Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer

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What is this study about?

This clinical trial is focused on studying a condition known as venous thromboembolism (VTE), which is a type of blood clot that can occur in patients with certain types of cancer, specifically gastrointestinal (GI) and genitourinary (GU) cancer. The study is comparing two treatments: Abelacimab, a new medication given as a solution for infusion, and Fragmin® (dalteparin sodium), a solution for injection that is already used to treat VTE. The purpose of the study is to see if Abelacimab is as effective as Fragmin® in preventing the recurrence of VTE in these patients.

Participants in the study will receive either Abelacimab or Fragmin® for a period of six months. The study is designed to monitor the recurrence of VTE and any bleeding events during this time. Abelacimab is administered through a method called subcutaneous use, which means it is injected under the skin. Similarly, Fragmin® is also given through subcutaneous injection. The study aims to determine if Abelacimab can prevent VTE recurrence as effectively as Fragmin® and, if successful, to see if it might be even better.

Throughout the study, participants will be closely monitored to track any occurrences of VTE and to ensure their safety. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. However, the evaluation of the study’s outcomes is blinded, meaning that the people assessing the results do not know which treatment the participants received, to ensure unbiased results. The study is expected to continue until 2025, providing valuable information on the effectiveness of Abelacimab in treating VTE in patients with GI or GU cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of cancer, and recent diagnosis of venous thromboembolism (VTE).

Written informed consent is required to participate.

2 randomization

Participants are randomly assigned to receive either abelacimab or dalteparin sodium.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

If assigned to abelacimab, the medication is administered as a 150 mg/ml solution for infusion, given subcutaneously.

If assigned to dalteparin sodium (Fragmin® 5000 IU), it is administered as a solution for injection, also given subcutaneously.

The treatment continues for a duration of 6 months.

4 monitoring and evaluation

Throughout the study, participants are monitored for any recurrence of VTE and any bleeding events.

The primary endpoint is the time to the first event of centrally adjudicated VTE recurrence within 6 months post-randomization.

5 completion of study

The study is estimated to conclude by September 1, 2025.

Upon completion, data from the study will be analyzed to determine the effectiveness of abelacimab compared to dalteparin sodium in preventing VTE recurrence.

Who Can Join the Study?

  • Participants must be male or female and at least 18 years old or the legal age of maturity in their country.
  • Participants must have a confirmed diagnosis of gastrointestinal (GI) or genitourinary (GU) cancer. This includes cancers of the colon, pancreas, stomach, esophagus, liver, kidneys, bladder, prostate, or urethra. The cancer must be either not removable by surgery, locally advanced, spread to other parts of the body, or not spread but with no planned surgery to cure it during the study.
  • Participants must have a confirmed deep vein thrombosis (DVT) in the upper part of the leg or a pulmonary embolism (PE), which is a blood clot in the lung. This can be either a clot causing symptoms or one found by chance. Participants must join the study within 120 hours (5 days) of being diagnosed with the blood clot.
  • Participants must need anticoagulation therapy with a type of medication called low molecular weight heparin (LMWH) for at least 6 months.
  • Participants must be able to provide written informed consent, which means they understand the study and agree to take part.

Who Cannot Join the Study?

  • Patients who do not have gastrointestinal (related to the stomach and intestines) or genitourinary (related to the genital and urinary organs) cancer.
  • Patients who have not been recently diagnosed with venous thromboembolism (VTE), which is a condition where blood clots form in the veins.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a history of allergic reactions to the study medications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Medical University Of Vienna Vienna Austria
Universitaet Leipzig Leipzig Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Haga Hospital Hague The Netherlands
Centre Hospitalier Universitaire Rouen Rouen France
Orszagos Onkologiai Intezet Budapest Hungary
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
CHU Gabriel-Montpied Clermont Ferrand France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Bon Secours Hospital Cork Cork Ireland
Hospital Universitario De Jaen Jaen Spain
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Daugavpils regionala slimnica SIA Daugavpils Latvia
Hospital Universitario Virgen De Las Nieves Granada Spain
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
MD Anderson Cancer Center Madrid Spain
Ikazia Ziekenhuis Rotterdam The Netherlands
Hospital La Milagrosa S.A. Madrid Spain
Hospital Universitario Del Vinalopo Elche Spain
Region Vaesternorrland Sundsvall Sweden
Centre Hospitalier Du Puy Le Puy-En-Velay France
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Azienda Ospedaliera di Padova Padua Italy
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
University Of Debrecen Debrecen Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Meander Medical Center Amersfoort The Netherlands
Universita’ Di Pisa Pisa Italy
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Sykehuset Oestfold HF Kalnes Graalum Norway
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Hospital Universitario Lucus Augusti Lugo Spain
Liepajas Regionala Slimnica SIA Liepaja Latvia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Staedtisches Klinikum Dresden Dresden Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Spaarne Gasthuis Hoofddorp The Netherlands
Fakultni Thomayerova nemocnice Prague Czechia
Beaumont Hospital Dublin Ireland
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Nba Lur Glxhsxjjwg Ttalaremqqybs Glns Wiener Neustadt Austria
Ugytahmerl Mrnshlp Ctbtfg Hkpotebzsepejfgup Hamburg Germany
Lkyhx Ukcinjyntoim Mauwioh Cebwthx (aackw Leiden The Netherlands
Hlvbuqps Uvvyfqjogdiuv Mebuhpm Dd Vvncfmmbfx Santander Spain
Cskf Umumxsrypy Hrdzssrg Cork Ireland
Pakxqx fkfe Gawrxkdzpgmhq Goerlitz Germany
Ajqbbtj Ohdtsrslidlsqereaewvvtqqz Dl Cqeqtop Cosenza Italy
Pdgn Ttlje Hxkeelzm Ukywyzrahrys Sabadell Spain
Btnqvbxlrub Vdubrbint Ocjzyjsbmhkm Kecskemet Hungary
Fonldafs ntrzrujhp Maxtl a Hpdyuwi Prague Czechia
Cvdmei Hkzlezkbwau Ea Uojegfqrkxffm Dw Lijizwq Limoges France
Angmssamn Umi Amsterdam The Netherlands
Auyqjqtj Uzpethhnsu Hlhkgtae Lorenskog Norway
Cuxb Dr Nojmt Vandoeuvre Les Nancy France
Azjsaec Unc Iczdy Dj Rzeugz Eomrut Reggio Emilia Italy
Aiyczli Osluyhanlwj Pqkq Ghpwyceb Xoedn Bergamo Italy
Cyyrqn Hlnfujronhk Royzpaak Dfhtpvlyxkchls Angers France
Iagvbvta dy Cjfpcikepvit Hcwvpwseuyl Uyqdjkdtauied dg Ssssw Eythxfc (xkwlous Saint Priest En Jarez France
Hxnclmvs Uowqzzyhhlpzqc Svobowsyum &vmwlyv Hrdjxuv dy Hgsxbmzavrz STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2021
Czechia Czechia
Not recruiting
01.04.2021
France France
Not recruiting
01.04.2021
Germany Germany
Not recruiting
01.04.2021
Hungary Hungary
Not recruiting
01.04.2021
Ireland Ireland
Not recruiting
01.04.2021
Italy Italy
Not recruiting
01.04.2021
Latvia Latvia
Not recruiting
01.04.2021
Norway Norway
Not recruiting
01.04.2021
Spain Spain
Not recruiting
01.04.2021
Sweden Sweden
Not recruiting
01.04.2021
The Netherlands The Netherlands
Not recruiting
01.04.2021

Trial locations

Investigated drugs:

Abelacimab is a medication being studied to see if it can prevent blood clots from coming back in patients who have certain types of cancer, specifically gastrointestinal or genitourinary cancer. The study is looking at how well abelacimab works compared to another medication, focusing on its ability to stop blood clots without causing too much bleeding.

Dalteparin is a medication that is already used to prevent and treat blood clots. In this study, it is being used as a comparison to see if abelacimab is as effective or better at preventing blood clots in patients with specific types of cancer. The goal is to see if abelacimab can provide the same benefits as dalteparin with fewer side effects.

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to the lungs, causing a pulmonary embolism. VTE often occurs in the deep veins of the legs, known as deep vein thrombosis (DVT). In patients with gastrointestinal or genitourinary cancer, the risk of developing VTE is increased due to factors like immobility, cancer treatments, and the cancer itself. The progression of VTE can vary, with some individuals experiencing mild symptoms, while others may have significant swelling, pain, or redness in the affected area. If not managed, VTE can lead to further complications, including chronic pain and swelling in the legs.

Trial ID:
2024-513992-42-00
Protocol code:
ANT-008
NCT ID:
NCT05171075
Trial Phase:
Therapeutic use (Phase IV)

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