Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067080
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2003-08-11
Brief Title:
Safety of ICL670 vs Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Open Label Phase II Study on Safety and Efficacy of Long Term Treatment of ICL670 Relative to Deferoxamine in Sickle Cell Disease Patients With Transfusional Hemosiderosis
Status:
COMPLETED
Status Verified Date:
2017-08
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:
None
Brief Summary:
The purpose of this study is to determine if the new orally active iron chelator ICL670 is 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 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