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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00879242

First received: April 8, 2009

Last updated: November 14, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 8, 2009

Last Updated Date

November 14, 2011

Start Date ^ICMJE

February 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Unsatisfactory response is a monthly MRI T2* improvement lower than 3% versus baseline.

Original Primary Outcome Measures ^ICMJE

Change from baseline in cardiac T2* value [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00879242 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in cardiac functions parameters (LVEF, LVESV and LVEDV) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline liver T2* value [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Beta Thalassemia Transfusion Dependent

Intervention ^ICMJE

Drug: Deferasirox

Dispersible tables of 125, 250 and 500 mg at the dose of 30 mg/kg/day, oral administration.

Study Arm (s)

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.

Intervention: Drug: Deferasirox

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

10 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00879242

Other Study ID Numbers ^ICMJE

CICL670AIT07, EUDRACT Code :2008-003230-22

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top