Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura


Lead Sponsor: Rigel Pharmaceuticals

Source Rigel Pharmaceuticals
Brief Summary

The purpose of this study is to determine whether fostamatinib is safe and effective in treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 5 year period.

Overall Status Active, not recruiting
Start Date July 2014
Completion Date March 2020
Primary Completion Date March 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with platelet count of at least 50,000/µL as a Measure of Safety and Efficacy 5 years
Enrollment 124

Intervention Type: Drug

Intervention Name: Fostamatinib Disodium

Description: Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day

Arm Group Label: Fostamatinib Disodium



Inclusion Criteria:

- Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.

- Able and willing to give written informed consent

Exclusion Criteria:

- Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response

- Poorly controlled hypertension during Study C935788-047 or Study C935788-048

- Significant infection, an acute infection such as influenza, or known inflammatory process

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.
Arizona Oncology Associates | Tucson, Arizona, 85710, United States
Bleeding & Clotting Disorders Institute | Peoria, Illinois, 61615, 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
Weill Cornell Medicine | New York, New York, 10065, United States
East Carolina University, Brody School of Medicine | Greenville, North Carolina, 27834, United States
W.G. "Bill" Hefner VA Medical Center | Salisbury, North Carolina, 28144, United States
Signal Point Clinical Research Center LLC | Middletown, Ohio, 45042, United States
Concord Repatriation General Hospital | Concord, New South Wales, 2139, 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
The Alfred | Melbourne, Victoria, 3004, Australia
Perth Blood Institute | Nedlands, Western Australia, 6009, Australia
Hanusch-Krankenhaus Wiener Gebietskrankenkasse | Vienna, 1140, 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, 1756, Bulgaria
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology | Pleven, 5800, Bulgaria
UMHAT Aleksandrovska, EAD | Sofia, 1431, Bulgaria
MHAT Hristo Botev, AD, Vratsa, First Internal Department | Vratsa, 3000, Bulgaria
Hamilton Health Sciences Corporation | Hamilton, Ontario, L8N 3Z5, Canada
St. Michael's Hospital | Toronto, Ontario, M5B1W8, Canada
Fakultni nemocnice Brno | Brno, 625 00, Czechia
Fakultni nemocnice Ostrava | Ostrava-Poruba, 708 52, Czechia
Herlev Hospital | Herlev, DK, 2730, Denmark
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika | Pecs, H-7624, Hungary
Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli" | Bologna, BO, 40138, Italy
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica | Udine, 33100, Italy
HAGA ziekenhuis | Den Haag, NL, 2545 CH, Netherlands
Haukeland universitetssykehus, Helse Bergen HF | Bergen, 5021, Norway
Sykehuset Østfold Kalnes | Grålum, 1714, Norway
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw | Wroclaw, Dolnoslaski, 50-367, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka | Slupsk, PO, 76-200, Poland
Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne | Gdansk, 80-952, Poland
SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii | Kraków, 31-501, Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi | Lodz, 93-510, Poland
Specjalistyczny Gabinet Lekarski | Lublin, 20-601, Poland
Szpital Wojewodzki w Opolu | Opole, 45-061, Poland
Instytut Hematologii I Transfuzjologii | Warszawa, 02-776, Poland
Spitalul Clinic Colentina, Hematologie | Bucuresti, 020125, Romania
Hospital Universitari Vall d'Hebron | Barcelona, 08035, Spain
Hospital Universitario La Paz | Madrid, 28046, Spain
Hospital Universitari i Politécnic La Fe de Valencia | Valencia, 46026, Spain
Colchester General Hospital | Colchester, Essex, CO4 5JL, United Kingdom
Royal Victoria Infirmary | Newcastle-upon-Tyne, UK, NE1 4LP, United Kingdom
Kent & Canterbury Hospital | Kent, CT1 3NG, United Kingdom
Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom
Royal Liverpool University Hospital | Liverpool, L78XP, United Kingdom
Imperial College Healthcare NHS Trust | London, W12 0HS, United Kingdom
University College Hospital | London, WC1E 6AG, United Kingdom
James Paget University Hospital | Norfolk, NR31 6LA, United Kingdom
Cancer and Haematology Centre | Oxford, OX3 7LE, United Kingdom
University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital | Stoke-on-Trent, ST4 6QG, United Kingdom
St. James's Hospital | West Yorkshire, LS9 7TF, United Kingdom
Location Countries














United Kingdom

United States

Verification Date

September 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Fostamatinib Disodium

Type: Experimental

Description: Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)