Trials / Terminated
TerminatedNCT05171075
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 417 (actual)
- Sponsor
- Anthos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Abelacimab | Abelacimab 150 mg |
| DRUG | Dalteparin | Dalteparin 200 IU/kg/day followed by 150 IU/kg/day |
Timeline
- Start date
- 2022-09-27
- Primary completion
- 2026-04-10
- Completion
- 2026-04-10
- First posted
- 2021-12-28
- Last updated
- 2026-04-17
Locations
117 sites across 20 countries: United States, Australia, Austria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05171075. Inclusion in this directory is not an endorsement.