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

Who is this study for? Adult patients with Short Bowel Syndrome
What treatments are being studied? Apixaban
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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. 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• patients with SBS (small bowel length of <2m after Treitz ligament) on long term (>3 months) PN or fluids who are anticoagulation 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 anticoagulation 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

Locations
Other Locations
Belgium
University Hospitals Leuven
Recruiting
Leuven
Contact Information
Primary
Barbara Deleenheer, PharmD
barbara.deleenheer@uzleuven.be
003216342504
Time Frame
Start Date: December 20, 2020
Estimated Completion Date: December 2024
Participants
Target number of participants: 84
Treatments
Experimental: Anticoagulation and teduglutide naive short bowel syndrome
Anticoagulation and teduglutide naive patients with short bowel syndrome requiring long term parenteral support
Experimental: Healthy volunteers
Anticoagulation naive healty volunteers
Other: Short bowel syndrome on apixaban
Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily
Other: Patients with a normal gastrointestinal tract on apixaban
Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily
Experimental: Anticoagulation naive short bowel syndrome on teduglutide
Anticoagulation naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov

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