Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608901
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy Safety Pharmacokinetics and Pharmacodynamic Effects of REGN7544 an Antagonist Monoclonal Antibody to NPR1 in Patients With Sepsis-Induced Hypotension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an experimental drug called REGN7544 called study drug The study is focused on adult patients 18 to 85 years hospitalized due to a serious infection called sepsis and receiving standard-of-care medications for low blood pressure called vasopressors due to sepsis
The aim of the study is to see how safe tolerable and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during your stay in the hospital
The study is looking at several other research questions including
How the study drug changes the blood pressure and the amount of intravenous IV fluids given to participants with low blood pressure due to sepsis
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The aim of the study is to see how safe tolerable and effective the study drug is by observing the effects on blood pressure and the total amount of vasopressor dose received during your stay in the hospital
The study is looking at several other research questions including
How the study drug changes the blood pressure and the amount of intravenous IV fluids given to participants with low blood pressure due to sepsis
What side effects may happen from taking the study drug
How much study drug is in the blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None