BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

NCT02077751 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 200710747-12P01HL046925-16A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Biotin labelled RBCs

EXPERIMENTAL

Subjects receive biotin labelled autologous red blood cells.

Drug: biotin labelled RBCs

Interventions

biotin labelled RBCs DRUG

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.

Also known as: biotinylated RBCs

Biotin labelled RBCs

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• John A Widness: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• John A Widness, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: May 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)