Status:
COMPLETED
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.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelodysplastic Syndrome
Thalassemia
Eligibility:
All Genders
2+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01250951
Start Date
December 1 2009
End Date
September 1 2011
Last Update
December 12 2016
Active Locations (2)
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1
Novartis Investigative Site
Moscow, Russia
2
Novartis Investigative Site
Saint Petersburg, Russia