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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Anthos Therapeutics, Inc.
Study ID
NCT05171075
Phase
PHASE3
Status
Terminated

Conditions

  • Deep Venous Thrombosis
  • Pulmonary Embolism
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abelacimab — BIOLOGICAL
    Abelacimab 150 mg
  • Dalteparin — DRUG
    Dalteparin 200 IU/kg/day followed by 150 IU/kg/day

Study Details

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)

Key Dates

Start date
Sep 27, 2022
Status verified
Apr 2026
Primary completion
Apr 10, 2026
Completion
Apr 10, 2026

Study Design

Enrollment
417 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Abelacimab
    Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously
  • Active Comparator: Dalteparin
    Dalteparin administered subcutaneously daily

Primary Outcome Measure

Time to first event of centrally adjudicated VTE recurrence [ Time Frame: up to 6 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Washington DC VAMCWashington D.C.District of Columbia20422-
NorthShore University Health SystemEvanstonIllinois60201-
Barnes-Jewish HospitalSt LouisMissouri63110-
Memorial Sloan Kettering Cancer Center-MiddletownMiddletownNew Jersey07748-
Memorial Sloan Kettering Cancer Center-CommackCommackNew York11725-
Memorial Sloan Kettering Cancer Center-West HarrisonHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-0005-
Weill Cornell Medical CollegeNew YorkNew York10021-
Duke University Medical CenterDurhamNorth Carolina27705-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-

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