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Clinical Trials in Italy / NCT04138927
Enrolling by invitation Phase 3

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 Italy 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
No
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)

FacilityCityRegionStatus
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
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 Italy