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 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT00110266
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients with low or intermediate (INT-1) risk MDS
* Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO).
* Age greater than or equal to 18 years
* Availability of transfusion records for the 12 weeks prior to registration
* A lifetime minimum of 30 previous packed red blood cell transfusions
* Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration
* Serum Ferritin:
For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.
Serum ferritin ≥ 1000 ng/mL at screening via the central lab.
* Life expectancy ≥ 6 months
* Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
* Able to provide written informed consent
Exclusion Criteria:
* Serum creatinine above the upper limit of normal
* Alanine aminotransferase (ALT) \> 500 U/L during screening
* Clinical or laboratory evidence of active Hepatitis B or C
* Urinary protein/creatinine ratio \> 0.5 mg/mg
* History of HIV positive test result (ELISA or Western blot)
* Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2
* Patients with uncontrolled systemic hypertension
* Unstable cardiac disease not controlled by standard medical therapy
* Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
* Pregnancy or breast feeding
* Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00110266
Study Brief:
Protocol Section:
NCT00110266