Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
- Registration Number
- NCT04881825
- Lead Sponsor
- Zealand Pharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 129
- Informed consent obtained before any trial-related activity
- Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)
- Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description once-weekly glepaglutide Glepaglutide All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
- Primary Outcome Measures
Name Time Method Incidence and type of Adverse Events (AEs) After 108 weeks For AEs with onset or worsening following Visit 1
- Secondary Outcome Measures
Name Time Method Change in hematology - white blood cell count Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - calcium Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - phosphorous Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - alkaline phosphatase Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - aspartate aminotransferase (AST) Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - potassium Week 0 in lead-in trial (EASE SBS 1), Week 108 Incidence and type of Serious Adverse Events (SAEs) After 108 weeks For AEs with onset or worsening following Visit 1
Change in hematology - hematocrit Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in body temperature Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in hematology - platelet count Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - sodium Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - bicarbonate Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - blood urea nitrogen Week 0 in lead-in trial (EASE SBS 1), Week 108 Reduction of at least 20 percent in weekly PS volume Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in body weight Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - alanine aminotransferase (ALT) Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - International Normalized Ratio (INR) Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - gamma-glutamyl transferase (GGT) Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - conjugated bilirubin Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - total bilirubin Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - total protein Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - pH Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - protein Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - sodium Week 0 in lead-in trial (EASE SBS 1), Week 108 Anti-glepaglutide antibodies Week 0, Week 108 Cross-reactivity to glucagon-like peptide-2 (GLP-2) Week 0, Week 108 Incidence and type of Adverse Events of Special Interest (AESIs) After 108 weeks For AEs with onset or worsening following Visit 1
Change in heart rate Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in blood pressure Week 0 in lead-in trial (EASE SBS 1), Week 108 Seated diastolic and systolic blood pressure
Number of participants with clinically significant changes in 12-Lead electrocardiogram (ECG) Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in hematology - hemoglobin Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - creatinine clearance Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - glucose Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - lactic dehydrogenase Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - blood Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - potassium Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - chloride Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - creatinine Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - albumin Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - amylase Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - uric acid Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in biochemistry - C-reactive protein Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - glucose Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - leukocytes Week 0 in lead-in trial (EASE SBS 1), Week 108 Reduction in weekly Parenteral Support (PS) volume Week 0 in lead-in trial (EASE SBS 1), Week 108 Change in urinalysis - osmolality Week 0 in lead-in trial (EASE SBS 1), Week 108 Glepaglutide neutralizing antibodies Week 0, Week 108 Antibody reactivity to ZP1848 Week 0, Week 108 Reduction in days on PS greater than or equal to 1 day per week Week 0 in lead-in trial (EASE SBS 1), Week 108 Reduction in weekly PS volume of 100 percent (weaned off) Week 0 in lead-in trial (EASE SBS 1), Week 108
Trial Locations
- Locations (19)
Rigshospitalet
🇩🇰Copenhagen, Denmark
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
UMC Radboud Nijmegen
🇳🇱Nijmegen, Netherlands
Szpital Skawina sp. z o.o. im. Stanley Dudricka
🇵🇱Skawina, Poland
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
🇵🇱Łódź, Poland
Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Bénite, France
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
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Belgium
Hôpital Beaujon
🇫🇷Clichy, France
Asklepios Kliniken Hamburg GmbH
🇩🇪Hamburg, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
St Mark's Hospital
🇬🇧Harrow, United Kingdom
UCLH Foundation NHS Trust
🇬🇧London, United Kingdom
Norfolk and Norwich University Hospitals
🇬🇧Norwich, United Kingdom