Multicenter, open label, prospective study to evaluate the efficacy and safety of deferasirox 30 mg/kg/day for 52 weeks, in transfusion-dependent &amp;#946;-thalassemic patients with cardiac MRI T2* <20 msec - ND

Active, not recruiting

• Conditions: cardiac iron overload; MedDRA version: 9.1Level: LLTClassification code 10019024Term: Haemosiderosis

• Registration Number: EUCTR2008-003230-22-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Both sexes, aged &#8805;10 years &#946;-thalassemic patients receiving regular transfusions with an history of at least 20 transfusional events Patients naive for deferasirox Serum ferritin levels &#8805;1000ng/mL (average of the last 6 months assays); Cardiac MRI T2* >5 and <20 msec. LVEF at MRI &#8805;56% Written Informed Consent obtained from the patient if adult or from the parents or the legal guardian for pediatric patients and consent of the pediatric patient themselves if capable of reading and understanding the meaning of the text Women of child bearing potential should use a valid contraceptive method.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients that have already started deferasirox therapy Existing contraindications to the performance of MRI procedure, including presence of metallic prostheses not compatible with the MRI procedure other than those approved as safe for use in MRI scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina), pacemaker, intractable claustrophobia and incapability to follow the instruction for the correct performance of the MRI (e.g. to maintain a supine position, to hold breath, etc.) Clinical conditions requiring intensive chelating therapy on the basis of Investigator?s judgment Severe liver impairment of ALT (SGOT) and/or AST (SGOT) > 5 times upper limit of the normal range (ULN) Uncontrolled systemic hypertension Estimated creatinine clearance <60 mL/min History of nephrotic syndrome History of clinically significant ocular toxicity related to the chelating therapy Psychiatric disorders or drug dependence that might impair the capability of the patient to provide their Informed Consent or to be administered the study treatment Pregnancy or breastfeeding Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or elimination of the any drugs, particularly: 1) History of intestinal inflammatory disease, gastritis, ulceration, gastro-intestinal and/or rectal bleeding 2) History of major gastro-intestinal surgery, such as gastrectomy, gastro-enterostomy, intestinal resection 3) History of pancreatic damage or pancreatitis; signs of pancreatic failure, such as alteration of lipases or amylases serum levels 4) History or presence of renal insufficiency as indicated by alteration of serum creatinine or BUN levels 5) History of urinary obstruction or voiding difficulty Patient judged potentially non-compliant and/or non-cooperative with the study procedures Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding Known sensitivity to study drug(s) or class of study drug(s) Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) Use of any other investigational agent in the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified