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BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

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ClinicalTrials.gov Identifier: NCT02077751
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Anemia Drug: biotin labelled RBCs Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: BioRBC Survival in Adults With Prior Antibody Response to BioRBCs
Study Start Date : May 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Biotin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077751


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John A Widness, MD University of Iowa
More Information

Responsible Party: John A Widness, Professor, Department of Pediatrics, University of Iowa
ClinicalTrials.gov Identifier: NCT02077751     History of Changes
Other Study ID Numbers: 200710747-1
2P01HL046925-16A1 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Antibodies
Biotin
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances