Spots Global Cancer Trial Database for Thrombosomes® in Bleeding Thrombocytopenic Patients Study
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Trial Identification
Brief Title: Thrombosomes® in Bleeding Thrombocytopenic Patients Study
Official Title: A Prospective, Multicenter, Randomized, Open-Label Phase 2, Parallel, Dose Ranging Multidose Study of Thrombosomes® vs Liquid Stored Platelets (LSP) in Bleeding Thrombocytopenic Patients
Study ID: NCT04631211
Study Description
Brief Summary: This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Medstar Georgetown, Washington, District of Columbia, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Rambam Medical Center, Haifa, , Israel
Helse Bergen Haukeland University Hospital, Bergen, , Norway
Contact Details
Name: Terry Gernsheimer, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
Name: Mike Fitzpatrick, PhD
Affiliation: Cellphire Therapeutics, Inc.
Role: STUDY_DIRECTOR
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