Status:
UNKNOWN
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Short Bowel Syndrome
Anticoagulation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Short bowel syndrome (SBS) is defined as a loss of function of the small intestine resulting in a malabsorptive disorder. In SBS, oral drug absorption may be altered due to extensive intestinal resect...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04344717
Start Date
December 20 2020
End Date
December 1 2024
Last Update
February 23 2024
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000