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Trial registered on ANZCTR
Registration number
ACTRN12618001715268
Ethics application status
Approved
Date submitted
12/10/2018
Date registered
17/10/2018
Date last updated
25/09/2019
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and tolerability of an inhaled chelator in combination with antibiotic treatment for lung infection in patients with cystic fibrosis
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Scientific title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of an Inhaled Dry Powder Formulation of CaEDTA when given with Inhaled TOBI Dry Powder for treatment of Pseudomonas aeruginosa infection in Cystic Fibrosis Patients - a Phase I dose-ranging Study
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Secondary ID [1]
296322
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None
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Universal Trial Number (UTN)
U1111-1222-1814
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Trial acronym
TEDDPI-001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cystic fibrosis
310032
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Condition category
Condition code
Respiratory
308783
308783
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cohort One
Tobramycin (TOBI dry powder) - dry powder capsules
112mg twice daily for 4 weeks
Calcium disodium ethylenediamine tetraacetate (dry powder capsules - which are inserted into a mododose inhaler which pierces the capsule so it can be inhaled)
Week 1 - 37.5mg twice daily
Week 2 - 75mg twice daily
Week 3 - 75mg twice daily
Week 4 - 150mg twice daily
Cohort Two
Tobramycin (TOBI dry powder)
112mg twice daily for 4 weeks
Calcium disodium ethylenediamine tetraacetate (dry powder capsules)
Week 1 - 37.5mg twice daily
Week 2 - 75mg twice daily
Week 3 - 75mg twice daily
Week 4 - 75mg four times a day
Cohort Three
Tobramycin (TOBI dry powder)
112mg twice daily for 4 weeks
Calcium disodium ethylenediamine tetraacetate (dry powder capsules)
Week 1 - 37.5mg twice daily
Week 2 - 75mg twice daily
Week 3 - 75mg twice daily
Week 4 - 150mg twice daily
Cohort Four
Tobramycin (TOBI dry powder)
112mg twice daily for 4 weeks
Cohort One, Two and Three will use participant diary for drug adherence. All used and unused CaEDTA dry powder capsules will be returned to site by participant at every visit and will be counted for drug adherence. Site staff will be going through tobramycin adherence with the participant at every visit and noting down any missed doses.
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Intervention code [1]
312649
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Treatment: Drugs
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Comparator / control treatment
Cohort 4 (control group) takes TOBI dry powder without added CaEDTA for duration of study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Acute tolerability will be measured by FEV1 changes pre-and post-dose. This will be calculated using Easy One portable spirometer.
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Assessment method [1]
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Timepoint [1]
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Pre dose FEV1 at Day 1, 8, 15, 22, 29
5 minute post dose FEV1 Day 1, 8, 15, 22, 29
2 and 4 hour post dose FEV1 at Day 1 and Day 29
All time points will be used to calculate tolerability
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Primary outcome [2]
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Safety - blood tests include kidney and liver function (creatinine, ALT, GGT), iron- related markers (ferritin, iron, transferrin and transferrin saturation), as well as haemoglobin, blood urea nitrogen, calcium and magnesium
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Assessment method [2]
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Timepoint [2]
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Pre dose at Day 1, 15, 29
20 minutes, 2 and 4 hour post dose Day 1, 29
All time points will be used to calculate safety
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Primary outcome [3]
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Safety - Adverse events, respiratory symptoms
Any changes in health - if participant had headache, increased cough, stomach cramps etc. will be collected from participant throughout the study. They will have a hand out to take home to fill in time and dates of heath events, plus coordinator will go through any changes in health at every visit.
Coordinator will ask participant at every visit whether they have had a change in respiratory symptoms i.e. - increased cough, increased sputum production, shortness of breath, wheezing etc.
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Assessment method [3]
307775
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Timepoint [3]
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Day 1 through to Day 57
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Secondary outcome [1]
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Blood concentration of ethylenediamine tetraacetate (EDTA) in blood samples (millimolar, mM)
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Assessment method [1]
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Timepoint [1]
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Blood samples will be collected pre-dose, and at ½ hour, 2 hours, and 4 hours post-dose at designated visits to assess serum CaEDTA levels at Day 1 and Day 29. A baseline CaEDTA levels will also be taken after the washout period at Day 57.The 30 minutes post-dose sample will represent the peak serum level - as is usually the case with most inhaled drugs. The clearance characteristics and serum half-life of CaEDTA are well known (serum half- life ~20 minutes and maximally up to 60 minutes).
