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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT04269850
Eligibility Criteria:
Inclusion Criteria:
* Age 5-70 years
* Histologically confirmed gastrointestinal acute GVHD
* Grade III-IV gastrointestinal GVHD based on 2016 MAGIC criteria
* Ability for oral drug intake
* Signed informed consent
Exclusion Criteria:
* Requirement for oxigen and/or vasopressor support
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits,creatinine clearance \< 60 mL/min
* Ongoing fluconazole therapy
* Any malignancy requiring systemic therapy at the time of enrollment
* Mixed chimerism at last evaluation
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Severe concurrent illness that can interfere with study procedures
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04269850
Study Brief:
Protocol Section:
NCT04269850