A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Sponsors

Lead sponsor: Rigel Pharmaceuticals

Source Rigel Pharmaceuticals
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).

Overall Status Completed
Start Date July 14, 2014
Completion Date April 21, 2016
Primary Completion Date April 21, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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) From Week 14 to Week 24
Secondary Outcome
Measure Time Frame
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
Mean of World Health Organization (WHO) Bleeding Scale Assessed over the 24-week study period
Enrollment 76
Condition
Intervention

Intervention type: Drug

Intervention name: Fostamatinib disodium

Description: Fostamatinib (100 mg PO bid or 150 mg PO bid)

Arm group label: Fostamatinib Disodium

Intervention type: Drug

Intervention name: Placebo

Description: Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Clinical diagnosis of autoimmune hemolytic anemia

- Uncontrolled or poorly controlled hypertension

- History of coagulopathy including prothrombotic conditions

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rigel Pharmaceuticals, Inc. Study Director Rigel Pharmaceuticals, Inc.
Location
facility
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 | Pecs, 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 | Milano, 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
Location Countries

Australia

Canada

Denmark

Hungary

Italy

Netherlands

United Kingdom

United States

Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Fostamatinib Disodium

Arm group type: Experimental

Description: 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.

Arm group label: Placebo

Arm group type: Other

Description: Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Acronym FIT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov