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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05825833
Eligibility Criteria:
Inclusion Criteria:
* Age of the patients between 0 and 18;
* Allogeneic HSCT recipient;
* Onset of clinical signs of acute skin, gastrointestinal or hepatic GVHD according to the Glucksberg classification;
* At least five days of steroid treatment (minimum 1 mg/kg of methylprednisone or equivalent) for systemic aGVHD without clinical or laboratory signs of response or no steroid treatment for onset of grade I-II hepatic/gastroesophageal/intestinal isolated aGVHD;
* Patients who consent for the off-label use of infliximab and data processing for research purposes;
* At least one dose of infliximab received during aGVHD management;
* Minimum follow-up after infliximab administration of 6 months
Exclusion Criteria:
* Active fungal or bacterial infection with life-threatening clinical condition (shock or respiratory distress needing mechanical ventilation)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT05825833
Study Brief:
Protocol Section:
NCT05825833