Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
Study NCT ID:
NCT05350956
Status:
UNKNOWN
Last Update Posted:
2022-04-28
First Post:
2022-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
Study Overview
Official Title:
A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_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:
The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia
Detailed Description:
CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.
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?: