Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients
NCT ID: NCT00110617
Last Updated: 2011-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2005-05-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Deferasirox (ICL670)
Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
Deferasirox (ICL670)
Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
Deferoxamine (DFO) then ICL670
Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
Deferasirox (ICL670)
Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
Deferoxamine (DFO)
Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.
Interventions
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Deferasirox (ICL670)
Deferasirox was provided in 125 mg, 250 mg, and 500 mg dispersible tablets and was administered orally at an initial dose of 20 mg/kg/day.
Deferoxamine (DFO)
Deferoxamine was supplied in vials of 500 mg and 2000 mg administered subcutaneously for a weekly dose of 175 mg/kg.
Eligibility Criteria
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Inclusion Criteria
* Male or female patients with sickle cell disease (SS, SC, SD, Sβo or Sβ+ thalassemia)
* Iron overload from repeated blood transfusion, as defined by one of the following:
1. For patients \> 16 years old receiving simple transfusions: lifetime history of receipt of at least 120 ml/kg or 30 adult units of packed red blood cells, OR
2. For patients ≤ 16 years old receiving simple transfusions: lifetime history of receipt of at least 120 ml/kg of packed red blood cells, OR
3. For all patients receiving exchange transfusions in the absence of a previous attempt to achieve negative iron balance: lifetime performance of at least 20 procedures, OR
4. For all patients: liver iron content ≥ 7 mg Fe/g dry weight as measured by biopsy, Magnetic Resonance Imaging (MRI), or magnetic susceptibility performed within 3 months prior to entry into screening
* For entry into the screening period: serum ferritin of ≥ 1000 µg/mL on at least two occasions during the prior year obtained in the absence of concomitant infection.
* Body weight \> 10 kg
* No known allergy or contraindication to the administration of deferoxamine
* Ability to comply with all study-related procedures, medications, and evaluations
* Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
* Written informed consent by the patient or for pediatric patient's consent of the patient's legal guardian. The definition of the term 'pediatric' for enrollment and study conduct will be in accordance with the local legislation.
Exclusion Criteria
* Significant proteinuria
* History of nephrotic syndrome
* Alanine aminotransferase (ALT) ≥ 250 U/L at screening
* Clinical evidence of active hepatitis B or hepatitis C
* History of HIV
* Fever or other signs/symptoms of infection within 10 days prior to the screening visit
* Uncontrolled systemic hypertension
* History of Myocardial Infarction, Congestive Heart Failure or unstable cardiac disease not controlled by standard medical therapy
* Clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation
* Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug
* History of drug or alcohol abuse within the 12 months prior to enrollment
* Pregnant or breast feeding patients
* Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug 7 days prior to the screening visit
* Randomization in a previous clinical trial involving ICL670
2 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
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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University of Alabama Pediatric Hematology/Oncology
Birmingham, Alabama, United States
University of Alabama Medical center
Birmingham, Alabama, United States
University of South Alabama Medical Center
Mobile, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Oakland
Oakland, California, United States
Center for Cancer and Blood Disorders
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Miami Children's Hospital
Miami, Florida, United States
Tampa Children's Hospital at St Joseph's
Tampa, Florida, United States
Tampa Children's Hospital at St. Joseph's
Tampa, Florida, United States
H. Lee Muffit Cancer Center and Research Institute/James A. Haley Veterans Hospital
Tampa, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Adult Sickle Cell Clinic
Augusta, Georgia, United States
Backus Children's Hospital
Savannah, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Pediatric Sickle Cell Program/James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States
St. Jude Children's Hospital Affiliate
Baton Rouge, Louisiana, United States
Tulane University Sickle Cell Center
New Orleans, Louisiana, United States
Children's Hospital
New Orleans, Louisiana, United States
LSU Health Sciences Center/Carroll W. Feist Professor of Cancer Research
Shreveport, Louisiana, United States
Brigham and Woman's Hospital/Harvard Medical School
Boston, Massachusetts, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Columbia University
New York, New York, United States
Sickle Cell Center, Montefiore Hospital
The Bronx, New York, United States
Carolinas Medical Transplant Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
The University of Oklahoma
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology/Hematology
Philadelphia, Pennsylvania, United States
Jefferson University
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Liberty Hematology Oncology Center
Columbia, South Carolina, United States
Palmetto Health Clinical Trials
Columbia, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
St Jude's Children's Research Hospital
Memphis, Tennessee, United States
St. Jude's Children Research Hospital
Memphis, Tennessee, United States
Cooks Children's Hospital
Fort Worth, Texas, United States
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States
Scott and White Memorial Hospital & Clinics
Temple, Texas, United States
Children's Hospital of the King's Daughter
Norfolk, Virginia, United States
Medical College of Virginia
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hopital Ste-Justine
Montreal, Quebec, Canada
Countries
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Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CICL670A2201
Identifier Type: -
Identifier Source: org_study_id
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