A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and Intestinal Failure (SBS-IF)

Who is this study for? Adult patients with short bowel syndrome
What treatments are being studied? Apraglutide
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Signed informed consent for this trial prior to any trial specific assessment.

• Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).

• Subject must require PS at least 3 days per work and be considered stable.

• No restorative surgery intended to change PS requirements in the trial period.

• Age ≥18 years at screening.

Locations
United States
California
Ronald Reagan UCLA Medical Center
Recruiting
Los Angeles
Washington, D.c.
Georgetown University Hospital
Recruiting
Washington
Florida
Gastroenterology Group of Naples
Recruiting
Naples
Illinois
University of Illinois, Outpatient Care Center
Recruiting
Chicago
Massachusetts
Boston Children's Hospital
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
Michigan
Henry Ford Medical Center - Columbus
Recruiting
Novi
Minnesota
Mayo Clinic
Recruiting
Rochester
North Carolina
Duke University Hospital
Recruiting
Durham
Nebraska
University of Nebraska Medical Center
Recruiting
Omaha
New York
Mount Sinai Medical Center
Recruiting
New York
Ohio
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Pennsylvania
Hospital of the University of Pennsylvania
Recruiting
Philadelphia
Tennessee
Vanderbilt University Medical Center, Center for Human Nutrition
Recruiting
Nashville
Washington
University of Washington Medical Center
Recruiting
Seattle
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
Recruiting
Milwaukee
Other Locations
Argentina
University Hospital Foundation Favaloro
Recruiting
Buenos Aires
Belgium
University Hospital Brussels
Recruiting
Brussels
University Hospital Antwerp
Recruiting
Edegem
Universitair Ziekenhuis Leuven - Gasthuisberg
Recruiting
Leuven
France
CHU de Caen Normandie
Recruiting
Caen
Hôpital Beaujon
Recruiting
Clichy
CHU Hôtel Dieu
Recruiting
Nantes
Hôpital ARCHET II
Recruiting
Nice
Hôpital Haut-Lévèque
Recruiting
Pessac
Hospices Civils de Lyon
Recruiting
Pierre Benite
Rennes University Hospital Center - Hospital Pontchaillou
Withdrawn
Rennes
Brabois Adults Hospital
Recruiting
Vandœuvre-lès-nancy
Germany
Charité - Universitätsmedizin Berlin
Recruiting
Berlin
University Hospital Bonn
Recruiting
Bonn
Asklepios Klinik St. Georg
Recruiting
Hamburg
University Hospital Heidelberg
Recruiting
Heidelberg
University Hospital Muenster
Recruiting
Münster
Israel
Soroka University Medical Center
Recruiting
Be'er Sheva
Rambam Health Care Campus
Recruiting
Haifa
Rabin Medical Center
Recruiting
Petah-tikva
The Tel Aviv Sourasky Medical Center
Recruiting
Tel Aviv
Sheba Medical Center
Recruiting
Tel Hashomer
Italy
Polyclinic S. Orsola-Malpighi
Recruiting
Bologna
University Polyclinic Foundation Agostino Gemelli - IRCCS
Recruiting
Rome
Citta della salute e della Scienza di Torino Hospital
Recruiting
Torino
Japan
Toho University Sakura Medical Center
Recruiting
Chiba
Fukuoka University Chikushi Hospital
Recruiting
Fukuoka
Yokohama City University Medical Center
Recruiting
Kanagawa
Yokohama Municipal Citizen's Hospital
Recruiting
Kanagawa
National University Corportation Tohoku University Tohoku University Hospital
Recruiting
Miyagi
Osaka University Hospital
Recruiting
Osaka
Norway
Alesund Hospital
Recruiting
Ålesund
Gjovik Hospital
Recruiting
Gjøvik
Akershus University Hospital
Recruiting
Lørenskog
Poland
Stadmedica, Non-Public Healthcare Facility
Recruiting
Bydgoszcz
COPERNICUS Limited Liability Company
Recruiting
Gdansk
M. Pirogow Provincial Specialized Hospital
Recruiting
Łódź
Gastromed Poland Sp. z o.o.
Recruiting
Lublin
SOLUMED Medical Center
Recruiting
Poznań
Stanley Dudrick Multispecialty Hospital
Recruiting
Skawina
Republic of Korea
Keimyung University Dongsan Medical Center
Withdrawn
Daegu
The Catholic University of Korea, Seoul St. Mary's Hospital
Recruiting
Seoul
Asan Medical Center
Recruiting
Soeul
Samsung Medical Center
Recruiting
Soeul
Spain
University General Hospital Gregorio Maranon
Recruiting
Madrid
University Hospital 12 de Octubre
Recruiting
Madrid
University Hospital Virgen del Rocio
Recruiting
Sevilla
Sweden
Sahlgrenska University Hospital
Recruiting
Göteborg
Taiwan
Far Eastern Memorial Hospital
Recruiting
New Taipei City
China Medical University Hospital (CMUH)
Recruiting
Taichung
Taichung Veterans General Hospital
Recruiting
Taichung
United Kingdom
University College Hospital
Recruiting
London
Salford Royal Hospital
Recruiting
Salford
Contact Information
Primary
Fritze
clinicaltrials@vectivbio.com
+41615513030
Time Frame
Start Date: January 26, 2021
Estimated Completion Date: October 31, 2023
Participants
Target number of participants: 144
Treatments
Experimental: Apraglutide SC injections, once weekly
Peptide analogue of GLP-2
Placebo Comparator: Placebo
Placebo for apraglutide, SC injection once weekly
Related Therapeutic Areas
Sponsors
Leads: VectivBio AG

This content was sourced from clinicaltrials.gov

Similar Clinical Trials