Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS (EASE SBS 1)
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| ClinicalTrials.gov Identifier: NCT03690206 |
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Recruitment Status :
Completed
First Posted : October 1, 2018
Last Update Posted : October 31, 2022
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Sponsor:
Zealand Pharma
Information provided by (Responsible Party):
Zealand Pharma
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Brief Summary:
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Short Bowel Syndrome | Drug: glepaglutide Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 106 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS) |
| Actual Study Start Date : | October 4, 2018 |
| Actual Primary Completion Date : | July 26, 2022 |
| Actual Study Completion Date : | July 26, 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Glepaglutide SC injections twice weekly
Intervention: Glepaglutide
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Drug: glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Other Name: ZP1848 |
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Experimental: Glepaglutide SC injections once weekly and placebo once weekly
Intervention: Glepaglutide
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Drug: glepaglutide
Glucagon-Like Peptide-2 (GLP-2) analog
Other Name: ZP1848 |
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Placebo Comparator: Placebo SC injections twice weekly
Intervention: Placebo
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Drug: Placebo
Placebo for glepaglutide |
Primary Outcome Measures :
- Change in weekly Parenteral Support (PS) volume [ Time Frame: 24 weeks ]Change in weekly PS volume from baseline
Secondary Outcome Measures :
- Clinical response in PS volume [ Time Frame: 20 and 24 weeks ]Achieving at least 20 percent reduction in weekly PS volume from baseline
- Days off PS [ Time Frame: 24 weeks ]Achieving 1 or more days per week off PS
- Clinical response in PS volume [ Time Frame: 12 and 24 weeks ]Reduction of at least 20 percent in PS volume from baseline
- Weaned off PS [ Time Frame: 24 weeks ]Reduction in weekly PS volume of 100 percent (weaned off)
- Fluid composite effect [ Time Frame: 24 weeks ]Change in fluid composite effect from baseline
- Energy content [ Time Frame: 24 weeks ]Change in energy content of PS from baseline
- Days on PS [ Time Frame: 24 weeks ]Change in number of days on PS per week from baseline
- Change in PS volume per week [ Time Frame: 20 and 24 weeks ]Achieving 40 percent in PS volume from baseline
- Patient Global Impression of Change scale (PGIC) [ Time Frame: 24 weeks ]Change PGIC
- Safety - Adverse Events [ Time Frame: 28 weeks ]Incidence and type of Adverse Events
- Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG) [ Time Frame: 28 weeks ]Number of patients with clinically significant changes in ECG will be reported
- Safety - Changes in blood pressure from baseline [ Time Frame: 28 weeks ]Changes in blood pressure will be reported
- Safety - Changes in body temperature from baseline [ Time Frame: 28 weeks ]Changes in body temperature will be reported
- Immunogenicity - Occurrence of anti-drug antibodies [ Time Frame: 28 weeks ]Occurrence of antibodies against glepaglutide
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activity.
- Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
- Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
- In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.
Exclusion Criteria:
- More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
- Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
- Bowel obstruction.
- Known radiation enteritis or significant villous atrophy.
- Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening.
- Clinically significant abnormal ECG.
- Repeated systolic blood pressure measurements > 180 mm Hg.
- Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
- Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
- Estimated creatinine clearance < 30 mL/min.
- Severe hepatic impairment.
- Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
- Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
- Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
- Unstable biological therapy within 6 months prior to Screening.
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods.
- Previous exposure to glepaglutide.
- Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
- Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690206
Locations
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Sponsors and Collaborators
Zealand Pharma
Investigators
| Study Director: | Study Director | Zealand Pharma |
| Responsible Party: | Zealand Pharma |
| ClinicalTrials.gov Identifier: | NCT03690206 |
| Other Study ID Numbers: |
ZP1848-17111 |
| First Posted: | October 1, 2018 Key Record Dates |
| Last Update Posted: | October 31, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Short Bowel Syndrome Syndrome Disease Pathologic Processes Malabsorption Syndromes |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Postoperative Complications |