- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06419374
Undersøgelse for at evaluere effektiviteten og sikkerheden af Pegozafermin hos deltagere med kompenseret skrumpelever på grund af MASH
2. juni 2026 opdateret af: 89bio, Inc.
Et fase 3-studie til evaluering af Pegozafermins effektivitet og sikkerhed hos personer med kompenseret skrumpelever på grund af metabolisk dysfunktion-associeret steatohepatitis (MASH) (ENLIGHTEN-cirrhosis)
Studiet vil vurdere effektiviteten og sikkerheden af pegozafermin administreret til deltagere med kompenseret cirrhose på grund af MASH (biopsi-bekræftet fibrose stadium F4 MASH [tidligere kendt som nonalcoholic steatohepatitis, NASH]).
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
762
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: ENLIGHTEN clinical trial
- Telefonnummer: 1-415-432-9270
- E-mail: enlighten@89bio.com
Studiesteder
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Buenos Aires, Argentina, CP 1061
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Buenos Aires, Argentina, C1125ABE
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Buenos Aires, Argentina, C1012AAR
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Buenos Aires, Argentina, C1425BGH
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Buenos Aires, Argentina, C1425
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Buenos Aires, Argentina, C1199ABB
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CABA, Argentina, C1430CKE
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Capital Federal, Argentina, C1280AEB
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Pilar, Argentina, B1629AHJ
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Adelaide, Australien, SA 5000
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Fitzroy, Australien, 03065
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Greenslopes, Australien, 04120
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Heidelberg, Australien, 3084
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Herston, Australien, Qld 4029
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Murdoch, Australien, 06150
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Perth, Australien, 06000
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South Brisbane, Australien, 04101
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Brussels, Belgien, 01070
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Brussels, Belgien, 01090
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Brussels, Belgien, 1200
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Edegem, Belgien, 02650
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Genk, Belgien, 03600
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Ghent, Belgien, 09000
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Roeselare, Belgien, 08800
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Barretos, Brasilien, 14784-400
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Belo Horizonte, Brasilien, 30220-140
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Botucatu, Brasilien, 18618-687
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Goiânia, Brasilien, 74605-050
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Porto Alegre, Brasilien, 90035-903
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Rio de Janeiro, Brasilien, 21941-617
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Salvador, Brasilien, 41820-460
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São José do Rio Preto, Brasilien, 15090-000
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São Paulo, Brasilien, 04038-002
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Vitória, Brasilien, 29055-450
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Gorna Oryahovitsa, Bulgarien, 05100
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Sofia, Bulgarien, 01407
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Sofia, Bulgarien, 01202
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Stara Zagora, Bulgarien, 06003
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Vaughan, Canada, L4L 4Y7
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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British Columbia
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Vancouver, British Columbia, Canada, V6Z2K5
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Vancouver, British Columbia, Canada, V5Z 1M9
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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Ontario
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London, Ontario, Canada, N6A5A5
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M6H3M1
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Aberdeen, Det Forenede Kongerige, AB25 2ZN
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Bristol, Det Forenede Kongerige, BS10 5NB
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Leeds, Det Forenede Kongerige, LS9 7TF
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London, Det Forenede Kongerige, SE5 9RS
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London, Det Forenede Kongerige, E1 1BB
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London, Det Forenede Kongerige, W2 1NY
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London, Det Forenede Kongerige, NW3 2QG
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Oxford, Det Forenede Kongerige, OX3 9DU
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Plymouth, Det Forenede Kongerige, PL6 8DH
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Port Talbot, Det Forenede Kongerige, SA12 7BR
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Portsmouth, Det Forenede Kongerige, P06 3LY
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Southampton, Det Forenede Kongerige, SO16 6YD
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
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Homewood, Alabama, Forenede Stater, 35209
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Flagstaff, Arizona, Forenede Stater, 86001
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Peoria, Arizona, Forenede Stater, 85381
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Phoenix, Arizona, Forenede Stater, 85054
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Tucson, Arizona, Forenede Stater, 85712
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Tucson, Arizona, Forenede Stater, 85716
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Tucson, Arizona, Forenede Stater, 85715
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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North Little Rock, Arkansas, Forenede Stater, 72117
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California
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Camarillo, California, Forenede Stater, 93012
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Canoga Park, California, Forenede Stater, 91304
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Coronado, California, Forenede Stater, 92118
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Fountain Valley, California, Forenede Stater, 92708
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Fresno, California, Forenede Stater, 93720
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Huntington Park, California, Forenede Stater, 90255
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La Jolla, California, Forenede Stater, 92037-0887
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Los Angeles, California, Forenede Stater, 90033
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Los Angeles, California, Forenede Stater, 90048
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Pasadena, California, Forenede Stater, 91105
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Poway, California, Forenede Stater, 92064
