DRUG
Apixaban single dose
A single dose of apixaban 2.5 mg and 5 mg (wash out period of at least 7 days) will be administered and PK characteristics will be measured
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
Status
Unknown
Phase
Phase 4
Enrollment
84
Locations
1
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
DRUG
Apixaban steady-state
Steady-state apixaban PK characteristics will be measured in patients already treated with apixaban
Timeline
From registration to results.
First posted
Apr 14, 2020
Study start
Dec 20, 2020
Primary completion
Dec 2024
Study completion
Dec 2024
Results posted
Not reported
Registry updated
Feb 23, 2024
Outcomes
What the study measures.
Primary outcomes
Difference in Cmax of apixaban between SBS and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in peak level (Cmax) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
Secondary outcomes
Difference in estimated trough level (Cmin) of apixaban between SBS and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate differences in estimated Cmin (12h after administration) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
Difference in time to reach Cmax (Tmax) of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate differences in Tmax after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
Difference in exposure (AUC0-12h) of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate differences in AUC0-12 after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
Difference in absorption rate constant of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in absorption rate constant between patients with and without SBS requiring long-term PN
Difference in bioavailability of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in bioavailability between patients with and without SBS requiring long-term PN
Difference in volume of distribution of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in volume of distribution between patients with and without SBS requiring long-term PN
Difference in clearance of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in clearance between patients with and without SBS requiring long-term PN
Difference in half-life of apixaban between SBS patients and patients with a normal gastrointestinal tract
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in half-life between patients with and without SBS requiring long-term PN
To set up an optimized dosing scheme of apixaban for SBS patients
Time frame · Through study completion, an average of 1.5 years
To set up an optimized dosing scheme of apixaban, using PK modeling, for SBS patients taking into account identified covariates (eg. sex, age, race...) and PK measurements from outcome 1-9.
Difference in Cmax between SBS patients with and without teduglutide
Time frame · Through study completion, an average of 1.5 years
To investigate the difference in Cmax between SBS patients with and without teduglutide
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- Yes
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
Study locations
1 registered sites.
Belgium. Showing up to 24 locations stored in the fast local snapshot.
University Hospitals Leuven
Leuven, Belgium
Publications
Results and literature.
PMID 24486858 ↗Jeppesen PB. Spectrum of short bowel syndrome in adults: intestinal insufficiency to intestinal failure. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):8S-13S. doi: 10.1177/0148607114520994. Epub 2014 Jan 31.PMID 30136101 ↗Santamaria MM, Villafranca JJA, Abiles J, Lopez AF, Rodas LV, Goitia BT, Navarro PU. Systematic review of drug bioavailability following gastrointestinal surgery. Eur J Clin Pharmacol. 2018 Dec;74(12):1531-1545. doi: 10.1007/s00228-018-2539-9. Epub 2018 Aug 22.PMID 28355459 ↗Eikelboom JW, Quinlan DJ, Hirsh J, Connolly SJ, Weitz JI. Laboratory Monitoring of Non-Vitamin K Antagonist Oral Anticoagulant Use in Patients With Atrial Fibrillation: A Review. JAMA Cardiol. 2017 May 1;2(5):566-574. doi: 10.1001/jamacardio.2017.0364.
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