Other Clinical Trial - Efficacy & Safety Study of Deferasirox in Patients

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00873041` - Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study	Phase 2

NCT number	NCT01709838
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 4
Start date	December 6, 2012
Completion date	January 17, 2019

Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia — THETIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms