Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
- Registration Number
- NCT02077192
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief Summary
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fostamatinib Disodium Fostamatinib Disodium Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
- Primary Outcome Measures
Name Time Method 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 Up to 12 months Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
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 Up to 12 months A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.
- Secondary Outcome Measures
Name Time Method Duration of Platelet Response Based on Platelet Count and Rescue Medication Up to 12 months The duration of platelet response was defined as the time from when the subject first achieved a platelet count of at least 50,000/µL, until the first of 2 visits with platelet counts \< 50,000/µL that were at least 4 weeks apart without an intervening visit with a platelet count less than equal to (\<=) 50,000/µL unrelated to rescue therapy. Duration of platelet response was analyzed using the Kaplan-Meier method. Treated Population was defined as all enrolled and treated subjects. Here, a number of subjects analyzed included all subjects evaluable for this endpoint.
Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count Up to 12 months The percentage of subjects in whom a reduction in the dose of concomitant ITP therapy could be achieved while maintaining an adequate platelet count, the reduction event was clarified to apply only to reductions in the dose of concomitant ITP therapy occurring within a period of platelet response and the reduction event was not be prompted by an adverse event.
Trial Locations
- Locations (55)
HAGA ziekenhuis
🇳🇱Den Haag, NL, Netherlands
UMHAT Aleksandrovska, EAD
🇧🇬Sofia, Bulgaria
East Carolina University, Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Horizon Oncology Research, Inc
🇺🇸Lafayette, Indiana, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Colchester General Hospital
🇬🇧Colchester, Essex, United Kingdom
Fakultni nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czechia
Hospital Universitario La Paz
🇪🇸Madrid, Spain
The Alfred
🇦🇺Melbourne, Victoria, Australia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Sykehuset Østfold Kalnes
🇳🇴Grålum, Norway
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Signal Point Clinical Research Center LLC
🇺🇸Middletown, Ohio, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
🇵🇱Slupsk, PO, Poland
Specjalistyczny Gabinet Lekarski
🇵🇱Lublin, Poland
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi
🇵🇱Lodz, Poland
Hospital Universitari i Politécnic La Fe de Valencia
🇪🇸Valencia, Spain
St. James's Hospital
🇬🇧Leeds, United Kingdom
James Paget University Hospital
🇬🇧Great Yarmouth, United Kingdom
Cancer and Haematology Centre
🇬🇧Oxford, United Kingdom
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" - Clinica Ematologica
🇮🇹Udine, Italy
Kent & Canterbury Hospital
🇬🇧Canterbury, United Kingdom
University Hospital of North Midlands NHS Trust, Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
Perth Blood Institute
🇦🇺Nedlands, Western Australia, Australia
Pecsi Tudomanyegyetem Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
🇭🇺Pecs, Hungary
Instytut Hematologii I Transfuzjologii
🇵🇱Warszawa, Poland
Spitalul Clinic Colentina, Hematologie
🇷🇴Bucuresti, Romania
UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology
🇧🇬Pleven, Bulgaria
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocrlaw
🇵🇱Wroclaw, Dolnoslaski, Poland
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Hanusch-Krankenhaus Wiener Gebietskrankenkasse
🇦🇹Vienna, Austria
MHAT Hristo Botev, AD, Vratsa, First Internal Department
🇧🇬Vratsa, Bulgaria
SPZOZ Szpital Uniwersytecki w Krakowie Pracownia Separacji Krwinek i Bank Komórek Krwiotwórczych Klinika Hematologii
🇵🇱Kraków, Poland
Haukeland universitetssykehus, Helse Bergen HF
🇳🇴Bergen, Norway
Herlev Hospital
🇩🇰Herlev, DK, Denmark
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Bleeding & Clotting Disorders Institute
🇺🇸Peoria, Illinois, United States
Weill Cornell Medical College/New York Presbyterian Hospital
🇺🇸New York, New York, United States
W.G. "Bill" Hefner VA Medical Center
🇺🇸Salisbury, North Carolina, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
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, Bulgaria
Istituto di Ematologia "Lorenzo e Ariosto Seràgnoli"
🇮🇹Bologna, BO, Italy
Lkinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Szpital Wojewodzki w Opolu
🇵🇱Opole, Poland
Royal Victoria Infirmary
🇬🇧Newcastle-upon-Tyne, UK, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
University College Hospital
🇬🇧London, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom