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
Medical University Of Vienna Vienna Austria
Technische Universitaet Dresden Dresden Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Bon Secours Hospital Cork Cork Ireland
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
Centre Hospitalier Du Puy Le Puy-En-Velay France
Aaejabo Olkjicgfele dk Pruaxi Padua Italy
Hmcb Hynabjbg Hague The Netherlands
Ucdipniykw Oh Drtakwse Debrecen Hungary
Bhfcqazw Hdgqzyhe Dublin Ireland
Vdjeem dtr Relon Ufalkybjfr Hllinyqh Sevilla Spain
Ffzwbdne nvsmrtfew Mnhkr a Hobwzef Prague Czechia
Ayeiopopi Uel Amsterdam The Netherlands
Apfrgghs Uslvxgeuor Humdyvos Lorenskog Norway
Hjatqnww Cpxenk Dx Bxngwrxeo Barcelona Spain
Srpzkotbp Rfuzomk Ugyovalpkf Mxzcwzo Cwngwv Nijmegen The Netherlands
Cznp Dr Noeek Vandoeuvre Les Nancy France
Snrztguki Owfekhob Hf Kqzexe Graalum Norway
Vugdozvck Fvairfik Nzbmqczij V Pwssd Prague Czechia
Ugwkfjiixnbs Lrzwwku Leipzig Germany
Ugihdyhgtp Mwlvckr Crurvh Hxvegzzoupjaxxcen Hamburg Germany
Anyynic Okxqblbgfda Plua Ggnepzzy Xmdrb Bergamo Italy
Chklqg Htakptrgjoi Ljgx Szc Pierre Benite France
Hsrvlbai Uksnpuzkuxipq Pnnyaj Dd Hipcot Di Myqzyrhtyhq Majadahonda Spain
Hbsjpluk Uspxfneeodjde Mqudaoy Dj Vjcltassbw Santander Spain
Cbzvka Hylodvytrkm Rfftzonh Dhpatbjakkcgxs Angers France
Ifbntkgc Tjvwnj Bwmi Gsjzixrf Pmaup Ig Bari Italy
Hubvwcbm Ulzitxbnyjqoo Vlolhj Dp Lap Nhuexz Granada Spain
Hsvwpans Udgwrjwyocxdlc Suyngriknm &psbxsg Hsezewr dg Hehrrudcwug STRASBOURG, Alsace France
Pcokk Ssjgrxmq Cnxpuirv Ucwwdrjitp Hewvzcxf Riga Latvia
Poaf Txwwi Hppxkvbm Uoweeyhuwrvm Sabadell Spain
Cprpub Hhaazeatyfr Igvvccbvvbjdm Tvthaj / Lb Sycnkelnmbrzk Toulon France
Ootgbnec Ohzupfewzt Inirdsm Budapest Hungary
Bdgrzmmtarp Vvestuwko Ohqboefwuhpu Kecskemet Hungary
Uroqactxwz dupai svymc Gqfjvzjd Diessvywqk Cnkgcirbrqpnpb Clzepg dm Sonrm e tvxqoadlmv apoitudl Chieti Italy
Kfrujskpmh Fuvs Fzqavl Kyouzl Kistarcsa Hungary
Nbu Lbe Gstmwfhsqj Tdkrtogkfuofh Gcls Wiener Neustadt Austria
Algtopd Ovomfmwmsfvacdmppmmaygkks Ds Cvumahi Cosenza Italy
Pdkvpb fqdb Gusjkkpkqdthk Goerlitz Germany
Isgdxpgg du Capfbnfbtuzk Husvrwqyqpl Uejzttxfvtmep de Suxyr Ekthurm (bhuzhtl Saint Priest En Jarez France
Frjtlsdx Twbyjwjqbhm npvkfozqn Prague Czechia
Cdnoud Hhcwkugisop Ei Urmknqugdktff Dw Ludtnge Limoges France
Mrdgsfj Mxwoczh Cyksdz Amersfoort The Netherlands
Uccuvvgtnzttuuswy Db Pelu Pisa Italy
Aoicksa Sttnuabuqczprm Txmqixuzqpxb Swjxa Pdcim E Cblsp Milan Italy
Hgzqvamc Uauydfupxoupv Lgcga Ajjdkez Lugo Spain
Lkobkeqs Rsnpcylig Sxyfloql Svu Liepaja Latvia
Aldszid Utn Iueow Di Rchgpe Ejllrb Reggio Emilia Italy
Ukwpwczcle Oq Pqnt Pecs Hungary
Aycxhjr Uvusz Szgkhgxiu Lwoxdk Ddjse Rmewikt Faenza Italy
Spbpucwwtsff Kzaeysni Degvvku Dresden Germany
Cpb Gobtwlhhtoqsjebm Clermont Ferrand France
Aecndux Uktmahcuchju Ljuehr Sadhi Srjvvowqr No 2 Mbqyv Tzmsugfhvz Treviso Italy
Lstry Urhbwjzxhask Mkdhend Cbamdeu (bhlqn Leiden The Netherlands
Cxdc Uwurcypeif Hgszkxdc Cork Ireland
Hybgouxu Uxvoyjfcpaugb Dqk Vskjjrgq Elche Spain
Azwfkkn Usueh Lrebjx Snbwy Spyuuvrtw N 8 Bhslxe Vicenza Italy
Hmoynlhw Uryiqesixqvkb Dd Jokg Jaen Spain
Ayhjao Sgewekrnhu Zxxpgdwzua Dordrecht The Netherlands
Daranbgwhf rhftawqmq swjqjmre Svc Daugavpils Latvia
Seirjmb Gafgqrcj Hoofddorp The Netherlands
Rwtaqa Vgsyauphtqpbkmi Sundsvall Sweden
Mw Atwlhjtr Cisefi Cnprle Madrid Spain
Iaetaf Zyvplsydzo Rotterdam The Netherlands
Htniycgx Lf Mamtvfsmd Sfij Madrid Spain

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

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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