Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
NCT01033747 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2011-08-11
Summary
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
Conditions
- Liver Iron Overload
Interventions
- DRUG
-
Deferasirox
10 mg/kg or 30 mg/kg orally daily
- DRUG
-
Deferasirox
5 mg/kg or 30 mg/kg orally daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Primary Completion
- 2008-01-31
- Completion
- 2008-01-31
Countries
- Italy
Study Locations
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