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ACTIVE NOT RECRUITING
NCT04055909
PHASE2

Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock

Sponsor: Inotrem

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

Official title: Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

355

Start Date

2019-11-13

Completion Date

2023-05-09

Last Updated

2023-04-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

nangibotide low dose

nangibotide 0.3 mg/kg/h

DRUG

nangibotide high dose

nangibotide 1.0 mg/kg/h

DRUG

placebo

matching placebo

Locations (43)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

UZ Gent

Ghent, Belgium

Centre hospitalier Jolimont-Lobbes

La Louvière, Belgium

CHU Marie Curie

Lodelinsart, Belgium

Clinique Saint-Pierre

Ottignies, Belgium

CHU UCL Namur asbl

Yvoir, Belgium

Nordsjællandshospital Hillerød

Hillerød, Denmark

Helsinki University Hospital Adult ICU PPDS

Helsinki, Finland

Kuopion Yliopistollinen sairaala

Kuopio, Finland

Tampereen yliopistollinen sairaala

Tampere, Finland

CHU Angers

Angers, France

Centre hospitalier Victor Dupouy

Argenteuil, France

Centre hospitalier de Béthune

Béthune, France

Hôpital Fleyriat

Bourg-en-Bresse, France

CHU Dijon - Hôpital François Mitterrand

Dijon, France

CHD les Oudairies

La Roche-sur-Yon, France

Hôpital de Bicêtre

Le Kremlin-Bicêtre, France

CHU LE Mans

Le Mans, France

CHRU Lille - Hôpital Roger Salengro

Lille, France

Hôpital Universitaire Dupuytren

Limoges, France

Centre Hospitalier Lyon Sud

Lyon, France

Hôpital Nord

Marseille, France

Centre hospitalier de Melun

Melun, France

CHRU Nancy - Hôpital Central

Nancy, France

Hôtel Dieu - Nanates

Nantes, France

CHU de Nîmes

Nîmes, France

Hôpital de la source

Orléans, France

Hôpital Lariboisière

Paris, France

Hôpital Saint Louis

Paris, France

Groupe hospitalier Pitié-Salpêtrière

Paris, France

Hôpital Cochin

Paris, France

CHRU Hôpital Bretonneau

Tours, France

Hôpital d'instruction des Armées Robert Picqué

Villenave-d'Ornon, France

St Jame's Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Hospital del mar

Barcelona, Spain

Hospital Universitario Vall d'Hebrón

Barcelona, Spain

Hospital Clinical San Carlos

Madrid, Spain

Hospital Universitario Dentral de Asturias

Oviedo, Spain

Hospital Universitari Mutua de Terrassa

Terrassa, Spain

Hospital universitario DR. Peset Aleixandre

Valencia, Spain

Hospital Universitario y Politecnico la Fe

Valencia, Spain