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Redwood City, California, Forenede Stater, 94063
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Rialto, California, Forenede Stater, 92377
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Sacramento, California, Forenede Stater, 95817
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Santa Ana, California, Forenede Stater, 92704
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Colorado
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Littleton, Colorado, Forenede Stater, 80120
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Florida
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Clermont, Florida, Forenede Stater, 34711
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Fort Myers, Florida, Forenede Stater, 33912
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Gainesville, Florida, Forenede Stater, 32610
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Hialeah Gardens, Florida, Forenede Stater, 33016
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Homestead, Florida, Forenede Stater, 33030
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Jacksonville, Florida, Forenede Stater, 32256
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Jacksonville, Florida, Forenede Stater, 32224
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Lady Lake, Florida, Forenede Stater, 32159
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Lakewood Rch, Florida, Forenede Stater, 34211
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Lehigh Acres, Florida, Forenede Stater, 33936
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Maitland, Florida, Forenede Stater, 32751
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Miami, Florida, Forenede Stater, 33176-1530
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Miami, Florida, Forenede Stater, 33144
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Miami, Florida, Forenede Stater, 33176-7947
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New Port Richey, Florida, Forenede Stater, 34653
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Ocala, Florida, Forenede Stater, 34471
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Ocoee, Florida, Forenede Stater, 34761
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Orlando, Florida, Forenede Stater, 32825
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University Park, Florida, Forenede Stater, 34201
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Viera, Florida, Forenede Stater, 32940
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Winter Park, Florida, Forenede Stater, 32789
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Georgia
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Athens, Georgia, Forenede Stater, 30607
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Atlanta, Georgia, Forenede Stater, 30309
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
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Indiana
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Hammond, Indiana, Forenede Stater, 46324
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New Albany, Indiana, Forenede Stater, 47150
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South Bend, Indiana, Forenede Stater, 46635
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
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Topeka, Kansas, Forenede Stater, 66606
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Louisiana
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Lafayette, Louisiana, Forenede Stater, 70503
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Lake Charles, Louisiana, Forenede Stater, 70605
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West Monroe, Louisiana, Forenede Stater, 71291
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
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Glen Burnie, Maryland, Forenede Stater, 21061
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Greenbelt, Maryland, Forenede Stater, 20770
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Massachusetts
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Burlington, Massachusetts, Forenede Stater, 01805
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
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Clinton Township, Michigan, Forenede Stater, 48038
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Detroit, Michigan, Forenede Stater, 48202
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Wyoming, Michigan, Forenede Stater, 49519
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Ypsilanti, Michigan, Forenede Stater, 48197
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55413
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Rochester, Minnesota, Forenede Stater, 55905
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
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Tupelo, Mississippi, Forenede Stater, 38801
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
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St Louis, Missouri, Forenede Stater, 63123
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
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New Jersey
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Florham Park, New Jersey, Forenede Stater, 07932
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Somers Point, New Jersey, Forenede Stater, 08244
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
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New York
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New York, New York, Forenede Stater, 10016
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New York, New York, Forenede Stater, 10021
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New York, New York, Forenede Stater, 10033
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- 89bio Clinical Study Site
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
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Charlotte, North Carolina, Forenede Stater, 28207
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Kontakt:
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Durham, North Carolina, Forenede Stater, 27710
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Fayetteville, North Carolina, Forenede Stater, 28304
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Greenville, North Carolina, Forenede Stater, 27834
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Winston-Salem, North Carolina, Forenede Stater, 27103
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Ohio
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Akron, Ohio, Forenede Stater, 44320
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Cincinnati, Ohio, Forenede Stater, 45267
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Cleveland, Ohio, Forenede Stater, 44106
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Kontakt:
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Columbus, Ohio, Forenede Stater, 43210
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Kontakt:
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Dayton, Ohio, Forenede Stater, 45414
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Liberty Township, Ohio, Forenede Stater, 45044
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Westlake, Ohio, Forenede Stater, 44145
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
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Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19148
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
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Rhode Island
-
East Greenwich, Rhode Island, Forenede Stater, 02818
