Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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:
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.
You may not be 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
