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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT04318405
Eligibility Criteria:
Inclusion Criteria:
* Legally capable male and female patients, aged ≥ 18 years (no upper limit);
* Written informed consent of the patient with regard to the pseudonymized documentation;
* The patients are not selected by specific inclusion or exclusion criteria, but by the indication listed in the Swiss SmPC (Summary of Product Characteristics) of Monofer®;
* Decision is taken to treat the patient with IIM in accordance with the current Swiss SmPC of Monofer® and by prescription; this decision is taken prior to and independent from the inclusion into the study.
Exclusion Criteria:
* Any contraindication regarding IIM treatment as specified in the Swiss SmPC of Monofer®;
* Retrospective observation of IIM infusion;
* Current or upcoming participation in an interventional clinical trial;
* Prior IV iron treatment or transfusion within 3 months prior to enrolment;
* Instable and/or untreated comorbidities potentially hampering the observation of the primary outcome parameter of this study;
* Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04318405
Study Brief:
Protocol Section:
NCT04318405