, 3, 6, 12 and 24 months after initiation of therapy

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

1/02/2021

Actual

3/05/2021

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The Government of Western Australia, Department of Health

Address [1]

189 Royal Street
East Perth WA 6004
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee [EC00382]

Ethics committee address [1]

Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/09/2018

Approval date [1]

24/09/2018

Ethics approval number [1]

HREC/45334/MonH-2018-152902

Ethics committee name [2]

Western Australian Aboriginal Health Ethics Committee

Ethics committee address [2]

450 Beaufort Street
Highgate
Western Australia
6003

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/11/2018

Approval date [2]

30/11/2018

Ethics approval number [2]

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

A/Prof Tom Snelling

Address

Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872

Country

Australia

Phone

+61 8 63191817

Fax

tom.snelling@telethonkids.org.au

Contact person for public queries

Name

Tom Snelling

Address

Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872

Country

Australia

Phone

+61 8 63191817

Fax

tom.snelling@telethonkids.org.au

Contact person for scientific queries

Name

Tom Snelling

Address

Wesfarmers Centre of Vaccines and Infectious Diseases
Telethon Kids Institute
PO Box 855
West Perth, WA 6872

Country

Australia

Phone

+61 8 63191817

Fax

tom.snelling@telethonkids.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Subject to necessary approvals

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A platform in the use of medicines to treat chronic hepatitis C (PLATINUM C): protocol for a prospective treatment registry of real-world outcomes for hepatitis C.	2020	https://dx.doi.org/10.1186/s12879-020-05531-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically