Enrolling by invitation NCT04138927
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fostamatinib disodium.
- Who it may be relevant to
- Registry conditions: Warm Antibody Autoimmune Hemolytic Anemia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Belarus, Belgium +13
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Interventions
- Drug Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Primary outcome measures
- Adverse Events [Time frame: 104 weeks]
- Blood Pressure [Time frame: 104 weeks]
- Absolute Neutrophil Count (ANC) [Time frame: 104 weeks]
Secondary outcome measures (3)
- Achievement of Durable Hemoglobin Response [Time frame: 24 weeks]
- Total Duration of Response [Time frame: During the Intervention period up to 104 weeks]
- Corticosteroid dose [Time frame: During the Intervention period up to 104 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
1\. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Lab — Los Angeles
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
- Lombardi Comprehensive Cancer Center — Washington D.C.
- John Hopkins Bayview Medical Center — Baltimore
- Massachusetts General Hospital — Boston
- Comprehensive Cancer Centers of Nevada — Las Vegas
- American Oncology Network Vista Oncology Division — Olympia
- University of Washington — Seattle
Bulgaria · 3 centers
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic — Pleven
- University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic o — Sofia
- Specialized Hospital for Active Treatment of Hematological Disease EAD, — Sofia
Italy · 3 centers
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia — Milan
- Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia — Milan
- SCDU Ematologia AOU "Maggiore della Carità" — Novara
Australia · 2 centers
- Princess Alexandra Hospital - Cancer Trials Unit — Brisbane
- The Alfred Hospital — Melbourne
Austria · 2 centers
- Hanusch-Krankenhaus — Vienna
- Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie — Vienna
Belarus · 2 centers
- Vitebsk Regional Clinical Hospital — Vitebsk
- Vitebsk Regional Clinical Oncology Dispensary — Vitebsk
Czechia · 2 centers
- Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika — Brno
- Fakultni nemocnice Ostrava Klinika hematoonkologie — Ostrava
Georgia · 2 centers
- LTD Multiprofile Clinic Consilium Medulla — Tbilisi
- M. Zodelava Hematology Centre, Tbilisi — Tbilisi
Russia · 2 centers
- National Research Center for Hematology — Moscow
- State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health — Sochi
Spain · 2 centers
- Hospital Vall d'Hebron — Barcelona
- Hospital Clinic de Barcelona — Barcelona
Ukraine · 2 centers
- City Clinical Hospital № 4, Hematology Center — Dnipro
- Kyiv City Clinical Hospital №9, hematology department №1 — Kyiv
Belgium · 1 center
- AZ Nikolaas — Sint-Niklaas
France · 1 center
- CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infect — Pessac
Germany · 1 center
- Universitätsklinikum Essen — Essen
Netherlands · 1 center
- Academisch Medisch Centrum — Amsterdam
Norway · 1 center
- Haukeland University Hospital — Bergen
Serbia · 1 center
- Clinical Centre of Vojvodina, Clinic for Hematology — Novi Sad
United Kingdom · 1 center
- Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpo — Liverpool
Identifiers
NCT: NCT04138927 · C-935788-058