Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03825744
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2019-01-30
Brief Title:
Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
A Phase III Multicenter Randomized Study of Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
This is a multicenter randomized placebo-control phase III study to investigate hetrombopag in subjects with severe AA who are treated naive
180 treated naive patients with SAA will be enrolled in the study The primary objective of the study will be the rate of complete hematologic response at six months
180 treated naive patients with SAA will be enrolled in the study The primary objective of the study will be the rate of complete hematologic response at six months
Detailed Description:
None
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