Status:
COMPLETED
Serum Hepcidin Immunoassay - Laboratory to Marketplace
Lead Sponsor:
Intrinsic LifeSciences, LLC
Collaborating Sponsors:
Boston Children's Hospital
Conditions:
Anemia, Iron Deficiency
Eligibility:
All Genders
11+ years
Brief Summary
This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron ...
Detailed Description
This observational study is composed of two phases, and no investigational intervention agent. Oral iron therapy will be recommended by each subject's primary care clinician or his/her designate accor...
Eligibility Criteria
Inclusion
- Age at least 11 years
- Subjects must give informed assent/ consent prior to the blood draw. Subjects that are minors (\<18 years) must have a parent or guardian give informed consent and the subject must give assent to participate in the study.
- Willing to comply with all oral iron supplementation and follow up visits if they move to the Observation of Treatment Phase.
- Able to communicate in English.
Exclusion
- Acute febrile illness (Temp ≥100.4°F (38°C), or acute otitis media, gastroenteritis, pharyngitis or other URI, within the previous one week.
- History of known hemoglobinopathy (e.g., thalassemia trait or sickle cell)
- Any parenteral iron received in the 30 days prior to enrollment.
- Presently taking oral iron supplements (except for iron as part of multivitamin or oral contraceptive pill) or has taken it in the 30 days prior to enrollment.
- An allergy or hypersensitivity to oral iron sulfate.
- Has received a blood transfusion in the 90 days prior to enrollment.
- Any investigational drug use in the 30 days prior to enrollment.
- Any known malignancy.
- Receiving dialysis.
- Known to be pregnant or currently breast-feeding.
- Any lab abnormality, medical condition, or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Key Trial Info
Start Date :
June 30 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT03310736
Start Date
June 30 2016
End Date
February 28 2019
Last Update
June 18 2019
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115