Post Hematopoietic Stem Cell Transplantatio

• Conditions: -Iron overload; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001561-88-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Inclusion Criteria
•Patients who had HSCT for beta-thalassemia major
•HSCT was performed minimum 6 months and maximum 2 years ago
•The washout period after the immunosuppressive therapy should be at least 3 months.
•Signifacant IOL should be present including:

A. Serum ferritin >1000 µg/L or B. cardiac MRI <20 ms or C. liver iron concentration = 5 mg/g dry weight measured by R2* MRI

Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion Criteria
•Patients who have any contraindication for treatment with deferasirox according to the prescribing information
•Patients who depend on transfusion
•Patients with clinical symptoms of cardiac dysfunction (shortness of breath at rest or exertion, orthopnea, exercise intolerance, lower extremity edema, arrhythmias)
•Patients who are experiencing severe complication of HSCT (e.g. acute GVHD)
•Significant proteinuria / Increase in serum creatinine

Study & Design

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