Fase 3b-studie av Nadofaragene Firadenovec vs. observasjon hos deltakere med middels risiko, ikke-muskelinvasiv blærekreft (ABLE-32)
28. oktober 2026 oppdatert av: Ferring Pharmaceuticals
En fase 3b, randomisert, kontrollert studie av Nadofaragene Firadenovec vs. observasjon hos deltakere med middels risiko, ikke-muskelinvasiv blærekreft
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
454
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ferring Pharmaceuticals
- Telefonnummer: 833-548-1402
- E-post: disclosure@ferring.com
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2V1P9
- Rekruttering
- Prostate Cancer Centre
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Ontario
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Burlington, Ontario, Canada, L7N 3V2
- Rekruttering
- G kenneth Jansz Medicine Professional Corporation
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Hamilton, Ontario, Canada, L8N 4A6
- Rekruttering
- Research St. Joseph's- Hamilton/St. Joseph's Healthcare Hamilton
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Toronto, Ontario, Canada, M5G 1Z5
- Rekruttering
- University Health Network UHN - Princess Margaret Cancer Centre
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Aarhus, Danmark, 8200
- Rekruttering
- Aarhus University Hospital
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Alabama
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Mobile, Alabama, Forente stater, 36606
- Rekruttering
- University of South Alabama (USA) Health System - USACM
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Mobile, Alabama, Forente stater, 56608
- Rekruttering
- Urology Associates of Mobile
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Rekruttering
- Mayo Clinic Arizona
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Tucson, Arizona, Forente stater, 85718
- Rekruttering
- Center for Neurosciences
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Arkansas
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Little Rock, Arkansas, Forente stater, 72211
- Rekruttering
- Arkansas Urology, North Little Rock
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California
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Bakersfield, California, Forente stater, 93301
- Rekruttering
- Michael G Oefelein, MD Clinical Trials
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Fresno, California, Forente stater, 93720
- Rekruttering
- Urology Associates of Central California
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Los Angeles, California, Forente stater, 90017
- Rekruttering
- American Institute of Research
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Murrieta, California, Forente stater, 92563
- Rekruttering
- Urology Center of Southern California
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Orange, California, Forente stater, 92868
- Rekruttering
- University of California, Irvine
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Santa Monica, California, Forente stater, 90404
- Rekruttering
- Providence Saint John's Cancer Institute
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Colorado
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Denver, Colorado, Forente stater, 80210
- Rekruttering
- Advent Health
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- Medstar Georgetown University Hospital
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- Mayo Clinic
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Lakeland, Florida, Forente stater, 33805
- Rekruttering
- Lakeland Regional Health North Campus - Hollis Cancer Center
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Largo, Florida, Forente stater, 33771
- Rekruttering
- Advanced Urology institute - Pinellas
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Sarasota, Florida, Forente stater, 34239
- Rekruttering
- Sarasota Memorial Healthcare System
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Emory University
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Illinois
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Lisle, Illinois, Forente stater, 60532
- Rekruttering
- NextStage Clinical Research
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Quincy, Illinois, Forente stater, 62301
- Rekruttering
- Blessing Health System
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Indiana
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Jeffersonville, Indiana, Forente stater, 47130
- Rekruttering
- First Urology Research (Jeffersonville)
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Iowa
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Clive, Iowa, Forente stater, 50325
- Rekruttering
- Urology Center of Iowa Research
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Kansas
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Wichita, Kansas, Forente stater, 67226
- Rekruttering
- Wichita Urology Group
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Kentucky
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Lexington, Kentucky, Forente stater, 40536
- Rekruttering
- University of Kentucky (UK) - Markey Cancer Center
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Maryland
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Annapolis, Maryland, Forente stater, 21401
- Rekruttering
- Anne Arundel Urology, PA
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Rekruttering
- Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic - Rochester Minnesota
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Mississippi
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Southaven, Mississippi, Forente stater, 38654
- Rekruttering
- The Urology Group P.C
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Missouri
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Creve Coeur, Missouri, Forente stater, 63141
- Avsluttet
- Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
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St Louis, Missouri, Forente stater, 63141
- Rekruttering
- Specialty Clinical Research of St. Louis
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Nebraska
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Omaha, Nebraska, Forente stater, 68114
- Rekruttering
- Adult and Pediatric Urology P.C.
