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RestoratiVE303 phase 3 study in recurrent Clostridioides difficile infection prevention
2022-502972-22-00Phase 3Authorised
- Sponsor
- Vedanta Biosciences
- Start
- Oct 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
- 22
01
Overview
Phase 3, randomised, double-blind trial in Clostridioides difficile colitis (CDI) comparing VE303 with Placebo (2 arms). Primary endpoint: Central laboratory confirmed CDI recurrence through Week 8. Planned start Oct 2024; status: authorised.
02
Drugs
VE303
03
Conditions
Clostridioides difficile colitis (CDI)
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