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 ]
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 ]
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