New pill aims to boost platelets in chronic bleeding disorder

NCT ID NCT04562766

Ongoing Disease control Sponsor: Principia Biopharma, a Sanofi Company Source: ClinicalTrials.gov ↗

Summary

This Phase 3 trial tested whether an oral medication called rilzabrutinib could safely and effectively raise and maintain platelet counts in adults and adolescents with persistent or chronic immune thrombocytopenia (ITP). Participants were randomly assigned to receive either the study drug or a placebo pill twice daily for up to 24 weeks, followed by an open-label period where everyone could receive the drug. The main goal was to see if the drug could durably increase platelets to safer levels and reduce bleeding risk.

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Contacts and locations

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Locations

ASCLEPES Research Centers_Investigational Site Number 84023

Weeki Wachee, Florida, 34607, United States
CEMEC Oncologica do Brasil Site Number : 7606

Belém, 66053-000, Brazil
CHU Sainte-Justine_Investigational site number 12405

Montreal, Quebec, H3T 1C5, Canada
Children's Healthcare of Atlanta_Investigational Site Number 84034

Atlanta, Georgia, 30322, United States
Children's Hospital Colorado_Investigational Site Number 84025

Aurora, Colorado, 80045, United States
Cleveland Clinic_Investigational Site Number 84026

Cleveland, Ohio, 44195, United States
Erasmus MC_Investigational Site Number 52801

Rotterdam, 3015 GD, Netherlands
HEMORIO - Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti Site Number : 7609

Rio de Janeiro, 20211030, Brazil
Hospital De Clinicas De Porto Alegre Site Number : 7605

Porto Alegre, Rio Grande do Sul, 90035 003, Brazil
Hospital Santa Marcelina Site Number : 7611

São Paulo, São Paulo, 08270-070, Brazil
Hospital Sao Rafael Instituto D'Or da Bahia Site Number : 7608

Salvador, Estado de Bahia, 41253190, Brazil
Hospital do Servidor Publico Estadual de Sao Paulo Site Number : 7607

São Paulo, 04039-004, Brazil
IMMUNOe International Research Centers_Investigational Site Number 84028

Centennial, Colorado, 80112, United States
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602

Tianjin, Tianjin Municipality, 300020, China
Investigational Site Number 27612

Düsseldorf, 40497, Germany
Investigational Site Number 79206

Izmir, 35100, Turkey (Türkiye)
Investigational Site Number 79208

Ankara, 06620, Turkey (Türkiye)
Investigational Site Number 79209

Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number 79210

Istanbul, 34093, Turkey (Türkiye)
Investigational Site Number : 12404

Edmonton, Alberta, T6G 2P4, Canada
Investigational Site Number : 12406

Toronto, Ontario, M5G 1X8, Canada
Investigational Site Number : 15201

La Serena, Coquimbo Region, 1720430, Chile
Investigational Site Number : 15202

Viña del Mar, Región de Valparaíso, 322000, Chile
Investigational Site Number : 15204

Santiago, Reg Metropolitana de Santiago, 7500653, Chile
Investigational Site Number : 15608

Hefei, China
Investigational Site Number : 15609

Wuxi, 214023, China
Investigational Site Number : 15610

Nanchang, 330006, China
Investigational Site Number : 15611

Hangzhou, 310018, China
Investigational Site Number : 15613

Tangshan, 63000, China
Investigational Site Number : 15614

Zhenjiang, 212001, China
Investigational Site Number : 25007

Pessac, 33600, France
Investigational Site Number : 25008

Paris, 75012, France
Investigational Site Number : 25009

Nantes, 44093, France
Investigational Site Number : 25010

Dijon, 21079, France
Investigational Site Number : 25011

Créteil, 94000, France
Investigational Site Number : 25012

Paris, 75019, France
Investigational Site Number : 25014

Angers, 49933, France
Investigational Site Number : 27610

Berlin, 10117, Germany
Investigational Site Number : 27611

Recklinghausen, 45659, Germany
Investigational Site Number : 27613

Frankfurt am Main, 60596, Germany
Investigational Site Number : 3205

Córdoba, Córdoba Province, X5003DCE, Argentina
Investigational Site Number : 3206

Capital Federal, Buenos Aires, C1280AEB, Argentina
Investigational Site Number : 3208

