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Completed

NCT Number: NCT00379483

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

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.

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Key information

Conditions

Transfusional Iron Overload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Cagliari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deferasirox

Drug

Other names: ICL670

Primary outcomes

  1. Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment

    Time frame: at 3, 4, 5 years

Secondary outcomes

  1. Change in liver iron content measured by SQUID, at 3, 4, and 5 years

    Time frame: at 3, 4, 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Sep 22, 2006
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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