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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT03920657
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis: Adult Myelodysplastic Syndrome (≥18 years).
* Revised IPSS: very low. low - intermediate
* Having received 5-20 packed red blood cell units
* Serum ferritin ≥300 ng/ml
* Transferrin saturation ≥ 60%
* Chelation naïve
* Capability to provide informed consent
Exclusion Criteria:
* Patients aged \<18 years old
* Higher risk (revised IPSS) MDS (Intermediate 2, high)
* Cumulative transfusion story of \> 20 packed red cell units
* Creatinine Clearance (CrCL): \<60 ml/min. Patients with CrCl of 40-60ml/min will be included only individually if no other renal risk factors are present.
* Serum creatinine \>2 x ULN at screening. If borderline serum creatinine will be measured within 7-10 days and the mean value will be used for eligibility criteria.
* Significant proteinuria as indicated by a urinary protein/creatinine ratio \> 0.5 mg/mg in a non-first void urine sample (or alternatively in two of three samples obtained for screening).
* ECOG performance status \>2.
* Left ventricular ejection fraction \< 50% by echocardiography
* A history of repeated hospitalization for congestive heart failure.
* Systemic diseases that would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
* Clinical or laboratory evidence of chronic Hepatitis B or Hepatitis C (definition of chronic hepatitis follows EASL 2017 criteria).
* History of HIV positive test result (ELISA or Western blot).
* Treatment with systemic investigational drug within 4 weeks or topical investigational drug within 7 days of study start.
* ALT or AST over 3 times superior to ULN at screening.
* ANC \< 500/ microL
* Platelets transfusion dependency
* Total bilirubin over 1.5 times superior to ULN at screening (patients with Gilbert syndrome are allowed to enter the study)
* Diagnosis of Child score C liver cirrhosis.
* Patients participating in another clinical trial other than an observational registry study.
* Patients with a history of another malignancy within the past 3 years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situ.
* History of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
* Presence of a surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug.
* Pregnant, intending-to-become pregnant, or breast-feeding patients.
* Women of potential maternity age who do not agree to practice effective contraceptive methods fo the entire study duration.
* History of drug or alcohol abuse within the 12 months prior to enrollment.
* Hypersensitivity to the active substance or to any of the excipients.
* Inability to provide a valid informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03920657
Study Brief:
Protocol Section:
NCT03920657