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

  • STATUS
    Recruiting
  • End date
    Nov 5, 2022
  • participants needed
    145
  • sponsor
    Zealand Pharma
Updated on 8 May 2021
Investigator
Associate Medical Director
Primary Contact
CHRU de Lille (0.0 mi away) Contact
+53 other location

Summary

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.

Description

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

Details
Condition Short Bowel Syndrome
Treatment Glepaglutide
Clinical Study IdentifierNCT03905707
SponsorZealand Pharma
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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