ClinicalTrials.gov
History of Changes for Study: NCT05559359
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Latest version (submitted April 16, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 26, 2022 None (earliest Version on record)
2 October 10, 2022 Contacts/Locations and Study Status
3 October 18, 2022 Contacts/Locations and Study Status
4 November 9, 2022 Recruitment Status, Contacts/Locations, Study Status, References and Oversight
5 November 22, 2022 Contacts/Locations and Study Status
6 December 8, 2022 Contacts/Locations and Study Status
7 December 26, 2022 Contacts/Locations and Study Status
8 January 6, 2023 Study Status and Study Identification
9 January 17, 2023 Contacts/Locations and Study Status
10 February 8, 2023 Contacts/Locations and Study Status
11 February 17, 2023 Contacts/Locations and Study Status
12 March 4, 2023 Contacts/Locations and Study Status
13 March 8, 2023 Study Status and Study Identification
14 March 24, 2023 Contacts/Locations and Study Status
15 April 7, 2023 Contacts/Locations and Study Status
16 April 19, 2023 Study Status
17 May 11, 2023 Contacts/Locations and Study Status
18 May 23, 2023 Contacts/Locations and Study Status
19 June 10, 2023 Contacts/Locations and Study Status
20 July 12, 2023 Contacts/Locations and Study Status
21 September 14, 2023 Contacts/Locations and Study Status
22 September 28, 2023 Contacts/Locations and Study Status
23 October 11, 2023 Study Status and Contacts/Locations
24 October 19, 2023 Contacts/Locations and Study Status
25 October 30, 2023 Contacts/Locations and Study Status
26 February 28, 2024 Contacts/Locations and Study Status
27 April 16, 2024 Contacts/Locations and Study Status
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Study NCT05559359
Submitted Date:  September 26, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: 18265
Brief Title: A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Secondary IDs: J2T-MC-KGBI [Eli Lilly and Company]
DRM06-AD13 [Dermira Inc]
2021-005232-29 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2022
Overall Status: Not yet recruiting
Study Start: October 31, 2022
Primary Completion: August 15, 2024 [Anticipated]
Study Completion: July 15, 2025 [Anticipated]
First Submitted: September 26, 2022
First Submitted that
Met QC Criteria:		 September 26, 2022
First Posted: September 29, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 26, 2022
Last Update Posted: September 29, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators: Dermira, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).
Detailed Description:
Open or close this module Conditions
Conditions: Atopic Dermatitis
Eczema
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lebrikizumab (Cohort 1)

Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS).

Dosing will be based on weight.

 Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06
Drug: Topical corticosteroid
Topical corticosteroid
Experimental: Lebrikizumab (Cohort 2)

Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS.

Dosing will be based on weight.

 Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06
Drug: Topical corticosteroid
Topical corticosteroid
Placebo Comparator: Placebo
Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
 Drug: Placebo
Placebo given SC
Drug: Topical corticosteroid
Topical corticosteroid
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
[ Time Frame: Baseline to Week 16 ]
2. Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
[ Time Frame: Baseline to Week 16 ]
Secondary Outcome Measures:
1. Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score
[ Time Frame: Baseline to Week 16 ]
2. Percentage Change from Baseline in EASI Score
[ Time Frame: Baseline, Week 16 ]
3. Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline
[ Time Frame: Baseline to Week 16 ]
4. Percentage Change from Baseline in Pruritus NRS Score
[ Time Frame: Baseline, Week 16 ]
5. Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
[ Time Frame: Baseline, Week 16 ]
6. Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline
[ Time Frame: Baseline to Week 1 ]
7. Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM)
[ Time Frame: Baseline, Week 16 ]
8. Change from Baseline in Body Surface Area (BSA)
[ Time Frame: Baseline, Week 16 ]
9. Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
[ Time Frame: Baseline, Week 16 ]
10. Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score
[ Time Frame: Baseline to Week 16 ]
11. Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration
[ Time Frame: Week 14 ]
12. Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
[ Time Frame: Week 14 ]
Open or close this module Eligibility
Minimum Age: 6 Months
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Have a diagnosis of AD prior to screening as stated in the criteria by the American

Academy of Dermatology for at least:

  • 12 months s if participants are ≥6 years of age, and
  • 6 months if participants are 6 months to <6 years of age
    • Have an EASI score ≥16 at the screening and baseline
    • Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
    • Have ≥10% BSA of AD involvement at the screening and baseline.

