Understanding how apixaban is processed in patients with short bowel syndrome on long-term nutrition
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
This study is trying to see how well the blood thinner apixaban works in adults with short bowel syndrome who need long-term nutrition through an IV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04344717 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics of apixaban, an anticoagulant, in adult patients suffering from short bowel syndrome (SBS) who require long-term parenteral nutrition. It aims to determine how SBS affects the absorption and effectiveness of apixaban, which is crucial for managing anticoagulation in these patients. The study includes both single-dose and steady-state assessments of apixaban in patients with SBS and healthy controls. By comparing these groups, the research seeks to clarify the drug's behavior in a malabsorptive condition.
Who should consider this trial
Good fit: Ideal candidates include adults with short bowel syndrome on long-term parenteral nutrition who are naive to apixaban and other anticoagulants.
Not a fit: Patients under 18 years old or those who are not Dutch speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anticoagulation management for patients with short bowel syndrome.
How similar studies have performed: While studies on pharmacokinetics in similar conditions exist, this specific investigation into apixaban in SBS is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- University Hospitals Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Barbara Deleenheer, PharmD
- Email: barbara.deleenheer@uzleuven.be
- Phone: 003216342504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.