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

VectivBio

Status and phase: Active, not recruiting; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: Apraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05018286

TA799-012

Details and patient eligibility

About

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

Full description

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 were trial subjects of 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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158 participants in 1 patient group

Apraglutide subcutaneous (SC) injections, once weekly

Experimental group

Description:

Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

Treatment:

Drug: Apraglutide