Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390858
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2006-10-18
Brief Title:
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety Tolerability Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mgkgDay of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major
Status:
COMPLETED
Status Verified Date:
2017-02
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:
In this 4-year extension study the safety efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed Patients who successfully completed the main 1 year trial NCT00390858 were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years
Detailed Description:
None
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