BioRBC Survival in Adults With Prior Antibody Response to BioRBCs
Objective: To gather safety and efficacy BioRBC data from adult subjects who previously developed transient BioRBC antibody responses by redosing them and observing for adverse clinical or laboratory (i.e., a positive BioRBC antibody titer) outcomes to determine if RBC kinetic study results differ from the previous study.
Hypothesis: BioRBC survival studies performed in adult subjects who previously developed a transient BioRBC antibody response will: 1) be associated with no adverse clinical or laboratory events; 2) experience a second transient, BioRBC antibody response; and 3) display a pattern of RBC survival that is identical to their prior dosing with BioRBCs at the same dose.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||BioRBC Survival in Adults With Prior Antibody Response to BioRBCs|
- Presence of biotin antibody in blood sample after transfusion of biotinylated RBCs [ Time Frame: 10 min to day when antibody is no longer detected, typically 6 months. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Biotin labelled RBCs
Subjects receive biotin labelled autologous red blood cells.
Drug: biotin labelled RBCs
Autologous red blood cells are biotin labelled and transfused to the subject. Survival of these red blood cells is tracked through examination of blood samples until no biotin labelled red blood cells remain.
Other Name: biotinylated RBCs
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02077751
|Contact: Gretchen Cress, BSfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: John A Widness, M.D. 319-356-8102 email@example.com|
|Contact: Gretchen A Cress, B.S.N. 319-356-2151 firstname.lastname@example.org|
|Principal Investigator: John A Widness, M.D.|
|Principal Investigator:||John A Widness, MD||University of Iowa|