Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Recruiting
Phase 3
Interventional Study
Short Bowel Syndrome
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Zealand Pharma · Industry
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About This Trial
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Signed informed consent;
* Age of 18 to 90 years;
* A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
* Stable PS need of ≥3 days per…
Contacts
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