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Trial · Interventional

CompletedPhase 4Registry data

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

Short name ABSORB

NCTNCT04344717 (opens ClinicalTrials.gov in a new tab)Other ids63950
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
70 participants (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Belgium

Start
20 Dec 2020
Primary completion
30 Sept 2025
Completion
30 Sept 2025
First posted
14 Apr 2020
Last update posted
15 Oct 2026
Conditions
Short Bowel Syndrome · Anticoagulation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023202420252026
  1. Ph 4

    ABSORB

    NCT04344717

    20 Dec 2020 to 30 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Apixaban single doseDrug
  • Apixaban steady-stateDrug

Arms5

  • Experimental

    Anticoagulation and teduglutide naive short bowel syndrome

    Apixaban-, vitamin K antagonist- and teduglutide naive patients with short bowel syndrome requiring long term parenteral support

  • Experimental

    Healthy volunteers

    Apixaban- and vitamin K antagonist naive healty volunteers

  • Other

    Short bowel syndrome on apixaban

    Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily

  • Other

    Patients with a normal gastrointestinal tract on apixaban

    Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily

  • Experimental

    Anticoagulation naive short bowel syndrome on teduglutide

    Apixaban- and vitamin K antagonist naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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(19)

  1. 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

    Registry description

    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

  2. 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

    Registry description

    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

  3. 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

    Registry description

    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

  4. 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

    Registry description

    To investigate the difference in absorption rate constant between patients with and without SBS requiring long-term PN

  5. 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

    Registry description

    To investigate the difference in bioavailability between patients with and without SBS requiring long-term PN

  6. 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

    Registry description

    To investigate the difference in volume of distribution between patients with and without SBS requiring long-term PN

  7. 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

    Registry description

    To investigate the difference in clearance between patients with and without SBS requiring long-term PN

  8. 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

    Registry description

    To investigate the difference in half-life between patients with and without SBS requiring long-term PN

  9. To set up an optimized dosing scheme of apixaban for SBS patients

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    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.

  10. Difference in Cmax between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in Cmax between SBS patients with and without teduglutide

  11. Difference in Cmin between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in Cmin between SBS patients with and without teduglutide

  12. Difference in Tmax between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in Tmax between SBS patients with and without teduglutide

  13. Difference in AUC SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in Cmax, Cmin, Tmax, AUC, absorption rate constant, bioavailability, volume of distribution, clearance and half-life between SBS patients with and without teduglutide

  14. Difference in AUC between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in Cmax, Cmin, Tmax, AUC, absorption rate constant, bioavailability, volume of distribution, clearance and half-life between SBS patients with and without teduglutide

  15. Difference in absorption rate constant between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in absorption rate constant between SBS patients with and without teduglutide

  16. Difference in bioavailability between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in bioavailability between SBS patients with and without teduglutide

  17. Difference in volume of distribution between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in volume of distribution between SBS patients with and without teduglutide

  18. Difference in clearance between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in clearance between SBS patients with and without teduglutide

  19. Difference in half-life between SBS patients with and without teduglutide

    Time frame · Through study completion, an average of 1.5 years

    Registry description

    To investigate the difference in half-life between SBS patients with and without teduglutide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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