EUCTR2013-002114-12-DE进行中（未招募）1 期
Open-label, randomized, parallel-group, active-controlled, multi-centre, non-inferiority study of dabigatran etexilate versus standard of care for venous thromboembolism treatment in children from birth to less than 18 years of age - The DIVERSITY study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
- •- Documented diagnosis of clinically stable VTE (e.g. DVT, PE, central line thrombosis, sinus vein thrombosis) per investigator judgment, initially treated (minimum 5 to 7 days, but not longer than 21 days) with parenteral anticoagulation therapy, such as unfractionated heparin (UFH) or a low molecular weight heparin (LMWH).
- •- Anticipated treatment duration with anticoagulants for the VTE episode (under inclusion 2) for at least 3 month period, inclusive of the initial parenteral therapy
- •- Written informed consent provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 141
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Conditions associated with an increased risk of bleeding
- •- Renal dysfunction (eGFR < 50 mL/min/1.73m2 for all patients using the Schwartz formula) or requirement for dialysis
- •- Active infective endocarditis
- •- Subjects with a heart valve prosthesis requiring anticoagulation
- •- Hepatic disease: Active liver disease, including known active hepatitis A, B or C or,
- •Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening. Transient increases of these parameters are acceptable, if retesting demonstrates results within these limits
- •- Pregnant or breast feeding females. Females who have reached menarche and are not using a medically accepted contraceptive method per local guidelines. Acceptable methods of birth control may include: Intra Uterine Device (IUD); oral, implantable or injectable contraceptives and estrogen patch; double barrier method (spermacide + diaphragm); or abstinence at the discretion of the investigator
- •- Patients in 0 to < 2 years with gestational age at birth < 37 weeks or with body weight lower than the 3rd percentile (according to the WHO Child growth standards)
- •- Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
- •- Patients who have taken prohibited or restricted medication within one week of the first dose of study medication other than medication for prior VTE treatment and P-glycoprotein inhibitors.
- •- Patients who have received an investigational drug in the past 30 days prior to screening
- •- Patients who are allergic/sensitive to any component of the study medication including solvent
- •- Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
- •- Patients or parents/legal guardians who are unwilling or unable to undergo or permit repeat of the baseline imaging tests required to confirm thrombus resolution at study day 84 (or at eEOT, whichever comes first) or in whom repeating such imaging tests at these pre-specified time points may not be medically in the patient’s best interest. Examples may include unwarranted radiation exposure as a result of a repeat CT scan at study day 84 (or eEOT, whichever comes first) for a patient with an isolated case of pulmonary embolism evaluated at baseline solely by a CT scan. In such cases, the baseline radiological assessment (e.g. CT) may be supplemented with an acceptable non-radiological assessment at baseline (e.g. MRI) which could then be repeated at day 84 (or eEOT, whichever comes first) hence alleviating any potential unwarranted radiation exposure
研究者
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