Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition (ABSORB)
Short Bowel Syndrome, Anticoagulation
About this trial
This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Apixaban, Pharmacokinetics
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 anticoagulation 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 anticoagulation 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 other anticoagulant agents
- 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 other anticoagulant agents
- 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
Sites / Locations
- University Hospitals LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Other
Other
Experimental
Anticoagulation and teduglutide naive short bowel syndrome
Healthy volunteers
Short bowel syndrome on apixaban
Patients with a normal gastrointestinal tract on apixaban
Anticoagulation naive short bowel syndrome on teduglutide
Anticoagulation and teduglutide naive patients with short bowel syndrome requiring long term parenteral support
Anticoagulation naive healty volunteers
Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily
Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily
Anticoagulation naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide