Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions
NCT ID: NCT00067080
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2003-05-31
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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ICL670 + deferoxamine
ICL670, deferoxamine
Interventions
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ICL670, deferoxamine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sickle cell disease patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day
* Serum ferritin greater than 1000 mg/ml
* Liver iron content greater than 2 mg iron/g dw assessed by means of superconducting quantum interference device (SQUID) for patients who receive simple transfusions and greater than 5 mg iron/ g dw for patients who receive exchange transfusions or who have a history of intermittent blood transfusion.
* Regular transfusion aimed at maintaining % Hb A above 50% or a previous history of simple transfusion being the recipient of at least 20 units of packed red blood cells.
Exclusion Criteria
* Documented toxicity to deferoxamine
* Elevated liver enzymes in the year preceeding enrollment
* Active hepatitis B or hepatitis C
* HIV seropositivity
* Elevated serum creatinine or significant proteinuria
* History of nephrotic syndrome
* Uncontrolled systemic hypertension
* Fever and other signs/symptoms of infection within 10 days prior to the start of the study
* Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation
* Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval (other than beta-adrenergic receptor blocking agents).
* Diseases (cardiovascular, renal, hepatic, etc.) that would prevent the patient from undergoing any of the treatment options
* Psychiatric or addictive disorders that would prevent the patient from giving informed consent
* History of drug or alcohol abuse within the 12 months prior to the study
* Pregnant or breast feeding patients
* Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of the study
* Patients who require concomitant therapy with hydroxyurea
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function
* Non-compliant or unreliable patients
* Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography
* Patients unable to undergo SQUID examination
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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U. of S. Alabama Medical Center
Mobile, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital & Research Center
Oakland, California, United States
Colorado Sickle Cell Treatment and Research Center
Denver, Colorado, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Tampa Children's Hospital at St Joseph's
Tampa, Florida, United States
Georgia Comprehensive Sickle cell Center, Grady Hospital
Atlanta, Georgia, United States
Adult Sickle Cell Clinic, Medical College of Georgia
Augusta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Tulane University Sickle Cell Center
New Orleans, Louisiana, United States
Children's Hospital, Department of Hematology/Oncology
New Orleans, Louisiana, United States
Children's Hospital Boston, Division of Hematology/Oncology
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
NY Methodist Hospital
Brooklyn, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
U. Of Rochester Medical Center
Rochester, New York, United States
Sickle Cell Center, Montefiore Hospital
The Bronx, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Barrett Center, University of Cincinnati
Cincinnati, Ohio, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
James Cancer Hospital
Columbus, Ohio, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
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
Baylor College of Medicine
Houston, 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
Countries
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References
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Vichinsky E, Onyekwere O, Porter J, Swerdlow P, Eckman J, Lane P, Files B, Hassell K, Kelly P, Wilson F, Bernaudin F, Forni GL, Okpala I, Ressayre-Djaffer C, Alberti D, Holland J, Marks P, Fung E, Fischer R, Mueller BU, Coates T; Deferasirox in Sickle Cell Investigators. A randomised comparison of deferasirox versus deferoxamine for the treatment of transfusional iron overload in sickle cell disease. Br J Haematol. 2007 Feb;136(3):501-8. doi: 10.1111/j.1365-2141.2006.06455.x.
Related Links
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Results for CICL670A0109 from the Novartis Clinical Trials website
Other Identifiers
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CICL670A0109
Identifier Type: -
Identifier Source: org_study_id
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