Pharmacokinetics of apixaban in patients with short bowel syndrome requiring long-term parenteral nutrition.
- Conditions
- short bowel syndrome
- Registration Number
- 2024-512061-14-00
- Lead Sponsor
- UZ Leuven
- Brief Summary
To investigate the difference in peak concentration (Cmax) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 84
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
- <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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium
UZ Leuven🇧🇪Leuven, BelgiumTim VanuytselSite contact003216341973tim.vanuytsel@uzleuven.be