Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec

December 8, 2016 updated by: Novartis Pharmaceuticals

Multicenter, Open Label, Prospective Study to Evaluate the Efficacy and Safety of Deferasirox 30 mg/kg/Day for 52 Weeks, in Transfusion-dependent Beta-thalassemic Patients With Cardiac MRI T2* < 20 Msec

This study will assess the safety and efficacy of deferasirox in patients with cardiac MRI T2* < 20 msec.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy
        • Novartis Investigative Site
      • Orbassano, Italy
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • β-thalassemic patients receiving regular transfusions with an history of at least 20 transfusional events
  • Patients naïve for deferasirox
  • Serum ferritin levels ≥1000ng/ml (average of the last 6 months assays);
  • Cardiac MRI T2* >5 and <20 msec.
  • LVEF at MRI ≥56%

Exclusion Criteria:

  • Patients that have already started deferasirox therapy
  • Existing contraindications to the performance of MRI procedure, including presence of metallic prostheses not compatible with the MRI procedure other than those approved as safe for use in MRI scanners (e.g., some types of aneurysm clips, shrapnel in proximity to vital organs such as the retina), pacemaker, intractable claustrophobia and incapability to follow the instruction for the correct performance of the MRI (e.g. to maintain a supine position, to hold breath, etc.)
  • Clinical conditions requiring intensive chelating therapy on the basis of Investigator's judgment
  • Stable average ALT levels >300 U/L in the preceding 12 months
  • Uncontrolled systemic hypertension
  • Estimated creatinine clearance <60 ml/min
  • History of nephrotic syndrome
  • History of clinically significant ocular toxicity related to the chelating therapy
  • Psychiatric disorders or drug dependence that might impair the capability of the patient to provide their Informed Consent or to be administered the study treatment
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deferasirox
30 mg/kg/day. The daily dose can be increased to 40 mg/kg in case of unsatisfactory response after 12 weeks of treatment.
Drug: Deferasirox
Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in cardiac T2* value
Time Frame: 52 weeks
Unsatisfactory response is a monthly MRI T2* improvement lower than 3% versus baseline.
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in cardiac functions parameters (LVEF, LVESV and LVEDV)
Time Frame: 52 weeks
52 weeks
Change from baseline liver T2* value
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670AIT07
  • EUDRACT Code :2008-003230-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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