Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
36
Countries
4
Sites
20
Coagulopathy
Key facts
- Sponsor
- Bayer AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2025-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515635-30-00
- ClinicalTrials.gov
- NCT06854640
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Coagulopathy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
4 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 7 | 4 |
| France | Ongoing, recruitment ended | 15 | 7 |
| Germany | Authorised, recruiting | 6 | 4 |
| Netherlands | Authorised, recruiting | 8 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Clinique Saint-Pierre
Intensive Care, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
Cliniques Universitaires Saint-Luc
Intensive Care, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire De Liege
Intensive Care, Avenue De L'hopital 1, 4000, Liege
Antwerp University Hospital
Intensive Care, Drie Eikenstraat 655, 2650, Edegem
Centre Hospitalier Departemental Vendee
Service de réanimation polyvalente, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Service de réanimation polyvalente, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Raymond-Poincare Hospital
Service de Médecine Intensive - Réanimation, Médecine Hyperbare, 104 Boulevard Raymond Poincare, 92380, Garches
Centre Hospitalier Universitaire D'Angers
Médecine Intensive Réanimation et Médecine Hyperbare, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Nantes
Service de Médecine Intensive - Réanimation, 30 Boulevard Jean Monnet, 44000, Nantes
Centre Hospitalier Regional Universitaire De Tours
Médecine Intensive Réanimation, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Les Hopitaux Universitaires De Strasbourg
Service de Médecine Intensive - Réanimation, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Klinikum der Universitaet Muenchen AöR
Klinik für Anaesthesiologie, Marchioninistrasse 15, Hadern, Munich
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Leipzig AöR
Interdisziplinare Internistische Intensivmedizin, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Kliniken der Stadt Koeln gGmbH
Lungenklinik, Ostmerheimer Strasse 200, Merheim, Cologne
Radboud universitair medisch centrum Stichting
Intensive Care, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Intensive Care, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Canisius Wilhelmina Ziekenhuis
Intensive Care, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Medisch Spectrum Twente
Intensive Care, Koningsplein 1, 7512 KZ, Enschede
Jeroen Bosch Ziekenhuis Stichting
Intensive Care, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-03-10 | 2025-03-12 | 2025-05-23 | ||
| France | 2025-04-10 | 2025-04-25 | 2025-05-23 | ||
| Germany | 2025-04-09 | ||||
| Netherlands | 2025-03-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-84575
- Halt date
- 2025-05-23
- Member states concerned
- France
- Publication date
- 2025-05-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Temporary halt of enrollment due to increase of coagulation parameters above the limit of quantification despite dose reduction per protocol.
- Follow-up measures
- Sponsor will conduct a thorough evaluation of the available data, including the safety data and based on the evaluation seek to restart the study following a substantial modification of the study protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-84573
- Halt date
- 2025-05-23
- Member states concerned
- Belgium
- Publication date
- 2025-05-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Temporary halt of enrollment due to increase of coagulation parameters above the limit of quantification despite dose reduction per protocol.
- Follow-up measures
- Sponsor will conduct a thorough evaluation of the available data, including the safety data and based on the evaluation seek to restart the study following a substantial modification of the study protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-84578
- Halt date
- 2025-05-23
- Member states concerned
- Netherlands
- Publication date
- 2025-05-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Temporary halt of enrollment due to increase of coagulation parameters above the limit of quantification despite dose reduction per protocol.
- Follow-up measures
- Sponsor will conduct a thorough evaluation of the available data, including the safety data and based on the evaluation seek to restart the study following a substantial modification of the study protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-84577
- Halt date
- 2025-05-23
- Member states concerned
- Germany
- Publication date
- 2025-05-28
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Temporary halt of enrollment due to increase of coagulation parameters above the limit of quantification despite dose reduction per protocol.
- Follow-up measures
- Sponsor will conduct a thorough evaluation of the available data, including the safety data and based on the evaluation seek to restart the study following a substantial modification of the study protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Germany | Acceptable 2025-02-03
|
2025-02-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-06 | Germany | Acceptable 2025-04-17
|
2025-04-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-28 | Acceptable | 2025-05-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-05 | Germany | Acceptable 2026-03-04
|
2026-03-04 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-26 | Germany | Acceptable 2026-03-04
|
2026-03-26 |