Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT04132050
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2019-10-15
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Sponsor:
Kissei Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Status:
COMPLETED
Status Verified Date:
2023-12
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 investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: