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

Pharmacokinetics of apixaban in patients with short bowel syndrome requiring long term parenteral nutrition - ABSORB: Pharmacokinetics of apixaban in short bowel syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001601-23-BE

Enrollment

Registered

2020-05-13

Start date

2020-06-18

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

theoretically none (PK study), but drug is used for prevention or treatment of VTE

Interventions

Trade Name: Eliquis Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - arm A (anticoagulation naive short bowel syndrome patients): - patients with SBS (small bowel length of 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the difference in peak level (Cmax) of apixaban between patients with and without SBS requiring long-term PN;Secondary Objective: - To investigate the difference in estimated trough level (Cmin), time to reach the peak level (Tmax) and area under the time to concentration curve (AUC) between patients with and without SBS requiring long-term PN - To investigate the difference in primary and secondary PK parameters (absorption rate constant, bioavailiability, volume of distribution, clearance and half-life) between patients with and without SBS requiring long-term PN - To describe the population PK and to quantify the impact of SBS on the PK of apixaban;Primary end point(s): To investigate the difference in peak level after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition;Timepoint(s) of evaluation of this end point: after sampling of the final patient	—

Measure

Time frame

Main Objective: To investigate the difference in peak level (Cmax) of apixaban between patients with and without SBS requiring long-term PN;Secondary Objective: - To investigate the difference in estimated trough level (Cmin), time to reach the peak level (Tmax) and area under the time to concentration curve (AUC) between patients with and without SBS requiring long-term PN - To investigate the difference in primary and secondary PK parameters (absorption rate constant, bioavailiability, volume of distribution, clearance and half-life) between patients with and without SBS requiring long-term PN - To describe the population PK and to quantify the impact of SBS on the PK of apixaban;Primary end point(s): To investigate the difference in peak level after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition;Timepoint(s) of evaluation of this end point: after sampling of the final patient

—

Secondary

Measure	Time frame
Secondary end point(s): - To investigate differences in estimated trough level (12h after administration), time to reach peak level and area under the curve (AUC0-12) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition - To investigate the difference in absorption rate constant, bioavailiability, volume of distribution, clearance and half-life between patients with and without short bowel syndrome requiring long-term parenteral nutrition - To perform in silico investigation of optimised dosing schemes taking into account explained interindividual variability (ie, group dosing based on identified covariates) and unexplained interindividual variability (ie, precision dosing based on pharmacokinetics measurements;Timepoint(s) of evaluation of this end point: after sampling of the final patient	—

Measure

Time frame

Secondary end point(s): - To investigate differences in estimated trough level (12h after administration), time to reach peak level and area under the curve (AUC0-12) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition - To investigate the difference in absorption rate constant, bioavailiability, volume of distribution, clearance and half-life between patients with and without short bowel syndrome requiring long-term parenteral nutrition - To perform in silico investigation of optimised dosing schemes taking into account explained interindividual variability (ie, group dosing based on identified covariates) and unexplained interindividual variability (ie, precision dosing based on pharmacokinetics measurements;Timepoint(s) of evaluation of this end point: after sampling of the final patient

—

Countries

Belgium

Contacts

Public ContactKarlien Geboers

University Hospitals of Leuven

karlien.geboers@uzleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026