A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

NCT04138927 · tracked via the Priya Life Science UK tracker

Sponsor

Rigel Pharmaceuticals

Phase

Phase 3

Started

2019-10-30

Last updated

2022-03-17

Condition(s) studied

Warm Antibody Autoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

Fostamatinib disodium

Fostamatinib disodium: Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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 outcome measure(s)

Adverse Events — 104 weeks
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
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

Trial sites (37)

Facility	City	Region
University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory	Los Angeles	California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
Lombardi Comprehensive Cancer Center	Washington D.C.	District of Columbia
John Hopkins Bayview Medical Center	Baltimore	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
American Oncology Network Vista Oncology Division	Olympia	Washington
University of Washington	Seattle	Washington
Princess Alexandra Hospital - Cancer Trials Unit	Brisbane	Queensland
The Alfred Hospital	Melbourne	Victoria
Hanusch-Krankenhaus	Vienna	Austria
Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie	Vienna	Austria
Vitebsk Regional Clinical Hospital	Vitebsk	Belarus
Vitebsk Regional Clinical Oncology Dispensary	Vitebsk	Belarus
AZ Nikolaas	Sint-Niklaas	Belgium
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology	Pleven	Bulgaria
University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology	Sofia	Bulgaria
Specialized Hospital for Active Treatment of Hematological Disease EAD,	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
M. Zodelava Hematology Centre, Tbilisi	Tbilisi	Georgia
Universitätsklinikum Essen	Essen	Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia	Milan	Italy
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - 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	Russia
State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory	Sochi	Russia
Clinical Centre of Vojvodina, Clinic for Hematology	Novi Sad	Serbia
Hospital Vall d'Hebron	Barcelona	Spain
Hospital Clinic de Barcelona	Barcelona	Spain
City Clinical Hospital № 4, Hematology Center	Dnipro	Ukraine
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04138927 on ClinicalTrials.gov ↗ ← All trials in the UK