A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
FIT
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
2 other identifiers
interventional
76
8 countries
52
Brief Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2014
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedStudy Start
First participant enrolled
July 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2016
CompletedResults Posted
Study results publicly available
January 11, 2019
CompletedFebruary 12, 2019
October 1, 2018
1.8 years
February 26, 2014
October 15, 2018
January 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)
A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24
From Week 14 to Week 24
Secondary Outcomes (6)
Number of Participants With Platelet Count ≥ 50,000/µL at Week 12
Week 12
Number of Participants With Platelet Count ≥ 50,000/µL at Week 24
Week 24
Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.
Baseline to Week 12
Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.
Baseline to Week 24
Mean of the ITP Bleeding Score (IBLS)
Assessed over the 24-week study period
- +1 more secondary outcomes
Study Arms (2)
Fostamatinib Disodium
EXPERIMENTALSubjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.
Placebo
OTHERPlacebo tablet PO bid (morning and evening) over the course of 24 weeks
Interventions
Fostamatinib (100 mg PO bid or 150 mg PO bid)
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of persistent/chronic ITP for at least 3 months.
- Average platelet count \< 30,000/µL (and none \> 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts
You may not qualify if:
- Clinical diagnosis of autoimmune hemolytic anemia
- Uncontrolled or poorly controlled hypertension
- History of coagulopathy including prothrombotic conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Arizona Oncology Associates
Tucson, Arizona, 85710, United States
University of Southern California
Los Angeles, California, 90089, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805-1965, United States
Bleeding & Clotting Disorders Institute
Peoria, Illinois, 61614, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, 47905, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065, United States
Pitt County Memorial Hospital
Greenville, North Carolina, 27858, United States
Bill Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Signal Point Clinical Research Center LLC
Middletown, Ohio, 45042, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Frankston Hospital
Frankston, Victoria, 3199, Australia
Dept of Haematology, The Alfred Hospital and Monash Medical Centre
Melbourne, Victoria, 3004, Australia
Perth Blood Institute
Nedlands, Western Australia, 6009, Australia
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8N 3Z5, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1 H8L6, Canada
St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Herlev Hospital University of Copenhagen, Department of Hematology L124
Herlev, DK, 2730, Denmark
Dept. of Haematology, Odense University Hospital
Odense C, DK, DK-5000, Denmark
Hematological department, Roskilde Hospital
Roskilde, DK, 4000, Denmark
Aarhus University Hospital
Aalborg, 9000, Denmark
Semmelweis University 1st
Budapest, H-1083, Hungary
University of Debrecen
Debrecen, H-1083, Hungary
Pecs University
Pécs, H-7624, Hungary
Ematologia - Padigilione 8, Policinico S. Orsola Malpighi, Azienda Ospedaliero Universitaria di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele S.r.l. Dipartimento di Oncoematologia
Milan, 20132, Italy
Universitã Federico II di Napoli
Napoli, 80131, Italy
OspedaleCivile-ClinicaEmatologica/PUGD
Udine, 33100, Italy
ULSS 6 Vicenza-Ospedale San Bortolo di Vicenza
Vicenza, Italy
HAGA ziekenhuis
Haag, NL, 2545 CH, Netherlands
Kent & Canterbury Hospital
Kent, Canterbury, CT1 3NG, United Kingdom
Colchester General Hospital
Colchester, Essex, CO4 5JL, United Kingdom
Royal Liverpool University Hospital
Liverpool, UK, L78XP, United Kingdom
St. James's Hospital
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Royal London Hospital
London, E1 2ES, United Kingdom
Hammersmith Hospital, Catherine Lewis Centre
London, W12 0HS, United Kingdom
University College Hospital
London, WC1E 6HX, United Kingdom
Manchester Royal Infirmary
Manchester, M139WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
James Paget University Hospital
Norfolk, NR31 6LA, United Kingdom
Oxford University Hospital
Oxford, OX3 9BQ, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG, United Kingdom
Sandwell General Hospital
West Bromwich, B71 4HJ, United Kingdom
Related Publications (1)
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.
PMID: 33995988DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne-Marie Duliege, MD
- Organization
- Rigel
Study Officials
- STUDY DIRECTOR
Rigel Pharmaceuticals, Inc.
Rigel Pharmaceuticals,Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
March 3, 2014
Study Start
July 14, 2014
Primary Completion
April 21, 2016
Study Completion
April 21, 2016
Last Updated
February 12, 2019
Results First Posted
January 11, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share