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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379483

Locations
Italy
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00379483     History of Changes
Other Study ID Numbers: CICL670A0105E1
Study First Received: October 14, 2005
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Transfusional iron overload
Deferasirox

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron
Deferasirox
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014