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Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.
Official title: A Phase III, Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (VAYHIT1)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
226
Start Date
2023-02-03
Completion Date
2028-09-07
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Ianalumab
Intravenous infusion, prepared from concentrate solution
Placebo
Intravenous infusion, prepared from matching placebo
Corticosteroids
Oral or parental (if clinically justified)
Locations (117)
Yuma Regional Medical Center
Yuma, Arizona, United States
Community Cancer Institute
Clovis, California, United States
Compassionate Care Res Group Inc
Fountain Valley, California, United States
University of Colorado Anschutz
Aurora, Colorado, United States
DH Cancer Research Center LLC
Margate, Florida, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Oncology Care Associates
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Clinical Research Alliance
Lake Success, New York, United States
Hematology Oncology Association of Rockland
Nyack, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
STAT Research Inc
Dayton, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
San Miguel Tucuman, Tucumán Province, Argentina
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Caba, Argentina
Novartis Investigative Site
Córdoba, Argentina
Novartis Investigative Site
Garran, Australian Capital Territory, Australia
Novartis Investigative Site
Wooloongabba, Queensland, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Innsbruck, Tyrol, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Brasschaat, Belgium
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Leuven, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Shenzhen, Guangdong, China
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Shijiazhuang, Hebei, China
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Luoyang, Henan, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changzhou, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Bengbu, China
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Dalian, China
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Tianjin, China
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Prague, Czechia
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Prague, Czechia
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Caen, France
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Chambéry, France
Novartis Investigative Site
Le Mans, France
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Lille, France
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Rennes, France
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Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
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Jena, Thuringia, Germany
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Dresden, Germany
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Essen, Germany
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Giessen, Germany
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New Territories, Hong Kong, Hong Kong
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Hong Kong, Hong Kong
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Ahmedabad, Gujarat, India
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Rishikesh, Uttarakhand, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Bologna, BO, Italy
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Florence, FI, Italy
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Roma, RM, Italy
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Trieste, TS, Italy
Novartis Investigative Site
Vicenza, VI, Italy
Novartis Investigative Site
Nagakute, Aichi-ken, Japan
Novartis Investigative Site
Shibukawa, Gunma, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Iruma-gun, Saitama, Japan
Novartis Investigative Site
Chiba, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Gifu, Japan
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Osaka, Japan
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
George Town, Malaysia
Novartis Investigative Site
Johor Bahru, Malaysia
Novartis Investigative Site
Kuala Selangor, Malaysia
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Grålum, Norway
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Bucharest, Romania
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Singapore, Singapore
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Singapore, Singapore
Novartis Investigative Site
Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Murcia, Spain
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Salamanca, Spain
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Seville, Spain
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Bangkok, Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Chiang Mai, Thailand
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative Site
Aydin, Efeler, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Birmingham, West Midlands, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Nottingham, United Kingdom
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Hanoi, Vietnam
Novartis Investigative Site
Ho Chi Minh City, Vietnam