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

Primary Purpose

Transfusional Iron Overload

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Deferasirox

About this trial

This is an interventional treatment trial for Transfusional Iron Overload focused on measuring Transfusional iron overload, Deferasirox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00379483

First Posted

October 14, 2005

Last Updated

March 18, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00379483

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

April 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Transfusional Iron Overload

Keywords

Transfusional iron overload, Deferasirox

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Deferasirox

Other Intervention Name(s)

ICL670

Primary Outcome Measure Information:

Title

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

Time Frame

at 3, 4, 5 years

Secondary Outcome Measure Information:

Title

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

Time Frame

at 3, 4, 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Cagliari

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

Country

Italy

Facility Name

Novartis Investigative Site

City

Milan

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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