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

NCT00379483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Transfusional Iron Overload

Interventions

DRUG

Deferasirox

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2003-04-30
Completion
2003-04-30

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379483 on ClinicalTrials.gov