A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Date Added
September 24th, 2019
PRO Number
Pro00091452
Researcher
Charles Greenberg

List of Studies


Keywords
Blood Disorders
Summary

The purpose of this study is to test the safety and effectiveness of a new study drug in adults who have warm antibody autoimmune hemolytic anemia (wAIHA). This study aims to determine if participants receiving the study drug, called fostamatinib, respond better than participants receiving placebo (an inactive substance) measured by an increase in red blood cell count. Participation in the study will be for a duration of at least 30 weeks with a total of approximately 15 visits to the study clinic.

Institution
MUSC
Recruitment Contact
Ormarie Vazquez Silva
843-792-7333
vazquezo@musc.edu

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

Date Added
August 27th, 2019
PRO Number
Pro00091006
Researcher
Charles Greenberg

List of Studies


Keywords
Blood Disorders, Drug Studies
Summary

The purpose of this study is to evaluate the likely safety and effectiveness of danaparoid sodium versus argatroban for patients suffering from heparin-induced thrombocytopenia (HIT). Patients with HIT will have low blood platelet counts due to being given the medication heparin. Adult and pediatric participants who are determined to be eligible to participate will be assigned by chance to treatment with danaparoid sodium or argatroban. The study drugs are administered through intravenous therapy (IV). Study and safety assessments, including blood draws and compression ultrasounds, will be completed at study visits. Participants will be in this study for at least 45 days, but could receive treatment longer depending on HIT severity. You will be hospitalized while you are receiving study drug treatment for a minimum fo 14 days. You will have 4 study follow-up visits after they have been discharged from the hospital.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu



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