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ACTIVE NOT RECRUITING
NCT04881825
PHASE3

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Sponsor: Zealand Pharma

View on ClinicalTrials.gov

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

Interventions

DRUG

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