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Columbia, South Carolina, Forenede Stater, 29204
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
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South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
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Tennessee
-
Cordova, Tennessee, Forenede Stater, 38018
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Hermitage, Tennessee, Forenede Stater, 37076
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Nashville, Tennessee, Forenede Stater, 37211
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
Texas
-
Amarillo, Texas, Forenede Stater, 79106
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Austin, Texas, Forenede Stater, 78745
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Austin, Texas, Forenede Stater, 78757-8059
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Austin, Texas, Forenede Stater, 78757-8066
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Brownsville, Texas, Forenede Stater, 78520
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
DeSoto, Texas, Forenede Stater, 75115
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Edinburg, Texas, Forenede Stater, 78539
- Trukket tilbage
- 89bio Clinical Study Site
-
Farmers Branch, Texas, Forenede Stater, 75234
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Harlingen, Texas, Forenede Stater, 78550
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Houston, Texas, Forenede Stater, 77099
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Houston, Texas, Forenede Stater, 77074
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Lewisville, Texas, Forenede Stater, 75067
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Lubbock, Texas, Forenede Stater, 79410
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mansfield, Texas, Forenede Stater, 76063
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Pearland, Texas, Forenede Stater, 77584
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
San Antonio, Texas, Forenede Stater, 78209
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
San Antonio, Texas, Forenede Stater, 78229-4801
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
San Antonio, Texas, Forenede Stater, 78229-5069
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
San Marcos, Texas, Forenede Stater, 78666
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Waco, Texas, Forenede Stater, 76712
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Waco, Texas, Forenede Stater, 76710
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
Utah
-
Sandy City, Utah, Forenede Stater, 84092
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
West Jordan, Utah, Forenede Stater, 84088
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
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Virginia
-
Richmond, Virginia, Forenede Stater, 23298
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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Richmond, Virginia, Forenede Stater, 23226
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Richmond, Virginia, Forenede Stater, 23229
- Trukket tilbage
- 89bio Clinical Study Site
-
Richmond, Virginia, Forenede Stater, 23236
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
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Washington
-
Seattle, Washington, Forenede Stater, 98105
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seattle, Washington, Forenede Stater, 98101
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Amiens, Frankrig, 80054
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
Dijon, Frankrig, 21000
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Limoges, Frankrig, 87000
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Lyon, Frankrig, 69004
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Montpellier, Frankrig, 34295
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Nice, Frankrig, 06202
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Paris, Frankrig, 75013
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Paris, Frankrig, 75012
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Paris, Frankrig, 75014
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Pessac, Frankrig, 33604
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Strasbourg, Frankrig, 67091
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Toulouse, Frankrig, 31400
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Vandœuvre-lès-Nancy, Frankrig, 54500
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Villejuif, Frankrig, 94800
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Vénissieux, Frankrig, 69694
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
-
Amsterdam, Holland, 1081 HV
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
Rotterdam, Holland, 3015GD
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Tilburg, Holland, 5022 GC
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
Utrecht, Holland, 3584 CX
- Trukket tilbage
- 89bio Clinical Study Site
-
-
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
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Shatin, Hong Kong
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Gujrāt, Indien, 360001
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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Sūrat, Indien, 395009
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
-
Afula, Israel, 1834111
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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Beersheba, Israel, 8410101
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Haifa, Israel, 3109601
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Haifa, Israel, 3436212
- Tilmelding efter invitation
- 89bio Clinical Study Site
-
Jerusalem, Israel, 9112001
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
Nahariya, Israel, 2210001
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Petah Tikva, Israel, 49100
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Tel Aviv, Israel, 69710
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Tel Litwinsky, Israel, 5265601
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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-
-
-
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Bergamo, Italien, 24127
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
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Foggia, Italien, 71121
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Milan, Italien, 20122
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Milan, Italien, 20162
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Novara, Italien, 28100
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Palermo, Italien, 90127
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Roma, Italien, 00128
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Rome, Italien, 00168
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Rozzano, Italien, 20089
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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Torino, Italien, 10124
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
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-
-
-
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Chihuahua City, Mexico, 31217
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
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Cuautitlán Izcalli, Mexico, CP 54769
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Cuernavaca, Mexico, 62250
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
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Jalisco, Mexico, 44130
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mexico City, Mexico, 03330
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mexico City, Mexico, 06700
