Trials Sponsors Conditions Drugs Pricing

Conditions

Short Bowel Syndrome

Keywords

Short Bowel SyndromeIntestinal FailureSBSSBS-IFGLP-2Short Bowel Syndrome Intestinal Failure

Outcome Measures

Primary Outcomes (1)

Relative change from baseline in actual weekly PS volume at Week 24.
At week 24 of treatment

Secondary Outcomes (15)

Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).
Weeks 24 and 48 of treatment
Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).
Weeks 12 / 24 / 48 of treatment
Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).
Weeks 24 / 48 of treatment
At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
Weeks 20 / 24 of treatment
Calorie reduction in the PN at Weeks 24.
Weeks 24 of treatment
+10 more secondary outcomes

Study Arms (2)

Apraglutide SC injections, once weekly

EXPERIMENTAL

Peptide analogue of GLP-2

Drug: apraglutide

Placebo

PLACEBO COMPARATOR

Placebo for apraglutide, SC injection once weekly

Drug: apraglutide

Interventions

apraglutideDrug

Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Apraglutide SC injections, once weeklyPlacebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

VectivBio AG
Industrylead

Study Sites (68)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Northwestern University

Chicago, Illinois, 60611, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Mayo Clinic

Rochester, Minnesota, 55905, United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Mount Sinai Medical Center

New York, New York, 10029, United States

MeSH Terms

Conditions

Short Bowel SyndromeIntestinal Failure

Interventions

apraglutide

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Tomasz Masior
VectivBio AG
STUDY DIRECTOR

Enrollment

164 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 13, 2020

Study Start

January 26, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Apraglutide SC injections, once weekly

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (68)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Apraglutide SC injections, once weekly

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (68)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations