Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

Details

This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue. The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.

Keywords

Short Bowel Syndrome Intestinal Failure SBS SBS-IF GLP-2 Short Bowel Syndrome Intestinal Failure Syndrome apraglutide Apraglutide SC injections, once weekly

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Signed informed consent for this trial prior to any trial specific assessment.
  2. 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).
  3. Subject must require PS at least 3 days per work and be considered stable.
  4. No restorative surgery intended to change PS requirements in the trial period.
  5. Age ≥18 years at screening.

You CAN'T join if...

  1. Pregnancy or lactation.
  2. Major abdominal surgery in the last 6 months prior to screening.
  3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
  4. Evidence of active inflammatory GI conditions in the previous 6 months.
  5. Evidence of decompensated heart failure.
  6. Evidence of severe renal or hepatic impairment.
  7. 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.

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VectivBio AG
ID
NCT04627025
Phase
Phase 3
Study Type
Interventional
Last Updated