This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.

Descriptive Information
Brief Title ^†	This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.
Official Title ^†	1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.
Brief Summary	This study will evaluate the efficacy and safety of deferasirox in patients with MDS, thalassemia and rare anemia patients with transfusion iron overload.
Detailed Description
Study Phase	Phase 4
Study Type ^†	Interventional
Study Design ^†	Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure ^†	changes in ferritin level, compared to baseline, in patients with transfusion-induced iron overload treated with Exjade
Secondary Outcome Measure ^†	changes in clinical manifestations of iron overload by means of echocardiogram (ECHO), electrocardiogram (ECG), routine laboratory assessments and physical examination
Condition ^†	Myelodysplastic Syndrome Thalassemia
Intervention ^†	DrugDeferasirox
Study Arms / Comparison Groups	Deferasirox
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	111
Start Date ^†	December 2009
Completion Date	September 2011
Primary Completion Date	July 2011
Eligibility Criteria ^†	Inclusion Criteria: Age ≥ 2 years Primary Diagnosis: Myelodysplastic Syndrome (presenting with low or intermediate-1 IPSS risk), thalassemia or rare anemias patients (anemia Diamond-Blackfan, Fanconi's anemia, Sideroblastic anemia, Red cell aplasia) ECOG Performance Status ≤ 2 Transfusion overload confirmed with ferritin level >1000 µg/l. No severe concomitant uncontrolled disease (uncontrolled diabetes mellitus, heart failure, renal failure). Serum creatine level > ULN No proteinuria Liver enzymes level < 5 ULN. No pregnancy or lactation Signed informed consent by adults. In case inclusion of children under 18 years old, the informed consent should be signed by parents. Exclusion Criteria: Age < 2 years No iron overload (Ferritin level <1000 µg/l). Primary iron overload (hereditary hemochromatosis) Severe concomitant disease (uncontrolled diabetes mellitus, heart failure, renal failure) Elevated serum creatinine > ULN or/and proteinuria Liver enzymes level >5 ULN. Pregnancy or lactation. Other protocol-defined inclusion/exclusion criteria may apply
Gender	Both
Ages	2 Years - N/A
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†	Russian Federation,
Administrative Information
NCT ID ^†	NCT01250951
Organization ID	CICL670ARU01
Secondary IDs ^††
Responsible Party	,
Study Sponsor ^†	Novartis Pharmaceuticals
Collaborators ^††
Investigators ^†	Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Information Provided By	Novartis
Verification Date	December 2011
First Received Date ^†	November 11, 2010
Last Updated Date	December 1, 2011

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.