efficacy and safety of deferasirox in patients with non-transfusion dependent thalassemia
- Conditions
- iron overload in patients with non-transfusion dependent thalassemiaMedDRA version: 20.0Level: HLTClassification code 10022979Term: Iron excessSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-000650-64-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 134
• Male or female aged = 10 years with non-transfusion-dependent congenital or chronic anemias inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)
• LIC = 5 mg Fe/g dw measured by R2 MRI at screening
• Serum ferritin = 300 ng/mL at screening (two consecutive values at least 14 days apart from each other)
Additional inclusion criteria as per full protocol may apply
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• HbS-beta Thalassemia
• Anticipated regular transfusion program during the study
• Any blood transfusion 6 months prior to study start
• Significant proteinuria
• creatinine clearance =40 ml/min
• serum creatinine >ULN; ALT >5xULN
Additional exclusion criteria as per full protocol may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method