Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

  • Interventional
  • Recruiting
  • NCT03905707
Eligibility Details Visit Clinicaltrials.gov

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Gender
All

Age Group
18 Years to 90 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Informed consent obtained before any trial-related activity

         - Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

        Exclusion Criteria:

         - Withdrawal of consent from the lead-in trial

         - 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

         - Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 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
  • Short Bowel Syndrome

At a Glance

National Government IDNCT03905707

IRB#IRB19-0603

Lead SponsorZealand Pharma

Lead PhysicianCarol Semrad

Collaborator(s)N/A

EligibilityAll
18 Years to 90 Years
Recruiting