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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04118556
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.
2. Signed written study informed consent once SR-aGvHD is confirmed.
Exclusion Criteria:
1. Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
2. Has received systemic treatment for aGvHD apart from steroids.
3. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome.
4. Pregnant or lactating women.
5. Significant respiratory disease.
6. Presence of severely impaired renal function
7. Any corticosteroid therapy for indications other than aGvHD
8. Previous participation in a study of any investigational treatment agent within 30 days
9. Known human immunodeficiency virus infection (HIV).
10. Patients suffering on active tuberculosis or viral hepatitis
11. Significant respiratory disease
12. Presence of severely impaired renal or liver function
13. History of progressive multifocal leuko-encephalopathy
14. Patients with coagulopathy
15. History of severe chronic history of heart disease
16. Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04118556
Study Brief:
Protocol Section:
NCT04118556