Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000081415
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
18/02/2025
Date last updated
18/02/2025
Date data sharing statement initially provided
18/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZCTR-393 Test
Scientific title
ANZCTR-393 Test
Secondary ID [1] 313805 0
12314145
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 336442 0
Condition category
Condition code
Blood 332963 332963 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 330395 0
Diagnosis / Prognosis
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 340500 0
test
Timepoint [1] 340500 0
test
Secondary outcome [1] 444272 0
test
Timepoint [1] 444272 0
test

Eligibility
Key inclusion criteria
test
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
test
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
test
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2025
Date of last participant enrolment
Anticipated
Actual
8/02/2025
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
1000
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27523 0
The Hills Clinic - Kellyville
Recruitment postcode(s) [1] 43635 0
2155 - Kellyville

Funding & Sponsors
Funding source category [1] 318272 0
Government body
Name [1] 318272 0
test
Country [1] 318272 0
Australia
Primary sponsor type
Hospital
Name
Test
Address
Country
Australia
Secondary sponsor category [1] 320660 0
None
Name [1] 320660 0
Address [1] 320660 0
Country [1] 320660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316912 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316912 0
Ethics committee country [1] 316912 0
Australia
Date submitted for ethics approval [1] 316912 0
11/02/2025
Approval date [1] 316912 0
11/02/2025
Ethics approval number [1] 316912 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139414 0
Mr Nathan Leung
Address 139414 0
test
Country 139414 0
Australia
Phone 139414 0
+61 412345678
Fax 139414 0
Email 139414 0
[email protected]
Contact person for public queries
Name 139415 0
Nathan Leung
Address 139415 0
test
Country 139415 0
Australia
Phone 139415 0
+61 412345678
Fax 139415 0
Email 139415 0
[email protected]
Contact person for scientific queries
Name 139416 0
Nathan Leung
Address 139416 0
test
Country 139416 0
Australia
Phone 139416 0
+61 412345678
Fax 139416 0
Email 139416 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
What individual participant data will be or are expected to be shared?
• De-identified Individual participant data for:
• Primary outcome(s)
What types of analyses could be conducted using the individual participant data?
• Studies exploring new research questions
When might the individual participant data become available to request access, and for how long?
From:
After completion of first data analysis
To:
A finite period of: 1 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: test repository

• Data sharing request system: test request system

• Journal publication or its supplementary materials: test journal publication

• Email of trial custodian, sponsor or committee: test email

• Postal Address: test postal address

• test other

Are there additional conditions or steps involved in requesting or accessing individual participant data?
Yes: test question 7

Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
test


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
No additional documents have been identified.