A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI) / genitourinary (GU)

Clinical Trial Details

This clinical trial is for men and women with gastrointestinal (GI) or genitourinary (GU) cancers who have been diagnosed with a blood clot called a venous thromboembolism (VTE) which can include deep venous thrombosis (DVT) in the leg veins, and/or a pulmonary embolism (PE), which is a clot in the pulmonary artery in the lungs.

The purpose of this study is to see if participants taking the study drug abelacimab have fewer bleeding events compared to those taking dalteparin. Dalteparin is a blood thinner approved by the United States Food and Drug Administration (FDA) to treat patients with an increased risk of blood clots.

Abelacimab is an antibody (a type of protein made by the immune system) that binds to another protein and plays an important role in blood clot formation. Abelacimab is not yet approved by the FDA for this use.

The total amount of time that participants are anticipated to be in the study is approximately 8 months.

Key Eligibility:

People over the age of 18 years old
Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers
Diagnosed with a venous thromboembolism (VTE), deep venous thrombosis (DVT) and/or a pulmonary embolism (PE)

Detailed eligibility will be reviewed with the study team.

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