Clinical Trial: Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients Wi

Brief Summary: This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment [ Time Frame: 24 Weeks ]

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.


Original Primary Outcome: To assess the safety of ICL670 compared to deferoxamine during 24 weeks in patients with sickle cell disease and iron overload from repeated blood transfusion.

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Long-term safety of ICL670

Information By: Novartis

Dates:
Date Received: May 10, 2005
Date Started: May 2005
Date Completion:
Last Updated: May 23, 2011
Last Verified: May 2011