Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction
NCT ID: NCT02864953
Last Updated: 2024-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
535 participants
INTERVENTIONAL
2018-08-29
2023-08-18
Brief Summary
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The objectives of Part 2 of the study are to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIIB093
BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
BIIB093
Administered as specified in the treatment arm.
Placebo
Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB093
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm\^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions.
3. Screening National Institutes of Health Stroke Scale (NIHSS) \>=10.
4. At the time of randomization, and in the Investigator's judgement, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal.
Exclusion Criteria
1. Participant is likely to have supportive care withdrawn on the first day.
2. Commitment to decompressive craniectomy (DC) prior to enrollment.
3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome.
18 Years
85 Years
ALL
No
Sponsors
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Remedy Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Remedy Pharmaceuticals
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Arizona Board of Regents, University of Arizona
Tucson, Arizona, United States
Stanford Stroke Center
Palo Alto, California, United States
University of California Davis Health System
Sacramento, California, United States
UCSD Health-La Jolla
San Diego, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida-Gainsville
Gainesville, Florida, United States
Lyerly Neurosurgery Baptist Health
Jacksonville, Florida, United States
University of Florida, Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
The Queens Medical Center
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Inc.
Jamaica Plain, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. John's Hospital
Detroit, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University Physicians
St Louis, Missouri, United States
JFK Medical Center
Edison, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Buffalo
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
UNC Hospitals
Chapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Guilford Neurologic Research, PA
Greensboro, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, United States
Miami Valley Hospital South
Dayton, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Ascension St. John
Tulsa, Oklahoma, United States
Providence Brain and Spine Institute
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Warren Alpert Medical School Brown University
Providence, Rhode Island, United States
Erlanger Health System
Chattanooga, Tennessee, United States
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States
TriStar Skyline Medical Center
Nashville, Tennessee, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
St.David's HealthCare Office of Research
Austin, Texas, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
University of Utah Neurology
Salt Lake City, Utah, United States
University of Washington School of Medicine
Seattle, Washington, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Universitair Ziekenhuis Gent
Ghent, East Flanders, Belgium
UZ Leuven
Leuven, Flemish Brabant, Belgium
CHU UCL Namur
Yvoir, Namur, Belgium
Clinique CHC MontLégia
Liège, , Belgium
HGF - Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Hospital do Rocio
Campo Largo, Paraná, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina, Brazil
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Anhui Provincial Hospital
Hefei, Anhui, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Bejing, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Renmin Hospital, Wuhan University
Wuhan, Hubei, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsushe, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
Xi’an, Shanxi, China
Army Specialty Medical Center of The Chinese People's Liberation Army
Chongqing, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
General Hospital Varazdin
Varaždin, Croatia Proper, Croatia
Clinical Hospital 'Sestre Milosrdnice'
Zagreb, Croatia Proper, Croatia
Clinical Hospital Centar Zagreb
Zagreb, Croatia Proper, Croatia
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian, Czechia
Fakultni nemocnice Brno
Brno, Moravia, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Moravia, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Prague, Czechia
Fakultni nemocnice v Motole
Prague, Prague, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Copenhagen University Hospital and Glostrup Hospital
Copenhagen, Copenhagen City, Denmark
Bispebjerg og Frederiksberg Hospital
Copenhagen NV, Copenhagen City, Denmark
Sjællands Universitetshospital
Roskilde, Østsjælland, Denmark
Helsinki University Hospital
Helsinki, Southern, Finland
Turun yliopistollinen keskussairaala
Turku, Western, Finland
CHU CAEN - Hôpital de la Côte de Nacre
Caen, Calvados, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Doubs, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, Finistere, France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
CHU Rennes - Hopital Pontchaillou
Rennes, Ille-et-Vilaine, France
CHU Nantes - Hopital Nord Laënnec
Saint-Herblain, Loire Atlantique, France
CHU Nancy - Hôpital Central
Nancy, Meurthe Et Moselle, France
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Klinikum Augsburg
Augsburg, Bavaria, Germany
Rhon-Klnikum Campus Bad Neustadt
Bad Neustadt Saale, Bavaria, Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, Germany
Klinikum Frankfurt Hoechst GmbH
Frankfurt am Main, Hesse, Germany
Klinikum Kassel GmbH
Kassel, Hesse, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Klinikum Altenburger Land GmbH
Altenburg, Thuringia, Germany
Universitaetsklinikum Jena
Jena, Thuringia, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, , Germany
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Budapest, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád-Csanád, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Somogy County, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Rabin MC
Petah Tikva, Central District, Israel
Soroka University Medical Center
Beersheba, Southern District, Israel
Rambam Health Care Center
Haifa, , Israel
Shaare Zedek
Jerusalem, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Roma, Italy
Policlinico Umberto I
Rome, Roma, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Rome, Roma, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Toyota Memorial Hospital
Toyota-shi, Aichi-ken, Japan
Hachinohe Red Cross Hospital
Hachinohe-shi, Aomori, Japan
Kimitsu Chuo Hospital
Kisarazu-shi, Chiba, Japan
NHO Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Chiyukai Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, Japan
Chiyukai Fukuoka Shinmizumaki Hospital
Onga-gun, Fukuoka, Japan
Chiyukai Shin Yukuhashi Hospital
Yukuhashi-shi, Fukuoka, Japan
Southern Tohoku General Hospital
Koriyama-shi, Fukushima, Japan
Gifu Prefectural General Medical Center
Gifu, Gifu, Japan
Showakai Brain Attack Center Ota Memorial Hospital
Fukuyama-shi, Hiroshima, Japan
Asahikawa Red Cross Hospital
Asahikawa-shi, Hokkaido, Japan
Ohnishi Neurological Center
Akashi-shi, Hyōgo, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura-shi, Ibaraki, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
NHO Sendai Medical Center
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan
Nippon Medical School Hospital
Bunkyō City, Tokyo-To, Japan
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo-To, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo-To, Japan
NHO Minami Wakayama Medical Center
Tanabe-shi, Wakayama, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, , Lithuania
Republican Vilnius University Hospital, Public Institution
Vilnius, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, , Lithuania
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, Aveiro District, Portugal
Unidade Local de Saúde de Matosinhos, E.P.E. - Hospital Pedro Hispano
Matosinhos Municipality, Porto District, Portugal
Hospital Garcia de Orta, EPE
Almada, Setúbal District, Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar de São João, E.P.E
Porto, , Portugal
SBEI HPE 'Kazan State Medical University' of the MoH of the RF
Kazan', Respublka Tatarstan, Russia
Saint-Petersburg Scientific-Research Institute of Emergency Care
Saint Petersburg, Sankt-Peterburg, Russia
SPb SBIH 'City Hospital # 26'
Saint Petersburg, Sankt-Peterburg, Russia
SHI "Territorial Clinical Hospital #1 n.a. S.V. Ochapovsky"
Krasnodar, , Russia
SBIH of Moscow 'City Clinical Hospital # 1 n. a. N. I. Pirogov'
Moscow, , Russia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsangnam-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Regional Universitario de Malaga
Málaga, Málaga, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Ospedale Regionale di Lugano
Lugano, Canton Ticino, Switzerland
Inselspital - Universitaetsspital Bern
Bern, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan District, , Taiwan
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
Imp Coll Health Nhst 1
London, Greater London, United Kingdom
The National Hospital for Neurology & Neurosurgery
London, Greater London, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, Nottinghamshire, United Kingdom
Queen Elizabeth University Hospital Campus
Glasgow, Strathclyde, United Kingdom
Newcastle University- Clinical Ageing Research Unit
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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References
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Sheth KN, Albers GW, Saver JL, Campbell BCV, Molyneaux BJ, Hinson HE, Cordonnier C, Steiner T, Toyoda K, Wintermark M, Littauer R, Collins J, Lucas N, Nogueira RG, Simard JM, Wald M, Dawson K, Kimberly WT; CHARM Trial investigators. Intravenous glibenclamide for cerebral oedema after large hemispheric stroke (CHARM): a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Neurol. 2024 Dec;23(12):1205-1213. doi: 10.1016/S1474-4422(24)00425-3.
Shu L, Zhang W, Yaghi S, Grilli A, de Havenon A, Barrett KM, Johnston KC, Goldstein ED. Prestroke and Poststroke Sulfonylurea Exposure and Functional Outcomes: A Post Hoc Analysis of the SHINE Trial. Stroke. 2023 Sep;54(9):e415-e416. doi: 10.1161/STROKEAHA.123.043496. Epub 2023 Jul 14. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RPI 301
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004854-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
252LH301
Identifier Type: -
Identifier Source: org_study_id
NCT04950972
Identifier Type: -
Identifier Source: nct_alias
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