Last reviewed · How we verify
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.
Details
| Lead sponsor | John A Widness |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 3 |
| Start date | 2013-05 |
| Completion | 2019-12 |
Conditions
- Anemia
Interventions
- biotin labelled RBCs
Primary outcomes
- Presence of biotin antibody in blood sample after transfusion of biotinylated RBCs — 10 min to day when antibody is no longer detected, typically 6 months.
Countries
United States