A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 3018250 in Patients With Symptomatic Proximal Deep Vein Thrombosis

Status: Recruiting
Location: See all (85) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT). DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT. BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors. The main purposes of this study are to learn: * How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and * How safe is BAY3018250 as a treatment for participants with proximal DVT? For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time. And researchers will collect the number of bleeding events that require medical attention. The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo. Researchers will closely monitor participants for 90 days after receiving the study treatment. During the study, the doctors and their study team will: * take blood samples * do physical examinations * examine heart health using electrocardiogram (ECG) * check vital signs such as blood pressure, heart rate * undergo ultrasound tests to measure the blood clots * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male and female (if postmenopausal or hysterectomized) aged 18 years or older

• Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:

‣ duration of symptoms 14 days or less

⁃ Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein

⁃ adequate visualization of the most proximal end of the thrombus

⁃ receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels

• Measured body weight within 50 to 130 kg

• Signed informed consent

Locations
Other Locations
Belgium
Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling
RECRUITING
Antwerp
Imelda - Vascular Surgery Dept
RECRUITING
Bonheiden
Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department
RECRUITING
Genk
UZ Gent
RECRUITING
Ghent
AZ Groeninge - Campus Kennedylaan
RECRUITING
Kortrijk
Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)
RECRUITING
Leuven
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
NOT_YET_RECRUITING
Liège
AZ Sint-Maarten
RECRUITING
Mechelen
Bulgaria
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
RECRUITING
Rousse
University Multiprofile Hospital For Active Treatment Kanev AD
RECRUITING
Rousse
Medical Institute Ministry of Interior
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment 'National Cardiology Hospital' EAD, Sofia
NOT_YET_RECRUITING
Sofia
University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
NOT_YET_RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD, Sofia
RECRUITING
Sofia
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology Department
RECRUITING
Veliko Tarnovo
Canada
Hamilton Health Sciences - Hamilton General Hospital (HGH)
WITHDRAWN
Hamilton
McGill University Health Centre - Glen Site
RECRUITING
Montreal
Niagara Health - St. Catharines Site
WITHDRAWN
St. Catharines
France
Centre Hospitalier Universitaire Amiens Picardie Site Sud
RECRUITING
Amiens Cedex1
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
RECRUITING
Brest
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
RECRUITING
Clermont-ferrand
Hôpital Louis Mourier - Colombes Cedex
RECRUITING
Colombes
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon
RECRUITING
La Tronche
AP-HP Hopital Europeen Georges-Pompidou (HEGP) - Service de medecine vasculaire
RECRUITING
Paris
CHU Rennes, H Pontchaillou, Cardiologie
WITHDRAWN
Rennes
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
RECRUITING
Saint-etienne
Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)
RECRUITING
Strasbourg
Hôpital Sainte Musse
RECRUITING
Toulon
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil - Service de medecine vasculaire
RECRUITING
Toulouse
Germany
UNIVERSITAETSKLINIKUM FREIBURG - Universitaets-Herzzentrum Bad Krozingen | Klinik für Kardiologie und Angiologie
NOT_YET_RECRUITING
Bad Krozingen
Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin
WITHDRAWN
Berlin
Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin
WITHDRAWN
Berlin
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie
RECRUITING
Dresden
Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik | Bereich Haemostaseologie
WITHDRAWN
Hamburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III | Angiologie
WITHDRAWN
Mainz
LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV | FB Angiologie
RECRUITING
München
Universitaetsklinikum Muenster | Klinik fuer Kardiologie I Sektion Angiologie
SUSPENDED
Münster
Greece
General Hospital Of Athens G Gennimatas- Department of Vascular Surgery
RECRUITING
Athens
