Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04964986
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2021-05-27
Brief Title:
Metabolic Balance Study of Apraglutide in Patients With SBS-IF and Colon-in-Continuity
Sponsor:
VectivBio AG
Organization:
VectivBio AG
Study Overview
Official Title:
A Multicenter Open-label Metabolic Balance Study to Evaluate the Effects of Apraglutide on Intestinal Absorption in Adult Subjects With Short Bowel Syndrome Intestinal Failure SBS-IF and Colon-in-Continuity CIC
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARSnutrition
Brief Summary:
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC
Detailed Description:
This is an international multicenter trial to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC The active pharmaceutical ingredient is apraglutide an investigational GLP-2 analogue The trial consists of an evaluation period of 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None