Exclusion Criteria:

  • Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Treatment with the following prior to the baseline:
  • An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
  • Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%.
  • Treatment with a topical investigational drug within 2 weeks prior to the baseline.
  • Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
Telephone: 1-317-615-4559
Email: ClinicalTrials.gov@lilly.com
Study Officials: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Locations: United States, Alabama
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
Contact:Contact: 205-209-4100
Contact:Principal Investigator: Weily Soong
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Contact:Contact: 6029332053
Contact:Principal Investigator: Harper Nichole Price
United States, Arkansas
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72217
Contact:Principal Investigator: Scott Michael Dinehart
United States, California
First OC Dermatology
Fountain Valley, California, United States, 92708
Contact:Contact: 714-531-2966
Contact:Principal Investigator: Vivian Laquer
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
Contact:Principal Investigator: Ricardo Antonio Tan
Dermatology Research Associates
Los Angeles, California, United States, 90045
Contact:Contact: 310-337-7171
Contact:Principal Investigator: Howard Sofen
Integrative Skin Science and Research
Sacramento, California, United States, 95815
Contact:Contact: 916-524-1216
Contact:Principal Investigator: Jennifer Ornelas
United States, Connecticut
UConn Health
Farmington, Connecticut, United States, 06030-2840
Contact:Contact: 860-679-3475
Contact:Principal Investigator: Jun Lu
United States, Florida
Solutions Through Advanced Research
Jacksonville, Florida, United States, 32256
Contact:Principal Investigator: Pearl Chu Kwong
ForCare Clinical Research
Tampa, Florida, United States, 33613-1244
Contact:Contact: 8132642155
Contact:Principal Investigator: Seth Benjamin Forman
United States, Idaho
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Contact:Contact: 208-813-6505
Contact:Principal Investigator: Elizabeth Swanson
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Contact:Contact: 312-695-3721
Contact:Principal Investigator: Amy Paller
United States, Kentucky
Allergy and Asthma Specialist
Owensboro, Kentucky, United States, 42301
Contact:Principal Investigator: Lee S. Clore
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact:Contact: 804-301-9948
Contact:Principal Investigator: JiaDe Yu
United States, Michigan
Oakland Hills Dermatology
Auburn Hills, Michigan, United States, 48326
Contact:Principal Investigator: Christofer Buatti
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
Contact:Contact: 989-895-9100
Contact:Principal Investigator: Brent Boyce
The Derm Institute of West Michigan
Caledonia, Michigan, United States, 49316
Contact:Principal Investigator: Kristi Hawley
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States, 48197
Contact:Contact: 734-528-0477
Contact:Principal Investigator: Jeffrey G. Leflein
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Contact:Contact: 603-650-3101
Contact:Principal Investigator: Brian Simmons
United States, Ohio
Wright State Physicians
Fairborn, Ohio, United States, 45324
Contact:Contact: 937-245-7500
Contact:Principal Investigator: Craig Rohan
United States, Pennsylvania
The Pennsylvania Centre for Dermatology, LLC
Exton, Pennsylvania, United States, 19341
Contact:Contact: 610-594-6660
Contact:Principal Investigator: Scott Gottlieb
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Contact:Principal Investigator: Lara Wine Lee
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact:Principal Investigator: Adelaide Hebert
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Contact:Contact: 210-852-2779
Contact:Principal Investigator: John Browning
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Contact:Contact: 414-955-3108
Contact:Principal Investigator: Kristen Holland
Argentina
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina, 1012
Contact:Contact: 541139899011
Contact:Principal Investigator: Pablo Javier Gonzalez
Asociación de Lucha contra la Parálisis Infantil (ALPI)
Buenos Aires, Argentina, 1425
Contact:Contact: 5491154583202
Contact:Principal Investigator: Maria Laura Galimberti
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Contact:Contact: 541170781548
Contact:Principal Investigator: Maria Florencia Fernández
Argentina, Buenos Aires
Instituto de Neumonología Y Dermatología
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425BEA
Contact:Principal Investigator: Paula Carolina Luna
Psoriahue
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1425DKG
Contact:Contact: 541148238755
Contact:Principal Investigator: Gabriel Alejandro Magariños
