Clinical Trial: Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

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

Official Title: A Single-arm, Open-label Study of the Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

Brief Summary: This single-arm, open-label, multi-center study will enroll 60 patients from approximately 20 centers. All patients who meet study criteria and are currently taking, beginning or resuming treatment with Deferasirox will be allowed. The study will begin with a one month run-in phase, where all patients will be instructed to take Deferasirox according to their physician's current prescribing information.

Detailed Summary: Following the run-in phase, patients will enter a three month, assessment phase. During the assessment phase, patients will have five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Palatability of Deferasirox as assessed by the Five-Point Facial Hedonic Scale [ Time Frame: at every week over 4 months (6 visits) ]

Original Primary Outcome: During the assessment phase, patients will have five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice. [ Time Frame: at every visit over 4 months (6 visits) ]

Current Secondary Outcome:

  • The safety and tolerability based on adverse events and laboratory variables. [ Time Frame: At every week over 4 months (6 visits) ]
  • Measure the pharmacokinetics of Deferasirox when administered with food or with different methods of administration [ Time Frame: at every week over 4 months (6 visits) ]
  • Change from baseline in serum ferritin. [ Time Frame: week 4, week 8, week 12, week 16 ]


Original Secondary Outcome:

  • The safety and tolerability based on adverse events and laboratory variables. [ Time Frame: At every visit over 4 months (6 visits) ]
  • Measure the pharmacokinetics of Deferasirox when administered with food or with different methods of administration [ Time Frame: Over 4 months ]
  • Measure changes in serum ferritin during the study [ Time Frame: over 4 months ]


Information By: Novartis

Dates:
Date Received: February 16, 2009
Date Started: March 2009
Date Completion:
Last Updated: May 7, 2014
Last Verified: May 2014