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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379483
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Transfusional Iron Overload Drug: Deferasirox Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
Study Start Date : July 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Deferasirox

Arm Intervention/treatment
Experimental: Arm 1 Drug: Deferasirox
Other Name: ICL670

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00379483     History of Changes
Other Study ID Numbers: CICL670A0105E1
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 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