Clinical Trial: Treatment of Iron Overload Requiring Chelation Therapy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A 48-week, Open-label, 2-arm, Parallel-group, Randomized Exploratory Study to Assess Liver Iron Concentration Measured by FerriScan® (R2) Magnetic Resonance Imaging in B-thalassemia Subjects Admi

Brief Summary: The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron overload.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Change in Liver Iron Concentration (LIC) from Baseline Utilizing R2 Magnetic Resonance Imaging (MRI) [ Time Frame: 48 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response Rate Utilizing R2* MRI [ Time Frame: 48 weeks ]
  • Change in Cardiac Iron Concentration (CIC) from baseline Utilizing T2* MRI [ Time Frame: 48 weeks ]
  • Change in Serum Ferritin Levels from Baseline [ Time Frame: 48 weeks ]
  • Change in Pancreas Iron Concentration (PIC) from Baseline Utilizing R2* MRI [ Time Frame: 48 weeks ]
  • Left Ventricular Ejection Fraction (LVEF) Utilizing MRI [ Time Frame: 48 weeks ]
  • Gastrointestinal Symptom Rating Scale [ Time Frame: 48 weeks ]
  • Total Neuropathy Score nurse (TNSn) [ Time Frame: 48 weeks ]


Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: August 20, 2013
Date Started: July 2014
Date Completion:
Last Updated: May 6, 2015
Last Verified: May 2015