Open Actively Recruiting

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

About

Brief Summary

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria

  • Signed informed consent for this trial prior to any trial specific assessment.
  • Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
  • Subject must require PS at least 3 days per work and be considered stable.
  • No restorative surgery intended to change PS requirements in the trial period.
  • Age ≥18 years at screening.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Major abdominal surgery in the last 6 months prior to screening.
  • History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
  • Evidence of active inflammatory GI conditions in the previous 6 months.
  • Evidence of decompensated heart failure.
  • Evidence of severe renal or hepatic impairment.
  • Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
20-001821
Category
Pediatrics
Contact
Susan Feist
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04627025
For detailed technical eligibility, visit ClinicalTrials.gov.