At a glance
ClinicalIndex Comparison Record- ✓Completion of the 12-month core study NCT00061750
- ✓Female patients after menarche who are sexually active must use contraception (double-barrier, oral plus barrier, or documented hysterectomy/ovariectomy/tubal ligation)
- ✓Written informed consent from patient and/or legal guardian
- ✕Pregnant or breast-feeding patients
- ✕History of non-compliance to medical regimens or potentially unreliable patients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload
In Brief
A Phase 3 clinical trial evaluating Deferasirox for Transfusional Iron Overload in β-thalassemia. Completed, enrolled 506 participants across 49 sites in 12 countries.
Detailed Summary
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.
Study Details
Timeline
Interventions
Tablets taken orally once a day.