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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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 resection. It remains unclear to what extent apixaban exposure is impacted in SBS.Therefore this study tries to investigate the pharmacokinetics (PK) of apixaban in adult patients with SBS requiring long-term parenteral nutrition (PN).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• SBS patients: patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) PN or fluids who are anticoagulation naive

• normal gastrointestinal tract patients: patients without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are anticoagulation naive and have to start anticoagulation for non-valvular atrial fibrillation with apixaban 2,5 mg or 5 mg twice daily

Exclusion Criteria:

• for both groups:

• <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 (<3 months) trial with an investigational product

• for SBS patients only:

• 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