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Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

NCT ID: NCT00845871

Last Updated: 2021-07-20

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

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-08-31

Brief Summary

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This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed. The study will began with a one month run-in phase, where all patients were instructed to take Deferasirox according to their physician's prescribing information.

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Detailed Description

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Following the run-in phase, patients entered a three month, assessment phase. During the assessment phase, patients were given five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.

Conditions

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Transfusional Hemosiderosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deferasirox

Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.

Group Type EXPERIMENTAL

deferasirox:

Intervention Type DRUG

Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.

Interventions

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deferasirox:

Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.

Intervention Type DRUG

Other Intervention Names

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Exjade Deferasirox

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with thalassemia major, sickle cell disease (SCD), low or intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and transfusional hemosiderosis.
* Patients who were on, starting, or resuming treatment with Exjade.
* Patients who were \>2 years (i.e., 2 years of age or older).

Exclusion Criteria

* Serum creatinine above the upper limit of normal (ULN) for age.
* Alanine aminotransferase (ALT) \>2.5 times the ULN.-High risk intermediate-2 or high risk MDS or acute leukemia.
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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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Children's Hospital and Research Center

Oakland, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Bay Area Cancer Research Group

Pleasant Hill, California, United States

Site Status

University of Colorado Denver, Colorado Sickle Cell Treatment and Research Center

Aurora, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

Children's Memorial

Chicago, Illinois, United States

Site Status

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Site Status

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Children's Hospital of Boston

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

St Joseph Children's Hospital

Paterson, New Jersey, United States

Site Status

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Site Status

St Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Texas Children's Cancer Center and Hematology Services

Houston, Texas, United States

Site Status

Countries

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United States

References

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Goldberg SL, Giardina PJ, Chirnomas D, Esposito J, Paley C, Vichinsky E. The palatability and tolerability of deferasirox taken with different beverages or foods. Pediatr Blood Cancer. 2013 Sep;60(9):1507-12. doi: 10.1002/pbc.24561. Epub 2013 Apr 23.

Reference Type DERIVED
PMID: 23637051 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=717

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

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2011-004217-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CICL670AUS32

Identifier Type: -

Identifier Source: org_study_id

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