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

July 1, 2025 updated by: VectivBio AG

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1093AAS
        • University Hospital Fundacion Favaloro
  • Belgium
      • Brussel, Belgium, B-1090
        • University Hospital Brussels
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Czechia
      • Brno, Czechia, 62500
        • University Hospital Brno
      • Hradec Králové, Czechia, 500 05
        • University hospital Hradec Králové
      • Nový Jičín, Czechia, 741 01
        • Hospital Novy Jicin
      • Pilsen, Czechia, 30460
        • University Hospital Plzen
      • Prague, Czechia, 12800
        • General University Hospital in Prague
      • Praha, Czechia, 10034
        • University Hospital Královské Vinohrady
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
  • France
      • Clichy, France, 92110
        • Beaujon Hospital
      • Lyon, France, 69495
        • South Lyon Hospital Center
      • Nantes, France, 44093
        • Nantes University Hospital Center - Hotel Dieu Hospital
      • Nice, France, 06200
        • Nice University Hospital Center - Archet 1 Hospital
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque
      • Vandœuvre-lès-Nancy, France, 54500
        • Brabois Adults Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charite - University Hospital Berlin
      • Bonn, Germany, 53127
        • University Hospital Bonn
      • Hamburg, Germany, 20099
        • Asklepios Clinic St. Georg
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Münster, Germany, 48149
        • University hospital Muenster
  • Hungary
      • Budapest, Hungary, 1115
        • Szent Imre University Teaching Hospital, Department of Gastroenterology
      • Budapest, Hungary, H-1062
        • Central Hospital of Northern Pest - Military Hospital
      • Budapest, Hungary, H-1062
        • Semmelweis University
      • Szeged, Hungary, 6725
        • University of Szeged
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, Institute of Gastroenterology
      • Tel HaShomer, Israel, 5262000
        • Chaim Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Polyclinic S. Orsola-Malpighi
      • Rome, Italy, 00168
        • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
      • Turin, Italy, 10126
        • City of Health and Science of Turin
  • Japan
      • Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Kanagawa, Japan, 232-0024
        • Yokohama Municipal Citizen's Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Sendai, Japan, 980-0872
        • Tohoku University Hospital
      • Tokyo, Japan, 169-0073
        • JCHO Tokyo Yamate Medical Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 063351
        • Samsung Medical Center
  • Norway
      • Ålesund, Norway, 6017
        • More og Romsdal Hospital Trust - Alesund Hospital
  • Poland
      • Bydgoszcz, Poland, 85-391
        • Stadmedica, Non-Public Healthcare Facility
      • Gdańsk, Poland, 80-152
        • COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
      • Lublin, Poland, 20-582
        • Gastromed Poland Sp. z o.o.
      • Skawina, Poland, 32-050
        • Stanley Dudrick Multispecialty Hospital
      • Łódź, Poland, 90-531
        • M. Pirogow Provincial Specialized Hospital
  • Spain
      • Madrid, Spain, 28041
        • University Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • University General Hospital Gregorio Maranon
      • Sevilla, Spain, 41013
        • University Hospital Virgen del Rocio (HUVR)
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • St Mark's Hospital
      • London, United Kingdom, E1 1BB
        • Royal London Hospital
      • London, United Kingdom, NW1 2BU
        • University College Hospital
      • Salford, United Kingdom, M6 8HD
        • Northern Care Alliance NHS Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
    • Florida
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Of Naples
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University - Chicago
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apraglutide subcutaneous (SC) injections, once weekly
Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
Drug: Apraglutide
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemostasis
Time Frame: From baseline to week 104
Hemostasis INR will be examined for clinically significant changes.
From baseline to week 104
Adverse events (AE)
Time Frame: From baseline to week 208
System organ class, frequency and severity
From baseline to week 208
Clinical chemistry
Time Frame: From baseline to week 208
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
From baseline to week 208
Hematology
Time Frame: From baseline to week 208
Hematology panel of analytes will be examined for clinically significant changes.
From baseline to week 208
Urinalysis
Time Frame: From baseline to week 208
Urinanalysis panel of analytes will be examined for clinically significant changes.
From baseline to week 208
Occurrence of clinically relevant changes in vital signs
Time Frame: From baseline to week 208
  • 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.
From baseline to week 208
Occurrence of clinically relevant changes in electrocardiogram
Time Frame: From baseline to week 208
ECG; intervals and rhythm
From baseline to week 208

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects reaching enteral autonomy
Time Frame: From baseline to week 104
From baseline to week 104
Change from baseline in body weight
Time Frame: From baseline to week 104
Units: kg
From baseline to week 104
Change from baseline on the Patient Global Impression of Severity (PGIS)
Time Frame: From baseline to week 104
From baseline to week 104
Change from baseline in PS volume
Time Frame: From baseline to week 208
From baseline to week 208
Change from baseline in PS frequency
Time Frame: From baseline to week 208
Change in PS days/week from baseline to week 104
From baseline to week 208
Clinically significant changes in PS total energy
Time Frame: From baseline to week 208
Units: kcal
From baseline to week 208
Change from baseline in PS infusion time
Time Frame: From baseline to week 208
From baseline to week 208
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame: From baseline to week 208
From baseline to week 208
Change from baseline on the Patient Global Impression of Change (PGIC)
Time Frame: From baseline to week 208
From baseline to week 208
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Time Frame: From baseline to week 208
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
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
From baseline to week 208
Change from baseline on the Short Form (36) Health Survey (SF-36)
Time Frame: From baseline to week 208
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
From baseline to week 208

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VectivBio AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tomasz Masior, VectivBio AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TA799-012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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