NCT02720536

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

Detailed description

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients who had completed study CICL670F2201 * Provide patients who completed 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.

Conditions

• Chronic Iron Overload

Interventions

Type	Name	Description
DRUG	Deferasirox	Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Timeline

• Start date: 2016-08-16
• Primary completion: 2019-07-23
• Completion: 2019-07-23
• First posted: 2016-03-28
• Last updated: 2020-03-03
• Results posted: 2020-03-03

Locations

14 sites across 3 countries: Austria, Greece, Italy