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A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
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).
Study details:
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 criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-09-27
Primary completion: 2026-12-01
Study completion finish: 2027-02-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05171075
Intervention or treatment
BIOLOGICAL: Abelacimab
DRUG: Dalteparin
Conditions
- • Venous Thromboembolism
- • Deep Venous Thrombosis
- • Pulmonary Embolism
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Northern Health
Epping, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Abelacimab
| BIOLOGICAL: Abelacimab
|
ACTIVE_COMPARATOR: Dalteparin
| DRUG: Dalteparin
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Time to first event of centrally adjudicated VTE recurrence consisting of new proximal deep venous thrombosis, new pulmonary embolism (PE) or fatal PE, including unexplained death for which PE cannot be ruled out | Not Specified | 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Time to first event of ISTH-adjudicated major or clinically relevant non-major (CRNM) bleeding events | Not Specified | 6 months |
Net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding | Not Specified | 6 months |
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