Clinical Trial: Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201

Brief Summary: Extended evaluation of deferasirox film-coated tablet (FCT) formulation

Detailed Summary:

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients completing study CICL670F2201

  • Provide patients enrolled and completing 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
  • Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
  • Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 24 months or 30 days from last dose. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Absolute and relative change of serum ferritin level overtime [ Time Frame: Baseline, up to 24 months or 7 days of last dose ]

Decrease or maintenance according to the individual therapeutic goal.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: March 21, 2016
Date Started: August 16, 2016
Date Completion: May 31, 2019
Last Updated: May 17, 2017
Last Verified: May 2017