Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562738
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
Status:
RECRUITING
Status Verified Date:
2024-08
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 an investigator-initiated single-arm prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery
Detailed Description:
It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet 75109L After signing the informed consent letter the patients will enter the screening period up to 7 days and after passing the screening they will receive oral hexapopal treatment the specific medication regimen is 75mg once a day taken orally on an empty stomach before going to bed for a maximum of 14 days and stop the drug when PLT100109L During the oral administration of hexapopal the administration was suspended when PLT200109L and continued when the blood image was monitored weekly until PLT 100109L During the treatment period blood routine was monitored every 7 days and when PLT30109L or 300109L blood routine was monitored every 3 days Patients will have an end-of-treatment visit within 7 days of stopping treatment followed by a 30-day safe follow-up period
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