apixaban for Short bowel syndrome

Inclusion criteria

• {"criterion_text":"- 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\n- informed consent has to be signed\n- patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are apixaban- and vitamin K antagonist naive\n- already been included for arm A1a\n- at least 6 months on teduglutide therapy\n- informed consent has to be signed\n- healthy individuals without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are apixaban- and vitamin K antagonist naive\n- informed consent has to be signed\n- 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\n- informed consent has to be signed\n- 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\n- informed consent has to be signed"}

Exclusion criteria

• {"criterion_text":"- <18 years\n- non-Dutch/French speaking\n- recent (<6 months) gastrointestinal surgery (only for arm A)\n- gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, …) (only for arm A)\n- gastrointestinal fistulae (only for arm A)\n- SBS with intestinal failure resulting from gastric bypass surgery (only for arm A)\n- recent (<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients\n- creatinine clearance of < 15 mL/min or dialysis dependent\n- liver failure classified as Child Pugh C\n- total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal)\n- presence of coagulopathy and a clinically relevant bleeding risk\n- pregnancy or lactation\n- concomitant intake of strong combined inhibitors of CYP3A4 and P-gp\n- participation in a recent (<1 month) trial with an investigational product"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Difference in peak concentration (Cmax) of apixaban after two single dose administrations (2.5 mg and 5 mg) between patients with and without short bowel syndrome requiring long-term parenteral nutrition"}

Belgium

Earliest CTIS Part Ii Submission Date

30-04-2024

Latest Decision Or Authorization Date

14-05-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

84

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium