NCT00117507

Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients

An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-Risk and INT-1 Myelodysplastic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox. Deferasirox were administered orally once per day for 12 months.

Detailed description

Patients were screened for eligibility to determine if they meet all inclusion/exclusion criteria. The screening period were up to 4 weeks. Patient's baseline LIC will be determined non-invasively by means of MRI R2 analysis. In addition, blood and urine samples will be taken for the determination of baseline safety data.

Conditions

• Myelodysplastic Syndromes
• Iron Overload

Interventions

Type	Name	Description
DRUG	Deferasirox

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-07-07
• Last updated: 2021-06-24
• Results posted: 2021-06-24

Locations

3 sites across 1 country: United States