2024-512061-14-00招募中4 期
Pharmacokinetics of apixaban in patients with short bowel syndrome requiring long-term parenteral nutrition.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To investigate the difference in peak level after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
研究概览
简要总结
To investigate the difference in peak concentration (Cmax) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Arm A1a (apixaban-, vitamin K antagonist- and teduglutide naive short bowel syndrome (SBS) patients): - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are apixaban-, vitamin K antagonist- and teduglutide naive - informed consent has to be signed Arm A1b (apixaban- and vitamin K antagonist naive short bowel syndrome (SBS) patients): - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are XML File Identifier: MKk2ji91wd+iKlQV0oUrZ4sx7H0= Page 10/20 apixaban- and vitamin K antagonist naive - already been included for arm A1a - at least 6 months on teduglutide therapy - informed consent has to be signed Arm B1 (apixaban- and vitamin K antagonist naïve healthy volunteers with normal gastrointestinal tract): - healthy individuals without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are apixaban- and vitamin K antagonist naive - informed consent has to be signed Arm A2 (teduglutide naïve SBS patients on apixaban therapy) - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are teduglutide naive and who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days - informed consent has to be signed Arm B2 (patients with normal gastrointestinal tract on apixaban therapy): - patients without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days - informed consent has to be signed
排除标准
- •<18 years - non-Dutch/French speaking - recent (<6 months) gastrointestinal surgery (only for arm A) - gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, …) (only for arm A) - gastrointestinal fistulae (only for arm A) - SBS with intestinal failure resulting from gastric bypass surgery (only for arm A) - recent (<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients - creatinine clearance of < 15 mL/min or dialysis dependent - liver failure classified as Child Pugh C - total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal) - presence of coagulopathy and a clinically relevant bleeding risk - pregnancy or lactation - concomitant intake of strong combined inhibitors of CYP3A4 and P-gp - participation in a recent (<1 month) trial with an investigational product
结局指标
主要结局
To investigate the difference in peak level after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
To investigate the difference in peak level after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
次要结局
未报告次要终点
研究者
Deleenheer Barbara
Scientific
UZ Leuven
研究点 (1)
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