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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT00940602
Eligibility Criteria:
Inclusion Criteria:
* Weigh between 35-135 kilograms
* Low or int-1 risk MDS
* Ferritin \>1000 micrograms/liter at screening
* History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units
* Anticipated to be transfused with at least 8 units of PRBCs annually during the study
* Women of child-bearing potential using effective methods of contraception during dosing of study treatment
Exclusion Criteria:
* More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or deferiprone or 5×/week deferoxamine)
* More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period)
* Significant proteinuria
* History of hospitalization for congestive heart failure; other heart conditions as specified in the protocol
* Systemic diseases which would prevent study treatment
* Hepatitis B; Hepatitis C; HIV
* Liver cirrhosis
* Pregnant, or breast-feeding patients, or patients of child-bearing potential not employing an effective method of birth control
* History of drug or alcohol abuse within the 12 months prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00940602
Study Brief:
Protocol Section:
NCT00940602