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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00379483
Collaborator
(none)
66
Enrollment
4
Locations
1
Arm
9
Duration (Months)
16.5
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 1, 2002
Actual Primary Completion Date :
Apr 1, 2003
Actual Study Completion Date :
Apr 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Drug: Deferasirox
Other Names:
  • ICL670

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Cagliari Italy
    2 Novartis Investigative Site Genova Italy
    3 Novartis Investigative Site Milan Italy
    4 Novartis Investigative Site Torino Italy

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00379483
    Other Study ID Numbers:
    • CICL670A0105E1
    First Posted:
    Sep 22, 2006
    Last Update Posted:
    Mar 19, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Novartis Pharmaceuticals
    Transfusional iron overload
    Deferasirox
    Additional relevant MeSH terms:
    Iron Overload
    Deferasirox

    Study Results

    No Results Posted as of Mar 19, 2015