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

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 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
Condition
Intervention

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

Eligibility

Criteria:

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.
Location
Facility:
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

Australia

Austria

Bulgaria

Canada

Czechia

Denmark

Hungary

Italy

Netherlands

Norway

Poland

Romania

Spain

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)

Source: ClinicalTrials.gov