Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616415
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Clinical Study to Evaluate the Pharmacokinetics Efficacy and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open-label Single-arm Phase 4 Clinical Study to Evaluate the Pharmacokinetics Efficacy and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents Aged From 12 to Less Than 18 Years With Chronic Graft-versus-host Disease cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single group Phase 4 single-arm post-marketing study for treatment
The purpose of this study is to verify the pharmacokinetics efficacy and safety of belumosudil mesylate tablets in Chinese adolescent participants aged from 12 to less than 18 with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies
Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study
The purpose of this study is to verify the pharmacokinetics efficacy and safety of belumosudil mesylate tablets in Chinese adolescent participants aged from 12 to less than 18 with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies
Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study
Detailed Description:
None
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