Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Condition: Chronic Iron Overload
MeSH terms: Iron Overload
Intervention: Deferasirox
Intervention description: Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.
Intervention MeSH terms: Deferasirox
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: adult; pediatric,; anemia.; Myelodysplastic Syndrome; Thalassemia; Film coated tablet; ICL670; MDS; Chelation; Deferasirox; Iron overload

Summary:

      Extend evaluation of deferasirox film-coated tablet (FCT) formulation
    

Eligibility criteria:

        Key Inclusion Criteria for subjects:

          -  Completed 24-weeks of study treatment as described in the core protocol
             (CICL670F2201).

          -  Were deemed to have tolerated deferasirox treatment by the investigator.

          -  Provided written informed consent/assent before any study-specific procedures were
             performed. For pediatric patients, consent was obtained from parent(s) or legal
             patient's representative. Investigators were to have also obtained assent of patients
             according to local, regional or national guidelines.

        Key Exclusion for subjects:

        The exclusion criteria followed those described for the core protocol CICl670F2201, which
        were as follows:

          -  Creatinine clearance below the contraindication limit in the locally approved
             prescribing information.

          -  Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening

          -  Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,

          -  Significant proteinuria

          -  Patients with significant impaired gastrointestinal function or gastrointestinal
             disease

          -  Clinical or laboratory evidence of active Hepatitis B or Hepatitis C

          -  Patients with psychiatric or addictive disorders

          -  Patients with a known history of HIV seropositivity (Elisa or Western blot).

          -  History of malignancy of any organ system, treated or untreated, within the past 5
             years whether or not there was an evidence of local recurrence or metastases, with the
             exception of localized basal cell carcinoma of the skin.

          -  Patients with a history of hypersensitivity to any of the study drug or excipients.

          -  Patients with significant medical condition that could interfere with the ability to
             participate in this study

          -  Patients who were participating in another clinical trial or receiving an
             investigational drug.

          -  Patients using prohibited medication,

          -  Patients with liver disease with severity of Child-Pugh Class B or C.

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they were using effective methods of contraception during
             dosing of study treatment