A Randomized Controlled Study to Evaluate Efficacy and Safety of S-303 Treated Red Blood Cells in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion

CERUS CORPORATIO0 个研究点开始时间: 2012年10月16日最近更新: 2015年12月28日

适应症

试验速览

暂无简介。

•- Age >= 10 years, of either gender - Diagnosed with thalassemia major and currently participating in a chronic transfusion program - At least a one year history of chronic RBC transfusion support with a stable transfusion requirement (per treating physician) - Intervals of at least 14 days between RBC transfusions - All RBC components are given on one day for each transfusion episode - Negative direct antiglobulin tests (DAT) - Stable iron chelation regimen - Available for measurement of hemoglobin level at one hour post transfusion - Signed and dated informed consent form
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 35
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Baseline antibody specific to S-303 treated RBC (positive test, as defined in Section 8.4.1) - Evidence of splenic hyper function defined as a transfusion requirement >180 cc/kg/year (at 100% hematocrit) - Splenic enlargement: spleen palpable =4 cm below costal margin - Alloimmunization to minor blood group antigens to the extent that the ready provision of compatible blood may not be feasible for the study (alloimmunization alone is not an automatic exclusion) - Current specialized treatment with washed or frozen RBC Requirement for gamma irradiated RBC components (would present blinding difficulty due to blood component labeling regulations - Treatment with any medication that is known to adversely affect RBC viability - HIV or HCV infection (defined as RNA positive) - Pregnant or breast feeding female, or female of child-bearing potential not using a medically approved form of contraception - Acute or chronic medical disorder other than thalassemia that, in the opinion of the Investigator or medical monitor, may prevent the subject from completing participation in the study - Participation in another clinical study, either concurrently or within the previous 28 days, in which the study drug or device may influence red blood cell viability

发起方

CERUS CORPORATIO