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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00790127
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of beta thalassemia intermedia or hemoglobin E beta thalassemia
* Average of the initial two hemoglobin levels of less than 10 g/dL within ≥ 30 days prior to randomization.
* Age ≥ 12 and ≤ 60 years
* Able and willing to give informed consent or assent (if less than 18 years of age) and comply with all study procedures
* If female and of childbearing potential, must have a documented negative pregnancy test at Day -1 and must agree to use one or more locally medically accepted methods of contraception in the month prior to randomization, through the entire study, and for 4 weeks after the last dosing of study medication
Exclusion Criteria:
* Spleen palpable ≥ 2 cm below the left costal margin
* Pulmonary hypertension requiring oxygen therapy
* QTc \> 450 msec on screening ECG
* Infection with hepatitis C, hepatitis B requiring therapy
* Known infection with HIV
* Red blood cell (RBC) transfusions within 2 months prior to administration of study medication with stable hemoglobin levels
* Fever greater than 38.5°C in the week prior to administration of study medication
* ALT \> 4x upper limit of normal (ULN)
* Baseline elevation of CPK value prior to randomization
* Treatment with hydroxyurea within 2 months prior to administration of study medication
* Cancer diagnosis within 5 years of randomization (except for non-melanoma cutaneous malignancies)
* Serum creatinine \> 1.5 mg/dl
* Received investigational systemic therapy within 30 days prior to randomization
* Currently pregnant or breast feeding a child
* Subject history of clinically significant arrhythmias or syncope
* Known current drug or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
60 Years
Study:
NCT00790127
Study Brief:
Protocol Section:
NCT00790127