Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04961710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-07-14
First Post:
2021-07-12
Brief Title:
Extension Study of Hetrombopag in Severe Aplastic Anemia
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 placebo-control phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study
Subjects will receive the same study drug hetrombopag or placebo as in study HR-TPO-SAA-III with the same doses and administration schedule or with modifications based on the actual conditions
The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug hetrombopag or placebo after the completion of the HR-TPO-SAA-III study
Subjects will receive the same study drug hetrombopag or placebo as in study HR-TPO-SAA-III with the same doses and administration schedule or with modifications based on the actual conditions
The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug hetrombopag or placebo after the completion of the HR-TPO-SAA-III study
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