A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
NCT ID: NCT02076399
Last Updated: 2019-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2014-07-14
2016-04-21
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
Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.
Fostamatinib disodium
Fostamatinib (100 mg PO bid or 150 mg PO bid)
Placebo
Placebo tablet 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
Interventions
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Fostamatinib disodium
Fostamatinib (100 mg PO bid or 150 mg PO bid)
Placebo
Placebo tablet PO bid (morning and evening) over the course of 24 weeks
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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Arizona Oncology Associates
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Bleeding & Clotting Disorders Institute
Peoria, Illinois, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, United States
Pitt County Memorial Hospital
Greenville, North Carolina, United States
Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Signal Point Clinical Research Center LLC
Middletown, Ohio, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Frankston Hospital
Frankston, Victoria, Australia
Dept of Haematology, The Alfred Hospital and Monash Medical Centre
Melbourne, Victoria, Australia
Perth Blood Institute
Nedlands, Western Australia, Australia
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Herlev Hospital University of Copenhagen, Department of Hematology L124
Herlev, DK, Denmark
Dept. of Haematology, Odense University Hospital
Odense C, DK, Denmark
Hematological department, Roskilde Hospital
Roskilde, DK, Denmark
Aarhus University Hospital
Aalborg, , Denmark
Semmelweis University 1st
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
Pecs University
Pécs, , Hungary
Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna
Bologna, , Italy
Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia
Milan, , Italy
Universitã Federico II di Napoli
Napoli, , Italy
OspedaleCivile-ClinicaEmatologica/PUGD
Udine, , Italy
ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza
Vicenza, , Italy
HAGA ziekenhuis
Haag, NL, Netherlands
Kent & Canterbury Hospital
Kent, Canterbury, United Kingdom
Colchester General Hospital
Colchester, Essex, United Kingdom
Royal Liverpool University Hospital
Liverpool, UK, United Kingdom
St. James's Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Royal London Hospital
London, , United Kingdom
Hammersmith Hospital, Catherine Lewis Centre
London, , United Kingdom
University College Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
James Paget University Hospital
Norfolk, , United Kingdom
Oxford University Hospital
Oxford, , United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, , United Kingdom
Sandwell General Hospital
West Bromwich, , United Kingdom
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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2013-005452-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-935788-047
Identifier Type: -
Identifier Source: org_study_id
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