A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- Registration Number
- NCT04138927
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief Summary
The primary objective of this study is:
• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 90
- Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
- Subject must have completed all 24 weeks of participation in the study C-935788-057.
- Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fostamatinib Fostamatinib disodium Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.
- Primary Outcome Measures
Name Time Method Blood Pressure 104 weeks Change from baseline in blood pressure over time
Absolute Neutrophil Count (ANC) 104 weeks Change from baseline in absolute neutrophil count (ANC) over time
Adverse Events 104 weeks Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
- Secondary Outcome Measures
Name Time Method Achievement of Durable Hemoglobin Response 24 weeks Total Duration of Response During the Intervention period up to 104 weeks Corticosteroid dose During the Intervention period up to 104 weeks Net cumulative change from Baseline in corticosteroid dose
Trial Locations
- Locations (37)
University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
🇺🇸Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
John Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
American Oncology Network Vista Oncology Division
🇺🇸Olympia, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Princess Alexandra Hospital - Cancer Trials Unit
🇦🇺Brisbane, Queensland, Australia
Hanusch-Krankenhaus
🇦🇹Vienna, Austria
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
🇦🇹Wien, Austria
Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Belarus
Vitebsk Regional Clinical Hospital
🇧🇾Vitebsk, Belarus
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
🇨🇿Brno, Czechia
Fakultni nemocnice Ostrava Klinika hematoonkologie
🇨🇿Ostrava, Czechia
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
🇫🇷Pessac, France
LTD Multiprofile Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
Universitätsklinikum Essen
🇩🇪Essen, Germany
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
🇮🇹Milano, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
🇮🇹Milan, Italy
SCDU Ematologia AOU "Maggiore della Carità"
🇮🇹Novara, Italy
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Haukeland University Hospital
🇳🇴Bergen, Norway
National Research Center for Hematology
🇷🇺Moscow, Russian Federation
State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
🇷🇺Sochi, Russian Federation
Clinical Centre of Vojvodina, Clinic for Hematology
🇷🇸Novi Sad, Serbia
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Kyiv City Clinical Hospital №9, hematology department №1
🇺🇦Kyiv, Ukraine
Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
🇧🇬Pleven, Bulgaria
M. Zodelava Hematology Centre, Tbilisi
🇬🇪Tbilisi, Georgia
Specialized Hospital for Active Treatment of Hematological Disease EAD,
🇧🇬Sofia, Bulgaria
City Clinical Hospital № 4, Hematology Center
🇺🇦Dnipro, Ukraine