A Study of REGN7544 for the Treatment in Adult Patients With Sepsis-Induced Hypotension
NCT ID: NCT06608901
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
76 participants
INTERVENTIONAL
2025-05-05
2026-10-19
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REGN7544
REGN7544
Administered per the protocol
Placebo (PB)
PB
Administered per the protocol
Interventions
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REGN7544
Administered per the protocol
PB
Administered per the protocol
Eligibility Criteria
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Inclusion Criteria
2. Sepsis-induced hypotension that has not responded to Intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol
Exclusion Criteria
2. Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
3. Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest
4. Ejection fraction \<20% in the most recent known echocardiogram
5. Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization
6. History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months
7. Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol
8. Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration
9. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
18 Years
85 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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University of Arizona
Tucson, Arizona, United States
Yale University
New Haven, Connecticut, United States
Emory University Hospital
Atlanta, Georgia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Bellevue Hospital
New York, New York, United States
New York University Langone Health Tisch-Kimmel Hospital
New York, New York, United States
Montefiore Medical Center - Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Atrium Health
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MUSC SCTR Research Nexus Clinic and Lab
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Medical Center - Murray (Pulmonary Medicine)
Murray, Utah, United States
Centre Hospitalier Regional Universaitaire de Tours (CHRU de Tours)
Tours, Centre-Val de Loire, France
CHU Dupuytren
Limoges, Nouvelle-Aquitaine, France
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, France
Centre Hospitalier Departemental (CHD) Vendee
La Roche-sur-Yon, Vendee, France
Centre Hospitalier Universitaire Angers
Angers, , France
Raymond Poincare University Hospital
Garches, , France
Paris-Saclay University Hospitals
Le Kremlin-Bicêtre, , France
CHU Nantes
Nantes, , France
Centre Hospitalier Universitaire d'Orleans
Orléans, , France
CHU de Reims Hopital Robert Debre
Reims, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Hopital Nord Franche Comte
Trévenans, , France
Hopital Cochin
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Other Identifiers
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2024-514946-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
R7544-SIH-2435
Identifier Type: -
Identifier Source: org_study_id
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