Pharmacokinetics of apixaban in patients with short bowel syndrome requiring long term parenteral nutritio

Phase 1

Conditions: theoretically none (PK study), but drug is used for prevention ortreatment of VTE
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2020-001601-23-BE

Lead Sponsor: niversity Hospitals of Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

- arm A (anticoagulation naive short bowel syndrome patients):
- patients with SBS (small bowel length of <2m after Treitz ligament)
on long term (>3 months) PN or fluids who are anticoagulation naive
- informed consent has to be signed
- Arm B (patients with normal gastrointestinal tract starting on
apixaban treatment):
- patients without history of GI resections or other conditions
associated with impaired absorption (= controls), who are
anticoagulation naive and have to start anticoagulation for non-valvular
AF with apixaban 2,5 mg or 5 mg twice daily (depending on patient
characteristics cfr. 3.4.)
- informed consent has to be signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81

Exclusion Criteria

- <18 years
- non-Dutch speaking
- recent (<6 months) GI surgery (only for arm A)
- GI mucosal disease interfering with absorption (e.g. radio-enteritis,
inflammatory bowel disease, celiac disease, …) (only for arm A)
- GI 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 (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 (<3 months) trial with an investigational
product