Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload

Phase 4

Completed

• Conditions: Myelodysplastic Syndromes; Beta-Thalassemia
• Interventions: Drug: deferasirox

• Registration Number: NCT00564941
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Study Start: 2007-12
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deferasirox	deferasirox	-

Primary Outcome Measures

Name	Time	Method
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload	monthly during the therapy and at the end of the treatment (aftr 9 months therapy)

Secondary Outcome Measures

Name	Time	Method
patient's compliance during the study assessed by the number of the unused tablets returned by the patient safety assessed by patient laboratory data, adverse events, serious adverse events	during the treatment (9 months)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇭🇺 Szeged, Hungary