This study is in progress, not accepting new patients

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

a study on Short Bowel Syndrome

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

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

Details

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Keywords

Short Bowel Syndrome, SBS, Intestinal Failure, SBS-IF, Syndrome, Apraglutide

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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
  2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

You CAN'T join if...

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

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • University of Washington Medical Center
    Seattle Washington 98195 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VectivBio AG
ID
NCT05018286
Phase
Phase 3 Short Bowel Syndrome Research Study
Study Type
Interventional
Participants
About 158 people participating
Last Updated