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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02670564
Registration number
NCT02670564
Ethics application status
Date submitted
3/07/2015
Date registered
2/02/2016
Date last updated
16/04/2019
Titles & IDs
Public title
ALL SCTped FORUM - Pharmacogenomic Study (add-on Study)
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Scientific title
Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)
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Secondary ID [1]
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NZ 2015-069
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Secondary ID [2]
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ZH 2014-0535
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pharmacogenomics
Other interventions - Busulfan plasma level measurements
Experimental: Total body irradiation (TBI) - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Experimental: Busulfan - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Experimental: Treosulfan - The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses.
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
Other interventions: Pharmacogenomics
Blood samples (2x5ml EDTA tubes) should be collected just before the start of the conditioning regimen from every patient regardless of therapeutic arm by every centre and stored =-20°C Patient should be in remission (MRD negative) for this sampling, otherwise the sample should be taken using a mouth swab/saliva (not intravenously).
For second transplant patients, please provide DNA taken before first transplant or a fresh saliva samples.
Other interventions: Busulfan plasma level measurements
Bu PK analysis after the first dose of IV Bu (+potential subsequent ones).
Blood sampling:
->For Bu 4 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 15 min (Time 2), 30 min (Time 3), 1 hour (Time 4) and 4 hour (Time 5) after the end of infusion
->For Bu 1 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 1 hour (Time 2), 3 hour (Time 3), 5 hour (Time 4), 7 hour (Time 5) and 11 hour (Time 6) after the end of infusion.
For centers not performing BU TDM, perform Dried Blood Sampling (DBS) analysis:
-> 0.5ml blood sample should be collected and 5µl spotted onto DBS cards in duplicate. Dry them max 5 hours and then keep in a sealed envelope and store at -80°C, as below
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Intervention code [1]
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Other interventions
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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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Genetic variants in participants as a marker of risk of Adverse events and/or Efficacy of the studied agents
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Assessment method [1]
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Genotyping of candidates genes related to pharmacokinetics and pharmacodynamics of the studied agents.
Association study between the herein genetic variants and the below mentioned phenotypes (odd ratio).
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Timepoint [1]
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through study completion, an average of 2 years
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Secondary outcome [1]
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Number of participants with acute Graft-versus-host disease (aGvHD) according to the Glucksberg scale and Seattle criteria
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Assessment method [1]
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Timepoint [1]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [2]
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Number of participants with chronic Graft-versus-host disease (cGvHD) according to the Glucksberg scale and Seattle criteria
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Assessment method [2]
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Timepoint [2]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [3]
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Number of participants with VOD/SOS according to the Seattle criteria
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Assessment method [3]
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Timepoint [3]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [4]
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Number of participants with Neutrophil recovery as a measure of Safety and Tolerability
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Assessment method [4]
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defined as the first of 3 consecutive days with an absolute neutrophil count of 0.5x10^9/L or higher
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Timepoint [4]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [5]
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Number of participants with Platelet recovery as a measure of Safety and Tolerability
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Assessment method [5]
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Defined as the first of 3 consecutive days with platelet counts higher that 20x10^9/L without transfusion
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Timepoint [5]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [6]
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Number of participants with Primary graft failure or rejection as a measure of Safety and Tolerability
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Assessment method [6]
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Defined by persistent pancytopenia with no evidence of hematologic recovery of donor cells beyond 28 days after transplantation, and secondary graft failure by a rapid decrease in neutrophil count after successful engraftment
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Timepoint [6]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [7]
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Transplant related mortality (TRM)
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Assessment method [7]
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the time of transplant until all causes of death after transplant not related to relapse
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Timepoint [7]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [8]
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Event free survival (EFS)
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Assessment method [8]
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the time of transplant until death, relapse or graft failure, whichever occurs first.
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Timepoint [8]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [9]
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Overall survival (OS)
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Assessment method [9]
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the time between transplantation and death due to any causes
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Timepoint [9]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Secondary outcome [10]
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Cumulative incidence of relapse
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Assessment method [10]
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Timepoint [10]
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18 months after inclusion of first patient, afterwards, annually up to 10 years
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Eligibility
Key inclusion criteria
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to
the main study for further details.
Gender
- Both: both female and male participants are being studied
Age Limits
- Minimum Age: N/A
- Maximum Age: age at time of screening less than 18 years old
Accepts Healthy Volunteers: no
Eligibility Criteria
- Patients with ALL (except for patients with B-ALL)
- indication for allogeneic HSCT
- complete remission (CR) before HSCT
- written consent of the parents (legal guardian) and, if necessary, the minor patient
via "Informed Consent Form"
- no pregnancy
- no secondary malignancy
- no previous HSCT
- HSCT is performed in a study participating centre
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Minimum age
No limit
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Maximum age
18
Years
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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
- Non Hodgkin-Lymphoma
- ALL with extramedullary involvement with indication for TBI
- CNS involvement at the timepoint of screening
- Trisomy 21
- The whole protocol or essential parts are declined either by patient himself/herself
or the respective legal guardian
- No consent is given for saving and propagation of anonymous medical data for study
reasons
- Severe concomitant disease that does not allow treatment according to the protocol at
the investigator's discretion (e.g. malformation syndromes, cardiac malformations,
metabolic disorders)
- Karnofsky / Lansky score < 50%
- Subjects unwilling or unable to comply with the study procedures
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Study design
Purpose of the study
Basic Science
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
1/04/2013
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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
1/04/2026
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Switzerland
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State/province [1]
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Cansearch Laboratory
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Country [2]
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Switzerland
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State/province [2]
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Basel
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Country [3]
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Switzerland
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State/province [3]
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Geneva
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Country [4]
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Switzerland
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State/province [4]
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Zurich
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Funding & Sponsors
Primary sponsor type
Other
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Name
Swiss Pediatric Oncology Group
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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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ALL SCTped Forum
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient
genetic variations which influence activity of enzyme metabolizing or acting in the pathway
of prescribed chemotherapy drugs.
This add-on research aims to prospectively investigate variations in several candidate genes
related to all types of chemotherapeutic drugs and TBI used in the main related study NCT
01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK
variability and outcome of myeloablative therapy for pediatric patients receiving an
allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02670564
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Christina Peters, Prof. MD PhD
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Address
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St. Anna Kinderspital, Vienna, Austria
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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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Marc Ansari, MD, PD
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Address
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Country
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Phone
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+41 22 382 47 31
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02670564
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