Status:
TERMINATED
Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Aplastic Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in compar...
Detailed Description
The secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.
Eligibility Criteria
Inclusion
- Main diagnosis: aplastic anemia
- Absence of severe and/or uncontrolled comorbidities
- Confirmed iron overload (serum ferritin ≥ 1000 mkg/L)
- Serum creatinine is not higher than the upper limit of normal for the given age
- Absence of severe proteinuria. Protein/Creatinine ratio should be \< 0.5 mg/mg
- Liver enzymes are \< 5 ULN
- Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications
- WHO (ECOG) performance status ≤ 2
Exclusion
- No signed informed consent form
- Patient is under 18 years old
- Severe concomitant condition
- Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment.
- History of increased sensitivity to active substance and any other ingredient of the medicinal product.
- Creatinine clearance (CC) \< 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2.
- Severe liver disorders (class C by Child-Pugh scale).
- Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease.
- Significant proteinuria basing on protein creatinine ratio \> 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening);
- Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption;
- Pregnancy, lactation;
- Level of liver enzymes higher than 5 upper limits of age normal at Visits 1 and 2.
Key Trial Info
Start Date :
June 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01818726
Start Date
June 23 2014
End Date
October 17 2016
Last Update
August 16 2019
Active Locations (1)
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1
Novartis Investigative Site
Moscow, Russia, 125167