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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 14, 2005
Last updated: March 18, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Transfusional Iron Overload
Drug: Deferasirox
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment [ Time Frame: at 3, 4, 5 years ]

Secondary Outcome Measures:
  • Change in liver iron content measured by SQUID, at 3, 4, and 5 years [ Time Frame: at 3, 4, 5 years ]

Enrollment: 66
Study Start Date: July 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Deferasirox
Other Name: ICL670


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00379483

Novartis Investigative Site
Cagliari, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Torino, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00379483     History of Changes
Other Study ID Numbers: CICL670A0105E1
Study First Received: October 14, 2005
Last Updated: March 18, 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Transfusional iron overload

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017