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.
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
Glucagon-Like Peptide-2 (GLP-2) analog
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Safety - Adverse Events
Incidence and type of Adverse Events
Time frame: 2 years
Safety - Serious Adverse Events
Incidence and type of Serious Adverse Events
Time frame: 2 years
Safety - Adverse Events of Special Interest
Incidence and type of Adverse Events of Special Interest
Time frame: 2 years
Safety - Changes in blood pressure from baseline
Changes in systolic and diastolic blood pressure will be reported
Time frame: 2 years
Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)
Number of patients with clinically significant changes in ECG will be reported
Time frame: 2 years
Immunogenicity - Occurrence of anti-drug antibodies
Occurrence of antibodies against glepaglutide
Time frame: 2 years
Change in weekly Parenteral Support (PS) volume
Change in weekly PS volume from baseline
Time frame: 2 years
Number of patients with 20 percent reduction in PS volume
Achieving at least 20 percent reduction in weekly PS volume from baseline
Time frame: 2 years
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University of Chicago Children's Hospital
Chicago, Illinois, United States
Mayo Clinic College of Medicine
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center, Nashville
Nashville, Tennessee, United States
UZ Leuven
Leuven, Belgium
The Royal Alexandra Hospital
Edmonton, Canada
Western University
London, Canada
...and 17 more locations
Days off PS
Achieving 1 or more days per week off PS
Time frame: 2 years
Weaned off PS
Reduction in weekly PS volume of 100 percent (weaned off)
Time frame: 2 years
Changes in fluid composite effect
Reduction in PS plus reduction in oral fluid intake plus increase in urine volume from baseline
Time frame: 2 years
Energy content (lipids)
Change in lipids content (in kcal/L or kjoule/L) of PS from baseline
Time frame: 2 years
Energy content (glucose)
Change in glucose content (in kcal/L or kjoule/L) of PS from baseline
Time frame: 2 years
Energy content (amino acids)
Change in amino acids content (in kcal/L or kjoule/L) of PS from baseline
Time frame: 2 years
Days on PS
Change in number of days on PS per week from baseline
Time frame: 2 years
Number of patients with 40 percent change in PS volume per week
Achieving 40 percent in PS volume from baseline
Time frame: 2 years