Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
FerroKin BioSciences, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years old
Transfusion dependent (at least 8 transfusions per year) with transfusional iron overload needing treatment with deperoxamine, deferasirox or deperiprone.
Willing to discontinue current iron chelation therapy for 2-5 days prior to enrollment and for a total of up to 3 weeks
Willing to fast after midnight prior to each dose
Serum ferritin greater than 400ng/ml
Liver iron concentration greater than or equal to 1.5 mg iron. (determined by MRI or SQUID within 12 months prior to enrollment)
Cardiac iron greater than or equal to 12 milliseconds (determined by MRI t2\* within 18 months prior to enrollment)
Mean of last 3 pre-transfusion hemoglobin values must be greater than or equal to 7.5 g/dl
Agrees to use approved contraception from Screening and until 30 days after last administration of study drug. Abstinence OK.
You may not be if
Principal Investigator considers patient unfit for study after conducting a medical review, physical examination and other screening assessments.
Non-elective hospitalization with past 30 days
Evidence of clinically relevant oral, cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorder.
Evidence of significant renal insufficiency; serum creatine above upper limit of normal or proteinuria greater than 2 gm per day or calculated creatinine clearance of less than or equal to 60ml/min
Platelet count below 150,000,000/ml and/or absolute neutrophil count less then 1500/mm3
Alkaline phosphatase or AST greater than 5 times the upper limit of normal or ALT greater than 4 times the upper limit of normal
Female patients who are pregnant or lactating
Use of any investigational agent within the last 30 days
