Clinical trial NCT04138927: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Official title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Warm Antibody Autoimmune Hemolytic Anemia
Keywords: wAIHA
Warm Antibody Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
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 is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion Criteria:

1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.

Primary outcomes:
measure: Adverse Events
timeFrame: 104 weeks
measure: Blood Pressure
timeFrame: 104 weeks
measure: Absolute Neutrophil Count (ANC)
timeFrame: 104 weeks
Secondary outcomes:
measure: Achievement of Durable Hemoglobin Response
timeFrame: 24 weeks
measure: Total Duration of Response
timeFrame: During the Intervention period up to 104 weeks
measure: Corticosteroid dose
timeFrame: During the Intervention period up to 104 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Baltimore
country: United States
facility: John Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Olympia
country: United States
facility: American Oncology Network Vista Oncology Division
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital - Cancer Trials Unit
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
city: Wien
country: Austria
facility: Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Oncology Dispensary
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Hematological Disease EAD,
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava Klinika hematoonkologie
city: Pessac
country: France
facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
city: Tbilisi
country: Georgia
facility: LTD Multiprofile Clinic Consilium Medulla
city: Tbilisi
country: Georgia
facility: M. Zodelava Hematology Centre, Tbilisi
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
city: Novara
country: Italy
facility: SCDU Ematologia AOU "Maggiore della Carità"
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Moscow
country: Russian Federation
facility: National Research Center for Hematology
city: Sochi
country: Russian Federation
facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina, Clinic for Hematology
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Dnipro
country: Ukraine
facility: City Clinical Hospital № 4, Hematology Center
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital №9, hematology department №1
city: Liverpool
country: United Kingdom
facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Study officials:
References: