Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload

Phase 4

Completed

• Conditions: Iron Overload
• Interventions: Drug: Deferasirox

• Registration Number: NCT00654589
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
deferasirox	Deferasirox	-

Primary Outcome Measures

Name	Time	Method
To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox	52 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.	52 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Leipzig, Germany