Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518878
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-16
Brief Title:
Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia FLOWER
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Combination of Fixed Low-dose Eltrombopag and rhTPO for Treatment of Immune Thrombocytopenia
Status:
UNKNOWN
Status Verified Date:
2020-08
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:
This is a prospective single-arm study to investigate the efficacy and safety of the combination of fixed low-dose eltrombopag plus recombinant human thrombopoietin rhTPO as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia ITP patients during the COVID-19 pandemic
Detailed Description:
Eltrombopag a small molecule agonist of thrombopoietin receptor TPO-RA was recommended as the subsequent treatment for ITP patients which also already showed robust efficacyRecombinant human thrombopoietin rhTPO is a full-length glycosylated-TPO produced by Chinese hamster ovary cells which showed its effectiveness in ITP in a variety of studies
Both eltrombopag and rhTPO demonstrated good safety in ITP patients Because of their non-immunosuppressive nature both of them serve as a reasonable choice during the global COVID-19 pandemic
Since they increase the number of platelets through different mechanisms and previous studies demonstrated that they might exert synergic effect The investigators hypothesized that the combination of these two agents could be a promising option for treatment of corticosteroid-resistant or relapsed ITP patients
Both eltrombopag and rhTPO demonstrated good safety in ITP patients Because of their non-immunosuppressive nature both of them serve as a reasonable choice during the global COVID-19 pandemic
Since they increase the number of platelets through different mechanisms and previous studies demonstrated that they might exert synergic effect The investigators hypothesized that the combination of these two agents could be a promising option for treatment of corticosteroid-resistant or relapsed ITP patients
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