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An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

NCT ID: NCT00171210

Last Updated: 2011-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Brief Summary

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A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

Detailed Description

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Conditions

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Transfusional Iron Overload in β-thalassemia

Keywords

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β-thalassemia iron overload deferasirox

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deferasirox

All participants received Deferasirox (ICL670) orally once a day. Dosage based on body weight.

Group Type EXPERIMENTAL

Deferasirox

Intervention Type DRUG

Tablets taken orally once a day.

Interventions

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Deferasirox

Tablets taken orally once a day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who completed the 12-month core study (NCT00061750)
* Female patients after menarche and who were sexually active, if they used double-barrier contraception, oral contraceptive plus barrier contraceptive, or had undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
* Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation

Exclusion Criteria

* Pregnant or breast feeding patients
* Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital and Research Center at Oakland

Oakland, California, United States

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Stanford Hospital, Division of Oncology

Stanford, California, United States

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Children's Memorial Hospital

Chicago, Illinois, United States

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Children's Hospital Boston, Dept of Hematology

Boston, Massachusetts, United States

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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Novartis Investigative Site

Buenos Aires, , Argentina

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Córdoba, , Argentina

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Brussels, , Belgium

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Laken, , Belgium

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Liège, , Belgium

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Mons, , Belgium

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Campinas, , Brazil

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São Paulo, , Brazil

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Montreal, , Canada

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Toronto, , Canada

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Créteil, , France

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Marseille, , France

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Paris, , France

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Pierre-Bénite, , France

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Berlin, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Ulm, , Germany

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Athens, , Greece

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Ioannina, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Brindisi, , Italy

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Cagliari, , Italy

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Catania, , Italy

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Ferrara, , Italy

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Genova, , Italy

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Milan, , Italy

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Monza, , Italy

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Naples, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Roma, , Italy

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Sassari, , Italy

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Syracuse, , Italy

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Turin, , Italy

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Tunis, , Tunisia

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Adana, , Turkey (Türkiye)

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Isparta, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Novartis Investigative Site

London, , United Kingdom

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Countries

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United States Argentina Belgium Brazil Canada France Germany Greece Italy Tunisia Turkey (Türkiye) United Kingdom

References

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Cappellini MD, Bejaoui M, Agaoglu L, Canatan D, Capra M, Cohen A, Drelichman G, Economou M, Fattoum S, Kattamis A, Kilinc Y, Perrotta S, Piga A, Porter JB, Griffel L, Dong V, Clark J, Aydinok Y. Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. Blood. 2011 Jul 28;118(4):884-93. doi: 10.1182/blood-2010-11-316646. Epub 2011 May 31.

Reference Type DERIVED
PMID: 21628399 (View on PubMed)

Other Identifiers

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CICL670A0107E1

Identifier Type: -

Identifier Source: org_study_id