Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478537
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-13
Brief Title:
TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Thrombopoietin Receptor Agonist TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia ITP can induce immune tolerance develop immune balance in ITP patients and enable patients to achieve a sustained response SRoT after TPO-RA discontinuation
Detailed Description:
In this study ITP patients who has reached complete response PLT 100 x 109Lafter thrombopoietin receptor agonist TPO-RA therapy do not rush to reduce the drug dose so that a higher level of platelet count can be maintained for a period of time
The treatment goal is to maintain the patients platelet count at 300-600 109L and adjust the dosage of hetrombopag 25mgd75mgd based on the patients platelet count After 24-week TPO-RA treatment all patients with a platelet count of 50 109L after two consecutive visits will enter an 8-week reduction period All patients who successfully discontinued the drug and maintained their platelet count at 30109L entered the efficacy and safety follow-up period
The aim is to investigate whether this strategy could lead to the development or achievement of immune tolerance achieving sustained response off treatment SROT PLT50109L no other ITP-specific medications no bleeding after TPO-RA discontinuation
The treatment goal is to maintain the patients platelet count at 300-600 109L and adjust the dosage of hetrombopag 25mgd75mgd based on the patients platelet count After 24-week TPO-RA treatment all patients with a platelet count of 50 109L after two consecutive visits will enter an 8-week reduction period All patients who successfully discontinued the drug and maintained their platelet count at 30109L entered the efficacy and safety follow-up period
The aim is to investigate whether this strategy could lead to the development or achievement of immune tolerance achieving sustained response off treatment SROT PLT50109L no other ITP-specific medications no bleeding after TPO-RA discontinuation
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