Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061750
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2003-06-03
Brief Title:
Safety Efficacy of ICL670 vs Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Comparative Open Label Phase III Trial on Efficacy Safety of Long-term Treatment With ICL670 Compared to Deferoxamine in Beta-thalassemia Patients With Transfusional Hemosiderosis
Status:
COMPLETED
Status Verified Date:
2012-04
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:
None
Brief Summary:
The purpose of this study is to deterimine if the new orally active iron chelator ICL670 is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions
Detailed Description:
Patients who require repeated blood transfusions to live accumulate iron in the body as blood cells contain iron and there is no natural body mechanism to eliminate it After a while the iron levels get high enough to be toxic to the body The current therapy of choice is deferoxamine which does a good job of removing excess iron but is difficult to administer Deferoxamine requires subcutaneous under the skin infusions over 4 to 8 hours nightly 3 to 7 nights per week In addition to the need to wear an infusion pump nightly adverse reactions around the site of the injection are frequent
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