San Juan, 5400, Argentina
Investigational Site Number : 3209

Corrientes, W3410 FND, Argentina
Investigational Site Number : 3211

La Plata, Buenos Aires, B1900, Argentina
Investigational Site Number : 34801

Győr, 9024, Hungary
Investigational Site Number : 34802

Székesfehérvár, 8000, Hungary
Investigational Site Number : 34803

Budapest, 1083, Hungary
Investigational Site Number : 34804

Nyíregyháza, 4405, Hungary
Investigational Site Number : 34805

Debrecen, 4032, Hungary
Investigational Site Number : 3606

Frankston, Victoria, 3199, Australia
Investigational Site Number : 3607

Kogarah, New South Wales, 2217, Australia
Investigational Site Number : 3608

Westmead, New South Wales, 2145, Australia
Investigational Site Number : 3609

Adelaide, South Australia, 5000, Australia
Investigational Site Number : 3610

Perth, Western Australia, 6000, Australia
Investigational Site Number : 3611

Brisbane, Queensland, 4101, Australia
Investigational Site Number : 37605

Haifa, 3109601, Israel
Investigational Site Number : 37606

Kfar Saba, 4428164, Israel
Investigational Site Number : 37607

Tel Aviv, 6423906, Israel
Investigational Site Number : 37608

Tel Litwinsky, 52621, Israel
Investigational Site Number : 37609

Ẕerifin, 70300, Israel
Investigational Site Number : 38010

Trieste, 34125, Italy
Investigational Site Number : 38011

Vicenza, 36100, Italy
Investigational Site Number : 38012

Bologna, 40138, Italy
Investigational Site Number : 38013

Milan, 20142, Italy
Investigational Site Number : 38014

Florence, Tuscany, 50134, Italy
Investigational Site Number : 38015

Milan, 20123, Italy
Investigational Site Number : 39201

Iruma-gun, Saitama, 350-0495, Japan
Investigational Site Number : 39202

Suita-shi, Osaka, 565-0871, Japan
Investigational Site Number : 39203

Hiroshima, 730-8619, Japan
Investigational Site Number : 39204

Setagaya City, Tokyo, 157-0074, Japan
Investigational Site Number : 39205

Kanazawa, Ishikawa-ken, 920-8530, Japan
Investigational Site Number : 39206

Saitama-shi, 330-8777, Japan
Investigational Site Number : 39207

Sagamihara-shi, Kanagawa, 252-0375, Japan
Investigational Site Number : 39208

Bunkyo-ku, Tokyo, 113-8655, Japan
Investigational Site Number : 39209

Sumida-ku, Tokyo, 130-8575, Japan
Investigational Site Number : 39210

Meguro-ku, Tokyo, 152-8902, Japan
Investigational Site Number : 39212

Chiba, 60-0852, Japan
Investigational Site Number : 39214

Tsuchiura-shi, Ibaraki, Japan
Investigational Site Number : 4001

Linz, A4020, Austria
Investigational Site Number : 4002

Vienna, 1140, Austria
Investigational Site Number : 4003

Steyr, 4400, Austria
Investigational Site Number : 4004

Leoben, 8700, Austria
Investigational Site Number : 4005

Graz, 8036, Austria
Investigational Site Number : 41001

Suwon, Gyeonggi-do, 16499, South Korea
Investigational Site Number : 41003

Seoul, Seoul-teukbyeolsi, 02841, South Korea
Investigational Site Number : 41004

Busan, Busan, 49241, South Korea
Investigational Site Number : 41005

Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 41006

Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 48401

Monterrey, Nuevo León, 64460, Mexico
Investigational Site Number : 48402

Chihuahua City, 31200, Mexico
Investigational Site Number : 48403

Zapopan, 45030, Mexico
Investigational Site Number : 48404

Durango, 34000, Mexico
Investigational Site Number : 48405

Delegacion Benito Juarez, 03720, Mexico
Investigational Site Number : 48406

Mexico City, 06760, Mexico
Investigational Site Number : 57801

Grålum, 1714, Norway
Investigational Site Number : 57802

Bergen, 5021, Norway
Investigational Site Number : 61609

Słupsk, Pomeranian Voivodeship, 76-200, Poland
Investigational Site Number : 61612

Warsaw, 02-776, Poland
Investigational Site Number : 61613

Wroclaw, 50-556, Poland
Investigational Site Number : 61614

Poznan, 61 696, Poland
Investigational Site Number : 61615

Gdynia, 81-519, Poland
Investigational Site Number : 61617

Piła, Greater Poland Voivodeship, 64-920, Poland
Investigational Site Number : 64301

Pyatigorsk, 357502, Russia
Investigational Site Number : 64302

Saint Petersburg, 191024, Russia
Investigational Site Number : 64303

Tula, 300053, Russia
Investigational Site Number : 64304

Novosibirsk, 630090, Russia
Investigational Site Number : 64305

Moscow, 125167, Russia
Investigational Site Number : 64306

Samara, 443099, Russia
Investigational Site Number : 64307

Moscow, 119049, Russia
Investigational Site Number : 70201

Singapore, 119228, Singapore
Investigational Site Number : 70202

Singapore, 169608, Singapore
Investigational Site Number : 70203

Singapore, 308433, Singapore
Investigational Site Number : 72407

Valencia, Valenciana, Comunidad, 46010, Spain
Investigational Site Number : 72408

Málaga, Málaga, 29010, Spain
Investigational Site Number : 72409

Barcelona, 08041, Spain
Investigational Site Number : 72410

Madrid, 28007, Spain
Investigational Site Number : 72411

Murcia, 30008, Spain
Investigational Site Number : 72412

Barcelona, 08035, Spain
Investigational Site Number : 72413

Seville, 41013, Spain
Investigational Site Number : 72414

Barcelona, 08035, Spain
Investigational Site Number : 72416

Burgos, Spain
Investigational Site Number : 76401

Khon Kaen, 40002, Thailand
Investigational Site Number : 76402

Chiang Mai, 50200, Thailand
Investigational Site Number : 76403

Songkhla, 90110, Thailand
Investigational Site Number : 76404

Bangkok, 10400, Thailand
Investigational Site Number : 76405

Bangkok, 10330, Thailand
Investigational Site Number : 80408

Dnipropetrovsk, 49102, Ukraine
Investigational Site Number : 80409

Kryvyi Rih, 50025, Ukraine
Investigational Site Number : 80410

Kyiv, 03143, Ukraine
Investigational Site Number : 82603

Manchester, M13 9WL, United Kingdom
Investigational Site Number : 82604

Harrow, HA1 3UJ, United Kingdom
Investigational Site Number : 82605

Norfolk, NR31 6LA, United Kingdom
Investigational Site Number : 82606

London, SE5 9PJ, United Kingdom
Investigational Site Number : 82607

London, London, City of, W12 0HS, United Kingdom
Investigational Site Number : 82608

Southampton, SO16 6YD, United Kingdom
Investigational Site Number : 82609

London, W2 1NY, United Kingdom
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037

Torrance, California, 90502, United States
Massachusetts General Hospital Site Number : 84038

Boston, Massachusetts, 02114, United States
Montefiore Medical Center_Investigational Site Number 84032

The Bronx, New York, 10461, United States
Qilu Hospital of Shandong University - Investigational Site Number: 15605

Jinan, Shandong, 250012, China
Rush University Medical Center_Investigational Site Number 84029

Chicago, Illinois, 60612, United States
Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604

Kunming, Yunnan, 650101, China
Shaanxi Provincial People's Hospital - Investigational Site Number: 15607

Xi'an, Shaanxi, 710068, China
Shengjing Hospital of China Medical University - Investigational Site Number: 15603

Shenyang, Liaoning, 110022, China
The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027

Philadelphia, Pennsylvania, 19104, United States
The Oncology Institute of Hope and Innovation_Investigational Site Number 84031

Whittier, California, 90602, United States
UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020

San Francisco, California, 94158, United States
Uniao Oeste Paranaense de Estudos e Combates ao Cancer Site Number : 7610

Cascavel, Paraná, 85806-300, Brazil
University Hospitals Cleveland Medical Center Site Number : 84036

Cleveland, Ohio, 44106, United States
University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033

Louisville, Kentucky, 40202, United States
University of Southern California_Investigational Site Number 84024

Los Angeles, California, 90033, United States
University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035

Salt Lake City, Utah, 84112, United States
University of Washington Medical Centre Site Number : 84041

Seattle, Washington, 98195, United States
Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601

Wuhan, Hubei, 430022, China

Conditions

Explore the condition pages connected to this study.

IMMUNE THROMBOCYTOPENIA