venous thromboembolism (VTE)
Conditions
Sponsors
Anthos Therapeutics
Eligibility
Sex/Gender
All
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: oActive cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or oCurrently 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 DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic or incidental PE of a segmental, or larger pulmonary artery, and/or a confirmed symptomatic or incidental PE of two or more subsegmental pulmonary arteries. Patients are eligible within 120 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 828 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 827
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 120 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 180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment) •Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab (See Section 5.3.6 for highly effective contraceptive measures). •Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab •Pregnant or breast-feeding women •Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P-gp •History of hypersensitivity to any of the study drugs (including apixaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban •Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study •Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months post randomization in patients with cancer and recently diagnosed VTE. If non-inferiority is demonstrated, then superiority will be assessed.;Secondary Objective: •To assess whether abelacimab is superior to apixaban for preventing occurrence of the composite of major or CRNM bleeding •To assess whether abelacimab is superior to apixaban on net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding events •To assess whether abelacimab is superior to apixaban on the rate of permanent treatment discontinuation not due to death •To assess whether abelacimab is superior to apixaban for preventing occurrence of CRNM bleeding events •To assess whether abelacimab is superior to apixaban for preventing occurrence of major bleeding events •To assess whether abelacimab is superior to apixaban for preventing the occurrence of the composite of GI major and GI CRNM bleeding •To evaluate safety and tolerability of abelacimab relative to apixaban and to assess incidence rate of injection site reactions, hypersensitivity reactions and immunogenicity in patients treated with abelacimab ;Primary end point(s): Time to first event of centrally adjudicated VTE recurrence through 6 months;Timepoint(s) of evaluation of this end point: 6 months post randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first event of ISTH-adjudicated major or CRNM bleeding events through 6 months 2. Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated CRNM bleeding events through 6 months 3. Time to event of permanent treatment discontinuation not due to death 4. Time to first event of ISTH-adjudicated CRNM bleeding events through 6 months 5. Time to first event of ISTH-adjudicated major bleeding events through 6 months 6. Time to first event of GI ISTH-adjudicated major and CRNM bleeding events through 6 months 7. All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient years • For patients treated with abelacimab: o Percentage of patients with injection site reactions o Percentage of patients with injection site reactions by severity status o Percentage of patients with hypersensitivity reactions o Percentage of patients with hypersensitivity reactions by severity status o Percentage of patients with ADA formation o Percentage of patients with persistent ADA formation o Percentage of patients with neutralizing antibody (NAb) formation.;Timepoint(s) of evaluation of this end point: 6 months post randomization | — |
Countries
Australia, Austria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Republic of, Latvia, Netherlands, Norway, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactInformation Desk
Anthos Therapeutics
Outcome results
None listed