Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions

Completed · Phase 2

Conditions studied: Anemia, Sickle Cell

In brief

The purpose of this study is to determine if the new orally active iron chelator, ICL670, is as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.

Key facts

Study ID

NCT00067080

Run by

Novartis Pharmaceuticals

People needed

195

Starts

2003-05-01

Last updated by the study team

2017-08-22

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than or equal to 2 years
• 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.

You may not qualify if…

• Chronic anemias other than sickle cell disease
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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