Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372892
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
2006-09-06
Brief Title:
Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura ITP
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Pilot Trial of Rituximab for Non-splenectomized Adults With Acute Immune Thrombocytopenic Purpura Receiving Standard Treatment R-ITP
Status:
COMPLETED
Status Verified Date:
2012-06
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 assess the feasibility of a randomized double blind placebo controlled trial of add-on rituximab for non-splenectomized adults with acute immune thrombocytopenic purpura ITP
Detailed Description:
Immune thrombocytopenic purpura ITP is an autoimmune disease characterized by severe thrombocytopenia and bleeding With current standard therapies adult-onset ITP tends to recur thus exposing patients to prolonged risks of hemorrhage and toxicities of standard treatments Rituximab a chimeric anti-CD20 monoclonal antibody has been shown to be effectively raise the platelet count in some patients with ITP and there is clinical and biological evidence to suggest that if given early rituximab may prevent ITP relapses
We have designed a randomized double blind placebo controlled pilot trial of rituximab for the treatment of non-splenectomized adults with acute ITP who are receiving standard treatments The primary objectives of this trial are to determine the feasibility of recruitment randomization and blinding the safety of rituximab in ITP and the event rate in the control group which will be used to calculate the sample size for a larger trial Secondary objectives are to determine rates of 6-month event free survival where an event is defined as any of a platelet count 50 the need for rescue treatment or significant bleeding Data from this pilot trial will inform the design of a larger phase III trial
We have designed a randomized double blind placebo controlled pilot trial of rituximab for the treatment of non-splenectomized adults with acute ITP who are receiving standard treatments The primary objectives of this trial are to determine the feasibility of recruitment randomization and blinding the safety of rituximab in ITP and the event rate in the control group which will be used to calculate the sample size for a larger trial Secondary objectives are to determine rates of 6-month event free survival where an event is defined as any of a platelet count 50 the need for rescue treatment or significant bleeding Data from this pilot trial will inform the design of a larger phase III trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HC-104634 | None | None | None |