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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03959488




Registration number
NCT03959488
Ethics application status
Date submitted
21/05/2019
Date registered
22/05/2019

Titles & IDs
Public title
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
Scientific title
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
Secondary ID [1] 0 0
2019-000201-69
Secondary ID [2] 0 0
D5290C00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI8897
Treatment: Drugs - Palivizumab

Experimental: MEDI8897 - anti-RSV monoclonal antibody with an extended half-life

Active comparator: Palivizumab - anti-RSV monoclonal antibody


Treatment: Drugs: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life

Treatment: Drugs: Palivizumab
Approved anti-RSV monoclonal antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
Timepoint [1] 0 0
360 days post first dose
Secondary outcome [1] 0 0
Serum Concentrations of MEDI8897 and Palivizumab
Timepoint [1] 0 0
Day 15, Day 31, Day 151 post first dose in Season 1 and Season 2
Secondary outcome [2] 0 0
Incidence of Anti-drug Antibody (ADA) to MEDI8897 and Palivizumab in Serum
Timepoint [2] 0 0
360 days post first dose
Secondary outcome [3] 0 0
Incidence of Medically Attended Lower Respiratory Track Infection (LRTI) and Hospitalization Due to Reverse Transcriptase Chain Reaction (RT-PCR) Confirmed Respiratory Syncytial Virus (RSV) Through 150 Days Post First Dose
Timepoint [3] 0 0
150 days post first dose

Eligibility
Key inclusion criteria
Inclusion criteria

1. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born = 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:

1. Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
2. Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
2. For the CLD/CHD cohort:

1. Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
2. Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (= 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
3. Infants who are entering their first RSV season at the time of screening
4. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
5. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator
6. Subject is available to complete the follow-up period, which will be 1 year after Season 1/ Dose 1 for subjects without CLD/CHD, or 1 year after Season 2/Dose 1 (or last replacement dose as applicable for CHD) for subjects with CLD/CHD
Minimum age
0 Years
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Any fever (= 100.4°F [= 38.0°C], regardless of route) or acute illness within 7 days prior to randomization
2. Any history of LRTI or active LRTI prior to, or at the time of, randomization
3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
4. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
5. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
6. Anticipated cardiac surgery within 2 weeks after randomization
7. Anticipated survival of < 6 months after randomization
8. Receipt of any investigational drug
9. Known renal impairment
10. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
11. Clinically significant congenital anomaly of the respiratory tract
12. Chronic seizure, or evolving or unstable neurologic disorder
13. Prior history of a suspected or actual acute life-threatening event
14. Known immunodeficiency, including human immunodeficiency virus (HIV)
15. Mother with HIV infection (unless the child has been proven to be not infected)
16. Any known allergy, including to immunoglobulin products, or history of allergic reaction
17. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination
18. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study
19. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
20. Concurrent enrollment in another interventional study
21. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Study design
Purpose of the study
Prevention
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
30/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2023
Sample size
Target
Accrual to date
Final
925
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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District of Columbia
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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Mississippi
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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West Virginia
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
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Belgium
State/province [21] 0 0
Bruxelles
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Belgium
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Gent
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Bulgaria
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Montana
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Bulgaria
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Pazardzhik
Country [25] 0 0
Bulgaria
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Pleven
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Bulgaria
State/province [26] 0 0
Plovdiv
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Ruse
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sliven
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Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Veliko Tarnovo
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Czechia
State/province [33] 0 0
Praha 4
Country [34] 0 0
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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Tampere
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France
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Amiens Cedex 1
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France
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Bordeaux
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France
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Brest
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France
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Bron
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France
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Caen
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France
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Creteil Cedex
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France
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Grenoble Cedex 9
Country [44] 0 0
France
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Marseille
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France
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Pau Cedex
Country [46] 0 0
Germany
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Frankenthal
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Germany
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Leipzig
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Germany
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Mannheim
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Hungary
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Baja
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kecskemét
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Hungary
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Miskolc
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Italy
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Pisa
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Italy
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Verona
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Japan
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Fukui-shi
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Japan
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Fukuoka-shi
Country [58] 0 0
Japan
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Kitakyusyu-shi
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Japan
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Maebashi-shi
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Japan
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Saitama shi
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Japan
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Setagaya-ku
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Korea, Republic of
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Ansan-si
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Korea, Republic of
State/province [63] 0 0
Seoul
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Korea, Republic of
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Suwon-si
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Latvia
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Jekabpils
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Latvia
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Riga
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Lithuania
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Kaunas
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Mexico
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Cuernavaca
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Mexico
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Mexico
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New Zealand
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Christchurch
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Wroclaw
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Russian Federation
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Kazan
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Russian Federation
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Novosibirsk
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Russian Federation
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Perm
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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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Yaroslavl
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Pretoria
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South Africa
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Soweto
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Spain
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Alicante
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Spain
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Boadilla del Monte
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Spain
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Elche
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Spain
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Leganes
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pozuelo de Alarcon
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Spain
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Sant Cugat del Valles
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Spain
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Tarragona
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Sweden
State/province [96] 0 0
Stockholm
Country [97] 0 0
Turkey
State/province [97] 0 0
Adana
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Turkey
State/province [98] 0 0
Izmir
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Turkey
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Kocaeli
Country [100] 0 0
Ukraine
State/province [100] 0 0
Chernivts?
Country [101] 0 0
Ukraine
State/province [101] 0 0
Dnipro
Country [102] 0 0
Ukraine
State/province [102] 0 0
Ivano-Frankivsk
Country [103] 0 0
Ukraine
State/province [103] 0 0
Kharkiv Region
Country [104] 0 0
Ukraine
State/province [104] 0 0
Odesa
Country [105] 0 0
Ukraine
State/province [105] 0 0
Sumy
Country [106] 0 0
Ukraine
State/province [106] 0 0
Vinnytsia
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Leicester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
London
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Nottingham

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT03959488