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Rekruttering
- Atlantic Health
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New York
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Albany, New York, Forente stater, 10461
- Rekruttering
- Albany Medical College
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Cheektowaga, New York, Forente stater, 14225
- Rekruttering
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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Garden City, New York, Forente stater, 11530
- Rekruttering
- AccuMed Research Associates
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Lake Success, New York, Forente stater, 11042
- Rekruttering
- Northwell Health -The Arthur Smith Institute for Urology
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New York, New York, Forente stater, 10010
- Rekruttering
- Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
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New York, New York, Forente stater, 10016
- Rekruttering
- Integrated Medical Professionals, PLLC
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Poughkeepsie, New York, Forente stater, 12603
- Avsluttet
- Premier Medical Group of the Hudson Valley
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The Bronx, New York, Forente stater, 10468
- Rekruttering
- James J. Peters VA Medical Center
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North Carolina
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Raleigh, North Carolina, Forente stater, 27610
- Rekruttering
- WakeMed
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Ohio
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Cincinnati, Ohio, Forente stater, 45267
- Rekruttering
- University of Cincinnati
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health and Science University (Portland)
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- Rekruttering
- MidLantic Urology
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Lancaster, Pennsylvania, Forente stater, 17601
- Rekruttering
- Keystone Urology Specialists
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
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Pittsburgh, Pennsylvania, Forente stater, 15232
- Rekruttering
- University of Pittsburgh Medical Center - Shadyside Medical Building
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South Carolina
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Myrtle Beach, South Carolina, Forente stater, 29572
- Rekruttering
- Carolina Urologic Research Center
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)
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Texas
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Austin, Texas, Forente stater, 78759
- Rekruttering
- Urology Austin
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Dallas, Texas, Forente stater, 75231
- Rekruttering
- Urology Clinics of North Texas PLLC (Dallas)
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Houston Methodist Hospital (Houston)
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Houston, Texas, Forente stater, 77027
- Rekruttering
- Houston Metro Urology - Memorial City
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Virginia
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Virginia Beach, Virginia, Forente stater, 23462
- Rekruttering
- Urology of Virginia
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Washington
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Spokane, Washington, Forente stater, 99202
- Rekruttering
- Spokane Urology PLLC
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Paris, Frankrike, 75013
- Rekruttering
- Hopital La Pitie Salpetriere
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Auvergne-Rhône-Alpes
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Clermont-Ferrand, Auvergne-Rhône-Alpes, Frankrike, 63000
- Rekruttering
- CHU Clermont Ferrand - Hopital Gabriel Montpied
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31059
- Rekruttering
- CHU Toulouse - Hopital Rangueil
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Nantes
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Nantes, Nantes, Frankrike, 44093
- Rekruttering
- CHU Nantes - Hotel Dieu
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New Aquitaine
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Bordeaux, New Aquitaine, Frankrike, 33076
- Rekruttering
- CHU de Bordeaux - Hôpital Pellegrin
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Normandy
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Rouen, Normandy, Frankrike, 76031
- Rekruttering
- CHU de Rouen - Hopital Charles-Nicolle
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Occitanie
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Nîmes, Occitanie, Frankrike, 30229
- Rekruttering
- Centre Hospitalier Universitaire De Nimes (Nîmes)
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Rhone-Alpe
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Lyon, Rhone-Alpe, Frankrike, 69310
- Rekruttering
- Centre Hospitaliser Universitaire de Lyon Sud
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Rhône-Alps
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Lyon, Rhône-Alps, Frankrike, 69003
- Rekruttering
- Hospices Civils de Lyon - Edouard Herriot Hosp.
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75018
- Rekruttering
- APHP - Hopital Bichat
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Lazio
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Rome, Lazio, Italia, 00144
- Rekruttering
- Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
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Lombardy
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Rozzano, Lombardy, Italia, 20089
- Rekruttering
- Gruppo Humanitas - Humanitas Research Hospital (Instituto Clinico Humanitas)
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Aichi-ken
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Nagakute, Aichi-ken, Japan, 480-1195
- Rekruttering
- Aichi Medical University Hospital
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Nagoya, Aichi-ken, Japan, 466-8560
- Rekruttering
- Nagoya University Hospital
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Chiba
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Narita, Chiba, Japan, 286-8523
- Rekruttering
- Japanese Red Cross Narita Hospital
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan, 734-8551
- Rekruttering
- Hiroshima University Hospital
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Rekruttering
- Kobe University Hospital
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Ibaraki
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Hitachi, Ibaraki, Japan, 317-0077
- Rekruttering
- Hitachi General Hospital
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Tsukuba, Ibaraki, Japan, 305-8576
- Rekruttering
- University of Tsukuba Hospital
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Kanagawa
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Kawasaki, Kanagawa, Japan, 216-8511
- Rekruttering
- St. Marianna University Hospital
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Yokohama, Kanagawa, Japan, 236-0004
- Rekruttering
- Yokohama City University Hospital
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Kanto
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Tokyo, Kanto, Japan, 113-8655
- Rekruttering
- The University of Tokyo Hospital
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Rekruttering
- Kochi Medical School Hospital
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Rekruttering
- Mie University Hospital
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Nara
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Kashihara, Nara, Japan, 634-8522
- Rekruttering
- Nara Medical University Hospital
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Tokyo
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Bunkyō-Ku, Tokyo, Japan, 113-8519
- Rekruttering
- Institute of Science Tokyo Hospital
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Wakayama
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Wakayama, Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University Hospital
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-048
- Rekruttering
- IN-VIVO Bydgoszcz
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Wielkopolska
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Poznan, Wielkopolska, Polen, 61-731
- Rekruttering
- Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
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Woj. Mazowieckie
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Warsaw, Woj. Mazowieckie, Polen, 02-798
- Rekruttering
- Medical Concierge Centrum Medyczne
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Madrid, Spania, 28033
- Rekruttering
- MD Anderson Cancer Center
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Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 De Octubre (Madrid)
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Málaga, Spania, 29010
- Rekruttering
- Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
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Cantabria
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Santander, Cantabria, Spania, 39008
- Rekruttering
- Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
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Catalonia
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Barcelona, Catalonia, Spania, 08003
- Rekruttering
- Hospital del Mar
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Córdoba
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Córdoba, Córdoba, Spania, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
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Galicia
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A Coruña, Galicia, Spania, 15006
- Rekruttering
- Hospital Universitario de A Coruna
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Granada
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Granada, Granada, Spania, 18014
- Rekruttering
- Hospital Universitario Virgen De Las Nieves
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Madrid
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Alcorcón, Madrid, Spania, 28922
- Rekruttering
- Hospital Universitario Fundacion Alcorcon
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Madrid, Madrid, Spania, 28046
- Rekruttering
- Universidad Autonoma de Madrid. Hospital Universitario La Paz
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Vizcaya
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Bilbao, Vizcaya, Spania, 48013
- Rekruttering
- Hospital Universitario Basurto
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Sør -Korea, 10408
- Rekruttering
- National Cancer Center
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Sør -Korea, 50612
- Rekruttering
- Pusan National University Yangsan Hospital
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Jeollanam-do
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Hwasun, Jeollanam-do, Sør -Korea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital (CNUHH)
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Seoul
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Seoul, Seoul, Sør -Korea, 02841
- Rekruttering
- Korea University Anam Hospital
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Seoul, Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
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Songpa-gu
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Seoul, Songpa-gu, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Songpa-gu, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital
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Kroměříž, Tsjekkia, 76701
- Rekruttering
- Kromerizska Nemocnice A S
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Liberec, Tsjekkia, 46300
- Rekruttering
- Krajska Nemocnice Liberec
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Prague, Tsjekkia, 140 59
- Rekruttering
- Fakultní Thomayerova Nemocnice
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Prague
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Prague, Prague, Tsjekkia, 160 00
- Rekruttering
- Androgeos, spol. s r.o. Location
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Prague, Prague, Tsjekkia, 140 59
- Rekruttering
- Fakultní Thomayerova Nemocnice
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
-
Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
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Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
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Recurrence within 1 year, low-grade Ta
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Solitary low-grade Ta >3 cm
-
Low-grade Ta, multifocal
-
Solitary high-grade Ta, ≤3 cm
-
Low-grade T1
- Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
- Restage TURBT may be done at the discretion of the investigator
-
Exclusion Criteria:
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
High risk NMIBC defined as:
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta >3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- Any variant histology
- Any prostatic urethral involvement
Low risk NMIBC defined as:
- First occurrence of low-grade solitary Ta ≤3 cm
- Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
- Papillary urothelial neoplasm of low malignant potential
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1 Nadofaragene Firadenovec
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits. |
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Andre navn:
|
|
Ingen inngripen: Arm 2 - Observation
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. . |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence Free survival
Tidsramme: 24 months
|
Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period. |
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Events
Tidsramme: up to 24 months
|
Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24 |
up to 24 months
|
|
Recurrence Free Survival at 12 Months
Tidsramme: 12 months
|
Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months |
12 months
|
|
Recurrence Free Survival at 24 Months
Tidsramme: 24 Months
|
Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months |
24 Months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Global Clinical Compliance, Ferring Pharmaceutical
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2024
Primær fullføring (Antatt)
30. september 2028
Studiet fullført (Antatt)
30. september 2032
Datoer for studieregistrering
Først innsendt
15. juli 2024
Først innsendt som oppfylte QC-kriteriene
15. juli 2024
Først lagt ut (Faktiske)
19. juli 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 000423
- U1111-1284-0685 (Annen identifikator: World Health Organization (UTN))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .