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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

7 Oct 2021 → ongoing

Decision date (initial)

2024-05-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512061-14-00

EudraCT number

2020-001601-23

ClinicalTrials.gov

NCT04344717

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

To investigate the difference in peak concentration (Cmax) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition

Conditions and MedDRA coding

short bowel syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Arm A1a (apixaban-, vitamin K antagonist- and teduglutide naive short bowel syndrome (SBS) patients): - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are apixaban-, vitamin K antagonist- and teduglutide naive - informed consent has to be signed Arm A1b (apixaban- and vitamin K antagonist naive short bowel syndrome (SBS) patients): - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are XML File Identifier: MKk2ji91wd+iKlQV0oUrZ4sx7H0= Page 10/20 apixaban- and vitamin K antagonist naive - already been included for arm A1a - at least 6 months on teduglutide therapy - informed consent has to be signed Arm B1 (apixaban- and vitamin K antagonist naïve healthy volunteers with normal gastrointestinal tract): - healthy individuals without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are apixaban- and vitamin K antagonist naive - informed consent has to be signed Arm A2 (teduglutide naïve SBS patients on apixaban therapy) - patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) parenteral nutrition or fluids who are teduglutide naive and who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days - informed consent has to be signed Arm B2 (patients with normal gastrointestinal tract on apixaban therapy): - 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 - informed consent has to be signed

Exclusion criteria 1

1. - <18 years - non-Dutch/French speaking - recent (<6 months) gastrointestinal surgery (only for arm A) - gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, …) (only for arm A) - gastrointestinal 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 - 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Deleenheer Barbara

Public contact point

Organisation

UZ Leuven

Contact name

Deleenheer Barbara

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications