Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823376
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-03-24
Brief Title:
Avatrombopag for Platelet Recovery Post-UCBT in Patients With Bone Marrow Failure Disease
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
Efficacy and Safety of Avatrombopag for Platelet Recovery After Unrelated Cord Blood Transplantation in Patients With Bone Marrow Failure Disease a Single-center Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2023-10
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:
AVA
Brief Summary:
To evaluate the efficacy and safety of Avatrombopag for platelet recovery after unrelated cord blood transplantation UCBT in patients with bone marrow failure disease
Detailed Description:
Persistent thrombocytopenia is a common complication after umbilical cord blood transplantation UCBT which necessitates platelet transfusion and leads to increased transplant-related mortality This is a single-center single-arm phase II clinical trial aimed at evaluating the efficacy and safety of Avatrombopag for platelet recovery after UCBT in patients with bone marrow failure disease BMFD The study was conducted in patients diagnosed with BFMD and receiving UCBT After the subjects signed and informed and qualified they received Avatrombopag treatment from the first day to the 28th day after transplantation In this study the cumulative of platelet implantation rate at 28 days after transplantation was used as the main therapeutic index and 40 patients were planned to be enrolled
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?:
False
Is an FDA AA801 Violation?:
None