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 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT00446602
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Myelodysplastic Syndromes (MDS) via bone marrow aspirate and biopsy according to World Health Organization (WHO) Criteria or French-American-British (FAB) Classification. All WHO and FAB subtypes of MDS are potentially eligible, provided the subject's International Prognostic Scoring System (IPSS) score is Low- or Intermediate-1 \[with the exception of chronic myelomonocytic leukemia (CMML)\]
* Documentation of IPSS score of Low- or Intermediate-1 risk disease (\<= 10% bone marrow blasts), based on bone marrow aspirate, biopsy, and cytogenetics, within 12 weeks prior to study entry
* Baseline hemoglobin (Hb) value of \<10 g/dL \[defined as the average of at least 2 measurements \[(not influenced by red blood cell (RBC) transfusions for at least 1 week) \>= 1 week apart\]. The Hb level prior to the first dose of PROCRIT (Epoetin alfa) cannot be \> 10.5 g/dL.
Exclusion Criteria:
* No anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding)
* No proliferative (White Blood Cells (WBC) \>= 12,000/mm3) chronic myelomonocytic leukemia (CMML)
* No history of (within 12 months) deep venous thrombosis \[(DVT), includes proximal and distal\], pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion
* No history of (within 6 months) cerebrovascular accident \[(CVA), includes ischemic, embolic and hemorrhagic\], transient ischemic attack (TIA), myocardial ischemia \[includes Unstable Angina, Q wave Myocardial Infarction (QwMI) and non-Q wave Myocardial Infarction (NQMI)\], or other arterial thrombosis
* No prior Erythropoietin Receptor Agonist (ERA) treatment within 4 weeks prior to the first study dose
* No prior ERA treatment failure (defined as having shown no Hb response or a Hb response \<1 g/dL after at least 6 weeks of ERA treatment) with minimum dose of Epoetin alfa 40,000 Units/week or Darbepoetin alfa 150 mcg/ week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00446602
Study Brief:
Protocol Section:
NCT00446602