A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Who is this study for? Adult patients with short bowel syndrome
What treatments are being studied? Glepaglutide
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: No
View:

• Informed consent obtained before any trial-related activity

• Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

Locations
United States
Arizona
Mayo Clinic
Withdrawn
Scottsdale
Washington, D.c.
Georgetown University Medical Center
Recruiting
Washington
Florida
Miami Transplant Institute
Withdrawn
Miami
Illinois
Division of Gastroenterology and Hepatology
Withdrawn
Chicago
University of Chicago Children's Hospital
Recruiting
Chicago
Kentucky
University of Louisville
Not yet recruiting
Louisville
Minnesota
Mayo Clinic College of Medicine
Recruiting
Rochester
Nebraska
University of Nebraska Medical Center
Recruiting
Omaha
New York
Mount Sinai Hospital
Recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
Tennessee
Vanderbilt University Medical Center, Nashville
Recruiting
Nashville
Texas
Houston Methodist Hospital
Withdrawn
Houston
Other Locations
Belgium
Hôpital Erasme
Withdrawn
Bruxelles
UZ Leuven
Recruiting
Leuven
Canada
The Royal Alexandra Hospital
Recruiting
Edmonton
Western University
Recruiting
London
University Health Network - Toronto General Hospital
Recruiting
Toronto
Denmark
Rigshospitalet
Recruiting
Copenhagen
France
Hôpital Beaujon
Recruiting
Clichy
CHRU de Lille
Withdrawn
Lille
CHRU Nancy
Withdrawn
Nancy
Hôpital de l'Archet
Withdrawn
Nice
Centre Hospitalier Lyon-Sud
Recruiting
Pierre-bénite
Germany
Charité - Universitätsmedizin Berlin
Recruiting
Berlin
Universitätsklinikum Bonn
Recruiting
Bonn
Universitätsklinikum Frankfurt - Med. Klinik I
Recruiting
Frankfurt
Asklepios Kliniken Hamburg GmbH
Recruiting
Hamburg
Universitätsmedizin Rostock
Recruiting
Rostock
Universitätsklinikum Tübingen - Innere Medizin I
Withdrawn
Tübingen
Italy
Azienda Ospedaliero-Universitaria
Withdrawn
Bologna
Azienda Ospedaliero Universitaria Federico II
Withdrawn
Napoli
Netherlands
UMC Radboud Nijmegen
Recruiting
Nijmegen
Poland
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Recruiting
Łódź
Solumed
Recruiting
Poznań
Szpital Skawina sp. z o.o. im. Stanley Dudricka
Recruiting
Skawina
United Kingdom
St Mark's Hospital
Recruiting
Harrow
UCLH Foundation NHS Trust
Recruiting
London
Salford Royal NHS Foundation Trust
Not yet recruiting
Manchester
University of East Anglia
Recruiting
Norwich
University Hospital Southampton NHS Foundation Trust
Recruiting
Southampton
Contact Information
Primary
Medical Director
mag@zealandpharma.com
+4588773600
Backup
Senior Clinical Trial Manager
teg@zealandpharma.com
+4588773600
Time Frame
Start Date: May 7, 2019
Estimated Completion Date: November 5, 2022
Participants
Target number of participants: 145
Treatments
Experimental: Glepaglutide SC injections twice weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.~In this long term safety study, there is no placebo arm.
Experimental: Glepaglutide SC injections once weekly and placebo once weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.~In this long term safety study, there is no placebo arm.
Related Therapeutic Areas
Sponsors
Leads: Zealand Pharma

This content was sourced from clinicaltrials.gov

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