Sickle Cell Disease/ Iron Overload
Conditions
Sponsors
Novartis Pharmaceuticals Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age greater than or equal to 2 years •Male or female patients with sickle cell disease (SS, SC, SD, Sßo or Sß+ thalassemia) •Iron overload from repeated blood transfusion Are the trial subjects under 18? yes Number of subjects for this age range: 203 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 77 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of ICL670 compared to deferoxamine during 24 weeks in patients with sickle cell disease and iron overload from repeated blood transfusions;Secondary Objective: Long term safety of ICL670 for up to 104 weeks in patients with sickle cell disease and iron overload from repeated blood transfusions;Primary end point(s): -The Number of Participants with Adverse Events (AEs) in the First 24 Weeks of Treatment -The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks;Timepoint(s) of evaluation of this end point: -24 weeks -24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Absolute Change in Serum Ferritin From Baseline to Week 24 [ Time Frame: Baseline, 24 Weeks ] -Absolute change from baseline serum ferritin after 24 weeks of treatment with Deferasirox (ICL670) and absolute change from baseline serum ferritin after 24 weeks of treatment with Deferoxamine. Means were adjusted for the amount of transfused blood -Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 24 and to Week 52 [ Time Frame: Start of Deferasirox (ICL670) treatment, 24 Weeks, 52 Weeks ] Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 24 and the absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 52 for the Deferasirox treatment group and the Deferoxamine then Deferasirox treatment group. Means were adjusted for the amount of transfused blood. -Absolute Change in Serum Ferritin After Start of Treatment With Deferasirox (ICL670) to Week 104 [ Time Frame: Start of Deferasirox (ICL670) treatment, 104 Weeks ] Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670) to week 104 for the Deferasirox treatment group. Means were adjusted for the amount of transfused blood. ;Timepoint(s) of evaluation of this end point: -24 weeks -24 weeks, 52 weeks -104 weeks | — |
Countries
Canada, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed