Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005652
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2000-05-02
Brief Title:
Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
Sponsor:
University of Alabama at Birmingham
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
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:
OBJECTIVES I Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura
II Evaluate the toxicity associated with this treatment regimen in these patients
III Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients
II Evaluate the toxicity associated with this treatment regimen in these patients
III Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients
Detailed Description:
PROTOCOL OUTLINE Patients receive rituximab IV on days 1 8 15 and 22 Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab
Patients are followed at 5 6 8 and 12 weeks and then at 6 and 9 months
Patients are followed at 5 6 8 and 12 weeks and then at 6 and 9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UAB-F990224001 | None | None | None |
| UAB-9866 | None | None | None |
| UAB-BB-IND-8136 | None | None | None |