Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients

Completed · Phase 2

Conditions studied: Sickle Cell Disease, Iron Overload, Hemolytic Anemia

In brief

This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

Key facts

Study ID

NCT00110617

Run by

Novartis Pharmaceuticals

People needed

212

Starts

2005-05-01

Expected to finish

2008-04-01

Last updated by the study team

2011-05-26

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
• 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:
• 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
• For patients ≤ 16 years old receiving simple transfusions: lifetime history of receipt of at least 120 ml/kg of packed red blood cells, OR
• 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
• 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.

You may not qualify if…

• Serum creatinine above the upper limit of normal
• 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
• Other protocol-related inclusion / exclusion criteria may apply.

Where it is running

• 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
• University of Alabama Pediatric Hematology/Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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