Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344149
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2006-06-22
Brief Title:
Rituximab as Second Line Treatment for ITP
Sponsor:
Ostfold Hospital Trust
Organization:
Ostfold Hospital Trust
Study Overview
Official Title:
Rituximab as Second Line Treatment for ITP A Multicenter Randomized Double Blind Placebo-controlled Phase III Study The RITP Study
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Immune thrombocytopenic purpura ITP is an autoimmune disorder characterized thrombocytopenia
Splenectomy is the standard treatment for patients who fails the first-line treatment corticosteroid Rituximab has recently emerged as a promising treatment for ITP The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions and consequently lead to the avoidance of splenectomy in a significant number of patients
Splenectomy is the standard treatment for patients who fails the first-line treatment corticosteroid Rituximab has recently emerged as a promising treatment for ITP The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions and consequently lead to the avoidance of splenectomy in a significant number of patients
Detailed Description:
ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading to premature platelet destruction and persistent thrombocytopenia often resulting in bleeding
The goal of treatment is to raise the platelet count to a hemostatically safe level
Treatment with corticosteroids rarely results in durable responses and most of the patients will ultimately require a second-line treatment Splenectomy results in a high rate of sustained remissions However the procedure is invasive and is associated with considerable short and long term morbidity and mortality Rituximab a chimeric anti-CD20 antibody with a B-cell depleting effect has recently emerged as a promising treatment for ITP
The study aims to determine whether early treatment with Rituximab can result in durable remissions and consequently avoidance of splenectomy in a clinical significant number of patients
The main objective of this study is to assess the rate of treatment failure splenectomy or meeting criteria for splenectomy after week 12 at 15-year in a prospective randomized placebo-controlled double-blind multi-centre
The goal of treatment is to raise the platelet count to a hemostatically safe level
Treatment with corticosteroids rarely results in durable responses and most of the patients will ultimately require a second-line treatment Splenectomy results in a high rate of sustained remissions However the procedure is invasive and is associated with considerable short and long term morbidity and mortality Rituximab a chimeric anti-CD20 antibody with a B-cell depleting effect has recently emerged as a promising treatment for ITP
The study aims to determine whether early treatment with Rituximab can result in durable remissions and consequently avoidance of splenectomy in a clinical significant number of patients
The main objective of this study is to assess the rate of treatment failure splenectomy or meeting criteria for splenectomy after week 12 at 15-year in a prospective randomized placebo-controlled double-blind multi-centre
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 |
|---|---|---|---|
| ITP001 | None | None | None |