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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01039350
Eligibility Criteria:
Inclusion Criteria:
* Age ³ 18 years
* Low or intermediate-1 risk MDS according to IPSS, and FAB classification of RA, RARS, or RAEB with blasts £ 10%
* Predictive variables of good response (serum erythropoietin levels \< 500 IU/l and transfusion requirements \< 2 packed RBC/month over the preceding 2 months)
* Anaemia (Hb £ 10 g/dL), confirmed in the 14 days before day 1 of the study
* Life expectancy of at least 6 months
* ECOG Performance status score of 0, 1, or 2
* Subject must sign and date the Informed Consent (approved by a Clinical Research Ethics Committee - CREC), before any study-specific procedure is performed
Exclusion Criteria:
* Known history of convulsive disorders
* Poorly controlled hypertension (diastolic blood pressure \> 100 mmHg) at screening
* Inadequate liver function (total bilirubin \> two times the upper limit of the normal range (ULN), and liver enzymes (ALT, AST) \> two times ULN)
* Inadequate renal function (serum creatinine concentration \> 2 mg/dL)
* Ferritin \< 100 ng/ml or transferrin saturation index (TSI) \< 16%; Vitamin B12 deficiency (\< 200 pg/ml) or folate deficiency (\< 2 ng/ml)
* Clinically-relevant haemorrhages
* Haemolytic anaemia
* Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia
* Clinically significant systemic infection or chronic inflammatory disease present at time of screening
* Any concomitant therapy used to treat MDS (including other growth factors than those described as part of this protocol, chemotherapy, antibody-based cancer treatment, hormonal therapy, interferon, and interleukins)
* Treatment with rHuEPO or darbepoetin alfa over the 4 weeks prior to Day 1 of the study
* More than 2 RBC transfusions over the 28 days prior to Day 1 of the study
* Pregnant or breast feeding women
* Subjects of childbearing-potential who do not take adequate contraceptive measures, in the opinion of the investigator
* Known hypersensitivity to any mammal-derived recombinant product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01039350
Study Brief:
Protocol Section:
NCT01039350