Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Running, not enrolling · Phase 3

Conditions studied: Short Bowel Syndrome

In brief

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Key facts

Study ID

NCT05018286

Run by

VectivBio AG

People needed

158

Starts

2021-07-13

Expected to finish

2027-10-30

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
• Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

You may not qualify if…

• Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
• Any other reason judged not eligible by the Investigator.
• Pregnancy or lactation

Where it is running

• Gastroenterology Group of Naples — Naples, Florida, United States
• Northwestern University - Chicago — Chicago, Illinois, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University Hospital Fundacion Favaloro — Buenos Aires, Argentina
• University Hospital Brussels — Brussels, Belgium
• UZ Leuven — Leuven, Belgium
• University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• Hospital Novy Jicin — Nový Jičín, Czechia
• University Hospital Plzen — Pilsen, Czechia
• University Hospital Kralovske Vinohrady — Prague, Czechia
• General University Hospital in Prague — Prague, Czechia
• Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases — Copenhagen, Denmark
• Beaujon Hospital — Clichy, France
• South Lyon Hospital Center — Lyon, France
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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