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Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

NCT04627025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-11-27

No results posted yet for this study

Summary

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

apraglutide

Apraglutide is a 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.

Sponsors & Collaborators

  • VectivBio AG

    lead INDUSTRY

Principal Investigators

  • Tomasz Masior · VectivBio AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2024-01-02
Completion
2024-02-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627025 on ClinicalTrials.gov