Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 10:21 AM
Study NCT ID:
NCT04852692
Status:
TERMINATED
Last Update Posted:
2025-05-23
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
Sponsor:
Janssen Korea, Ltd., Korea
Organization:
Study Overview
Official Title:
A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.
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 evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health \[NIH\] response defined complete response \[CR\] and partial response \[PR\]) at Week 24.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 54179060GVH4001 | OTHER | Janssen Korea, Ltd., Korea | View |