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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00379483

First received: October 14, 2005

Last updated: November 18, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2005

Last Updated Date

November 18, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment [ Time Frame: at 3, 4, 5 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00379483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in liver iron content measured by SQUID, at 3, 4, and 5 years [ Time Frame: at 3, 4, 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Transfusional Iron Overload

Intervention ^ICMJE

Drug: Deferasirox

Other Name: ICL670

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Deferasirox

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00379483

Other Study ID Numbers ^ICMJE

CICL670A0105E1

Has Data Monitoring Committee

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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