Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Novartis

Status and phase: Completed; Phase 2

Conditions: Transfusional Iron Overload

Treatments: Drug: Deferasirox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379483

CICL670A0105E1

Details and patient eligibility

About

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion criteria

• Pregnant or breast feeding patients
• Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Deferasirox