En undersøgelse af EDP-938 hos ikke-indlagte voksne med RSV, der har høj risiko for komplikationer. (RSVHR)
28. juli 2026 opdateret af: Enanta Pharmaceuticals, Inc
En fase 2b, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af EDP-938 hos ikke-hospitaliserede voksne med akut respiratorisk syncytial virusinfektion, som har høj risiko for komplikationer
Dette er et fase 2b, randomiseret, dobbeltblindt, placebokontrolleret studie af EDP-938 administreret oralt til behandling af ikke-hospitaliserede voksne forsøgspersoner med bekræftet RSV-infektion, som har høj risiko for komplikationer efter RSV-infektion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
187
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
- Instituto Medico Platense
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Mar del Plata, Buenos Aires, Argentina, B7600FYK
- Centro de Investigaciones Medica Mar del Plata
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Munro, Buenos Aires, Argentina, B1605
- Clinica Privada Independencia
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Ciudad Autónoma de BuenosAires
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Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
- Consultorios Médicos Dr. Doreski
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Córdoba Province
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Río Cuarto, Córdoba Province, Argentina, 5800
- Instituto Médico Río Cuarto
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Santa Fe Province
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Santa Fe, Santa Fe Province, Argentina, 3000
- Instituto Del Buen Aire
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000NWB
- Clínica Mayo de U.M.C.B. S.R.L
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Haskovo, Bulgarien, 6305
- Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
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Veliko Tarnovo, Bulgarien, 5006
- Medical Center Neuromedix EOOD
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Blagoevgrad
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Blagoevgrad, Blagoevgrad, Bulgarien, 2700
- Multiprofile Hospital for Active Treatment Puls AD - PPDS
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Burgas
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Burgas, Burgas, Bulgarien, 8000
- Medical Center For Life EOOD
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Gabrovo
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Sevlievo, Gabrovo, Bulgarien, 5400
- Diagnostic Consultative Center-1-Sevlievo EOOD
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Kozloduy
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Kozloduy, Kozloduy, Bulgarien, 3320
- Medical Center Zdrave-1 OOD
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Kyustendil
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Kyustendil, Kyustendil, Bulgarien, 2500
- Medical Center Hera - Kyustendil EOOD
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Lovech
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Troyan Municipality, Lovech, Bulgarien, 5600
- Specialized Hospital for Active Treatment of Pulmonary Diseases
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Montana
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Lom, Montana, Bulgarien, 3600
- Diagnostic Consultative Center 1- Lom EOOD
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Montana, Montana, Bulgarien, 3400
- Medical Center Hera EOOD, Montana
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Pernik
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Pernik, Pernik, Bulgarien, 2300
- Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
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Ruse
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Rousse, Ruse, Bulgarien, 7002
- Medical Center Prolet EOOD
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Sevlievo
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Sevlievo, Sevlievo, Bulgarien, 5400
- Medical Center Hipocrena
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Sofia
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Sofia, Sofia, Bulgarien, 1202
- Medical Center Hera EOOD
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Sofia, Sofia, Bulgarien, 1750
- University Multiprofile Hospital for Active Treatment Sofiamed OOD
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Sofia-Grad
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Sofia, Sofia-Grad, Bulgarien, 1431
- Medical Center Sanador M EOOD
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Varna
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Varna, Varna, Bulgarien
- Medical Centre Pratia Clinic EOOD Varna
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Veliko Tarnovo
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Veliko Tarnovo, Veliko Tarnovo, Bulgarien, 5000
- Medical Center Tara OOD
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Barranquilla, Colombia, 080020
- Oinsamed S.A.S - Clinica Misericordia
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Medellín, Colombia, 050021
- Fundacion Centro de Investigacion Clinica CIC
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Antioquia
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Medellín, Antioquia, Colombia, 50021
- Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
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Atlántico
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Barranquilla, Atlántico, Colombia, 080020
- Clinica de la Costa Ltda - PPDS
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Cundinamarca
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Chía, Cundinamarca, Colombia, 250001
- Clínica Universidad De la Sabana
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Risaralda Department
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Pereira, Risaralda Department, Colombia, 660003
- Fundación Centro De Investigaciones Clinicas Ips Cardiomet Pereira
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Arizona
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Tempe, Arizona, Forenede Stater, 85282-2455
- Voyage Medical
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California
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Fresno, California, Forenede Stater, 93701
- UCSF Fresno
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Lomita, California, Forenede Stater, 90717
- Torrance Clinical Research Institute
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Los Angeles, California, Forenede Stater, 90017
- Downtown LA Research Center Inc - ClinEdge - PPDS
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Westminster, California, Forenede Stater, 92683
- Allianz Research Institute Inc
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Colorado
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Aurora, Colorado, Forenede Stater, 80014
- Allianz Research Institute - Colorado
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Florida
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Bay Pines, Florida, Forenede Stater, 33744
- Bay Pines VA Healthcare System
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Cape Coral, Florida, Forenede Stater, 33990
- C&A Clinical Trials Corp
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Cutler Bay, Florida, Forenede Stater, 33157
- Beautiful Minds Clinical Research Center
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Hialeah, Florida, Forenede Stater, 33015
- Dinamo Research & Diagnostic center, LLC
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Kissimmee, Florida, Forenede Stater, 34741
- I.H.S Health LLC
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Miami, Florida, Forenede Stater, 33144
- Dynamic Medical Research, LLC
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Miami, Florida, Forenede Stater, 33179-2537
- Floridian Research Institute
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Orlando, Florida, Forenede Stater, 32827
- Orlando VA Healthcare System
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Ormond Beach, Florida, Forenede Stater, 32174
- Ormond Beach Clinical Research
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Port Saint Lucie, Florida, Forenede Stater, 34952
- CDC Research Institute, LLC
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Tampa, Florida, Forenede Stater, 33615
- Santos Research Center
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Tampa, Florida, Forenede Stater, 33607
- Research Bay, Inc.
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Georgia
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East Point, Georgia, Forenede Stater, 30344
- Covenant Pulmonary Criticial Care and Research Ins
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Snake River Research
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- University of Louisville
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Montana
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Butte, Montana, Forenede Stater, 59701
- Mercury Street Medical
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New York
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Syracuse, New York, Forenede Stater, 13210-1685
- Global Health Institute
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Progressive Medicine of the Triad, LLC
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Ohio
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Toledo, Ohio, Forenede Stater, 43617
- Toledo Institute of Clinical Research
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Texas
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Austin, Texas, Forenede Stater, 78704-7507
- IMA Clinical Research - Austin - PPDS
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Fort Worth, Texas, Forenede Stater, 76164-9041
- Valley Institute of Research
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Houston, Texas, Forenede Stater, 77022
- HDH Research, Inc.
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McKinney, Texas, Forenede Stater, 75069
- Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
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Mesquite, Texas, Forenede Stater, 75149
- SMS Clinical Research, LLC
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Washington
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Redmond, Washington, Forenede Stater, 98052
- Eastside Research Associates
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Sarawak
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Miri, Sarawak, Malaysia, 98000
- Hospital Miri
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Oaxaca City, Mexico, 68000
- Oaxaca Site Management Organization - Clinic - OSMO - PPDS
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- CICUM San Miguel
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Guadalajara, Jalisco, Mexico, 44100
- Instituto Jalisciense de Investigación Clínica Sa de Cv
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Investigación Clinica Médica y Farmacoló
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Guadalajara, Jalisco, Mexico, 45235
- Hospital Civil Fray Antonio Alcalde
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Mexico City
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Mexico City, Mexico City, Mexico, 06760
- Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
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Nuevo León
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Monterrey, Nuevo León, Mexico, 31000
- Accelerium, S. de R.L. de C.V. - PPDS
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Monterrey, Nuevo León, Mexico
- Camacho Ortiz, Adrian
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Veracruz
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Veracruz, Veracruz, Mexico, 91020
- Centro de Alta Especialidad Dr. Rafael Lucio
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Veracruz, Veracruz, Mexico, 91700
- FAICIC
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polen, 91-463
- Centrum Medyczne PROFAMILIA
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Spišská Nová Ves, Slovakiet, 052 01
- Plucna ambulancia Hrebenar, s.r.o.
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Santiago de Compostela, Spanien, 15706
- CHUS - H. Clinico U. de Santiago
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Alicante
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Alicante, Alicante, Spanien, 03010
- Hospital General Universitario Dr. Balmis
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Cordoba
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Cabra, Cordoba, Spanien, 14940
- Centro de salud Cabra Matrona Antonia Mesa Fernández
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Johannesburg, Sydafrika, 2001
- Newtown Clinical Research Centre
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Paarl, Sydafrika, 7646
- Be Part Yoluntu Centre
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Nový Knín, Tjekkiet, 262 03
- Res Medica s.r.o.
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Liberec Region
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Liberec, Liberec Region, Tjekkiet, 460 14
- MUDr. Jakub Strincl, s.r.o.
