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

Phase 3Active Not RecruitingNCT05018286

VectivBio AG158 enrolled

Overview

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Short Bowel Syndrome

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol. Exclusion Criteria: 1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements. 2. Any other reason judged not eligible by the Investigator. 3. Pregnancy or lactation

Locations (66)

Outcomes

Primary Outcomes

Adverse events (AE)

System organ class, frequency and severity

Time frame: From baseline to week 208

Clinical chemistry

Clinical Chemistry panel of analytes will be examined for clinically significant changes.

Time frame: From baseline to week 208

Hematology

Hematology panel of analytes will be examined for clinically significant changes.

Time frame: From baseline to week 208

Hemostasis

Hemostasis INR will be examined for clinically significant changes.

Time frame: From baseline to week 104

Urinalysis

Urinanalysis panel of analytes will be examined for clinically significant changes.

Time frame: From baseline to week 208

Occurrence of clinically relevant changes in vital signs

* Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.

Time frame: From baseline to week 208

Occurrence of clinically relevant changes in electrocardiogram

ECG; intervals and rhythm

Time frame: From baseline to week 208

Secondary Outcomes

Change from baseline in PS volume

Time frame: From baseline to week 208

Data from ClinicalTrials.gov

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Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Northwestern University - Chicago

Chicago, Illinois, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic - Rochester

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 Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

...and 56 more locations

Change from baseline in PS frequency

Change in PS days/week from baseline to week 104

Time frame: From baseline to week 208

Clinically significant changes in PS total energy

Units: kcal

Time frame: From baseline to week 208

Change from baseline in PS infusion time

Time frame: From baseline to week 208

Percentage of subjects reaching enteral autonomy

Time frame: From baseline to week 104

Change from baseline in body weight

Units: kg

Time frame: From baseline to week 104

Change from baseline on the Patient Global Impression of Severity (PGIS)

Time frame: From baseline to week 104

Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)

Time frame: From baseline to week 208

Change from baseline on the Patient Global Impression of Change (PGIC)

Time frame: From baseline to week 208

Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)

Time frame: From baseline to week 208

Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)

Time frame: From baseline to week 208

Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)

Time frame: From baseline to week 208

Change from baseline on the Short Form (36) Health Survey (SF-36)

Time frame: From baseline to week 208

Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

Time frame: From baseline to week 208