The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Administered twice weekly by subcutaneous injection for a maximum of 24 months
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska, United States
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio, United States
Vanderbilt University Medical Center-Tennesse-1211 21st Ave S
Nashville, Tennessee, United States
UZ Leuven - PPDS
Leuven, Belgium
LHSC - University Hospital
London, Ontario, Canada
AP-HP - Hôpital Beaujon
Clichy, Hauts-de-Seine, France
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
...and 6 more locations
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline to the safety follow-up visit (A maximum of 25 months)
Change in prescribed weekly parenteral support (PS) volume
Time frame: From baseline to Month 24 (End of Trial)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.