Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).

Completed · Phase 2

Conditions studied: Sickle Cell Disease

In brief

The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.

Key facts

Study ID

NCT01090323

Run by

Novartis Pharmaceuticals

People needed

185

Starts

2004-07-01

Last updated by the study team

2011-06-06

Who can join

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

You may qualify if…

• Patients were included who met the following criteria:
• Completion of the core [Study 0109]
• Serum ferritin greater than or equal to 500 µg/L
• Ability to comply with all study-related procedures, medications, and evaluations
• Sexually active post-menarche 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 and assent by the patient and or their parents or legal guardian.
• Additional inclusion criteria for pediatric patients The definition of the term 'pediatric' for enrollment and study conduct was in accordance with local law. Parents or the legal guardians were fully informed by the investigator as to the requirements of the study. The pediatric patients themselves were informed according to their capabilities in a language and terms that they were able to understand. Written informed consent was obtained from their legal guardian on the patient's behalf in accordance with national legislation. If capable, all patients had to also personally sign their written informed consent.

You may not qualify if…

• Patients who met the following criteria were to be excluded:
• History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
• Serum creatinine above the age-appropriate upper limit of normal within one week prior to entry
• Patients with ALT ≥ 500 U/L within one week prior to entry
• Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
• Pregnancy (as indicated by serum β-HCG pregnancy test for all female patients with the potential to become pregnant) and patients who are breastfeeding
• Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of South Alabama College of Medicine — 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 at Oakland — Oakland, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• St Joseph Children's Hospital of Tampa — Tampa, Florida, United States
• Grady Hospital, Georgia Comprehensive Sickle Cell Center — Atlanta, Georgia, United States
• 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 Medical Center — New Orleans, Louisiana, United States
• LSUHSC Dept of Pediatrics — Shreveport, Louisiana, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• New York Presbyterian Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Yasin — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Palmetto Health Richland — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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