Diseases

  • No diseases found

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.

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.
1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.

This study will evaluate the efficacy and safety of deferasirox in patients with MDS, thalassemia and rare anemia patients with transfusion iron overload.

Phase 4
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
changes in ferritin level, compared to baseline, in patients with transfusion-induced iron overload treated with Exjade
changes in clinical manifestations of iron overload by means of echocardiogram (ECHO), electrocardiogram (ECG), routine laboratory assessments and physical examination
  • Myelodysplastic Syndrome
  • Thalassemia
DrugDeferasirox
  • Deferasirox

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Drug
111
December 2009
September 2011
July 2011

Inclusion Criteria:

  1. Age ≥ 2 years

  2. 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)

  3. ECOG Performance Status ≤ 2

  4. Transfusion overload confirmed with ferritin level >1000 µg/l.

  5. No severe concomitant uncontrolled disease (uncontrolled diabetes mellitus, heart failure, renal failure).

  6. Serum creatine level > ULN

  7. No proteinuria

  8. Liver enzymes level < 5 ULN.

  9. No pregnancy or lactation

  10. Signed informed consent by adults. In case inclusion of children under 18 years old, the informed consent should be signed by parents.

Exclusion Criteria:

  1. Age < 2 years

  2. No iron overload (Ferritin level <1000 µg/l).

  3. Primary iron overload (hereditary hemochromatosis)

  4. Severe concomitant disease (uncontrolled diabetes mellitus, heart failure, renal failure)

  5. Elevated serum creatinine > ULN or/and proteinuria

  6. Liver enzymes level >5 ULN.

  7. Pregnancy or lactation.

    Other protocol-defined inclusion/exclusion criteria may apply

Both
2 Years - N/A
No
  • , ,
  • , ,
Russian Federation,
NCT01250951
CICL670ARU01
,
Novartis Pharmaceuticals
    Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
    Novartis
    December 2011
    November 11, 2010
    December 1, 2011
    Required WHO trial registration data element.
    †† WHO trial registration data element that is required only if it exists.