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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03394365
Registration number
NCT03394365
Ethics application status
Date submitted
29/12/2017
Date registered
9/01/2018
Titles & IDs
Public title
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy
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Scientific title
Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy
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Secondary ID [1]
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ATA129-EBV-302
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Universal Trial Number (UTN)
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Trial acronym
ALLELE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
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Solid Organ Transplant Complications
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Lymphoproliferative Disorders
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Allogeneic Hematopoietic Cell Transplant
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Stem Cell Transplant Complications
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Condition category
Condition code
Infection
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Other infectious diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Other - tabelecleucel
Experimental: SOT cohort -Subgroup A - Participants who have failed rituximab will receive IV tabelecleucel.
Experimental: SOT cohort -Subgroup B - Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.
Experimental: HCT cohort - Participants who have failed rituximab will receive IV tabelecleucel.
Treatment: Other: tabelecleucel
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
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Intervention code [1]
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Treatment: Other
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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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Objective response rate (ORR) in the SOT or HCT cohort
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Assessment method [1]
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Duration of response (DOR) in SOT and HCT cohorts separately
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Assessment method [1]
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Timepoint [1]
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2 years
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Secondary outcome [2]
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ORR and DOR in SOT and HCT cohorts combined
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Assessment method [2]
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Rates of complete response (CR) and partial response (PR)
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Assessment method [3]
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Time to response
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Assessment method [4]
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Time to best response
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Assessment method [5]
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Overall survival (OS)
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Assessment method [6]
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Rates of allograft loss or rejection episodes (SOT cohort)
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Assessment method [7]
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Timepoint [7]
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2 years
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Eligibility
Key inclusion criteria
1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort); or prior allogeneic HCT (HCT cohort)
2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD
3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor
4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score = 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used.For subjects with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT subgroup B) for treatment of PTLD.
6. Eastern Cooperative Oncology Group performance status = 3 for subjects aged = 16 years; Lansky score = 20 for subjects < 16 years
7. For HCT cohort only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission
8. Adequate organ function
1. Absolute neutrophil count = 1000/µL, (SOT cohort) or = 500/µL (HCT cohort), with or without cytokine support
2. Platelet count = 50,000/µL, with or without transfusion or cytokine support. For HCT cohort, platelet count < 50,000/µL but = 20,000/µL, with or without transfusion support, is permissible if the subject has not had grade = 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each < 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each = 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction
9. Subject or subject's representative is willing and able to provide written informed consent
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Minimum age
No limit
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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. Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis
3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE:Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.
4. Suspected or confirmed grade = 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment
5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment
6. For HCT cohort: active adenovirus viremia
7. Need for vasopressor or ventilatory support
8. Antithymocyte globulin or similar anti-T cell antibody therapy = 4 weeks prior to enrollment
9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only)
10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
11. Inability to comply with study-related procedures
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 3
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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
29/12/2017
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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
1/06/2027
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Actual
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Sample size
Target
66
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Accrual to date
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Final
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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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The Children's Hospital at Westmead (Pediatrics only) - Westmead
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Recruitment hospital [2]
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Westmead Hospital (Adults only) - Westmead
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Recruitment hospital [3]
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The Prince Charles Hospital (Adults only) - Chermside
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Royal Adelaide Hospital (Adults only) - Adelaide
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Recruitment hospital [5]
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The Royal Children's Hospital Melbourne (Pediatrics only) - Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital (Adults only) - Murdoch
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4032 - Chermside
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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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3052 - Melbourne
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
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United States of America
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California
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Connecticut
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District of Columbia
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Florida
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Illinois
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Maryland
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Canada
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Ontario
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France
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Aquitaine
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France
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Ile-de-France
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Torino
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Barcelona
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Madrid
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Sevilla
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Valencia
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United Kingdom
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England
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Atara Biotherapeutics
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
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Trial website
https://clinicaltrials.gov/study/NCT03394365
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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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Aditi Mehta, DO
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Address
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Atara Biotherapeutics
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Contact person for public queries
Name
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Aditi Mehta, DO
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Address
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Phone
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650-278-8930
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Email
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[email protected]
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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)?
No
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No/undecided IPD sharing reason/comment
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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/NCT03394365