This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by John A Widness, University of Iowa
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John A Widness, University of Iowa
ClinicalTrials.gov Identifier:
NCT02077751
First received: February 27, 2014
Last updated: April 19, 2017
Last verified: April 2017
  Purpose

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 Intervention Phase
Anemia Drug: biotin labelled RBCs Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

Resource links provided by NLM:


Further study details as provided by John A Widness, University of Iowa:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 4
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)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077751

Contacts
Contact: Gretchen Cress, BS 319-356-2151 gretchen-cress@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: John A Widness, M.D.    319-356-8102    john-widness@uiowa.edu   
Contact: Gretchen A Cress, B.S.N.    319-356-2151    gretchen-cress@uiowa.edu   
Principal Investigator: John A Widness, M.D.         
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 )
Study First Received: February 27, 2014
Last Updated: April 19, 2017

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

ClinicalTrials.gov processed this record on August 21, 2017