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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01642758
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of beta thalassemia intermedia
* Ages 16-50 years
* Average total Hgb levels between 6.0 and 9.0 gm/dl within 30 days of initial dose of study drug
* Able to comply with all study procedures
* If female and of childbearing potential, must have a documented negative pregnancy test prior to entry and every 4 weeks
Exclusion Criteria:
* Red blood cell transfusions within 3 months prior to administration of study drug
* QT Segment corrected (QTc)\> 450 msec
* Use of Erythropoiesis Stimulating Agents(ESAs)within 9 days of first dose
* Hydroxyurea treatment within 6 months of first study drug
* History of significant arrythmias, syncope, or resuscitation
* Alanine Transaminase (ALT)\> 4x upper limit of normal
* Serum creatinine \> 1.5 mg/dl
* Sse of iron chelating agents within 7 days of first dose
* Pulmonary hypertension requiring oxygen therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT01642758
Study Brief:
Protocol Section:
NCT01642758