Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00379483

Enrollment

Registered

2006-09-22

Start date

2002-07-31

Completion date

2003-04-30

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusional Iron Overload

Keywords

Transfusional iron overload, Deferasirox

Brief summary

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Interventions

DRUGDeferasirox

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion criteria

* Pregnant or breast feeding patients * Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Design outcomes

Primary

Measure	Time frame
Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment	at 3, 4, 5 years

Secondary

Measure	Time frame
Change in liver iron content measured by SQUID, at 3, 4, and 5 years	at 3, 4, 5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026