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Monterrey, Mexico, 64310
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mérida, Mexico, 97070
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Katowice, Polen, 40-752
- Trukket tilbage
- 89bio Clinical Study Site
-
Krakow, Polen, 31-501
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Lodz, Polen, 91-363
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Lodz, Polen, 90-302
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mysłowice, Polen, 41-400
- Trukket tilbage
- 89bio Clinical Study Site
-
Warsaw, Polen, 02-172
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Warsaw, Polen, 04-501
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Warsaw, Polen, 00-215
- Trukket tilbage
- 89bio Clinical Study Site
-
Wroclaw, Polen, 53-673
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
-
Manati, Puerto Rico, 00674
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Mayagüez, Puerto Rico, 00680
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
San Juan, Puerto Rico, 00927
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Singapore, Singapore, 308433
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Singapore, Singapore, 529889
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Singapore, Singapore, 169608
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Singapore, Singapore, 119074
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Almería, Spanien, 04009
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Badalona, Spanien, 08916
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Barcelona, Spanien, 08041
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Barcelona, Spanien, 08003
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Barcelona, Spanien, 08035
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Córdoba, Spanien, 14004
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Madrid, Spanien, 28007
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Málaga, Spanien, 29010
- Trukket tilbage
- 89bio Clinical Study Site
-
Pontevedra, Spanien, 36071
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Santander, Spanien, 39008
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Santiago de Compostela, Spanien, 15706
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Zaragoza, Spanien, 50009
- Rekruttering
- 89bio Clinical Study Site
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Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Bucheon-si, Sydkorea, 14584
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Busan, Sydkorea, 49241
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Daegu, Sydkorea, 42415
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Daegu, Sydkorea, 700-712
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Incheon, Sydkorea, 22332
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seoul, Sydkorea, 03080
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seoul, Sydkorea, 06591
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seoul, Sydkorea, 07061
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seoul, Sydkorea, 07895
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Seoul, Sydkorea, 130-872
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
-
Chiayi City, Taiwan, 60002
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Tainan, Taiwan, 00704
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06100
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Ankara, Tyrkiet (Türkiye), 6800
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Fatih, Tyrkiet (Türkiye), 34093
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Istanbul, Tyrkiet (Türkiye), 34010
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Istanbul, Tyrkiet (Türkiye), 34722
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Izmir, Tyrkiet (Türkiye), 35360
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Umraniye, Tyrkiet (Türkiye), 34764
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Yüreğir, Tyrkiet (Türkiye), 1370
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
Rize Province
-
Merkez, Rize Province, Tyrkiet (Türkiye), 53020
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
İzmir
-
Bornova, İzmir, Tyrkiet (Türkiye), 35040
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Chemnitz, Tyskland, 9116
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Frankfurt, Tyskland, 60590
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Freiburg im Breisgau, Tyskland, 79110
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Hanover, Tyskland, 30625
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Homburg, Tyskland, 66421
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Münster, Tyskland, 48149
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
-
-
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Budapest, Ungarn, 01027
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Budapest, Ungarn, 01088
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
Budapest, Ungarn, H-1097
- Rekruttering
- 89bio Clinical Study Site
-
Kontakt:
- 89bio Clinical Study Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Nøgleinklusionskriterier:
- Mænd eller ikke-gravide kvinder i alderen mellem 18 og 75 år (inklusive) på tidspunktet for underskrivelsen af den informerede samtykkeformular (ICF).
- Mindst 1 metabolisk risikofaktor.
- Biopsi-bekræftet fibrosestadium F4 MASH (pr. non-alkoholisk steatohepatitis [NASH] Clinical Research Network (CRN) system) med kompenseret cirrhose.
- Kropsmasseindeks (BMI) ved screening ≥25,0 (≥23,0 for asiatiske deltagere) og <50,0 kg (kg)/kvadratmeter (m^2).
Nøgleekskluderingskriterier:
- Andre leversygdomme end MASH.
- Anamnese eller tegn på leverdekompensation.
- Historie eller tegn på hepatocellulært karcinom.
- Har type 1 diabetes mellitus eller dårligt kontrolleret type 2 diabetes mellitus.
- ALT eller aspartataminotransferase (AST) ≥250 enheder pr. liter (U/L).
- Deltagere, der tager vitamin E (>400 internationale enheder [IE]/dag), skal have en stabil dosis i mindst 6 måneder før screening.
Andre inklusions- og eksklusionskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Matchet placebo
|
Subkutan injektion
|
|
Eksperimentel: Pegozafermin
|
Subkutan injektion
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Andel af deltagere, der opnår fibrose-regression
Tidsramme: Baseline til og med måned 24
|
Fibroseregression er defineret som forbedring af fibrose med ≥1 trin, ved måned 24 biopsi i forhold til baseline biopsi.
|
Baseline til og med måned 24
|
|
Tid til første forekomst af sygdomsprogression målt ved sammensat af protokol -specificerede kliniske begivenheder
Tidsramme: Baseline op til 5 år
|
Baseline op til 5 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ændring fra baseline i forbedret leverfibrose (ELF) score
Tidsramme: Baseline, op til måned 60
|
Baseline, op til måned 60
|
|
Skift fra baseline i alaninaminotransferase (ALT) niveau
Tidsramme: Baseline, op til måned 60
|
Baseline, op til måned 60
|
|
Ændring fra baseline i Fibroscan vibrationsstyret forbigående elastografi (VCTE)
Tidsramme: Baseline, op til måned 60
|
Baseline, op til måned 60
|
|
Andel af deltagere, der udvikler klinisk signifikant portalhypertension (CSPH)
Tidsramme: Baseline op til måned 60
|
Baseline op til måned 60
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Maya Margalit, MD, 89bio, Inc.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. maj 2024
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. august 2031
Datoer for studieregistrering
Først indsendt
14. maj 2024
Først indsendt, der opfyldte QC-kriterier
14. maj 2024
Først opslået (Faktiske)
17. maj 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BIO89-100-132
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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