Efficacy Study in Removing Excess Iron From the Heart (NCT00105495) | Clinical Trial Compass
CompletedPhase 4
Efficacy Study in Removing Excess Iron From the Heart
Greece, Italy60 participantsStarted 2002-12
Plain-language summary
The purpose of this study is to determine whether deferiprone has superior efficacy in removing excess iron from the heart when compared with deferoxamine.
Who can participate
Age range18 Years – 36 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of thalassemia major as confirmed by laboratory and clinical criteria
* Participants who are well transfused-maintaining a mean pre-transfusion Hb (hemoglobin) no less than 9 g/dL.
* Between 18 and 36 years of age.
* Receiving ongoing chelation therapy with deferoxamine for at least the past five years. Those who have been exposed to deferiprone for
≤ 6 months but not within the last 2 years prior to commencement of this study will be considered eligible to participate.
* Abnormal heart MRI T2\* greater than or equal to 8 ms and \< 20 ms.
* If female, fertile, and is neither pregnant nor lactating, confirms she will use an effective method of contraception for the length of the trial and has a negative pregnancy test immediately prior to commencement of study drug OR has had a tubal ligation OR a hysterectomy OR is post menopausal (at least 1 year no menses prior to enrollment in the study) OR their only sexual partner has been sterilized (if male).
* If male and fertile, he confirms that he and/or his partner will use an effective method of contraception for the length of the trial.
* Provide a signed and witnessed written informed consent obtained prior to the first study intervention.
Exclusion Criteria:
* Have anemia other than thalassemia.
* HIV antibody positive.
* Clinical evidence of cardiomyopathy as shown by LV Shortening Fraction \< 30 % and/or CMR derived LV (left ventricular) Ejection Fraction \< 56 %.
* Severe/significant ar…
What they're measuring
1
To determine whether deferiprone exhibits superior efficacy in removing excess iron from the heart compared to that of deferoxamine, as reflected by MRI T2* assessments in the heart in participants treated with either chelator