A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]

Inclusion Criteria:

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.

Exclusion Criteria:

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