NL-OMON38688已完成不适用
Pharmacokinetics and *dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study) - AMC_PDER_PA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
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
- •Inclusion criteria are:
- •- clinically stable adult male and female patients (age between 18 and 75 years),
- •- body weight between 50 and 100 kg,
- •- chronic (>3 months) use of home TPN due to short bowel syndrome after surgical resection and small bowel shorter than 160 cm after ligamentum of Treitz, irrespective of the presence of colon,
排除标准
- •Exclusion criteria are:
- •- moderate/severe renal impairment (CKD EPI Creatinine Clearance < 50 mL/min according to http://www.nephron.com/MDRD_GFR.cgi), or moderate/severe hepatic impairment (class B (7-9 points) or class C (10-15 points) at the Child-Pugh score),
- •- major bleeding events in the previous 6 months (according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients),
- •- cytochrome P450 3A4 and/or P-gp-dependent co-medications in the last 14 days (verapamil, azoles, amiodarone, dronedarone, azithromycin, erythromycin, clarythromycin, quinidine, ritonavir, cyclosporine, propafenone, isoniazid, rifampin, rifapentine, primidone, St. John*s wort, carbamazepine, oxcarbazepine, phenobarbital, pentobarbital, nevirapine, nafcillin, fosphenonytoin),
- •- ongoing anticoagulant treatment for an acute thrombotic event (prior 6 months) or for a condition estimated to be at high risk of recurrence (i.e., presence of mechanical heart valve),
- •- use of phenprocoumon,
- •- chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), or chronic treatment with aspirin (>100 mg/day), or dual antiplatelet therapy,
- •- current participation in any other investigational drug study or within the past 30 days,
- •- pregnancy,
- •- partial or total gastrectomy, and/or resection of the duodenum for any cause,
- •- presence of any condition that, as judged by the investigator, would place the subject at increased risk of harm if he participated in the study (i.e., recent CVC-related infection, sepsis)
- •- presence of significant haemostatic abnormalities (i.e., severe thrombocytopenia, severe prolongation of haemostatic tests PT and aPTT) in patients that are not being treated with any anticoagulant.
研究者
相似试验
招募中
不适用
Pharmacokinetics and –dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study)parenteral nutrition, thrombosis, pharmacokinetics, pharmacodynamics, anticoagulantNL-OMON26342Academic Medical Center, Amsterdam, The Netherlands6
已完成
1 期
Pharmacokinetics, Safety and Pharmacodynamics After Multiple Oral Doses of Dabigatran Etexilate Capsule in Healthy Japanese and Caucasian Male SubjectsHealthyNCT02171468Boehringer Ingelheim48
进行中（未招募）
1 期
Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve significant levels and thrombin inhibiting activity in the eye?Ocular accessibility of dabigatran in patients with retinal detachmentEUCTR2014-000388-41-NLThe Rotterdam Eye Hospital28
已完成
不适用
Does oral administration of dabigatran etexilate, a direct thrombin inhibitor, achieve clinical significant concentrations of dabigatran and thrombin inhibiting activity in vitreous and subretinal fluid?10015917proliferative vitreoretinopathyNL-OMON40980Oogziekenhuis Rotterdam24
进行中（未招募）
1 期
ninterrupted dabigatran etexilate in comparison to uninterrupted warfarin in pulmonary vein ablation (RE-CIRCUIT)Patients with non-valvular atrial fibrillation (NVAF) undergoing catheter ablation for atrial fibrillationMedDRA version: 18.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: PTClassification code 10043634Term: Thrombosis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2014-003890-40-ESBoehringer Ingelheim España, S.A.795