Extension trial to evaluate long-termefficacy and safety of glepaglutide in patients with short bowel syndrome

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Short bowel syndrome

• Registration Number: EUCTR2018-001429-26-GB
• Lead Sponsor: Zealand Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

The patient must meet all of the following inclusion criteria:
- Signed informed consent
Either of the following:
- Completed the full treatment period of the lead-in trial (ZP1848-17111), regardless of treatment adherence.
OR
- Completed the Phase 2 trial (ZP1848-15073).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

The patient must be excluded from this trial if any of the following criteria are met:
- Withdrew consent from lead-in or Phase 2 trial.
- Any condition, disease, or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or confounds planned assessments of the trial.
- Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, citrulline, somatostatin, or analogs thereof within 3 months. Note: Prior glepaglutide trial drug is allowed.
- Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Highly effective contraception methods and definition of child-bearing potential are described in Section 11.4.4 of there Study Protocol.
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- An employee of the sponsor or the Investigator or otherwise dependent on them.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified