Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia (NCT01709032) | Clinical Trial Compass
CompletedPhase 1/2
Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia
United States9 participantsStarted 2012-09
Plain-language summary
We hypothesize that the combination treatment with deferasirox and deferiprone will be well tolerated and will result in significant improvement in cardiac and liver iron levels.
Who can participate
Age range18 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:
* 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 a…
What they're measuring
1
Number of Participants With Improvement in Liver Iron Concentration