Phase 3
Completed N=70
Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Liver Iron Overload
Source: ClinicalTrials.gov NCT01033747 ↗
Enrolled (actual)
70
Serious AEs
28.6%
Results posted
Aug 2011
Primary outcomePrimary: The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox — -21.9; -23.1 Percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox |
-21.9; -23.1 | — |
| SECONDARY Relative Change in Serum Ferritin From Baseline to 3.5 Years |
32.4; 33.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
- Patients currently participating in the food-effect sub-study, according to amendment 3.
- Ability to provide written informed consent prior to participation in this non-comparative extension study.
- Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
- Body weight of at least 35 kg.
Exclusion Criteria
- Pregnant or breastfeeding patients.
- History of non-compliance to medical regimens and patients who are considered potentially unreliable.
- Proteinuria > 300 mg/L second void morning urine.
- Patients with serum creatinine above the upper limit normal.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01033747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.