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ACTIVE NOT RECRUITING
NCT05018286
PHASE3

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

Sponsor: VectivBio AG

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

158

Start Date

2021-07-13

Completion Date

2027-10-30

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

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

Locations (66)

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