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

Overview

About this study

The purpose of this study is to assess long-term safety and tolerability of apraglutide in subjects with Short Bowel Syndrome (SBS-IF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 have completed 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.

Exclusion Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/1/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Manpreet Mundi, M.D.

Closed for enrollment

Contact information:

Karen Evans

(507) 422-2944

gimresearchstudies@mayo.edu

More information

Publications

Publications are currently not available