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Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transfusional Iron Overload; Transfusional Hemosiderosis

Intervention: Core Study: Deferasirox (Drug); Core Study: Deferoxamine (Drug); Extension: deferoxamine to deferasirox (Drug); Extension: deferasirox to deferoxamine (Drug); Deferasirox (Drug); Deferoxamine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart. Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.

Clinical Details

Official title: A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment

Secondary outcome:

Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)

Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF)

Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment

Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI)

Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)

Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI)

Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine

Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period.

Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau)

Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Cmax)

Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Time Points of Concentration Data

Extension Study: Change From Baseline in Myocardial T2* After 24 Months Treatment

Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Ejection Fraction (LVEF)

Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Systolic Volume Indices (LVESVI)

Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI)

Extension Study: Cardiac Function From Baseline to Month 24 by Change in Left Ventricular Mass Indices (LVMI)

Extension Study: The Cardiac Iron Concentration From T2* Values

Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24

Extension Study: Change in Serum Ferritin From Baseline by Month

Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Maximum Plasma Concentration (Tmax)

Eligibility

Minimum age: 10 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Male or female patients, aged 10 years and above, with β-thalassemia major or DBA or

sideroblastic anemia on chronic transfusion therapy, having given written consent to participate in the study.

- Patients with cardiac iron as measured by a myocardial T2* value that is ≥ 6ms but

not ≥ 20 ms.

- Patients with a lifetime history of at least 50 units of red cell transfusions, and

must be receiving at least ≥10 units/yr of red blood cells transfusions.

- Patients with a left ventricular ejection fraction (LVEF) ≥ 56 % as determined by

cardiovascular magnetic resonance (CMR).

- Patients with liver iron content (LIC) value ≥ 3 mg Fe / g dw, as determined by liver

MRI. Exclusion criteria:

- Patients with clinical symptoms of cardiac dysfunction.

- Patients unable to undergo study assessments including MRI

- Patients participating in another clinical trial or receiving an investigational

drug. Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Limassol 3304, Cyprus

Novartis Investigative Site, Cairo, Egypt

Novartis Investigative Site, Mansoura, Egypt

Novartis Investigative Site, Hazmiyeh, Lebanon

Novartis Investigative Site, Taipei 10002, Taiwan

Novartis Investigative Site, Bangkok 10330, Thailand

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Adana 01330, Turkey

Novartis Investigative Site, Ankara 06100, Turkey

Novartis Investigative Site, Antalya 07070, Turkey

Novartis Investigative Site, Istanbul 34093, Turkey

Novartis Investigative Site, Izmir 35040, Turkey

Novartis Investigative Site, Dubai 9115, United Arab Emirates

Novartis Investigative Site, Leeds LS9 7TF, United Kingdom

Novartis Investigative Site, London N19 5NF, United Kingdom

Novartis Investigative Site, London NW1 2PJ, United Kingdom

Novartis Investigative Site, Cagliari, CA 09121, Italy

Novartis Investigative Site, Genova, GE 16128, Italy

Novartis Investigative Site, Nanning, Guangxi 530021, China

Novartis Investigative Site, Toronto, Ontario M5G 1X8, Canada

Novartis Investigative Site, Leeds, West Yorkshire LS9 7TF, United Kingdom

Additional Information

Starting date: November 2007
Last updated: August 13, 2014

Page last updated: August 20, 2015

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