Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05261646
Status:
WITHDRAWN
Last Update Posted:
2023-09-28
First Post:
2022-02-21
Brief Title:
A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor R D Strategy Adjustment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen ie delayed start dose reduction omission or discontinuation because of thrombocytopenia platelet count 100109L to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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