BioRBC Survival in Adults With Prior Antibody Response to BioRBCs
Completed · Phase 1
Conditions studied: Anemia
In brief
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.
Key facts
- Study ID
- NCT02077751
- Run by
- John A Widness
- People needed
- 3
- Starts
- 2013-05-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2021-04-29
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Female and male subjects
- Age 18 years or older
- Normal with respect to serum chemistry, and hematology panels. Values outside the normal range, but not considered to be a health risk by the investigator will not exclude a subject
- Consented for the study and have signed an IRB-approved Informed Consent
You may not qualify if…
- Subjects who had any of the following criteria were excluded from the study:
- History of a clinically significant acute or chronic disease process
- Evidence of previous or current significant cardiovascular (including uncontrolled hypertension), hematologic, gastrointestinal (including hepatic), renal, metabolic, or neurological disorders or clinically significant allergies
- History of autoimmune haemolytic anemia, RBC autoantibodies or alloantibodies, or autoimmune disease
- History of congenital red cell disorders including glucose-6-phosphate dehydrogenase (G-6PD) deficiency
- Positive pregnancy test result
- Whole blood donation within 8 weeks or 2-unit RBC collection within 16 weeks of planned study whole blood donation
- Inability of subject to comply with the protocol in the Investigator's opinion.
- A female who was breast-feeding an infant or child
- Positive Direct or Indirect Antiglobulin Test result
- Immunosuppressive therapy (e.g., oral or intravenous prednisone) within the preceding 28 days
- Subjects who participated in another clinical study concurrently or within 28 days prior to starting the study
- Presence of plasma or serum anti-biotin antibodies to biotinylated RBCs (i.e., RBC labelled at a density of 54 μg/mL when tested using IgG gel card method)
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.