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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02027805
Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from acute GVHD which is staged Grade II-IV according to the modified Glucksberg Criteria and progressing after 3 days, or not improving after 7 days, of methylprednisolone at a dose of 2 mg/kg per day.
* Age ≥18 years.
* Patients or an impartial witness (in case the patient is capable to provide verbal consent but not capable to sign the informed consent) should have given written informed consent.
Exclusion Criteria:
* Patients receiving concomitant investigational therapeutics for acute GVHD, including investigational agents used for GVHD prophylaxis, at the time of enrollment.
* Patients with signs or symptoms suggestive of chronic GVHD.
* Patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine \> 266 µmol/l (\> 3 mg/dl), or having a serum albumin level of 15 g/l or less.
* Patients having uncontrolled bacterial, viral or fungal infections, at the discretion of the investigator, at the start of therapy.
* Patients with current signs or symptoms of active intrapulmonary disease.
* Patients with known hypersensitivity to any of the components of the study drug.
* Female patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.
* Male patients who are, if sexually active, unwilling to use effective birth control for 30 days after the last infusion.
* Patients participating in a clinical trial with another investigational product within 30 days prior to providing informed consent.
* Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02027805
Study Brief:
Protocol Section:
NCT02027805