Short Bowel SyndromePhase 4ABSORBNCT04344717
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
A Phase 4 study testing Apixaban single dose and Apixaban steady-state in people with Short Bowel Syndrome and Anticoagulation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Short Bowel Syndrome, Anticoagulation
- What is being tested?
- Apixaban single dose and Apixaban steady-state
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Dec 2020to 30 Sep 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
- healthy individuals without history of GI resections or other conditions associated with impaired absorption, who are apixaban- and vitamin K antagonist naive
- 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
Who cannot join
- <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)
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- 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
- <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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Short Bowel Syndrome, Anticoagulation
- Being tested
- Apixaban single dose, Apixaban steady-state
- Keywords
- Apixaban, Pharmacokinetics
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban single doseDrug
Also called Eliquis 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
Apixaban steady-stateDrug
Also called Eliquis steady-state
Steady-state apixaban PK characteristics will be measured in patients already treated with apixaban
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation and teduglutide naive short bowel syndrome | Experimental | Apixaban-, vitamin K antagonist- and teduglutide naive patients with short bowel syndrome requiring long term parenteral support Receives: Drug: Apixaban single dose |
| Healthy volunteers | Experimental | Apixaban- and vitamin K antagonist naive healty volunteers Receives: Drug: Apixaban single dose |
| Short bowel syndrome on apixaban | Other | Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily Receives: Drug: Apixaban steady-state |
| Patients with a normal gastrointestinal tract on apixaban | Other | Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily Receives: Drug: Apixaban steady-state |
| Anticoagulation naive short bowel syndrome on teduglutide | Experimental | Apixaban- and vitamin K antagonist naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide Receives: Drug: Apixaban single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cmax of apixaban between SBS and patients with a normal gastrointestinal tract
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
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (19)
Difference in estimated trough level (Cmin) of apixaban between SBS and patients with a normal gastrointestinal tract
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
Measured: Through study completion, an average of 1.5 years
Difference in time to reach Cmax (Tmax) of apixaban between SBS patients and patients with a normal gastrointestinal tract
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
Measured: Through study completion, an average of 1.5 years
Difference in exposure (AUC0-12h) of apixaban between SBS patients and patients with a normal gastrointestinal tract
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
Measured: Through study completion, an average of 1.5 years
Difference in absorption rate constant of apixaban between SBS patients and patients with a normal gastrointestinal tract
To investigate the difference in absorption rate constant between patients with and without SBS requiring long-term PN
Measured: Through study completion, an average of 1.5 years
Difference in bioavailability of apixaban between SBS patients and patients with a normal gastrointestinal tract
To investigate the difference in bioavailability between patients with and without SBS requiring long-term PN
Measured: Through study completion, an average of 1.5 years
Difference in volume of distribution of apixaban between SBS patients and patients with a normal gastrointestinal tract
To investigate the difference in volume of distribution between patients with and without SBS requiring long-term PN
Measured: Through study completion, an average of 1.5 years
Difference in clearance of apixaban between SBS patients and patients with a normal gastrointestinal tract
To investigate the difference in clearance between patients with and without SBS requiring long-term PN
Measured: Through study completion, an average of 1.5 years
Difference in half-life of apixaban between SBS patients and patients with a normal gastrointestinal tract
To investigate the difference in half-life between patients with and without SBS requiring long-term PN
Measured: Through study completion, an average of 1.5 years
To set up an optimized dosing scheme of apixaban for SBS patients
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.
Measured: Through study completion, an average of 1.5 years
Difference in Cmax between SBS patients with and without teduglutide
To investigate the difference in Cmax between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in Cmin between SBS patients with and without teduglutide
To investigate the difference in Cmin between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in Tmax between SBS patients with and without teduglutide
To investigate the difference in Tmax between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in AUC SBS patients with and without teduglutide
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
Measured: Through study completion, an average of 1.5 years
Difference in AUC between SBS patients with and without teduglutide
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
Measured: Through study completion, an average of 1.5 years
Difference in absorption rate constant between SBS patients with and without teduglutide
To investigate the difference in absorption rate constant between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in bioavailability between SBS patients with and without teduglutide
To investigate the difference in bioavailability between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in volume of distribution between SBS patients with and without teduglutide
To investigate the difference in volume of distribution between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in clearance between SBS patients with and without teduglutide
To investigate the difference in clearance between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Difference in half-life between SBS patients with and without teduglutide
To investigate the difference in half-life between SBS patients with and without teduglutide
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start20 Dec 2020
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Interventional, non-randomized, open label, monocentric controlled study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344717
- Sponsor's protocol ID
- s63950
- Acronym
- ABSORB
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be coded according to General Data Protection Regulation
Publications
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.
PubMed 24486858Santamaria 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.
PubMed 30136101Eikelboom 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.
PubMed 28355459