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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02709343
Registration number
NCT02709343
Ethics application status
Date submitted
1/03/2016
Date registered
16/03/2016
Titles & IDs
Public title
Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction
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Scientific title
Phase 2 Randomised Controlled Trial of Bone-marrow Derived Mesenchymal Stromal Cells (MSC) for New Onset Chronic Lung Allograft Dysfunction (CLAD)
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Secondary ID [1]
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ASSIST-CLAD
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Universal Trial Number (UTN)
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Trial acronym
ASSIST-CLAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lung Allograft Dysfunction (CLAD)
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bone-marrow derived MSCs
Treatment: Drugs - Placebo
Experimental: Bone-marrow derived MSCs - 4 doses of Allogeneic bone-marrow derived MSCs (2x106 cells/kg) given intravenously twice weekly for 2 weeks
Placebo comparator: Placebo - Placebo product manufactured to look like MSCs
Treatment: Drugs: Bone-marrow derived MSCs
Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells
Treatment: Drugs: Placebo
Placebo product visually very similar to mesenchymal stromal cells
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival
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Assessment method [1]
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Progression-free survival is a composite end-point of freedom from CLAD progression or death from any-cause. CLAD progression is defined as fall in FEV1 \> 10% from the baseline (screening visit) FEV1 to the 12 month (week 54) visit.
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Timepoint [1]
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From baseline to week 54
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Secondary outcome [1]
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Time to fall in FEV1 > 10%
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Assessment method [1]
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Defined as fall in FEV1 \> 10% from the baseline (screening visit) FEV1
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Timepoint [1]
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From the baseline (screening) visit
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Secondary outcome [2]
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Freedom from Bronchiolitis Obliterans Syndrome (BOS) grade 3
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Assessment method [2]
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BOS grade 3 is defined as FEV1 \<50% of the best-post-transplant FEV1
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Timepoint [2]
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Week 54
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Secondary outcome [3]
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All cause mortality
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Assessment method [3]
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Timepoint [3]
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Week 54
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Secondary outcome [4]
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CLAD-specific mortality
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Assessment method [4]
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Defined as any death felt by the investigator to be at least partially related to CLAD.
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Timepoint [4]
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Week 54
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Secondary outcome [5]
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Freedom from acute rejection
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Assessment method [5]
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Acute rejection defined as any biopsy proven episode of acute vascular (A1-A4) or airway (B1R or B2R) rejection.
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Timepoint [5]
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From baseline to week 54
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Secondary outcome [6]
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Freedom from the development of new donor specific anti-HLA antibodies
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Assessment method [6]
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An anti-HLA antibody (any mean fluorescent intensity level) with specificity for a donor HLA type at 3 months which was not present prior to IMP treatment
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Timepoint [6]
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From baseline to week 14
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Secondary outcome [7]
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Freedom from CLAD progression
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Assessment method [7]
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CLAD progression is defined as fall in FEV1 \> 10% from the baseline (screening visit) FEV1 at 12 months.
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Timepoint [7]
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From baseline to week 54
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Secondary outcome [8]
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Rate of FEV1 decline
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Assessment method [8]
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Rate of FEV1 decline is defined as the slope of the regression line for FEV1 between the screening visit and week 54
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Timepoint [8]
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From baseline to week 54
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Secondary outcome [9]
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Rate of FVC decline
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Assessment method [9]
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Rate of FVC decline is defined as the slope of the regression line for FVC between the screening visit and week 54
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Timepoint [9]
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From baseline to week 54
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Secondary outcome [10]
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Change in 6-minute walk distance (6MWD)
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Assessment method [10]
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Change in 6MWD is defined as the difference between the 6MWD at screening and the week 54 visit. Patients who have died by week 54 will receive a 6MWD of 0.
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Timepoint [10]
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From baseline to week 54
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Secondary outcome [11]
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Change in St George's Respiratory Questionnaire (SGRQ) Score
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Assessment method [11]
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Change in SGRQ is defined as the difference between the total SGRQ at screening and the week 54 visit. Patients who have died by week 54 will receive a SGRQ of 0.
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Timepoint [11]
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From baseline to week 54
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Secondary outcome [12]
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Inpatient bed-days
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Assessment method [12]
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This is defined as the aggregate of inpatient bed-days between the screening visit and week 54.
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Timepoint [12]
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From baseline to week 54
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Eligibility
Key inclusion criteria
1. Bilateral lung transplant recipients aged = 18 years and at least 6 months post-transplant. Patients with other organs transplanted (eg heart, liver, kidney) or those who have undergone lobar transplantation, or re-transplantation, are potentially eligible.
2. New-onset CLAD (defined as a persistent (3weeks apart) fall in FEV1 of at least 20% from the mean of the two best post-transplant values taken at least 3 weeks apart) in the 12 months prior to the screening visit. Other causes of a fall in FEV1 (acute cellular or humoral rejection, active infection, anastomotic stenosis etc.) must be excluded as per international guidelines.
3. Stable immunosuppression regimen, as assessed by the investigator, in the 8 weeks prior to the screening visit.
4. Available for all specified assessments at the study site through the completion of the study, including the protocol bronchoscopies.
5. Provision of written informed consent.
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Minimum age
18
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
1. Any condition that in the opinion of the Investigator may interfere with the safety of the patient, his / her completion of required follow-up visits or evaluation of the study objectives
2. Untreated cellular or humoral rejection
3. Clinically meaningful and untreated viral, bacterial or fungal infection
4. Use of azithromycin or another macrolide antibiotic, if commenced within 8 weeks of the screening visit
5. Intravenous pulsed methylprednisolone, within 4 weeks of the screening visit
6. Use of extracorporeal photopheresis, within 4 weeks of the screening visit
7. Use of total lymphoid irradiation, within 4 weeks of the screening visit
8. Poor functional status not expected to survive 6 months
9. Allergy to beef products
10. Women who are pregnant, breast-feeding or unwilling to use adequate contraception
11. Patients who are currently participating in another interventional clinical trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2023
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St Vincents Hospital - Sydney
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Recruitment hospital [2]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment hospital [5]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Isopogen
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Cell and Tissue Therapies
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed for lung transplant patients who have developed chronic lung allograft dysfunction (CLAD). Consented patients will receive 4 intravenous doses of allogeneic, bone-marrow-derived MSCs (2\*10\^6 cells/kg/dose) or matching placebo over a period of 2 weeks with a 12 month follow up.
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Trial website
https://clinicaltrials.gov/study/NCT02709343
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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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Daniel Chambers, MBBS MD
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Address
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University of Queensland & The Prince Charles Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified data will be analysed and shared with collaborators with the plan to publish the results.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02709343