Trials / Terminated
TerminatedNCT05171049
A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,150 (actual)
- Sponsor
- Anthos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
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. The two most common treatments today are low molecular weight heparin (LMWH) and direct anticoagulants (DOACs), in which each has limitations. DOACs are administered orally and are seen as a more convenient alternative though associated with bleeding risk; further, some cancer patients have difficulty swallowing or develop vomiting which leads to unpredictable pharmacodynamic effects with oral therapy. The ANT-007 study will compare treatment with abelacimab monthly administration to apixaban twice daily administration over a 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 | Apixaban | Apixaban 10 mg followed by 5 mg |
Timeline
- Start date
- 2022-05-05
- Primary completion
- 2026-02-04
- Completion
- 2026-02-04
- First posted
- 2021-12-28
- Last updated
- 2026-02-23
Locations
209 sites across 21 countries: United States, Australia, Austria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05171049. Inclusion in this directory is not an endorsement.