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

Warm Antibody Autoimmune Hemolytic Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04138927
• Other study ID #: C-935788-058
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 30, 2019
• Est. completion date: April 2024

Study information

• Verified date: July 2021
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Hemolysis
• Warm Antibody Autoimmune Hemolytic Anemia

Intervention

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

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital - Cancer Trials Unit	Brisbane	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	Hanusch-Krankenhaus	Vienna
Austria	Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie	Wien
Belarus	Vitebsk Regional Clinical Hospital	Vitebsk
Belarus	Vitebsk Regional Clinical Oncology Dispensary	Vitebsk
Belgium	AZ Nikolaas	Sint-Niklaas
Bulgaria	University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology	Pleven
Bulgaria	Specialized Hospital for Active Treatment of Hematological Disease EAD,	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology	Sofia
Czechia	Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika	Brno
Czechia	Fakultni nemocnice Ostrava Klinika hematoonkologie	Ostrava
France	CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses	Pessac
Georgia	LTD Multiprofile Clinic Consilium Medulla	Tbilisi
Georgia	M. Zodelava Hematology Centre, Tbilisi	Tbilisi
Germany	Universitätsklinikum Essen	Essen
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia	Milan
Italy	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia	Milano
Italy	SCDU Ematologia AOU "Maggiore della Carità"	Novara
Netherlands	Academisch Medisch Centrum	Amsterdam
Norway	Haukeland University Hospital	Bergen
Russian Federation	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
Serbia	Clinical Centre of Vojvodina, Clinic for Hematology	Novi Sad
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Ukraine	City Clinical Hospital ? 4, Hematology Center	Dnipro
Ukraine	Kyiv City Clinical Hospital ?9, hematology department ?1	Kyiv
United Kingdom	Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust	Liverpool
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	University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory	Los Angeles	California
United States	American Oncology Network Vista Oncology Division	Olympia	Washington
United States	University of Washington	Seattle	Washington
United States	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California
United States	Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Czechia,  France,  Georgia,  Germany,  Italy,  Netherlands,  Norway,  Russian Federation,  Serbia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study	104 weeks
Primary	Blood Pressure	Change from baseline in blood pressure over time	104 weeks
Primary	Absolute Neutrophil Count (ANC)	Change from baseline in absolute neutrophil count (ANC) over time	104 weeks
Secondary	Achievement of Durable Hemoglobin Response		24 weeks
Secondary	Total Duration of Response		During the Intervention period up to 104 weeks
Secondary	Corticosteroid dose	Net cumulative change from Baseline in corticosteroid dose	During the Intervention period up to 104 weeks