Clinical Trial: Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

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

Official Title: A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hem

Brief Summary: Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) [ Time Frame: 0 to 48 weeks ]

Mean absolute change in serum ferritin from baseline to the end of the extension study.


Original Primary Outcome: Incidence and severity of adverse events

Current Secondary Outcome: Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) [ Time Frame: 4, 8, 12, 16, 20, and 24 weeks ]

A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.


Original Secondary Outcome:

  • Efficacy based on serum ferritin
  • Pharmacokinetic parameters (PK) of deferasirox


Information By: Novartis

Dates:
Date Received: November 1, 2006
Date Started: August 2006
Date Completion:
Last Updated: May 24, 2011
Last Verified: May 2011