How well is the blood thinner apixaban absorbed in people with short bowel syndrome?

Pharmacokinetic profiling of apixaban in patients with short bowel syndrome using Bayesian re-estimation of a published population pharmacokinetic model

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN80601124

Enrollment

Registered

2025-07-03

Start date

2023-09-23

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Short bowel syndrome (SBS) Digestive System

Interventions

Blood samples were obtained to capture the expected peak plasma steady state concentrations (Tmax) of apixaban in outpatients on standard dose as recommended by the treating physician, in accordance w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults with SBS type 1–3 2. Clinically stable 3. Receiving apixaban chronically 4. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Pregnancy or lactation 3. Body mass index (BMI) <18 kg/m² 4. Active IBD 5. Liver failure (Child-Pugh C) 6. <6 weeks after resection 7. Hemodialysis

Design outcomes

Primary

Measure	Time frame
Plasma concentration of apixaban measured by LC-MS/MS at 30 minutes before morning dose, followed by post-dose samples at 1 ± 0.5, 2.5 ± 0.5, 3 ± 0.5, and 4.5 ± 0.5 hours on the day of steady-state sampling	—

Secondary

Measure	Time frame
1. Relationship between apixaban concentrations and clinical covariates (e.g. nutritional status, parenteral nutrition, teduglutide use, bilirubin) assessed on the day of PK sampling 2. Variability in pharmacokinetic parameters calculated using Bayesian re-estimation	—

Countries

Czech Republic

Contacts

Public ContactKarolína Hronová

karolina.hronova@lf1.cuni.cz+420 (0)224968113

Outcome results

None listed

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