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Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
First received: March 13, 2007
Last updated: April 25, 2012
Last verified: April 2012

March 13, 2007
April 25, 2012
February 2006
November 2009   (final data collection date for primary outcome measure)
Cardiac Iron in B thalassemia patients [ Time Frame: From baseline to week 25 and weeks 49 and 77 of the trial ] [ Designated as safety issue: Yes ]
Cardiac Iron in B thalassemia patients
Complete list of historical versions of study NCT00447694 on ClinicalTrials.gov Archive Site
  • Safety and tolerabilty of deferasirox [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
  • Changes in liver iron concentration (LIC) [ Time Frame: From baseline to week 25 and weeks 49 and 77 of trial ] [ Designated as safety issue: Yes ]
  • Changes in ventricular ejection fraction [ Time Frame: From baseline to weeks 25, 49 and 77 ] [ Designated as safety issue: Yes ]
  • Ferritin, NTBI (LPI and DCI)& iron metabolism parameters [ Time Frame: From Baseline through week 25, and weeks 49 and 77 of trial ] [ Designated as safety issue: Yes ]
  • Compliance with deferasirox [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Safety and tolerabilty of deferasirox
  • Changes in liver iron concentration (LIC)
  • Changes in ventricular ejection fraction
  • Ferritin, NTBI (LPI and DCI)& iron metabolism parameters
  • Compliance with deferasirox
Not Provided
Not Provided
 
Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment
An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Beta-thalassemia
  • Iron Overload
Drug: Deferasirox
Oral deferasirox 30mg/kg/day once per day for 77 weeks.
Experimental: deferasirox every day for 77 weeks
particpants will be given oral deferasirox 30mg/kg/day for 77 weeks.
Intervention: Drug: Deferasirox

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • - Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as > 8 transfusions per year)
  • Lifetime minimum of 100 previous packed red blood cell transfusions
  • Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug
  • Age ≥ 10 years
  • Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.

Exclusion Criteria:

  • Ejection Fraction < 56 % measured using steady-state free precession imaging by MRI
  • Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia
  • Abnormal laboratory values as defined by the protocol
  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
  • History of HIV positive test result (ELISA or Western blot)
  • Uncontrolled systemic hypertension
  • Second or third degree A-V block
  • Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year
  • History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy
  • History of clinically relevant ocular toxicity related to iron chelation
  • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
  • Pregnancy or breast feeding (documented negative pregnancy test required for study entry)
  • Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study
  • Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
  • Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
  • History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
  • Other inclusion/exclusion criteria may apply
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00447694
CICL670AUS04
Not Provided
Novartis
Novartis
Not Provided
Principal Investigator: Thomas Coates, MD Childresn's Hospital of Los Angeles
Principal Investigator: Alexis Thompson, MD Children's Memorial Hospital of Chicago
Principal Investigator: Paul Harmatz, MD Children's Hospital and Research Center at Oakland
Novartis
April 2012

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