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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03774914
Registration number
NCT03774914
Ethics application status
Date submitted
11/12/2018
Date registered
13/12/2018
Titles & IDs
Public title
LEMTRADA Pregnancy Registry in Multiple Sclerosis
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Scientific title
International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
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Secondary ID [1]
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EU PAS - cat 3
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Secondary ID [2]
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OBS13436
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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:
Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Alemtuzumab (GZ402673)
Lemtrada - Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course
Treatment: Drugs: Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
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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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Spontaneous abortions (=20 weeks gestation)
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Assessment method [1]
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Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [1]
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32 weeks gestation
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Secondary outcome [1]
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Major congenital malformations
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Assessment method [1]
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Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [1]
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From birth to 1 year after delivery
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Secondary outcome [2]
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Minor congenital malformations
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Assessment method [2]
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Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [2]
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From birth to 1 year after delivery
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Secondary outcome [3]
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Stillbirth (any non-deliberate foetal death at >20 weeks gestation)
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Assessment method [3]
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Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [3]
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26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
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Secondary outcome [4]
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Full-term live birth i.e. infants born maturely (=37 gestation weeks)
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Assessment method [4]
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Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [4]
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Within 6 weeks after the end of the pregnancy
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Secondary outcome [5]
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Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)
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Assessment method [5]
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Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [5]
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26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
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Secondary outcome [6]
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Elective terminations i.e. any induced or voluntary fetal loss
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Assessment method [6]
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Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [6]
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16-20 weeks' gestation
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Secondary outcome [7]
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Small for gestational age at birth i.e. birth size (weight, length, or head circumference) =10th percentile for gender and gestational age
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Assessment method [7]
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Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
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Timepoint [7]
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Within 6 weeks after the end of the pregnancy
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Secondary outcome [8]
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Any other adverse pregnancy outcomes
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Assessment method [8]
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Numbers of adverse events
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Timepoint [8]
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Baseline to week 40
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Secondary outcome [9]
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Infant postnatal growth (up to the first year of life)
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Assessment method [9]
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Numbers and rates of infants with postnatal size (weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants.
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Timepoint [9]
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1 year after delivery
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Secondary outcome [10]
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Infant development impairment (up to the first year of life)
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Assessment method [10]
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Numbers and rates of infants with development impairment
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Timepoint [10]
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1 year after delivery
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Eligibility
Key inclusion criteria
Inclusion criteria :
* Women with Multiple Sclerosis who were or became pregnant within the period of time between the first infusion of a course of treatment with LEMTRADA to 4 months after their last infusion for that course.
* Women able and willing to provide informed consent for study participation and the requirement of the study. Informed consent will be obtained at the time of enrollment in accordance with local regulatory requirements.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Previous enrollment in this study for a previous pregnancy.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
1/09/2015
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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
22/11/2021
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Investigational Site Number :036001 - Box Hill
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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Austria
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State/province [2]
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Linz
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Country [3]
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Belgium
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State/province [3]
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Charleroi
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Country [4]
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Canada
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State/province [4]
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Canada
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Country [5]
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Denmark
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State/province [5]
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Aarhus C
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Country [6]
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Germany
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State/province [6]
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Bochum
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Country [7]
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Italy
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State/province [7]
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Gallarate (VA)
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Country [8]
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Netherlands
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State/province [8]
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Netherlands
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Country [9]
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Spain
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State/province [9]
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Spain
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Country [10]
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Sweden
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State/province [10]
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Göteborg
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Country [11]
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Switzerland
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State/province [11]
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Zürich
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Country [12]
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United Kingdom
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State/province [12]
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genzyme, a Sanofi Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective: The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis. Secondary Objective: The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.
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Trial website
https://clinicaltrials.gov/study/NCT03774914
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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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Clinical Sciences & Operations
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Address
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Sanofi
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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?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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/NCT03774914