Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720234
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2023-01-11
Brief Title:
Avatrombopag Combined With IST as First-line Treatment for SAA
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
The Efficacy and Safety Study of Avatrombopag Combined With IST as First-line Treatment for Severe Aplastic Anemia A Single-arm Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2022-11
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:
This single-center study aims to evaluate the early efficacy and safety of avatrombopag combined with immunosuppressive therapy IST in the first-line treatment of severe aplastic anemia SAA
Detailed Description:
This is a single center single arm phase II clinical study Fifty-three patients will be enrolled
Treatment protocol is as follows 1 Anti-human thymocyte porcine immunoglobulin P-ATG 20mgkgd or rabbit anti human thymocyte globulin R-ATG 30mgkgd was administered intravenously for 5 days 2 Cyclosporine CSA is given at 3-5 mgkgd in divided doses for at least 6 months The trough concentration is maintained at 150-250 ngml 3 Avatrombopag is given orally at 60 mg once a day for patients with body weight 50 kg and 40 mg orally once a day for patients with body weight50 kg for a total of 12 weeks
Treatment protocol is as follows 1 Anti-human thymocyte porcine immunoglobulin P-ATG 20mgkgd or rabbit anti human thymocyte globulin R-ATG 30mgkgd was administered intravenously for 5 days 2 Cyclosporine CSA is given at 3-5 mgkgd in divided doses for at least 6 months The trough concentration is maintained at 150-250 ngml 3 Avatrombopag is given orally at 60 mg once a day for patients with body weight 50 kg and 40 mg orally once a day for patients with body weight50 kg for a total of 12 weeks
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?:
None