Trial intelligence / Profile preview

Phase 3 RESTORATiVE303 trial of VE303 to prevent recurrent Clostridioides difficile infection

MOH_2024-08-01_013427Phase 3Not yet recruiting

Sponsor
Vedanta Biosciences
Start
Apr 2024
Modality
Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Countries
1
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Overview

Phase 3, randomised, double-blind trial of VE303 in Clostridioides difficile colitis (CDI) and Clostridioides difficile infection recurrence (rCDI) (4 arms), sponsored by Vedanta Biosciences. Primary endpoints: Recurrent Clostridioides difficile infection at Week 8 and Safety. Planned start Apr 2024; status: not yet recruiting.

02

Drugs

VE303
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Conditions

Clostridioides difficile colitis (CDI)Clostridioides difficile infection recurrence (rCDI)

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