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Clinical Trial Summary

Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug.

BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.

Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03982797
Study type Interventional
Source Biofabri, S.L
Contact Ingrid Murillo, MSc.
Phone 0034986330400
Email ingrid.murillo@biofabri.es
Status Recruiting
Phase Phase 2
Start date May 17, 2019
Completion date March 3, 2022

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