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Keep this study
Lead
Zealand Pharma
This trial is a 104-week, multicenter, open-label, single-arm, phase 3 extension trial investigating the long-term safety and efficacy of glepaglutide in adult patients with short bowel syndrome (SBS) rolling over from the EASE SBS 2 or 3 trials.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has provided signed informed consent and agrees to comply with protocol requirements.
Is being
1. Actively treated and has completed at least 6 months of glepaglutide treatment in the EASE SBS 2 trial, or
2. Actively treated in the EASE SBS 3 trial.
You may not be if
Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.
Use of GLP-1, GLP-2 (e.g., teduglutide), HGH, DPP-4 inhibitors, somatostatin, or analogs thereof. Note: Prior use of glepaglutide is allowed.
Had major protocol deviation(s) (as determined by the sponsor) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial.
Has permanently discontinued the trial treatment because of an AE, assessed as related to the trial drug in the EASE SBS 2 or EASE SBS 3 trial. (Note: AEs are treatment-emergent unless otherwise specified.)
If female, is of childbearing potential, pregnant, breastfeeding, intends to become pregnant, or is not using contraceptive methods. Refer to Section 10.2.2 for the definition of contraception.
Has a known or suspected hypersensitivity to glepaglutide or related products.
Has committed to an institution by virtue of an order issued by the judicial or administrative authorities.
Is an employee of the sponsor or investigator or otherwise dependent on them.
Clareo Health | Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
