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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00565578

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 III

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Blood Transfusion and Donation

Drug Information available for: Deferasirox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload

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

Secondary Outcome Measures:

Safety assessed by serum Ferritin Tolerability assessed by safety profile Evaluate the relationship between serum ferritin and potential surrogate markers

Estimated Enrollment:	185
Study Start Date:	July 2006

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

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CICL670A2409E1
Study First Received:	November 29, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00565578
Health Authority:	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

Study placed in the following topic categories:

Myelodysplastic syndromes
Metabolic Diseases
Deferasirox
Myelodysplastic Syndromes
Myelodysplasia
Anemia
Aase syndrome
Iron Metabolism Disorders

Thalassemia
Preleukemia
Diamond Blackfan anemia
Anemia, Diamond-Blackfan
Iron Overload
Metabolic disorder
Iron

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009