Argentina, Ciudad Aut
Fundacion Cidea
Buenos Aires, Ciudad Aut, Argentina, C1121ABE
Contact:Contact: 541153521290
Contact:Principal Investigator: Jorge Fernando Máspero
Argentina, Santa Fe
Fundación de Estudios Clínicos
Rosario, Santa Fe, Argentina, S2000DEJ
Contact:Contact: 5493415060005
Contact:Principal Investigator: Maria Fernanda Maccario
Australia, New South Wales
Sydney Childrens Hospital
Randwick, New South Wales, Australia, 2031
Contact:Principal Investigator: Linda Martin
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Contact:Contact: 0403130173
Contact:Principal Investigator: Li-Chuen Wong
Australia, Queensland
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Contact:Contact: 61730391300
Contact:Principal Investigator: Lynda Spelman
Canada, Alberta
Dermatology Research Institute
Calgary, Alberta, Canada, T2J 7E1
Contact:Contact: 4032633376
Contact:Principal Investigator: Vimal Hasmukh Prajapati
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada, T6G 1C3
Contact:Contact: 7804377189
Contact:Principal Investigator: Jaggi Rao
Canada, Ontario
DermEdge Research
Mississauga, Ontario, Canada, L4Y 4C5
Contact:Contact: 9052749996
Contact:Principal Investigator: Mark Lomaga
Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czechia, 10034
Contact:Principal Investigator: Spyridon Gkalpakiotis
Czechia, Brno-město
Detska nemocnice FN Brno
Brno, Brno-město, Czechia, 613 00
Contact:Contact: 420532234538
Contact:Principal Investigator: Blanka Pinkova
Czechia, Hradec Králové
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Hradec Králové, Czechia, 500 05
Contact:Principal Investigator: Jirina Bartonova
Czechia, Olomoucký Kraj
PreventaMed
Olomouc, Olomoucký Kraj, Czechia, 779 00
Contact:Contact: 42073089006
Contact:Principal Investigator: Martina Matzenauer
Czechia, Praha 8
Nemocnice Na Bulovce
Prague, Praha 8, Czechia, 180 81
Contact:Principal Investigator: Filip Rob
France, Drôme
Hôpitaux Drôme Nord - Romans
Romans-sur-Isère, Drôme, France, 26102
Contact:Contact: 3304756837
Contact:Principal Investigator: Francois Skowron
France, Ille-et-Vilaine
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France, 35033
Contact:Contact: 33299284349
Contact:Principal Investigator: Catherine Droitcourt
France, Loire-Atlantique
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France, 44093 Cede
Contact:Principal Investigator: Sebastien Barbarot
France, Midi-Pyrénées
CHU de Toulouse - Hopital Larrey
Toulouse, Midi-Pyrénées, France, 31400
Contact:Contact: 33567778141
Contact:Principal Investigator: Juliette Mazereeuw-Hautier
France, Nord-Pas-de-Calais
Hôpital Saint Vincent-de-Paul
Lille, Nord-Pas-de-Calais, France, 59020
Contact:Principal Investigator: Audrey Lasek
Germany, Hessen
Rosenpark Research GmbH
Darmstadt, Hessen, Germany, 64283
Contact:Contact: 496151627070
Contact:Principal Investigator: Oliver Weirich
Universitätsklinikum Frankfurt
Frankfurt, Hessen, Germany, 60590
Contact:Contact: 004969630183
Contact:Principal Investigator: Andreas Pinter
Germany, Niedersachsen
Fachklinik Bad Bentheim
Bad Bentheim, Niedersachsen, Germany, 48455
Contact:Contact: 495922745290
Contact:Principal Investigator: Athanasios Tsianakas
Studienzentrum an der Hase Dr. Weyergraf/Dr. Frick/T. Heiber GbR
Bramsche, Niedersachsen, Germany, 49565
Contact:Principal Investigator: Ansgar Weyergraf
Germany, Nordrhein-Westfalen
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, Germany, 48149
Contact:Contact: 00492518356558
Contact:Principal Investigator: Nina Magnolo
Germany, Sachsen
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Sachsen, Germany, 01307
Contact:Contact: 49351458340
Contact:Principal Investigator: Susanne Abraham
Japan
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Contact:Principal Investigator: Akio Tanaka
Okayama City General Medical Center Okayama City Hospital
Okayama, Japan, 700-8557
Contact:Principal Investigator: Akira Manki
Japan, Aichi
Fujita Health University
Toyoake, Aichi, Japan, 470-1192
Contact:Principal Investigator: Kazumitsu Sugiura
Japan, Hiroshima
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan, 721-8511
Contact:Principal Investigator: Masanori Ikeda
Japan, Hokkaido
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, Japan, 078-8510
Contact:Principal Investigator: Satomi Igawa
Japan, Kanagawa
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan, 252-0315
Contact:Contact: 0427428311
Contact:Principal Investigator: Motohiro Ebisawa
Japan, Nagano
Ina Central Hospital
Ina, Nagano, Japan, 396-0033
Contact:Principal Investigator: MASAO FUKUZAWA
Japan, Osaka
Osaka Habikino Medical Center
Habikino, Osaka, Japan, 583-8588
Contact:Contact: 81729572121
Contact:Principal Investigator: Yoko Kataoka
Dermatology and Ophthalmology Kume Clinic
Sakai City, Osaka, Japan, 593-8324
Contact:Principal Investigator: Akihiro Kume
