Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00171301
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2005-09-12
Brief Title:
Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis Study Amended to 2-year Duration
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
1-year Extension to CICL670A2402 an Open-label Multi-center Trial of the Efficacy and Safety of Long-term Treatment With Deferasirox 10 to 20 mgkgDay in Beta-thalassemia Patients With Transfusional Hemosiderosis Study Amended to 2- Year Duration
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCALATOR
Brief Summary:
To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success change in liver iron content LIC and change in serum ferritin levels Safety was mainly assessed by incidence of adverse events AEsand clinically significant lab parameters
Detailed Description:
Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron Deferasirox Exjade ICL670 is an oral chelator with high iron-binding potency and selectivity This extension study aimed at collecting efficacy and safety data during 2 years of treatment with deferasirox in the extension study or until deferasirox became commercially available in the countries where the centers were located whichever came first The population comprised of β-thalassemia patients with transfusional hemosiderosis who could not be satisfactorily treated with deferoxamine or deferiprone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None