NCT04344717 (ABSORB) is a Phase 4 clinical trial of Apixaban single dose in Short Bowel Syndrome, sponsored by Universitaire Ziekenhuizen KU Leuven.

Who is sponsoring NCT04344717?

NCT04344717 is sponsored by Universitaire Ziekenhuizen KU Leuven.

What drugs are being tested in NCT04344717?

Interventions in NCT04344717: Apixaban single dose, Apixaban steady-state.

What condition does NCT04344717 study?

NCT04344717 studies Short Bowel Syndrome, Anticoagulation.

Is NCT04344717 still recruiting?

NCT04344717 is currently status unknown. Last updated 21 February 2024.

Last reviewed 2024-02-21 · How we verify

NCT04344717: ABSORB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 4 Last updated 21 February 2024

What this trial tests

Phase 4 trial testing Apixaban single dose in Short Bowel Syndrome in 84 participants. Status unknown.

Timeline

20 December 2020

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	20 December 2020
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across Belgium

Drugs / interventions tested

Apixaban single dose — full drug profile →
Apixaban steady-state — full drug profile →

Conditions studied

Short Bowel Syndrome — all drugs for Short Bowel Syndrome →
Anticoagulation — all drugs for Anticoagulation →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

18 and older, any sex, with Short Bowel Syndrome or Anticoagulation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Anticoagulation and antiplatelet therapy in short bowel syndrome: A systematic review.
Mercer C, Crawford A, Shapiro S, Allan PJ, et al · · 2024 · PMID 41646114 · DOI 10.1016/j.intf.2024.100007

Verify or expand the search:

Other recruiting trials for Short Bowel Syndrome

Currently open trials in the same condition.

NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS · Phase 3 · recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A · NA · recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome · EARLY_PHASE1 · recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question · recruiting

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04344717 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
Last refreshed: 21 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04344717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing