Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896528
Status:
UNKNOWN
Last Update Posted:
2021-05-21
First Post:
2021-04-28
Brief Title:
Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia Induced by Targeted Therapy and Immunotherapy Combination Treatment
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC 50109L
Detailed Description:
This phase II trial is a single-arm non-randomized and single-center clinical study
It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag The investigators will follow up and collect subjects data each month to evaluate the efficacy and safety of treatment Primary outcome measure is percentage of participants whose PLT reaches 75109L or increases by 50109L or 100 from baseline at least once within 20 days of initial treatment
Secondary outcome measure1Number of days required for PLT to reach 50109L after treatment 2Number of days required for PLT to reach 75109L after treatment 3Percentage of subjects without platelet transfusion within 20 days of treatment 4Percentage of subjects without clinically relevant bleeding within 20 days of treatment
Study Type Interventional Masking Open Label
It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag The investigators will follow up and collect subjects data each month to evaluate the efficacy and safety of treatment Primary outcome measure is percentage of participants whose PLT reaches 75109L or increases by 50109L or 100 from baseline at least once within 20 days of initial treatment
Secondary outcome measure1Number of days required for PLT to reach 50109L after treatment 2Number of days required for PLT to reach 75109L after treatment 3Percentage of subjects without platelet transfusion within 20 days of treatment 4Percentage of subjects without clinically relevant bleeding within 20 days of treatment
Study Type Interventional Masking Open Label
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