A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
89bio, Inc.
762 participants
May 24, 2024
INTERVENTIONAL
Conditions
Summary
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Eligibility
Inclusion Criteria4
- Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
- Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
- Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
- Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).
Exclusion Criteria6
- Liver disorder other than MASH.
- History or evidence of hepatic decompensation.
- History or evidence of hepatocellular carcinoma.
- Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
- ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
- Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.
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Interventions
Subcutaneous injection
Subcutaneous injection
Locations(291)
89bio Clinical Study Site
Birmingham, Alabama, United States
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Homewood, Alabama, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Camarillo, California, United States
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Canoga Park, California, United States
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Coronado, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Huntington Park, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Redwood City, California, United States
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Rialto, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Littleton, Colorado, United States
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Clermont, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah Gardens, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lady Lake, Florida, United States
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Lakewood Rch, Florida, United States
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Lehigh Acres, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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University Park, Florida, United States
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Viera, Florida, United States
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Winter Park, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Hammond, Indiana, United States
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New Albany, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Topeka, Kansas, United States
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Lafayette, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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Burlington, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Clinton Township, Michigan, United States
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Detroit, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Florham Park, New Jersey, United States
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Somers Point, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Liberty Township, Ohio, United States
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Westlake, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Greenwich, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Rapid City, South Dakota, United States
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Cordova, Tennessee, United States
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Hermitage, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Brownsville, Texas, United States
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DeSoto, Texas, United States
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Edinburg, Texas, United States
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Farmers Branch, Texas, United States
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Fort Worth, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Mansfield, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Waco, Texas, United States
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Waco, Texas, United States
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Sandy City, Utah, United States
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West Jordan, Utah, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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CABA, Argentina
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Capital Federal, Argentina
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Pilar, Argentina
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Adelaide, Australia
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Fitzroy, Australia
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Greenslopes, Australia
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Heidelberg, Australia
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Herston, Australia
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Murdoch, Australia
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Perth, Australia
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South Brisbane, Australia
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Brussels, Belgium
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Genk, Belgium
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Ghent, Belgium
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Roeselare, Belgium
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Barretos, Brazil
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Belo Horizonte, Brazil
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Botucatu, Brazil
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Goiânia, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Gorna Oryahovitsa, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Canada
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Amiens, France
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Dijon, France
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Limoges, France
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Lyon, France
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Montpellier, France
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Nice, France
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Paris, France
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Paris, France
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Paris, France
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Pessac, France
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Strasbourg, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Vénissieux, France
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Villejuif, France
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Chemnitz, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Homburg, Germany
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Münster, Germany
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Afula, Israel
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Beersheba, Israel
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Haifa, Israel
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Haifa, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bergamo, Italy
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Foggia, Italy
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Milan, Italy
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Milan, Italy
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Novara, Italy
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Palermo, Italy
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Roma, Italy
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Rome, Italy
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Rozzano, Italy
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Torino, Italy
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Chihuahua City, Mexico
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Cuautitlán Izcalli, Mexico
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Cuernavaca, Mexico
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Jalisco, Mexico
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Mexico City, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Mysłowice, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Mayagüez, Puerto Rico
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San Juan, Puerto Rico
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Bucheon-si, South Korea
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Busan, South Korea
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Daegu, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Almería, Spain
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Badalona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Málaga, Spain
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Pontevedra, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Zaragoza, Spain
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Chiayi City, Taiwan
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Bornova, İzmir, Turkey (Türkiye)
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Merkez, Rize Province, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Fatih, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Yüreğir, Turkey (Türkiye)
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Aberdeen, United Kingdom
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Bristol, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
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Plymouth, United Kingdom
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Port Talbot, United Kingdom
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Portsmouth, United Kingdom
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Southampton, United Kingdom
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06419374