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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01034657
Eligibility Criteria:
Key Inclusion Criteria:
* Patients with a lower risk MDS (LOW or INT-1 according to IPSS)
* Red blood cell transfusion dependency of at least 4 Units/8 weeks.
* Not responding to Erythropoietin stimulating agents (ESA) or having a low chance to do so
* Age-adjusted normal cardiac, kidney, liver function
Key Exclusion Criteria:
* Concomitant use of ESA
* Concomitant use of any other investigational drug
* Other malignancy that is not in remission for at least 1 year
* Platelet Count \< 75 x 109/L
* Impaired cardiac function or clinically significant cardiac diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01034657
Study Brief:
Protocol Section:
NCT01034657