Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475423
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2007-05-17
Brief Title:
A Study of MabThera Rituximab in Patients With Idiopathic Thrombocytopenic Purpura
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory Relapsing or Chronic Idiopathic Thrombocytopenic Purpura
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory relapsing or chronic idiopathic thrombocytopenic purpura ITP Patients will receive infusions of MabThera 1000mg iv on days 1 and 15 The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
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