Tranfusional hemosiderosis
Conditions
Interventions
Trade Name: Exjade
Product Name: Exjade
Product Code: ICL670
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: DEFERASIROX
CAS Number: 201530-41-8
Current Sponsor code: CICL670A2402E1
Conce
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients completing the planned 12-month core study (NCT00171171) Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation Are the trial subjects under 18? yes Number of subjects for this age range: 162 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 69 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or breast feeding patients. Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available.;Secondary Objective: To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters. ;Primary end point(s): 1.Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age 2. Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category ;Timepoint(s) of evaluation of this end point: 1. From Core Study Baseline, to Extension End of Study, Up to 3 Years 2. From Baseline of Core Study to End of Extension Study, up to 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Absolute Change in Serum Ferritin Level Measured From Core Study Baseline (BL) to End of Extension Study 2. Absolute Change in Serum Ferritin Level for All Participants Measured From Core Study Baseline (BL) to End of Extension Study, by Baseline Liver Iron Content (LIC) ;Timepoint(s) of evaluation of this end point: 1. From Baseline of Core Study to End of Extension Study, up to 3 years 2. From Baseline of Core Study to End of Extension Study, up to 3 years | — |
Countries
Egypt, Lebanon, Oman, Saudi Arabia, Syria
Contacts
Public ContactClinical trial Information Desk
Novartis pharma AG
Outcome results
None listed