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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT04190693
Eligibility Criteria:
Inclusion Criteria:
* All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical trial who are willing to participate to this long-term follow-up study.
Exclusion criteria:
* Ongoing pregnancy or lactation
* History of or current malignancy (except excised basal cell skin cancer)
* Primary or secondary immune deficiency disorders
* Human Immunodeficiency virus (HIV) infection.
* Ongoing treatment with immunosuppressive agents with the exception of topical or intra nasal corticosteroids.
* Treatment with an investigational drug within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
31 Years
Study:
NCT04190693
Study Brief:
Protocol Section:
NCT04190693