Loading clinical trials...

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT04627025•VectivBio AG

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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 (68)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Northwestern University

Chicago, Illinois, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Mayo Clinic

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 Hospital

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Key Dates

Start Date

January 26, 2021

Primary Completion Date

January 2, 2024

Completion Date

February 22, 2024

Last Updated

November 27, 2024

Enrollment

164

ACTUAL participants

Conditions

Short Bowel Syndrome

Interventions

apraglutide

DRUG

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

NCT07197944

Short Bowel Syndrome

View study

RECRUITING

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

NCT05561647

Short Bowel Syndrome (SBS)

View study

RECRUITINGPHASE3

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

NCT06973304

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

A 90 Day Observational Study as an Extension to the Phase 3,Open Labeled Exploratory Study of RELiZORB

Registry for Participants With Short Bowel Syndrome

Assessing Metabolic and Sleep Consequences of Overnight Home Parenteral Nutrition