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Uromune for Recurrent UTI in Women
NCT04096820Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2019
- Primary completion
- Oct 2022
- Countries
- 1
- Sponsor
- Queen's University
- Modality
- Microbiome Therapeutics, Vaccines & Immunotherapeutics
- Drugs
- MV140
- Conditions
- urinary tract infection (UTI)
01
Overview
Phase 2, open-label, single-arm trial of MV140 in urinary tract infection (UTI), sponsored by Queen's University. Primary endpoint: Complete Responder (No UTI in efficacy period) at 12 months. Started Sep 2019; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Open Label
Uromune sublingual vaccine
03
Who it enrols
Women with recurrent UTIs (3+ in 12 months or 2+ in 6 months), free of infection at inclusion, post-menopausal or using contraception.
04
Endpoints
Primary
Complete Responder (No UTI in efficacy period)
Secondary
Number of UTI in the Efficacy Period
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