Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
NCT ID: NCT05018286
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
158 participants
INTERVENTIONAL
2021-07-13
2027-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF
NCT04627025
Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC)
NCT04964986
Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome
NCT00169637
Evaluate the Efficacy and Safety Growth Hormone, Glutamine and Diet in Patients With Short Bowel Syndrome (SBS)
NCT00742157
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
NCT01560403
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Apraglutide subcutaneous (SC) injections, once weekly
Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.
Exclusion Criteria
2. Any other reason judged not eligible by the Investigator.
3. Pregnancy or lactation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VectivBio AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tomasz Masior
Role: STUDY_DIRECTOR
VectivBio AG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Washington Medical Center
Seattle, Washington, United States
University Hospital Fundacion Favaloro
Buenos Aires, , Argentina
University Hospital Brussels
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
University Hospital Brno
Brno, , Czechia
University Hospital Hradec Kralove
Hradec Králové, , Czechia
Hospital Novy Jicin
Nový Jičín, , Czechia
University Hospital Plzen
Pilsen, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
General University Hospital in Prague
Prague, , Czechia
Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
Copenhagen, , Denmark
Beaujon Hospital
Clichy, , France
South Lyon Hospital Center
Lyon, , France
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, , France
Nice University Hospital Center - Archet 1 Hospital
Nice, , France
Hôpital Haut-Lévèque
Pessac, , France
Brabois Adults Hospital
Vandœuvre-lès-Nancy, , France
Charite - University Hospital Berlin
Berlin, , Germany
University Hospital Bonn
Bonn, , Germany
Asklepios Clinic St. Georg
Hamburg, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University Hospital Muenster
Münster, , Germany
Szent Imre University Teaching Hospital, Department of Gastroenterology
Budapest, , Hungary
Central Hospital of Northern Pest - Military Hospital
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
University of Szeged
Szeged, , Hungary
Rambam Health Care Campus, Institute of Gastroenterology
Haifa, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Polyclinic S. Orsola-Malpighi
Bologna, , Italy
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
Rome, , Italy
City of Health and Science of Turin
Turin, , Italy
Yokohama City University Medical Center
Kanagawa, , Japan
Yokohama Municipal Citizen's Hospital
Kanagawa, , Japan
Osaka University Hospital
Osaka, , Japan
Tohoku University Hospital
Sendai, , Japan
JCHO Tokyo Yamate Medical Center
Tokyo, , Japan
More og Romsdal Hospital Trust - Alesund Hospital
Ålesund, , Norway
Stadmedica, Non-Public Healthcare Facility
Bydgoszcz, , Poland
COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
Gdansk, , Poland
M. Pirogow Provincial Specialized Hospital
Lodz, , Poland
Gastromed Poland Sp. z o.o.
Lublin, , Poland
Stanley Dudrick Multispecialty Hospital
Skawina, , Poland
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
University General Hospital Gregorio Maranon
Madrid, , Spain
University Hospital 12 de Octubre
Madrid, , Spain
University Hospital Virgen del Rocio (HUVR)
Seville, , Spain
Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
Gothenburg, , Sweden
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
St Mark's Hospital
Harrow, , United Kingdom
Royal London Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Northern Care Alliance NHS Foundation Trust
Salford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TA799-012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.