NL-OMON53552招募中3 期
A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing 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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female subjects >=18 years old or other legal maturity age according
- •to the country of residence
- •Confirmed GI (colorectal, pancreatic, gastric, esophageal, gastro-esophageal
- •junction or hepatobiliary) or confirmed GU (renal, ureteral, bladder, prostate,
- •or urethra) cancers if:
- •o Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and
- •o No intended curative surgery during the study
- •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 LMWH for at least 6 months is indicated.
- •Able to provide written informed consent
排除标准
- •Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to
- •treat the current (index) DVT and/or PE
- •More than 72 hours of pre-treatment with therapeutic doses of UFH, LMWH, or
- •other anticoagulants
- •An indication to continue treatment with therapeutic doses of an
- •anticoagulant other than that for VTE treatment prior to randomization (e.g.,
- •AF, mechanical heart valve, prior VTE)
- •PE leading to hemodynamic instability (blood pressure [BP] <90 mmHg or
- •Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4
- •weeks of screening
- •Brain trauma or a cerebral or spinal cord surgery 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
- •Bleeding requiring medical attention at the time of randomization or within
- •the preceding 4 weeks
- •Planned major surgery at baseline
- •History of heparin-induced thrombocytopenia
- •Primary brain cancer or untreated intracranial metastasis
- •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at
- •Life expectancy <3 months at randomization
- •Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault
- •Platelet count <50,000/mm3
- •Hemoglobin <8 g/dL
- •Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
- •aminotransferase (ALT) >=3 x and/or bilirubin >=2 x upper limit of normal (ULN)
- •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 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
- •History of hypersensitivity to any of the study drugs (including dalteparin)
- •or its excipients, to drugs of similar chemical classes, or any
- •contraindication listed in the label for dalteparin
- •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 PD effect has returned to baseline,
- •whichever is longer. Participation in academic non-interventional studies or
- •interventional studies testing different strategies or different combinations
- •of registered drugs is permitted.
研究者
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