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Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00565578
First received: November 29, 2007
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.


Condition Intervention Phase
Transfusion-Dependent Iron Overload
 Drug: Deferasirox
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload

Resource links provided by NLM:

Drug Information available for: Deferasirox
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To Evaluate if fixed starting dose of ICL670, based on transfusional history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by serum Ferritin Tolerability assessed by safety profile Evaluate the relationship between serum ferritin and potential surrogate markers [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Enrollment: 282
Study Start Date: July 2006
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deferasirox Drug: Deferasirox
Other Name: ICL670

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients presenting with transfusion-dependent anemias (independent of underlying condition) with transfusional iron overload as shown by a serum ferritin level of ≥ 1000 ng/ml
  • Patients of either gender and aged ≥ 2 years
  • Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.

Exclusion criteria:

  • Non-transfusional hemosiderosis
  • Patients with clinical evidence supporting the need for intensive chelation, base on the investigator's judgment
  • Patients with mean levels of Alanine aminotransferase (ALT) >300 U/l
  • Patients with uncontrolled systemic hypertension
  • Patients with serum creatinine above the upper limit of normal (ULN)

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565578

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00565578     History of Changes
Other Study ID Numbers: CICL670A2409E1
Study First Received: November 29, 2007
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Pharmaceutical Inspectorate
China: Ministry of Health
Egypt: Ministry of Agriculture and Land Reclamation
France: Ministry of Health
Italy: Ministry of Health

Keywords provided by Novartis:
Thalassemia
Myelodysplastic Syndrome
MDS
Sickle cell
Diamond-Blackfan anemia
 Transfusion
Anemia
Fanconi
Chelation
Deferasirox

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Deferasirox
 Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013