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Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
Sponsor: Zealand Pharma
Summary
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.
Official title: A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2021-06-16
Completion Date
2026-04
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Locations (19)
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic College of Medicin
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Vanderbilt University Medical Center, Nashville
Nashville, Tennessee, United States
Universitair Ziekenhuis Leuven
Leuven, Belgium
Rigshospitalet
Copenhagen, Denmark
Hôpital Beaujon
Clichy, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Universitätsmedizin Rostock
Rostock, Germany
UMC Radboud Nijmegen
Nijmegen, Netherlands
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz, Poland
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Skawina, Poland
St Mark's Hospital
Harrow, United Kingdom
UCLH Foundation NHS Trust
London, United Kingdom
Norfolk and Norwich University Hospitals
Norwich, United Kingdom