Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 90
Updated:3/20/2019
Start Date:October 4, 2018
End Date:October 23, 2020
Contact:Senior Clinical Trial Manager
Email:cll@zealandpharma.com
Phone:+45 88 77 36 00

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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)

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.

A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to
evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients
with short bowel syndrome (SBS).

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.
We found this trial at
12
sites
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Bruxelles,
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Bruxelles,
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1801 NW 9th Ave
Miami, Florida 33136
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Miami, FL
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Nashville, TN
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New York, New York 10029
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New York, NY
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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200 1st St SW
Rochester, Minnesota 55905
(507) 284-2316
Mayo Clinic College of Medicine Mayo Medical School enrolls a select class of 50 medical...
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Rochester, MN
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Scottsdale, Arizona 85259
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Scottsdale, AZ
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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