Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02077751
Eligibility 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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02077751
Study Brief:
Protocol Section:
NCT02077751