A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT ID: NCT02076412
Last Updated: 2019-01-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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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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Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
Placebo
Placebo tablet PO bid (morning and evening)
Interventions
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Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
Placebo
Placebo tablet PO bid (morning and evening)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Average platelet count\< 30,000/µL (and none \> 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts
Exclusion Criteria
* Uncontrolled or poorly controlled hypertension
* History of coagulopathy including prothrombotic conditions
18 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rigel Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Rigel Pharmaceuticals,Inc.
Locations
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Hematology Oncology Associates of Rockland Division of Highland Medical PC
Nyack, New York, United States
Medizinische Universitaet Wien / AKH Wien
Vienna, AU, Austria
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
Vienna, AU, Austria
LKH Feldkirch at LKH Rankweil
Rankweil, , Austria
Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
Sofia, BG, Bulgaria
MHAT Hristo Botev, AD, Vratsa, First Internal Department
Vratsa, BG, Bulgaria
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
Pleven, , Bulgaria
UMHAT Aleksandrovska, EAD, Clinic of Clinical Hematology
Sofia, , Bulgaria
Fakultni nemocnice Brno
Brno, CZ, Czechia
Hospital Kyjov
Kyjov, CZ, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice, Linterní Klinika, Klinika hematologie
Prague, , Czechia
Universitaetsklinikum Giessen und Marburg (UKGM)
Giessen, DE, Germany
Werlhof Institut GmbH
Hanover, DE, Germany
Charit Berlin - Campus Benjamin Franklin
Berlin, , Germany
Marien Hospital Duesseldorf
Düsseldorf, , Germany
Universittsklinikum Essen
Essen, , Germany
Haukeland University Hospital
Bergen, , Norway
Sykehuset Østfold Fredrikstad
Fredrikstad, , Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Szpital Uniwersytecki
Krakow, , Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
Lodz, , Poland
Specjalistyczny Gabinet Lekarski
Lublin, , Poland
Szpital Wojewodzki w Opolu
Opole, , Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Słupsk, , Poland
Instytut Hematologii I Transfuzjologii
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
Wroclaw, , Poland
Spitalul Clinic Judetean de Urgenta Tirgu-Mures, Sectia Medicina Interna 1, Compartiment Hematologie
Târgu Mureş, Mureș County, Romania
Spitalul Clinic Colentina, Hematologie
Bucharest, , Romania
Spitalul Clinic Coltea, Hematologie
Bucharest, , Romania
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitariola Paz
Madrid, , Spain
Hospital Universitari i Politécnic La Fe de Valencia
Valencia, , Spain
Countries
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References
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Cooper N, Altomare I, Thomas MR, Nicolson PLR, Watson SP, Markovtsov V, Todd LK, Masuda E, Bussel JB. Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib. Ther Adv Hematol. 2021 Apr 30;12:20406207211010875. doi: 10.1177/20406207211010875. eCollection 2021.
Other Identifiers
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2013-005453-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-935788-048
Identifier Type: -
Identifier Source: org_study_id
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