CTIS2024-513992-42-00招募中1 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) - ANT-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,008
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 65+（—）
- 性别
- All
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: Unresectable, locally advanced, metastatic, or non-metastatic GI/GU cancer and No intended curative surgery during the study, 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 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 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., History of heparin-induced thrombocytopenia, Infective acute or subacute endocarditis at the time of presentation, Primary brain cancer or untreated intracranial metastasis, 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, Platelet count <50,000/mm3 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, More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, or other anticoagulants., 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 noninterventional studies or interventional studies testing different strategies or different combinations of registered drugs is permitted., 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 shock), Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks of 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, Bleeding requiring medical attention at the time of randomization or within the preceding 4 weeks, Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization
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