logo Hematology/Oncology Research Studies: Open for Enrollment Date: 10/22/18

Category: THALASSEMIA

Evaluate the Efficacy and Safety of RBCs Derived from Mirasol-treated Whole Blood Compared with Conventional RBCs in Patients Requiring Chronic Transfusion Support

NCT#/Phase: NCT03329404
IRB#: 2016-073
Description: Patients will be randomized 1:1 to receive either Mirasol-treated RBCs followed by conventional RBCs, or to receive conventional RBCs followed by Mirasol-treated RBCs. The primary objective of the PRAISE study is to determine if percent survival of RBCs derived from Mirasol-treated Whole Blood (WB) is non-inferior to conventional RBCs when transfused into patients requiring chronic RBC transfusion support. The secondary objectives include comparing other efficacy and safety endpoints between treatment groups. The Mirasol System for WB is an extracorporeal blood treatment process which uses ultraviolet (UV) light energy and riboflavin (vitamin B2) to inhibit nucleic acid replication in WB for the production of Mirasol-treated RBC.
Inclusion: Individuals who are >= 18 years of age and have transfusion dependent thalassemia patients with 2-4 week mean transfusion intervals for the prior 6 months.
Enrollment Status: Open for enrollment
Sponsor: Terumo
Principal Investigator(s): Ashutosh Lal, MD
Contact(s): Kacie Smith (510-428-3885 x2752)

Study Link: https://clinicaltrials.gov/ct2/show/NCT03329404

UCSF Benioff Children's Hospital Oakland • 747 52nd Street, Oakland, California 94609 &bull Phone: (510) 428-3000