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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/NCT03961204
Registration number
NCT03961204
Ethics application status
Date submitted
22/05/2019
Date registered
23/05/2019
Date last updated
31/10/2023
Titles & IDs
Public title
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
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Scientific title
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)
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Secondary ID [1]
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2019-000069-19
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Secondary ID [2]
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MS700568_0026
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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 (MS)
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Data Collection
Other: Cohort A - The participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
Other interventions: Data Collection
No study treatment was administered as part of this study
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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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Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher
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Assessment method [1]
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EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day. Score of 8.0 is defined as Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms.
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Timepoint [1]
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3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
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Secondary outcome [1]
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Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
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Assessment method [1]
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EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as "intermittent or unilateral constant assistance (cane, crutch and brace) required to walk about 100 meters with or without resting".
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Timepoint [1]
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At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
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Secondary outcome [2]
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Clinical and Demographic Characteristic: Age, Disease Duration
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Assessment method [2]
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Clinical and demographic characteristics including age and disease duration is reported in the form of long term responders and non-responder. Here long term responder is defined as study participants not requiring disease modifying drug (DMD) 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [2]
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At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [3]
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Number of Participants in Each Category of Clinical and Demographic Characteristics
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Assessment method [3]
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Clinical and demographic characteristics included gender, race, disease classification (relapsing remitting multiple sclerosis [RRMS], Secondary Progressive Multiple Sclerosis [SPMS], unknown & no MS disease), Prior use of DMDs & high-disease activity (HAD) status, education level and employment status. Number of participants in each category of clinical and demographic characteristics were reported in form of long term responders & non-responder. Here long term responder is defined as participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD < 4 years following their last dose of IMP in parent study.
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Timepoint [3]
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At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [4]
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Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
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Assessment method [4]
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EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDSS scores range from 0.0 (normal) to 10.0 (dead). Clinical characteristics of EDSS score in form of long-term responders & non-responder was reported for at parent study baseline (based on retrospective data collection [based on chart review] at study visit 1) & study visit 1. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD < 4 years following their last dose of IMP in parent study.
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Timepoint [4]
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At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [5]
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Clinical Characteristic: Number of Relapses
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Assessment method [5]
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Relapse was defined as participant-reported symptoms & objectively observed signs typical of an acute inflammatory demyelinating event in CNS, developing acutely or sub-acutely with duration of at least 24 hours, in absence of fever or infection. Clinical characteristics of number of relapses during last year before enrollment of parent study (it is reported based on retrospective data collection [based on chart review] at study visit 1) in the form of long-term responders & non-responder was reported. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [5]
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At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [6]
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Number of Total T1-weighted (T1-W) Lesions
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Assessment method [6]
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Total number of T1-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [6]
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At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [7]
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Number of Total T2-weighted (T2-W) Lesions
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Assessment method [7]
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Total number of T2-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [7]
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At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [8]
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T1-weighted (T1-W) Lesion Volume
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Assessment method [8]
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T1-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [8]
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At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [9]
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T2-weighted (T2-W) Lesion Volume
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Assessment method [9]
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T2-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [9]
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At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Secondary outcome [10]
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Total Brain Volume
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Assessment method [10]
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Brain volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
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Timepoint [10]
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At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
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Eligibility
Key inclusion criteria
- Participants with relapsing remitting multiple sclerosis (RRMS) randomised in
CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=)
1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo
- Participants with their first clinical demyelinating event randomised in ORACLE MS
clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo
- Participants who has sign informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form and this protocol
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Minimum age
18
Years
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Maximum age
65
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
- Participants who has any uncontrolled disease state other than MS, that in the
Investigator's opinion, constitutes an inappropriate risk or a contraindication for
participation in the study or that could interfere with the study objectives, conduct,
or evaluation
- For study participants at selected sites where MRI assessment will be conducted
following exclusion criteria will apply to MRI assessments only:
- Female study participants who are pregnant
- Participants who are taking Cladribine Tablets as part of another study at the time of
the start of this study
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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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
Single group
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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
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
15/08/2019
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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
13/05/2021
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Sample size
Target
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Accrual to date
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Final
662
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of Sydney - Camperdown
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment outside Australia
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Georgia
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Illinois
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Linz
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Hasselt
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Nottingham
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
EMD Serono Research & Development Institute, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck KGaA, Darmstadt, Germany
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Ethics approval
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Summary
Brief summary
The objective of this study was to collect data both retrospectively and prospectively in
order to evaluate the long-term outcomes, durability of effect, and real-world treatment
patterns following treatment with Cladribine Tablets or placebo in participants with multiple
sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and
CLARITY/CLARITY-EXT).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03961204
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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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Medical Responsible
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Address
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03961204
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