Trials Sponsors Conditions Drugs Pricing

Conditions

short bowel syndrome Short Bowel Syndrome

Keywords

Short Bowel SyndromeSBSIntestinal FailureSBS-IF

Outcome Measures

Primary Outcomes (7)

Adverse events (AE)
System organ class, frequency and severity
From baseline to week 208
Clinical chemistry
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
From baseline to week 208
Hematology
Hematology panel of analytes will be examined for clinically significant changes.
From baseline to week 208
Hemostasis
Hemostasis INR will be examined for clinically significant changes.
From baseline to week 104

Secondary Outcomes (14)

Change from baseline in PS volume
From baseline to week 208
Change from baseline in PS frequency
From baseline to week 208
Clinically significant changes in PS total energy
From baseline to week 208
Change from baseline in PS infusion time
From baseline to week 208
Percentage of subjects reaching enteral autonomy
From baseline to week 104
+9 more secondary outcomes

Study Arms (1)

Apraglutide subcutaneous (SC) injections, once weekly

EXPERIMENTAL

Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

Drug: Apraglutide

Interventions

ApraglutideDrug

Apraglutide is a synthetic 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 subcutaneous (SC) injections, once weekly

ApraglutideType not reported

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:

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 were trial subjects of 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.

Sponsors & Collaborators

VectivBio AG
Industrylead

Study Sites (66)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Northwestern University - Chicago

Chicago, Illinois, 60611, United States

Henry Ford Health System

Detroit, Michigan, 48202, United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

University of Nebraska Medical Center

Omaha, Nebraska, 68105, 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

158 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

August 24, 2021

Study Start

July 13, 2021

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (14)

Study Arms (1)

Apraglutide subcutaneous (SC) injections, once weekly

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (14)

Study Arms (1)

Apraglutide subcutaneous (SC) injections, once weekly

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations