Clinical trial • Phase III • Cardiology|Infectious Disease|Haematology
BAY 3389934 for Sepsis|Sepsis-induced coagulopathy|Coagulopathy
Phase III trial of BAY 3389934 for Sepsis|Sepsis-induced coagulopathy|Coagulopathy. 36 participants.
Overview
- Trial Therapeutic Area
- Cardiology|Infectious Disease|Haematology
- Trial Disease
- Sepsis|Sepsis-induced coagulopathy|Coagulopathy
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 04-10-2024
- First CTIS Authorization Date
- 04-02-2025
Trial design
Phase III trial in Germany, Belgium, France and others.
- Target Sample Size
- 36
Eligibility
Recruits 36 Vulnerable population selected; no details provided on consent or assent handling in the provided source..
- Vulnerable Population
- Vulnerable population selected; no details provided on consent or assent handling in the provided source.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 22
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 36
Germany
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Interdisziplinare Internistische Intensivmedizin
- Principal Investigator Name
- Sirak Petros
- Principal Investigator Email
- Sirak.Petros@medizin.uni-leipzig.de
- Contact Person Name
- Sirak Petros
- Contact Person Email
- Sirak.Petros@medizin.uni-leipzig.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Jan Beyer-Westendorf
- Principal Investigator Email
- Jan.Beyer-Westendorf@ukdd.de
- Contact Person Name
- Jan Beyer-Westendorf
- Contact Person Email
- Jan.Beyer-Westendorf@ukdd.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Klinik für Anaesthesiologie
- Principal Investigator Name
- Sandra Frank
- Principal Investigator Email
- Sandra.Frank@med.uni-muenchen.de
- Contact Person Name
- Sandra Frank
- Contact Person Email
- Sandra.Frank@med.uni-muenchen.de
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- Lungenklinik
- Principal Investigator Name
- Christian Karagiannidis
- Principal Investigator Email
- KaragiannidisC@kliniken-koeln.de
- Contact Person Name
- Christian Karagiannidis
- Contact Person Email
- KaragiannidisC@kliniken-koeln.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-01-2025
- Latest Decision Or Authorization Date
- 18-04-2025
- Processing Time Days
- 100
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- Intensive Care
- Principal Investigator Name
- Nathalie Layios
- Principal Investigator Email
- sigen@chuliege.be
- Contact Person Name
- Nathalie Layios
- Contact Person Email
- sigen@chuliege.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Intensive Care
- Principal Investigator Name
- Xavier Wittebole
- Principal Investigator Email
- datanurse@saintluc.uclouvain.be
- Contact Person Name
- Xavier Wittebole
- Contact Person Email
- datanurse@saintluc.uclouvain.be
- Site Name
- Antwerp University Hospital
- Department Name
- Intensive Care
- Principal Investigator Name
- Dominique Robert
- Principal Investigator Email
- studies.INZO@uza.be
- Contact Person Name
- Dominique Robert
- Contact Person Email
- studies.INZO@uza.be
- Site Name
- Clinique Saint-Pierre
- Department Name
- Intensive Care
- Principal Investigator Name
- Nicolas De Schryver
- Principal Investigator Email
- nicolas.deschryver@cspo.be
- Contact Person Name
- Nicolas De Schryver
- Contact Person Email
- nicolas.deschryver@cspo.be
France
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 05-02-2025
- Processing Time Days
- 19
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Service de réanimation polyvalente
- Principal Investigator Name
- Gwenhaël Colin
- Principal Investigator Email
- gwenhael.colin@ght85.fr
- Contact Person Name
- Gwenhaël Colin
- Contact Person Email
- gwenhael.colin@ght85.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de Médecine Intensive - Réanimation
- Principal Investigator Name
- Jérémie Lemarié
- Principal Investigator Email
- jeremie.lemarie@chu-nantes.fr
- Contact Person Name
- Jérémie Lemarié
- Contact Person Email
- jeremie.lemarie@chu-nantes.fr
- Site Name
- Raymond-Poincare Hospital
- Department Name
- Service de Médecine Intensive - Réanimation, Médecine Hyperbare
- Principal Investigator Name
- Djillali Annane
- Principal Investigator Email
- djillali.annane@aphp.fr
- Contact Person Name
- Djillali Annane
- Contact Person Email
- djillali.annane@aphp.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Médecine Intensive Réanimation
- Principal Investigator Name
- Emmanuelle Mercier
- Principal Investigator Email
- emmanuelle.mercier@univ-tours.fr
- Contact Person Name
- Emmanuelle Mercier
- Contact Person Email
- emmanuelle.mercier@univ-tours.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service de réanimation polyvalente
- Principal Investigator Name
- Bruno François
- Principal Investigator Email
- bruno.francois@chu-limoges.fr
- Contact Person Name
- Bruno François
- Contact Person Email
- bruno.francois@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Médecine Intensive Réanimation et Médecine Hyperbare
- Principal Investigator Name
- Pierre Asfar
- Principal Investigator Email
- piasfar@chu-angers.fr
- Contact Person Name
- Pierre Asfar
- Contact Person Email
- piasfar@chu-angers.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Médecine Intensive - Réanimation
- Principal Investigator Name
- Julie Helms
- Principal Investigator Email
- julie.helms@chru-strasbourg.fr
- Contact Person Name
- Julie Helms
- Contact Person Email
- julie.helms@chru-strasbourg.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-01-2025
- Latest Decision Or Authorization Date
- 18-04-2025
- Processing Time Days
- 95
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Intensive Care
- Principal Investigator Name
- Nicole Juffermans
- Principal Investigator Email
- ICV@erasmusmc.nl
- Contact Person Name
- Nicole Juffermans
- Contact Person Email
- ICV@erasmusmc.nl
- Site Name
- Jeroen Bosch Ziekenhuis Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Koen Simons
- Principal Investigator Email
- ResearchIC@jbz.nl
- Contact Person Name
- Koen Simons
- Contact Person Email
- ResearchIC@jbz.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Intensive Care
- Principal Investigator Name
- Albertus Beishuizen
- Principal Investigator Email
- ResearchIC@mst.nl
- Contact Person Name
- Albertus Beishuizen
- Contact Person Email
- ResearchIC@mst.nl
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Intensive Care
- Principal Investigator Name
- Oscar Hoiting
- Principal Investigator Email
- researchic@cwz.nl
- Contact Person Name
- Oscar Hoiting
- Contact Person Email
- researchic@cwz.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Intensive Care
- Principal Investigator Name
- Peter Pickkers
- Principal Investigator Email
- icresearchverpleegkundigen.ic@radboudumc.nl
- Contact Person Name
- Peter Pickkers
- Contact Person Email
- icresearchverpleegkundigen.ic@radboudumc.nl
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BAY 3389934
Related trials
Other published trials that may interest you.