Last updated on June 2018

Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)


Brief description of study

In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

Detailed Study Description

This is a Phase III clinical study to investigate the efficacy and safety of FP-1201-lyo (recombinant human interferon [IFN] beta-1a) compared to placebo in patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). Primary objective is to demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation. Currently there are no approved drugs for treating moderate or severe ARDS patients. FP-1201-lyo is a lyophilised powder form of recombinant human IFN beta-1a reconstituted in water for injection and is administered intravenously. Recombinant human IFN beta-1a is an approved treatment for patients for other indication and its safety profile in such patients is well characterised.

Clinical Study Identifier: NCT02622724

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Matti Karvonen, MD

Erasmus Hospital
Brussels, Belgium

Matti Karvonen, MD

UZ Brussel
Brussels, Belgium

Matti Karvonen, MD

UZ Antwerpen
Edegem, Belgium

Matti Karvonen, MD

UZ Gent
Gent, Belgium

Matti Karvonen, MD

Centre Hospitalier Universitaire de Li ge
Liège, Belgium

Matti Karvonen, MD

CHU Charleroi Site H pital Civil Marie Curie
Lodelinsart, Belgium

Matti Karvonen, MD

CHU Dinant Godinne UCL Namur
Yvoir, Belgium

Matti Karvonen, MD

Helsinki University Hospital
Helsinki, Finland

Matti Karvonen, MD

Kuopio University Hospital
Kuopio, Finland

Matti Karvonen, MD

Tampere University Hospital
Tampere, Finland

Matti Karvonen, MD

Turku University Central Hospital
Turku, Finland

Matti Karvonen, MD

Nouvel H pital Civil
Strasbourg, France

Matti Karvonen, MD

Centre Hospitalier R gional d'Orl ans
Orléans, France

Matti Karvonen, MD

CHU D'Angers
Angers, France

Matti Karvonen, MD

CHU De Poitiers
Poitiers, France

Matti Karvonen, MD

H pital de la Croix Rousse
Lyon, France

Matti Karvonen, MD

H pital Charles-Nicolle
Rouen, France

Matti Karvonen, MD

CHU Cavale Blanche
Brest, France

Matti Karvonen, MD

Centre Hospitalier Universitaire de Bic tre
Le Kremlin-Bicêtre, France

Matti Karvonen, MD

H pital Nord Chemin des Bourrely
Marseille, France

Matti Karvonen, MD

Piti -Salp tri re Hospital
Paris, France

Matti Karvonen, MD

CHU Bretonneau
Tours, France

Matti Karvonen, MD

H pital Cochin, R animation M dicale Hospitalisation
Paris, France

Matti Karvonen, MD

Klinikum Augsburg Klinik f r An sthesiologie
Augsburg, Germany

Matti Karvonen, MD

Charit - Universit tsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany

Matti Karvonen, MD

Universit tsklinikum Bonn Klinik und Poliklinik f r An sthesiologie
Bonn, Germany

Matti Karvonen, MD

Universit tsklinikum Carl Gustav Carus Klinik f r An sthesiologie und Intensivmedizin
Dresden, Germany

Matti Karvonen, MD

Universit tsmedizin G ttingen Klinik f r An sthesiologie
Göttingen, Germany

Matti Karvonen, MD

Universit tsklinikum Hamburg-Eppendorf Klinik f r Intesivmedizin
Hamburg, Germany

Matti Karvonen, MD

Kliniken der Stadt K ln Klinikum Merheim
Köln, Germany

Matti Karvonen, MD

Universit tsklinik Leipzig Klinik und Poliklinik f r An esthesiologie und Intensivtherapie
Leipzig, Germany

Matti Karvonen, MD

Azienda Ospedaliera Universitaria Sant' Anna
Cona, Italy

Matti Karvonen, MD

IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy

Matti Karvonen, MD

ASST Monza
Monza, Italy

Matti Karvonen, MD

Azienda Ospedaliera Universitaria Maggiore
Novara, Italy

Matti Karvonen, MD

Universita degli Studi di Roma "La Sapienza"
Roma, Italy

Matti Karvonen, MD

Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy

Matti Karvonen, MD

AOU Citt della Salute e della Scienza di Torino
Torino, Italy

Matti Karvonen, MD

Hospital de la Santa Creu I Sant Pau
Barcelona, Spain

Matti Karvonen, MD

Hospital Universitari Vall d'Hebron
Barcelona, Spain

Matti Karvonen, MD

Hospital Cl nic i Provincial de Barcelona
Barcelona, Spain

Matti Karvonen, MD

Hospital Universitario del Henares
Coslada, Spain

Matti Karvonen, MD

Hospital Universitario de Getafe
Getafe, Spain

Matti Karvonen, MD

Hospital Universitario de Gran Canaria Dr Negrin
Las Palmas de Gran Canaria, Spain

Matti Karvonen, MD

Hospital Universitari Son Espases
Palma, Spain

Matti Karvonen, MD

Corporaci Sanit ria Parc Taul
Sabadell, Spain

Matti Karvonen, MD

Hospital Universitari M tua de Terrassa
Terrassa, Spain

Matti Karvonen, MD

Hospital Universitario Rio Hortega
Valladolid, Spain

Matti Karvonen, MD

Queen Alexandra Hospital / Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom

Matti Karvonen, MD

Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust
Bristol, United Kingdom

Matti Karvonen, MD

University Hospital of Wales
Cardiff, United Kingdom

Matti Karvonen, MD

Royal Infirmary of Edinburgh
Edinburgh, United Kingdom

Matti Karvonen, MD

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Hampshire, United Kingdom

Matti Karvonen, MD

University College London Hospitals, NHS Foundation Trust
London, United Kingdom

Matti Karvonen, MD

Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom

Matti Karvonen, MD

King's College Hospital NHS Foundation Trust
London, United Kingdom

Matti Karvonen, MD

St George's University Hospitals, NHS Foundation Trust
London, United Kingdom

Matti Karvonen, MD

Hammersmith Hospital Imperial College Healthcre NHS Trust
London, United Kingdom

Matti Karvonen, MD

Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom

Matti Karvonen, MD

Charing Cross Hospital Imperial College Healthcare NHS Trust
London, United Kingdom

Matti Karvonen, MD

Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom

Matti Karvonen, MD

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom

Matti Karvonen, MD

Lancashire Treaching Hospitals NHS Foundation Trust
Preston, United Kingdom

Recruitment Status: Closed


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