Japan, Saitama
Enomoto Clinic
Kumagaya, Saitama, Japan, 360-0018
Contact:Principal Investigator: Shinya Enomoto
Japan, Tokyo
Sugamo Sengoku Dermatology
Toshima, Tokyo, Japan, 170-0002
Contact:Principal Investigator: Maaya Konishi
Mexico
Scientia Investigacion Clinica S.C.
Chihuahua, Mexico, 31203
Contact:Principal Investigator: Mavi Patricia Lopez
Arké SMO S.A de C.V
Veracruz, Mexico, 91910
Contact:Contact: 2299314102
Contact:Principal Investigator: Claudia Bernabe del Rio
Mexico, Distrito Federal
Hospital de Jesús Nazareno
Mexico City, Distrito Federal, Mexico, 06090
Contact:Contact: 5528880413
Contact:Principal Investigator: Luis Hernandez
Trials in Medicine
Mexico City, Distrito Federal, Mexico, 06700
Contact:Principal Investigator: Diana Fernandez
Hospital Infantil de Mexico Federico Gomez
Mexico City, Distrito Federal, Mexico, 06720
Contact:Contact: 5554331566
Contact:Principal Investigator: MIRNA ERENDIRA TOLEDO BAHENA
Mexico, Morelos
PanAmerican Clinical Research - Cuernavaca
Cuernavaca, Morelos, Mexico, 62290
Contact:Principal Investigator: Patricia Sepulveda
Mexico, Nuevo León
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, Mexico, 64460
Contact:Contact: 8183471977
Contact:Principal Investigator: Remigio Francisco Gonzalez Soto
Eukarya PharmaSite
Monterrey, Nuevo León, Mexico, 64718
Contact:Principal Investigator: Daniel Gonzalez Gaytan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico, 66460
Contact:Contact: 528183485421
Contact:Principal Investigator: Gloria Maria Rosales Solis
Poland, Mazowieckie
Centrum Medyczne Evimed
Warsaw, Mazowieckie, Poland, 02-625
Contact:Principal Investigator: Monika Slowinska
Poland, Małopolskie
Diamond Clinic
Krakow, Małopolskie, Poland, 31-559
Contact:Contact: 4869604902
Contact:Principal Investigator: Barbara Rewerska
Poland, Pomorskie
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomorskie, Poland, 80-546
Contact:Contact: 48513104911
Contact:Principal Investigator: Aleksandra Okuniewska
Poland, Łódzkie
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, Łódzkie, Poland, 90-265
Contact:Contact: 48426631444
Contact:Principal Investigator: Aleksandra Kaszuba
Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Contact:Contact: 915035900
Contact:Principal Investigator: Antonio Torrelo Fernandez
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Contact:Contact: 917792261
Contact:Principal Investigator: Sara Isabel Palencia Perez
Hospital Universitario La Paz
Madrid, Spain, 28046
Contact:Principal Investigator: Raul de Lucas Laguna
Spain, Barcelona [Barcelona]
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Contact:Contact: 932804000
Contact:Principal Investigator: Eulalia Baselga
Spain, Las Palmas
Hospital Universitario de Gran Canaria Doctor Negrín
Las, Las Palmas, Spain, 35010
Contact:Contact: 34928450658
Contact:Principal Investigator: Gregorio Carretero Hernandez
Spain, Madrid
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid, Spain, 28223
Contact:Principal Investigator: Javier Pedraz
Spain, Navarra
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Contact:Contact: 34948255400
Contact:Principal Investigator: Nuria Rodriguez-Garijo
Spain, Pontevedra [Pontevedra]
CHOP-Centro De Especialidades De Mollabao
Pontevedra, Pontevedra [Pontevedra], Spain, 36001
Contact:Contact: 0034986800272
Contact:Principal Investigator: Maria Angeles Florez Menendez
Spain, València
Hospital de Manises
Manises, València, Spain, 46940
Contact:Contact: 961845065
Contact:Principal Investigator: Antonio Martorell
Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu, Taiwan, 300
Contact:Contact: 88635326151
Contact:Principal Investigator: HSIEN-YI CHIU
National Taiwan University Hospital
Taipei, Taiwan, 10002
Contact:Contact: 886223562141
Contact:Principal Investigator: Chia-Yu Chu
Chang Gung Memorial Hospital-Taipei
Taipei, Taiwan, 105
Contact:Contact: 886227135211
Contact:Principal Investigator: Yu-Huei Huang
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Contact:Contact: 88697536633
Contact:Principal Investigator: Chin-Yi Yang
Taiwan, Kaohsiung
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Contact:Contact: 8867317123229
Contact:Principal Investigator: Ji-Chen Ho
Taiwan, Taichung
Chung Shan Medical University Hospital
Taichung City, Taichung, Taiwan, 402
Contact:Contact: 8862473959534
Contact:Principal Investigator: Po-Ju Lai
Taiwan, Taipei
Taipei Veterans General Hospital
Taipei City, Taipei, Taiwan, 112
Contact:Principal Investigator: Chih-Chiang Chen
Open or close this module IPDSharing
Plan to Share IPD: Yes
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria:
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/
Open or close this module References
Citations:
Links:
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
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