Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04737850
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2021-01-17
Brief Title:
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopeniaa Randomized Multicenter Placebo-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
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:
The purpose of this study is to investigate the efficacy safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age This is a 2 part study In part A patients will receive Hetrombopag for 8 weeks In part B all patients will receive Hetrombopag for 24 weeks
Detailed Description:
This is a two-part double-blind randomized placebo-controlled and open-label Phase III study to investigate the efficacy safety of Hetrombopag in pediatric patients with previously treated chronic ITP In Part A patients will receive Hetrombopag for 8 weeks After completing Part A patients will begin Part B in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind placebo-controlled treatment period following an open-label 12 week treatment period
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