Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-02 @ 6:38 AM
Study NCT ID:
NCT03258866
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2017-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Different Dose Rituximab in the Treatment of ITP
Sponsor:
Shandong University
Organization:
Study Overview
Official Title:
The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia
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 project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).
Detailed Description:
62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: