A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
NCT06608901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-05-20
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 the 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)
Conditions
- Sepsis-Induced Hypotension
Interventions
- DRUG
-
REGN7544
Administered per the protocol
- DRUG
-
PB
Administered per the protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-05
- Primary Completion
- 2026-02-01
- Completion
- 2026-04-28
- FDA Drug
- Yes
Countries
- United States
- France
Study Locations
More Related Trials
-
Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe Sepsis
NCT01486524 ·Status: UNKNOWN
-
A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
NCT00158769 ·Status: COMPLETED ·Phase: PHASE1
-
Defining Circulating Micro-RNA Biomarkers for the Early Diagnosis and Prognosis of Sepsis
NCT02544490 ·Status: COMPLETED
-
A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFab™) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock
NCT01145560 ·Status: COMPLETED ·Phase: PHASE2
-
Immune Reconstitution of Immunosuppressed Sepsis Patients
NCT02797431 ·Status: TERMINATED ·Phase: PHASE2
-
Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator
NCT06426407 ·Status: TERMINATED
-
Efficacy of SGLT2 Inhibitors in Adults With Sepsis
NCT06473844 ·Status: RECRUITING ·Phase: NA
-
Application of Stimulated Immune Response Change to Predict Outcome of Patient With Severe Sepsis
NCT02887274 ·Status: UNKNOWN
-
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
NCT00046072 ·Status: COMPLETED ·Phase: PHASE2
-
Angiotensin II Antagonist in Severe Sepsis
NCT01992796 ·Status: UNKNOWN ·Phase: PHASE3
-
NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock
NCT02454348 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
NCT02794025 ·Status: COMPLETED ·Phase: NA
-
Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
NCT02508649 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
MID-STEP (MIDodrine for Sepsis Treatment and Early vasoPressor Weaning) Trial
NCT06319248 ·Status: RECRUITING ·Phase: PHASE2
-
Discontinuation Order of Vasopressors in Septic Shock
NCT01493102 ·Status: TERMINATED ·Phase: NA
-
Study of Early Enteral Dextrose in Sepsis
NCT03454087 ·Status: COMPLETED ·Phase: NA
-
Dendritic Cells-Derived Exosomes in Human Sepsis
NCT02957279 ·Status: UNKNOWN
-
Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock
NCT05824767 ·Status: COMPLETED ·Phase: PHASE4
-
Midodrine in the Recovery Phase of Septic Shock
NCT02990546 ·Status: WITHDRAWN ·Phase: PHASE3
-
Dexmedetomidine and Vasopressin in Septic Shock
NCT06302998 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Near Patient Molecular Testing in Sepsis
NCT05469048 ·Status: COMPLETED
-
Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs
NCT05826223 ·Status: COMPLETED
-
Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock
NCT06122987 ·Status: RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation
NCT02654561 ·Status: RECRUITING ·Phase: PHASE3
-
Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
NCT06446947 ·Status: RECRUITING