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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT05742035
Eligibility Criteria:
Inclusion Criteria:
* Age:18-75 years
* Body weight \> 50 Kg
* Haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females)
* In subjects of the HH and non-HH group: ferritin values \>500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the Blood Donation service or elsewhere), not followed by a blood donation or a phlebotomy
* In subjects of the HH group: genetic test demonstrating the presence of p.C282Y homozygous or p.C282Y/p.H63D compound heterozygous HFE-gene mutation
* In subjects of the control group: ferritin values \< 300 ng/ml (males) or \< 200 ng/ml (females)
* Written informed consent to the participation in the study
Exclusion Criteria:
* Inadequate vein access for whole blood collection
* Body weight \< 50 kg
* Chronic viral infection (hepatitis B or C, HIV)
* Previous acute coronary heart disease
* Previous or current history of epilepsy
* Other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation
* No informed consent
* Pregnancy (according to the information on the standard blood donor questionnaire)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05742035
Study Brief:
Protocol Section:
NCT05742035