Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Apr 9, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called apixaban works in people with a condition known as short bowel syndrome (SBS). SBS affects how the small intestine absorbs nutrients, which can also impact how well medications are absorbed. The researchers want to understand how apixaban is processed by the body in adults with SBS who are receiving long-term nutrition through an intravenous (IV) line. This study will help determine if patients with SBS need different doses of apixaban compared to those without the condition.

To participate in this trial, you must be an adult with SBS who has been on long-term IV nutrition for at least three months and has never taken apixaban or similar blood-thinning medications. Alternatively, you could qualify if you're healthy and have no history of surgeries that affect the intestines. Participants will receive either a single dose of apixaban or take it regularly for several days, depending on their group. Throughout the study, participants will be monitored closely to gather information about how their bodies respond to the medication. If you're considering joining this trial, it's important to discuss it with your healthcare provider to understand how it may affect your health.

Gender

ALL

Eligibility criteria

• Inclusion criteria SBS single dose:
• • - patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are apixaban-, vitamin K antagonist- and teduglutide naive
• Inclusion criteria SBS steady-state:
• • - patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are teduglutide naive and who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days
• Inclusion criteria non-SBS single dose:
• • - healthy individuals without history of GI resections or other conditions associated with impaired absorption, who are apixaban- and vitamin K antagonist naive
• Inclusion criteria non-SBS steady-state:
• • - 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
• Exclusion criteria SBS (single dose+ steady-state):
• • \<18 years
• • non-Dutch speaking
• • recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20)
• • 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
• • recent (\<6 months) gastrointestinal surgery
• • gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, ...)
• • gastrointestinal fistulae
• • SBS with intestinal failure resulting from gastric bypass surgery
• Exclusion criteria non-SBS (single dose+ steady-state):
• • \<18 years
• • non-Dutch speaking
• • recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20)
• • 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
• • use of prokinetics, antimotility drugs or opioids
• • participation in a recent (\<1 month) trial with an investigational product