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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03580356




Registration number
NCT03580356
Ethics application status
Date submitted
26/06/2018
Date registered
9/07/2018

Titles & IDs
Public title
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Scientific title
A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Secondary ID [1] 0 0
2018-000840-24
Secondary ID [2] 0 0
CQGE031C2303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ligelizumab
Treatment: Other - Omalizumab
Other interventions - Placebo

Experimental: Ligelizumab 120 mg - Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Experimental: Ligelizumab 72 mg - Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Active comparator: Omalizumab 300 mg - Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo comparator: Placebo - Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48


Treatment: Other: Ligelizumab
Liquid in vial

Treatment: Other: Omalizumab
Lyophilized powder for solution in vial

Other interventions: Placebo
Liquid in vial
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [6] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
Key

* Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
* Male and female subjects = 12 years of age at the time of screening.
* CSU diagnosis for = 6 months.
* Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
* The presence of itch and hives for = 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
* UAS7 score (range 0-42) = 16 and HSS7 (range 0-21) = 8 during the 7 days prior to randomization (Visit 110, Day 1)
* Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
* Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Key
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
* Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
* Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
* Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
* Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
* Prior exposure to ligelizumab or omalizumab.
* H1-AH used as background medication at greater than locally label-approved doses after visit 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2022
Sample size
Target
Accrual to date
Final
1078
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3002 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
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State/province [3] 0 0
Arkansas
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California
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Florida
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Idaho
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Illinois
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Maryland
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Minnesota
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Missouri
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Montana
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Nebraska
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Utah
Country [21] 0 0
United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Santa Fe
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Caba
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Salta
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Belgium
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Brussel
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Bruxelles
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Gent
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RJ
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Brazil
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SP
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Chile
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Santiago
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Chile
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Osorno
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Helsinki
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Clermont Ferrand
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Nice
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France
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Paris
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France
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Rouen
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Germany
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Bad Bentheim
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Germany
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Dresden
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Frankfurt
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Gera
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Halle
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Heidelberg
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Leipzig
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Muenchen
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Germany
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Osnabrueck
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Germany
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Quedlinburg
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Simmern
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Stade
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Tuebingen
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Rajasthan
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Afula
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Haifa
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Jerusalem
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Kfar Saba
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Ramat Gan
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Israel
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Rehovot
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Italy
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CA
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Italy
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CT
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Italy
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FI
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Italy
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MI
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Italy
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MO
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Italy
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SI
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Japan
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Aichi
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Hyogo
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Kumamoto
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Osaka
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Shimane
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Tokyo
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Hiroshima
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Lebanon
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Ashrafieh
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Lebanon
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Saida
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Jalisco
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Netherlands
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CK
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Netherlands
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Bergen op Zoom
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Rotterdam
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Utrecht
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Batangas
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Metro Manila
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Quezon
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Gdansk
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Krosno
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Lodz
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Ossy
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Poland
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Sopot
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Poland
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Warszawa
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Romania
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District 2
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Romania
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Brasov
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Iasi
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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St Petersburg
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Russian Federation
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St.-Petersburg
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Russian Federation
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Stavropol
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Slovakia
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Slovak Republic
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Slovakia
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Kezmarok
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Slovakia
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Komarno
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Slovakia
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Nove Zamky
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Slovakia
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Povazska Bystrica
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Slovakia
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Svidnik
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Topolcany
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Slovakia
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Zilina
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Spain
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Andalucia
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Santa Cruz De Tenerife
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Spain
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Granada
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Tao Yuan
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Tunisia
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Tunusia
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Tunisia
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Sousse
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Tunisia
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Tunis
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United Kingdom
State/province [144] 0 0
London
Country [145] 0 0
Vietnam
State/province [145] 0 0
Hanoi
Country [146] 0 0
Vietnam
State/province [146] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03580356