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Secondary outcome [2]
352882
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Sputum concentration of ethylenediamine tetraacetate (EDTA) in sputum samples (millimolar, mM)
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Assessment method [2]
352882
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Timepoint [2]
352882
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- pre-dose and ½-hour post-dose at enrolment Day 1 and at Day 29 to assess trough and peak levels at the different doses,
- 2 hours, 4 hours post-dose at visits Day 1 and Day 29 to assess clearance and area-under-the-curve (AUC) levels,
- single collection at the end of safety phase Day 57 for total clearance levels or evidence of accumulation.
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Secondary outcome [3]
352883
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Urine concentration of ethylenediamine tetraacetate (EDTA) in urine samples (millimolar, mM)
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Assessment method [3]
352883
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Timepoint [3]
352883
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pre-dosing at Day 1 and Day 57 visits
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Eligibility
Key inclusion criteria
- Male or female patients 12 or more years of age with a documented diagnosis of CF (positive sweat chloride test, genotype with two identifiable CF mutations) accompanied by one or more clinical features consistent with the CF phenotype
- FEV1 >40% of predicted values
- At least one positive sputum culture for PsA in the previous 12 months
- Due to start a four week course of inhaled tobramycin dry powder for treatment of
PsA infection
- Must be able to give informed consent or have legally acceptable representative who can give informed consent in accordance with ICH/GCP
- Females of child-bearing potential must agree to use an acceptable method of contraception for the duration of the trial and to have 4 pregnancy tests. Appropriate forms of contraception include; willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 3-week follow-up period.
- Patient capable of using a dry powder inhaler
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who in addition to culturing PsA in their sputum, have also cultured B Cepacia, Staph aureus, Achromobacter, Stenotrophomonas, Acinetobacter, and non-tuberculous mycobacterium species within the last year.
- Known hypersensitivity to the investigational product or its components or known relevant medication allergy
- Currently taking oral prednisone or IV methylprednisolone for ABPA
- Participation in another study with an investigational drug within 1 month of the planned first dose of investigational product
- Known relevant substance abuse
- Female patients who are pregnant or lactating
- Clinically significant disease or other medical condition other than CF or CF-related conditions that would, in the opinion of the Investigator, compromise the safety of the patient or quality of the data
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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Date of first participant enrolment
Anticipated
3/12/2018
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Actual
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Date of last participant enrolment
Anticipated
1/01/2020
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Actual
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Date of last data collection
Anticipated
2/03/2020
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Perth Children's Hospital - Nedlands
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Recruitment hospital [2]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
24344
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Telethon Perth Children's Hospital Research Fund
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Address [1]
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Research Development Unit
Department of Health
PO Box 8172
Perth Business Centre
PERTH WA 6849
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Country [1]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Telethon Kids Institute
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Address
15 Hospital Avenue
Nedlands WA 6009
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
300490
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Address [1]
300490
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Country [1]
300490
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Ethics University of Western Australia [EC00272]
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Ethics committee address [1]
301690
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M459, 35 Stirling Highway
Crawley WA 6009
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Ethics committee country [1]
301690
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Australia
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Date submitted for ethics approval [1]
301690
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18/07/2018
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Approval date [1]
301690
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07/09/2018
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Ethics approval number [1]
301690
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RA/4/20/4615
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Ethics committee name [2]
301691
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Children and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [2]
301691
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Perth Children's Hospital
Locked Bag 2010
NEDLANDS WA 6909
P: 6456 0516
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Ethics committee country [2]
301691
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Australia
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Date submitted for ethics approval [2]
301691
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19/09/2017
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Approval date [2]
301691
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24/01/2018
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Ethics approval number [2]
301691
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RGS0000000626
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Summary
Brief summary
This will be an open-label, unblinded, dose-escalating study. Participants will consist of 24 CF patients (three treatment groups and one control group) who are about to start a standard 4-week course of inhaled TOBI dry powder for outpatient (home) treatment of Pseudomonas aeruginosa infection.
Hypothesis: Inhalation of a dry powder chelator in combination with antibiotic therapy is safe and well tolerated in patients with cystic fibrosis
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Barry Clements
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Address
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Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
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Australia
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Phone
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+61863190836
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Fax
87786
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Email
87786
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[email protected]
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Contact person for public queries
Name
87787
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Dr Barry Clements
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Address
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Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
87787
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Australia
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Phone
87787
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+61863190836
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Fax
87787
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Email
87787
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[email protected]
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Contact person for scientific queries
Name
87788
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Dr Barry Clements
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Address
87788
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Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
87788
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Australia
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Phone
87788
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+61863190836
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Fax
87788
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Email
87788
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Study was terminated due to funding withdrawal - no participants were ever recruitment for the study.
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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.
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