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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05018286Tipo: INTERVENTIONALInicio: 13 de jul de 2021Fin estimado: 30 de oct de 2027

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
Any other reason judged not eligible by the Investigator.
Pregnancy or lactation

Intervenciones

drug

Apraglutide

Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Ubicaciones

University Hospital Fundacion Favaloro

Buenos Aires, Argentina

Patrocinadores

PrincipalVectivBio AG

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