Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

• Status: Recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VectivBio AG

Criteria

Inclusion Criteria:

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who have completed parent trials TA799-007 or TA799-013

2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion Criteria:

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.

2. Any other reason judged not eligible by the Investigator.

3. Pregnancy or lactation