Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
First received: March 13, 2007
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Beta-thalassemia Iron Overload |
Drug: Deferasirox |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months |
Resource links provided by NLM:
Genetics Home Reference related topics:
beta thalassemia
Drug Information available for:
Deferasirox
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 30 |
| Study Start Date: | February 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: deferasirox every day for 77 weeks
particpants will be given oral deferasirox 30mg/kg/day for 77 weeks.
|
Drug: Deferasirox
Oral deferasirox 30mg/kg/day once per day for 77 weeks.
|
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447694
Locations
| United States, California | |
| Childrens Hospital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
Sponsors and Collaborators
Novartis
Investigators
| 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 |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00447694 History of Changes |
| Other Study ID Numbers: | CICL670AUS04 |
| Study First Received: | March 13, 2007 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Iron Chelation Deferasirox Chelator |
Desferal beta-thalassemia Iron overload |
Additional relevant MeSH terms:
|
Beta-Thalassemia Thalassemia Iron Overload Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies |
Genetic Diseases, Inborn Iron Metabolism Disorders Metabolic Diseases Deferasirox Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013