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A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

NCT05171075•Anthos Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

Detailed Description

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
•Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate, or urethra) cancers if:
•* Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
•* No intended curative surgery during the study
•Confirmed symptomatic or incidental proximal lower limb deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
•Anticoagulation therapy with LMWH for at least 6 months is indicated
•Able to provide written informed consent

Exclusion Criteria

•Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
•More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants
•An indication to continue treatment with therapeutic doses of an anticoagulant other than for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
•PE leading to hemodynamic instability (systolic BP \<90 mmHg or shock).
•Acute ischemic or hemorrhagic stroke or intracranial hemorrhage, in the last 4 weeks preceding screening.
•Brain trauma, or cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
•Need for aspirin in a dosage of more than 100 mg/day or, any other antiplatelet agent alone or in combination with aspirin
•Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
•Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
•History of heparin induced thrombocytopenia
+15 more criteria

Locations (117)

Washington DC VAMC

Washington D.C., District of Columbia, United States

NorthShore University Health System

Evanston, Illinois, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center-Middletown

Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center-Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center-West Harrison

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

September 27, 2022

Primary Completion Date

December 31, 2026

Completion Date

February 28, 2027

Last Updated

December 19, 2025

Enrollment

417

ACTUAL participants

Conditions

Venous ThromboembolismDeep Venous ThrombosisPulmonary Embolism

Interventions

Abelacimab

BIOLOGICAL

Dalteparin

DRUG

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

NCT06183944

Pulmonary Embolism

View study

RECRUITINGNA

CLEANer Aspiration for Pulmonary Embolism

NCT06189313

Pulmonary EmbolismAcute Pulmonary Embolism+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

Inclusion Criteria

Exclusion Criteria

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

CLEANer Aspiration for Pulmonary Embolism

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