Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (NCT03690206) | Clinical Trial Compass
CompletedPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
United States106 participantsStarted 2018-10-04
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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.
* U…