Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload (CORDELIA)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600938
First received: January 14, 2008
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transfusional Iron Overload Transfusional Hemosiderosis |
Drug: Deferasirox Drug: Deferoxamine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Diamond-Blackfan anemia
X-linked sideroblastic anemia
X-linked sideroblastic anemia and ataxia
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Relative change from baseline in myocardial T2* after 12 months treatment with deferasirox versus deferoxamine. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cardiac function after 6 & 12 months of treatment with deferasirox vs. deferoxamine, by change in left ventricular ejection fraction, left ventricular systolic & diastolic volumes, and the proportion of patients dropping out due to cardiac dysfunction. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Absolute and relative change from baseline in liver iron content (LIC) by liver MRI, and serum ferritin after 6 and 12 months treatment with deferasirox vs. deferoxamine. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety and tolerability of deferasirox vs deferoxamine over the 12 months treatment period. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Single and repeated dose pharmacokinetics of deferasirox. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Additional safety and efficacy for deferasirox and deferoxamine for patients treated beyond 12 months in the extension phase. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 980 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Deferasirox | Drug: Deferasirox |
| Active Comparator: Deferasirox Placebo | Drug: Deferoxamine |
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600938
Locations
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| China, Guangxi | |
| Novartis Investigative Site | |
| Nanning, Guangxi, China, 530021 | |
| Cyprus | |
| Novartis Investigative Site | |
| Limassol, Cyprus, 3304 | |
| Egypt | |
| Novartis Investigative Site | |
| Cairo, Egypt | |
| Novartis Investigative Site | |
| Mansoura, Egypt | |
| Italy | |
| Novartis Investigative Site | |
| Cagliari, CA, Italy, 09121 | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16128 | |
| Lebanon | |
| Novartis Investigative Site | |
| Hazmiyeh, Lebanon | |
| Taiwan | |
| Novartis Investigative Site | |
| Taipei, Taiwan, 10002 | |
| Thailand | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10700 | |
| Novartis Investigative Site | |
| Bangkok, Thailand, 10330 | |
| Turkey | |
| Novartis Investigative Site | |
| Adana, Turkey, 01330 | |
| Novartis Investigative Site | |
| Ankara, Turkey, 06100 | |
| Novartis Investigative Site | |
| Antalya, Turkey, 07070 | |
| Novartis Investigative Site | |
| Istanbul, Turkey, 34093 | |
| Novartis Investigative Site | |
| Izmir, Turkey, 35040 | |
| United Arab Emirates | |
| Novartis Investigative Site | |
| Al Wasl, Dubai, United Arab Emirates, 9115 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Leeds, United Kingdom, LS9 7TF | |
| Novartis Investigative Site | |
| London, United Kingdom, N19 5NF | |
| Novartis Investigative Site | |
| London, United Kingdom, NW1 2PJ | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00600938 History of Changes |
| Other Study ID Numbers: | CICL670A2206, 2007-000766-20 |
| Study First Received: | January 14, 2008 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration Brazil: Ministry of Health Canada: Health Canada China: Food and Drug Administration Colombia: Ministry of Health Cyprus: Bioethics Committee Egypt: Ministry of Health and Population Greece: Ministry of Health and Welfare Italy: Ministry of Health Lebanon: Ministry of Public Health Thailand: Ministry of Public Health Turkey: Ministry of Health Taiwan: Department of Health United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
iron overload cardiac iron haemosiderosis myocardial T2* left ventricular ejection fraction LVEF cardiac dysfunction thalassaemia Diamond Blackfan anemia DBA |
sideroblastic anemia myelodysplastic syndromes MDS (low and INT-1 risk as per the IPSS for MDS) liver MRI deferasirox deferoxamine ICL670 DFO cardiovascular magnetic resonance imaging |
Additional relevant MeSH terms:
|
Hemosiderosis Iron Overload Iron Metabolism Disorders Metabolic Diseases Deferoxamine Deferasirox |
Siderophores Iron Chelating Agents Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013