venous thromboembolism
Conditions
Interventions
1. Abelacimab 150 mg iv on Day 1 then, starting approximately 30 days later,
abelacimab 150 mg sc every month for an additional 5 months
(sc administration planned on Days 31, 61, 91, 121, and 151 ±
Sponsors
Anthos Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female subjects >=18 years old or another legal maturity age according to the country of residence • Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following: o Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/oro Currently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months. • Confirmed symptomatic or incidental proximal lower limb acute DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic PE, or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 72 hours from diagnosis of the qualifying VTE. • Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated. • Able to provide written informed consent.
Exclusion criteria
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 72 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants • An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE) • Platelet count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months post andomization in patients with cancer and recently diagnosed VTE. If non- nferiority is demonstrated, then superiority will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess whether abelacimab is superior to apixaban for preventing occurrence of the composite of major or CRNM bleeding at 6 months post randomization • To assess whether abelacimab is superior to apixaban on net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding events at 6 months post randomization • To assess whether abelacimab is superior to apixaban on the rate of permanent treatment discontinuation not due to death at 6 months post randomization • To assess whether abelacimab is superior to apixaban for preventing occurrence of CRNM bleeding events at 6 months post randomization • To assess whether abelacimab is superior to apixaban for preventing occurrence of major bleeding events at 6 months post randomization • To assess whether abelacimab is superior to apixaban for preventing the occurrence of the composite of GI major and GI CRNM bleeding at 6 months post randomization • To evaluate safety and tolerability of abelacimab relative to apixaban through 6 months post randomization and to assess the incidence of injection site reactions, hypersensitivity reactions and immunogenicity in patients treated with abelacimab | — |
Countries
Netherlands
Outcome results
None listed