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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT01709032
Eligibility Criteria:
Inclusion Criteria:
* Alpha or beta thalassemia
* Receiving chronic transfusions (at least 20 transfusions in lifetime) with iron overload requiring treatment with chelation
* Serum ferritin \>500 ng/ml
* Liver iron concentration equal to or greater than 10 mg/g dw (by R2 MRI) or 7 to 10 mg/g dw (by R2 MRI) and not improving OR cardiac T2\* between 6 and \<20 ms
* Women of childbearing age must have a negative pregnancy test
* Agree to use approved method of contraception for the duration of the study
* Subjects must have a good understanding of the study and be willing to comply with study procedures
Exclusion Criteria:
* Subjects with past history of unexplained neutropenia (ANC \< 1500/mcL), clinically significant renal disease (creatinine above the upper limit of normal), proteinuria \>300 mg/L, clinically significant liver disease (ALT \> 5x upper limit of normal), pulmonary or cardiovascular disease
* History of other clinically relevant oral, endocrine, neurologic, psychiatric, immunologic, bone marrow or skin disorder that contraindicates dosing with deferasirox or deferiprone
* History of adverse reaction or known allergy to either deferasirox or deferiprone necessitating drug discontinuation
* Currently receiving treatment for active hepatitis
* Use of any investigational agent in the past 30 days
* Cardiac T2\* \<6 ms, left ventricular ejection fraction \< 56%, and/or arrhythmia (certain subjects may be eligible if they have already had a trial of deferoxamine and deferiprone). Subjects who refuse to use deferoxamine after extensive consultation with at least 2 health care providers will also be allowed to participate.
* Pregnant or breastfeeding females
* Unwilling or unable to comply with study related procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01709032
Study Brief:
Protocol Section:
NCT01709032