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A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Official title: A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2023-02-02
Completion Date
2028-04-08
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Ianalumab
Concentrate for solution for infusion for intravenous use
Eltrombopag
Film-coated tablet for oral use
Placebo
Concentrate for solution for infusion for intravenous use.
Locations (74)
Yuma Regional Medical Center
Yuma, Arizona, United States
University of Colorado Anschutz
Aurora, Colorado, United States
NorthShore University Health System
Evanston, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Hematology Oncology Association of Rockland
Nyack, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novartis Investigative Site
CABA, Argentina
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Yvoir, Namur, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Binzhou, Shandong, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Jinan, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Blois, France
Novartis Investigative Site
Le Mans, France
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Rishikesh, Uttarakhand, India
Novartis Investigative Site
Kolkata, West Bengal, India
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Trieste, TS, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Kofu, Yamanashi, Japan
Novartis Investigative Site
Kumamoto, Japan
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
Novartis Investigative Site
Subang Jaya, Selangor, Malaysia
Novartis Investigative Site
George Town, Malaysia
Novartis Investigative Site
Johor Bahru, Malaysia
Novartis Investigative Site
Kuala Selangor, Malaysia
Novartis Investigative Site
Saltillo, Coahuila, Mexico
Novartis Investigative Site
Morelia, Michoacán, Mexico
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Leiden, South Holland, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Makati City, Philippines
Novartis Investigative Site
Quezon, Philippines
Novartis Investigative Site
Craiova, Dolj, Romania
Novartis Investigative Site
Timișoara, Romania
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Jeollanam, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Salamanca, Spain
Novartis Investigative Site
Taoyuan District, Taiwan
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Chiang Mai, Thailand
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Bilkent Cankaya, Turkey (Türkiye)
Novartis Investigative Site
Aydin, Efeler, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey (Türkiye)
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom