To characterize the PK of deferasirox in pediatric β-thalassemia major patients aged from 2
to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.
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Full eligibility criteria for NCT01724138
Ages eligible for Study
2 Years to 71 Years
Genders eligible for Study
Accepts Healthy Volunteers
Pediatric patients aged from 2 to less than 6 years old.
Patients with transfusion dependent β-thalassemia major.
Serum ferritin values ≥ 1000 ng/ml at screening.
Written informed consent must be obtained from the patient's legal guardian in accordance with local law and regulation prior to any screening procedures.
Systemic diseases which would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.)
Serum creatinine > age adjusted ULN.
Significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥ 0.5mg/mg in a non-first void urine sample at screening. If UPCR is found to be ≥ 0.5 mg/mg the test can be repeated after 1 month.
ALT/AST > 2.5xULN and total bilirubin > 1×ULN.
Left ventricular ejection fraction < 56% by echocardiography.
Patient has a known history of HIV seropositivity or history of active/treated hepatitis B or C (a test for screening is not required).
A history of clinically relevant ocular and/or auditory toxicity related to iron chelation therapy
Any surgical or medical conditions which will significantly alter the absorption, distribution, metabolism or excretion of the drug(e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection).
Other conditions which investigator deems potential harm to patients if participate the study.
All locations for NCT01724138
View full eligibility
Tris trial is registered with FDA with number: NCT01724138. The sponsor of the trial is Novartis Pharmaceuticals and it is looking for 0 volunteers for the current phase.
Official trial title: An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old
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