Clinical trial NCT02077192: Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Official title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immune Thrombocytopenic Purpura
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP


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

Primary outcomes:
measure: Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1
timeFrame: Up to 12 months
measure: Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2
timeFrame: Up to 12 months
Secondary outcomes:
measure: Duration of Platelet Response Based on Platelet Count and Rescue Medication
timeFrame: Up to 12 months
measure: Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Peoria
country: United States
facility: Bleeding & Clotting Disorders Institute
state: Illinois
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc
state: Indiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medical College/New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Greenville
country: United States
facility: East Carolina University, Brody School of Medicine
state: North Carolina
city: Salisbury
country: United States
facility: W.G. "Bill" Hefner VA Medical Center
state: North Carolina
city: Middletown
country: United States
facility: Signal Point Clinical Research Center LLC
state: Ohio
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Nedlands
country: Australia
facility: Perth Blood Institute
state: Western Australia
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus Wiener Gebietskrankenkasse
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology;
state: BG
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska, EAD
city: Vratsa
country: Bulgaria
facility: MHAT Hristo Botev, AD, Vratsa, First Internal Department
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Herlev
country: Denmark
facility: Herlev Hospital
state: DK
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
city: Bologna
country: Italy
facility: Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli"
state: BO
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica
city: Den Haag
country: Netherlands
facility: HAGA ziekenhuis
state: NL
city: Bergen
country: Norway
facility: Haukeland universitetssykehus, Helse Bergen HF
city: Grålum
country: Norway
facility: Sykehuset Østfold Kalnes
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
state: Dolnoslaski
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka
state: PO
city: Gdansk
country: Poland
facility: Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne
city: Kraków
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii
city: Lodz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Opole
country: Poland
facility: Szpital Wojewodzki w Opolu
city: Warszawa
country: Poland
facility: Instytut Hematologii I Transfuzjologii
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina, Hematologie
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe de Valencia
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: Essex
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
state: UK
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
city: Leeds
country: United Kingdom
facility: St. James's Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: University College Hospital
city: Oxford
country: United Kingdom
facility: Cancer and Haematology Centre
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Rigel Pharmaceuticals, Inc.
role: STUDY_DIRECTOR
References:
citation: 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.