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Clinical Trials List

Protocol NumberANT-007
NCT Number(ClinicalTrials.gov Identfier)NCT05171049
Completed

2022-04-01 - 2027-03-26

Phase III

Recruiting8

ICD-10I82.0

Budd-Chiari syndrome

ICD-9453.0

Budd-Chiari syndrome

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 邱倫瑋 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHENG-HSIEN LIN Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Hua Hsiao Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Sheng-chieh Chou Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 余垣斌 Division of Hematology & Oncology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Venous Thromboembolism

Objectives

評估在癌症且最近診斷出 VTE 的患者隨機分配後 6 個月時，abelacimab在預防 VTE 復發方面是否不劣於apixaban。

Test Drug

注射劑

Active Ingredient

Abelacimab

Dosage Form

270

Dosage

150mg

Endpoints

•評估在隨機分配後 6 個月時，abelacimab在預防嚴重出血或 CRNM 出血的複合事件發生方面是否優於apixaban
•評估abelacimab在淨臨床效益方面是否優於apixaban，淨臨床效益是指隨機分配後 6 個月時無 VTE 復發或嚴重出血或 CRNM 出血事件的生存率
•評估在隨機分配後 6 個月時，abelacimab在預防 VTE 復發方面是否優於apixaban
•評估在隨機分配後 6 個月時，abelacimab在非死亡原因導致的永久停止治療的比率方面是否優於apixaban
•評估在隨機分配後 6 個月時，abelacimab在預防 CRNM 出血事件發生方面是否優於apixaban
•評估在隨機分配後 6 個月時，abelacimab在預防嚴重出血事件發生方面是否優於apixaban
•評估在隨機分配後 6 個月時，abelacimab在預防 GI 嚴重出血和 GI CRNM 出血的複合事件發生方面是否優於apixaban
•評價直到隨機分配後 6 個月時，abelacimab相對於apixaban的安全性和耐受性，並評估接受abelacimab治療患者的注射部位反應、過敏反應和免疫原性的發生率

Inclution Criteria

Inclusion Criteria:

Male or female subjects ≥18 years old or other legal maturity age according to the country of residence
Confirmed diagnosis of cancer (by histology, adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:

Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization and/or
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 deep vein thrombosis (DVT) (i.e., popliteal, femoral, iliac, and/or inferior vena cava [IVC] thrombosis) and/or a confirmed symptomatic pulmonary embolism (PE), or an incidental PE in a segmental, or larger pulmonary artery.
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

Exclusion Criteria

Exclusion Criteria:

Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) 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 VTE treatment prior to randomization (e.g., atrial fibrillation [AF], mechanical heart valve, prior VTE)
Platelet count <50,000/mm3 at the screening visit
PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or shock)
Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within the 4 weeks preceding screening
Brain trauma or a cerebral or spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia within 4 weeks of screening
Need for aspirin in a dosage of >100 mg/day or any other antiplatelet agent alone or in combination with aspirin
Primary brain cancer or untreated intracranial metastases at baseline
Acute myeloid or lymphoid leukemia
Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
Life expectancy <3 months at randomization
Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation) at the screening visit
Hemoglobin <8 g/dL at the screening visit
Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase (ALT) ≥3 x and/or bilirubin ≥2 x upper limit of normal (ULN) at the screening visit in absence of clinical explanation
Uncontrolled hypertension (systolic BP>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 apixaban 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 apixaban 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 excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
Subjects with any condition that in the Investigator's judgement 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(s) (PD) effect has returned to baseline, whichever is longer. Participation in academic non-interventional studies or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted

The Estimated Number of Participants

  • Taiwan

    37 participants

  • Global

    1655 participants

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