Trials / Active Not Recruiting
Active Not RecruitingNCT04881825
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 129 (estimated)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glepaglutide | Glepaglutide will be delivered in a single-use autoinjector. |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2021-05-11
- Last updated
- 2026-02-02
Locations
19 sites across 8 countries: United States, Belgium, Denmark, France, Germany, Netherlands, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04881825. Inclusion in this directory is not an endorsement.