University General Hospital Attikon - 1st Department of Vascular surgery University of Athens
RECRUITING
Athens
General Hospital Of Thessaloniki Papageorgiou- 1st Department of Surgery
RECRUITING
Efkarpia
University General Hospital Of Ioannina- Department of Surgery, Vascular Unit Faculty
RECRUITING
Ioannina
University General Hospital of Larissa - Department of Vascular surgery of University of Thessaly
NOT_YET_RECRUITING
Larissa
General University Hospital Of Patras- Department of Vascular Surgery
RECRUITING
Pátrai
Hungary
Bekes Varmegyei Kozponti Korhaz - Dr. Rethy Pal Tagkorhaz
NOT_YET_RECRUITING
Békéscsaba
Semmelweis Egyetem - Belgyógyászati és Hematológiai Klinika, Kardiológia
NOT_YET_RECRUITING
Budapest
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Általános Belgyógyászati Osztály
RECRUITING
Kaposvár
Kistarcsai Flor Ferenc Korház - II. Belgyógyászat - Angiológia
RECRUITING
Kistarcsa
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz - Kardiovaszkularis es Belgyogyaszati centrum
WITHDRAWN
Miskolc
Pecsi Tudomanyegyetem Klinikai Kozpont - I. sz. Belgyogyaszati Klinika
WITHDRAWN
Pécs
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
RECRUITING
Szeged
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz - II. Belgyogyaszat
NOT_YET_RECRUITING
Székesfehérvár
Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Angiologia e Malattie della Coagulazione
RECRUITING
Bologna
Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department
RECRUITING
Castelfranco Veneto
Azienda Ospedale-Università di Padova - Medicina Generale ad indirizzo trombotico-emorragico
RECRUITING
Padua
Azienda Unita Sanitaria Locale di Reggio Emilia | Arcispedale Santa Maria Nuova - Cardiovascular Medicine
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Malattie Emorragiche e Trombotiche
RECRUITING
Roma
Humanitas Mirasole S.p.A. - Centro Trombosi e Malattie Emorragiche
RECRUITING
Rozzano
AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Pronto Soccorso
RECRUITING
Treviso
ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi
RECRUITING
Varese
Netherlands
Rijnstate | Arnhem - Internal Medicine Department - Vascular Research
NOT_YET_RECRUITING
Arnhem
Albert Schweitzer Hospital | Internal Medicine - Hematology Department
RECRUITING
Dordrecht
Zuyderland Medical Centre | Internal Medicine Department
RECRUITING
Geleen
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
RECRUITING
Leiden
Maastricht University Medical Center | School for Cardiovascular Diseases - Biochemie
WITHDRAWN
Maastricht
Radboud University Medical Center | Afdeling Interne Geneeskunde
NOT_YET_RECRUITING
Nijmegen
Isala
WITHDRAWN
Zwolle
Slovakia
Stredoslovenský ústav srdcových a cievnych chorôb, a.s. - Oddelenie angiológie
WITHDRAWN
Banská Bystrica
Penta Hospitals | Nemocnica Bory - Department of Internal Medicine
WITHDRAWN
Bratislava
Kardiocentrum AGEL a.s. - Angiologické oddelenie
RECRUITING
Košice
Penta Hospitals | Zeleznicna Nemocnica Kosice - Angiologicka ambulancia
RECRUITING
Košice
Nemocnicná a.s. - Interné oddelenie
RECRUITING
Malacky
Penta Hospitals | Rimavska Sobota Hospital - Internal Medicine Department
NOT_YET_RECRUITING
Rimavská Sobota
Hospitale, s.r.o. - Interné oddelenie
RECRUITING
Šahy
Penta Hospitals | Hospital and Polyclinic Spisska Nova Ves - Internal Medicine Department
RECRUITING
Spišská Nová Ves
Spain
Hospital Universitari De Girona Doctor Josep Trueta-Medicina Interna
RECRUITING
Girona
Hospital Universitario la Paz-Medicina Interna
NOT_YET_RECRUITING
Madrid
Hospital Universitario de Navarra- Medicina Interna
WITHDRAWN
Pamplona
Hospital Universitario Infanta Sofia-Medicina Interna
RECRUITING
San Sebastián De Los Reyes
Turkey
Ankara Bilkent Sehir Hastanesi
NOT_YET_RECRUITING
Bilkent Ankara
Bagcilar Egitim ve Arastirma Hastanesi
NOT_YET_RECRUITING
Istanbul
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
RECRUITING
Istanbul
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospit
WITHDRAWN
Istanbul
Saglik Bilimleri Üniversitesi Dr. Siyami Ersek Gögüs Kalp ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi
RECRUITING
Istanbul
Izmir Sehir Hastanesi
RECRUITING
Izmir
Erciyes Universitesi Tip Fakultesi
RECRUITING
Kayseri
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2025-12-26
Participants
Target number of participants: 255
Treatments
Experimental: BAY3018250 Dose 1
Participants will receive BAY3018250 Dose 1.
Experimental: BAY3018250 Dose 2
Participants will receive BAY3018250 Dose 2.
Placebo_comparator: Placebo to BAY3018250
Participants will receive placebo to BAY3018250.
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov