Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
NCT ID: NCT04881825
Last Updated: 2023-11-27
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
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ENROLLING_BY_INVITATION
PHASE3
129 participants
INTERVENTIONAL
2021-06-16
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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once-weekly glepaglutide
All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Interventions
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Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)
Exclusion Criteria
* Not having a colonoscopy performed at End of Trial in EASE SBS 2 (for patients with remnant colon). Note. The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to End of Trial and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator
* Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed
* Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods
18 Years
90 Years
ALL
No
Sponsors
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Zealand Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Zealand Pharma
Role: STUDY_DIRECTOR
Zealand Pharma
Locations
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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
Countries
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Other Identifiers
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2020-005502-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1261-3358
Identifier Type: OTHER
Identifier Source: secondary_id
ZP1848-20110
Identifier Type: -
Identifier Source: org_study_id