BridgeMD
Pharmacokinetics of apixaban in patients with short bowel syndrome requiring long-term parenteral nutrition.
EU CTIS ID: 2024-512061-14-00
What this study is testing
To investigate the difference in peak concentration (Cmax) of apixaban between patients with and without short bowel syndrome requiring long-term parenteral nutrition
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- - <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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.