Serum Hepcidin Immunoassay - Laboratory to Marketplace

June 14, 2019 updated by: Intrinsic LifeSciences, LLC

Evaluation of the Intrinsic Hepcidin IDx™ Test to Detect Iron Deficiency and Predict Response to Oral Iron Therapy in Adolescents and Young Adults

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 deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 according to standard clinical care. There is no randomization. Subjects will be screened for enrollment by study personnel.

Diagnostic Testing Phase (Study Visit 1). Enrolled subjects will have a study blood draw. Enrolled subjects will be assessed for presence of ID as defined by the reference standard: ID: Ferritin < 20 ng/mL.

Enrolled subjects will be assessed for presence of anemia as defined by: Anemia - Hemoglobin ≤ 11 g/dL

Those determined to have ID and/or anemia and are prescribed oral iron therapy by their clinician will continue to the next phase in the study. For those without ID or anemia, or who meet Observation of Treatment Phase exclusion criteria, study participation will be complete. The expected duration of subject involvement for the Diagnostic Testing Phase is 1 week.

Observation of Treatment Phase (Study Visits 2 and 3). Subjects identified as having ID and/or anemia and who have been prescribed oral iron therapy by their physician according to standard of care, and do not meet Observation of Treatment Phase exclusion criteria, will continue to the Observation of Treatment Phase of the study.

The optimal dose, frequency, and timing of oral iron therapy are unknown and are based more on clinical experience than evidence. In 1998, based on expert opinion, the Centers for Disease Control (CDC) suggested 3 mg/kg/day of elemental iron for treatment of IDA in children. Patients with ID who do not have anemia (LID) should also have their iron stores repleted with treatment dose iron supplement. Given the effects of acute/chronic disease on serum ferritin and the dietary/diurnal variation of serum iron/TfSat, the absence of biochemical evidence of ID on a single measure does not rule out ID that may respond to empiric supplementation. Therefore, patients with anemia but without biochemical evidence of ID (AneID) may have masked ID and treatment with a finite course of supplemental iron therapy is unlikely to result in harm and may improve hemoglobin. Thus, we expect all subjects with ID and/or anemia will be recommended treatment by their clinician with ferrous sulfate at treatment at standard doses for adolescents and young adults of 3-5 mg elemental iron/kg/day, up to a maximum of 195 mg of elemental iron per day.

Investigators will provide responsible clinicians with recommendations for ferrous sulfate treatment along with references to relevant clinical guidelines and research. The clinicians will be asked to provide the research team confirmation that the patient followed the oral iron treatment recommendations. If they did not, they will be asked to indicate what treatment, if any, they did advise for the subject.

Subjects who continue to the Observation of Treatment Phase will have two follow-up visits and laboratory testing, including a study draw for hepcidin at each visit, to assess response to oral iron supplementation at:

  • 4-5 weeks (+/- 7 days) of therapy, and
  • 12 weeks (+/- 7 days) of therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The primary care clinic at Boston Children's Hospital (BCH) Adolescent/Young Adult (AYA) Clinic, BCH Sports Medicine Clinic, or at Boston Children's Physicians Weymouth

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the Intrinsic Hepcidin IDx test
Time Frame: 12 weeks
To demonstrate the diagnostic accuracy of the Intrinsic Hepcidin IDx TestTM to diagnose ID in adolescents and young adults, where diagnostic accuracy is defined by the lower 95% confidence interval on sensitivity (Se) being not less than 70% and the lower 95% confidence interval on specificity (Sp) not being less than 70%.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prediction of Response to Oral Iron Therapy
Time Frame: 12 weeks
To evaluate the ability of the Intrinsic Hepcidin IDx TestTM to predict a response to oral iron therapy in adolescents and young adults with ID
12 weeks
Predict Therapeutic Response to Oral Iron Therapy
Time Frame: 12 weeks
To evaluate the ability of the Intrinsic Hepcidin IDx TestTM to predict a therapeutic response to oral iron therapy in adolescents and young adults with anemia and no biochemical evidence of iron deficiency
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intrinsic LifeSciences, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew M Heeney, MD, Physician
  • Principal Investigator: Lydia A Shrier, MD, MPH, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILS-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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