Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Brief Title:
A Prospective Study on the Treatment of RecurrentRefractoryIntolerable NSAA With Lusutrombopag
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of RecurrentRefractoryIntolerable NSAA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
In a prospective single-arm study the efficacy and safety of Lusutrombopag in the treatment of relapsedrefractoryintolerable non-severe aplastic anemia NSAA were explored
Detailed Description:
The enrolled patients were given Lusutrombopag at 3mgqd orally for 12 weeks the starting dose of lusutrombopag was 3mg taken once daily After 2 weeks of continuous administration the dose was increased by 3mg every 2 weeks based on the platelet count and safety of the subjects The dose was gradually increased to 9mgd over a total of 12 weeks The treatment duration was at least 3 months When the platelet increase was 20109L the daily dose was increased by 3mg up to a maximum of 9mgday When the platelet increase was 50109L and 200109L the dose was maintained at the previous level When the platelet count was 200109L and 400109L the daily dose was reduced by 3mg When the platelet count was 400109L the drug could be suspended and the dose was reduced by 3mg when the platelet count decreased to 200109L In this case if the lowest dose of 3mgday was used the drug could be suspended Responders continued treatment for 6 months Other TPO-RA therapies were not allowed during the study period
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