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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT01609595
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Beta Thalassemia Intermedia
* Splenectomized
* Average of two Hgb levels between 6.0 and 9.0 g/dl
Exclusion Criteria:
* Red blood cell transfusion within 3 months of study drug initiation
* Enlarged spleen
* Use of hydroxyurea within 6 months
* QT Segment corrected (QTc)\> 450 msec (men) or 470 msec (women) on screening ECG
* Use of iron chelating agents within 7 days of first dose
* Alanine Transaminase(ALT)\> 4 times the upper limit of normal
* Use of erythropoiesis stimulating agents (ESAs) within 90 days of first dose
* serum creatinine \> 1.5 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01609595
Study Brief:
Protocol Section:
NCT01609595