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Mindst én af følgende tilstande, der disponerer dem for komplikationer efter RSV-infektion:
- Alder ≥65 år
- Kongestiv hjertesvigt (CHF)
- Astma
- Kronisk obstruktiv lungesygdom (KOL)
- Forsøgspersonen har en ny indtræden af et eller flere af følgende symptom(er) eller forværring af allerede eksisterende symptom(er) i overensstemmelse med en luftvejsinfektion højst 72 timer før administrationen af den første dosis af undersøgelseslægemidlet: feberfølelse , hovedpine, nakkesmerter, træthed, appetitløshed, afbrudt søvn, kropssmerter, ondt i halsen, tilstoppet næse, hoste, hoste med slim, hvæsende vejrtrækning eller åndenød.
- Forsøgspersonen rapporterer mindst 2 af følgende symptomer, hvoraf det ene skal rapporteres som mindst 'moderat' sværhedsgrad: hoste, hoste med slim, hvæsende vejrtrækning eller åndenød
- Forsøgspersonen er testet positiv for RSV-infektion ved hjælp af en NAAT (polymerasekædereaktion [PCR] eller andet) på en nasal/nasopharyngeal podningsprøve.
- En kvinde i den fødedygtige alder, som er seksuelt aktiv med en mand, skal acceptere at bruge to effektive præventionsmetoder fra screeningsdatoen indtil 30 dage efter hendes sidste dosis af undersøgelseslægemidlet.
- En mandlig forsøgsperson, som ikke har fået foretaget en vasektomi og er seksuelt aktiv med en kvinde i den fødedygtige alder, skal acceptere at bruge effektiv prævention fra screeningsdatoen til 90 dage efter hans sidste dosis af undersøgelseslægemidlet.
Ekskluderingskriterier:
- Forsøgspersonen har et forventet behov for hospitalsindlæggelse inden for 24 timer efter at have underskrevet Studie ICF
- Forsøgspersonen modtager systemisk antiviral, antibakteriel, svampedræbende eller antimykobakteriel behandling inden for 7 dage før underskrivelse af ICF-undersøgelsen
- Forsøgspersonen har samtidige luftvejsinfektioner, som er virale (bortset fra RSV, men inklusive influenza), bakterielle eller svampe, herunder systemiske bakterielle eller svampeinfektioner, inden for 7 dage før underskrivelse af ICF-undersøgelsen
- Forsøgspersonen har et SARS-CoV-2-testresultat, der er positivt inden for 28 dage før underskrivelse af ICF-undersøgelsen
- Forsøgspersonen har KOL med spirometriresultater (opnået inden for 1 år før underskrivelse af ICF-undersøgelsen) FEV1 ≤35 %
- Individet har en kendt positiv human immundefekt-virusinfektion, aktiv hepatitis A-virusinfektion, kronisk hepatitis B-virusinfektion og/eller nuværende hepatitis C-virus (HCV)-infektion; forsøgspersoner med en anamnese med HCV-infektion, som har opnået et dokumenteret vedvarende virologisk respons 12 uger efter afslutning af HCV-behandling, kan tilmeldes.
- Personen har en af følgende hjertesygdomme: enhver medfødt hjertesygdom, medfødt lang QT-syndrom eller enhver klinisk manifestation, der resulterer i forlængelse af QT-intervallet
- Individet har immunkompromitteret status
- Forsøgspersonen bor i institutionspleje eller plejehjem og modtager også akut behandling for enhver respiratorisk tilstand; Bemærk: Uafhængige boliger betragtes ikke som institutionspleje eller plejehjem
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: EDP-938
EDP-938 800 mg, én gang dagligt
|
Subjects took EDP-938 once daily for 5 days
|
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Placebo komparator: Placebo
Matchende placebo, én gang dagligt
|
Subjects took matching placebo, once daily for 5 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Resolution of RSV Lower Respiratory Tract Disease (LRTD) Symptoms
Tidsramme: Day 1 through Day 33
|
Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero or 1.
Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
|
|
Time to Complete Resolution of LRTD Symptoms for the mITT Population
Tidsramme: Day 1 through Day 33
|
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero.
Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
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Time to Complete Resolution of LRTD Symptoms for the HR3 Population
Tidsramme: Day 1 through Day 33
|
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) as assessed by RiiQTM Scale Score is zero.
Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma PK-koncentrationer af EDP-938
Tidsramme: Op til dag 5
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Op til dag 5
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Time to Resolution of LRTD Symptoms and 2 Systemic Symptoms
Tidsramme: Day 1 through Day 33
|
Resolution of LRTD and 2 Systemic Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm[sputum]) and each of the 2 systemic symptoms (feeling fever and fatigue/tiredness) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero or 1; Higher scores indicate worse outcomes (greater symptom intensity and greater impact on daily functioning).
Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
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Time to Resolution of All RSV Symptoms
Tidsramme: Day 1 through Day 33
|
Resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQ Scale Score is zero or 1.
Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
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Time to Complete Resolution of All RSV Symptoms for the mITT Population
Tidsramme: Day 1 through Day 33
|
Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero.
Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
|
|
Time to Complete Resolution of All RSV Symptoms for the HR3 Population
Tidsramme: Day 1 through Day 33
|
Complete resolution of all RSV Symptoms is defined as the first of two consecutive timepoints where each of the 13 RSV symptoms as assessed by RiiQTM Scale Score is zero.
Time to complete resolution is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
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Change From Baseline in Severity of RSV LRTD Symptoms
Tidsramme: Day 1 through Day 33
|
The RiiQ Infection Intensity Scale assesses 4 symptoms of LRTD (cough, shortness of breath, wheezing, and expectoration) on a scale from 0 (absent) to 3 (severe).
The composite LRTD Score is the average of all 4 individual item scores.
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Day 1 through Day 33
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Change From Baseline for Impact Scale
Tidsramme: Day 1 through Day 33
|
The RiiQ Impact Scale assesses daily activities (7 items), emotions (4 items), and social relationships (5 items) on a scale of 0 (no impact) to 3 (extreme impact).
The composite Impact Score is the average of all 16 individual item scores.
|
Day 1 through Day 33
|
|
Time to Resolution of Upper Respiratory Tract Disease Congestion, LRTD, and 2 Systemic Symptoms
Tidsramme: Day 1 through Day 33
|
Resolution of Symptoms is defined as the first of two consecutive timepoints where each of the RSV symptoms (4 LRTD symptoms [cough, short of breath, wheezing, coughing up phlegm [sputum]], 2 URTD symptoms [nasal congestion and sore throat], 2 Systemic symptoms [feeling feverish and fatigue[tiredness]]) as assessed by RiiQTM Scale Score is zero or 1.
Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
|
|
Time to no or Mild Impact of RSV Disease on Daily Activities, Emotions, and Social Relationships
Tidsramme: Day 1 through Day 33
|
Resolution of No or Mild Impact of RSV is defined as the first of two consecutive timepoints where each of the 3 impact Scale Scores (daily activities, emotions and social relationships) as assessed by RiiQTM Scale Score is zero or 1.
Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days.
|
Day 1 through Day 33
|
|
Percentage of Participants With Post-baseline RSV-related Complications
Tidsramme: Day 1 through Day 33
|
Day 1 through Day 33
|
|
|
Time to Improvement in RSV Disease
Tidsramme: Day 1 through Day 33
|
Time to Improvement is defined as the time from first dose to first timepoint where the response assessed by PGI-C is 'Much better'.
Time to Improvement is calculated as: date/time of Improvement - date/time of first timepoint.
|
Day 1 through Day 33
|
|
Change From Baseline for Health-Related Quality of Life
Tidsramme: Day 1 through Day 33
|
Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire; 5 dimensions (mobility, taking care of yourself, usual activities, pain/discomfort, and anxiety/depression) are scored on 5 levels from 1 (full health) to 5 (extreme disability).
An index score is derived based on the 5 reported levels where 1.0 represents full health and 0.0 the worst possible health.
|
Day 1 through Day 33
|
|
Time to Return to Usual Health
Tidsramme: Day 1 through Day 33
|
Time to return to usual health is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Health is 'Yes'.
Time to return to usual health is calculated as: date/time of return to usual health - date/time of response to 'Yes'.
|
Day 1 through Day 33
|
|
Time to Return to Usual Activities
Tidsramme: Day 1 through Day 33
|
Time to return to usual activities is defined as the time from first dose to first timepoint where the response as assessed by Adult Return to Usual Activities is 'Yes'.
Time to return to usual activities is calculated as: date/time of return to usual activities - date/time of first response to 'Yes'.
|
Day 1 through Day 33
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|
Percentage of Subjects Requiring Hospitalization for RSV or Other Causes
Tidsramme: Day 1 through Day 33
|
Day 1 through Day 33
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|
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Duration of Hospitalization for RSV or Other Causes
Tidsramme: Day 1 through Day 33
|
Day 1 through Day 33
|
|
|
All-cause Mortality
Tidsramme: Day 1 through Day 33
|
Day 1 through Day 33
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|
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RSV RNA Viral Load Change From Baseline for the mITT Population
Tidsramme: Days 3, 5, 9, and 14
|
Days 3, 5, 9, and 14
|
|
|
Change in Infectious RSV Viral Load Over Time
Tidsramme: Up to Day 14
|
Up to Day 14
|
|
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Proportion of Subjects With RSV RNA Viral Load Target Not Detected (TND) for the mITT Population
Tidsramme: Days 1, 3, 5, 9 and 14
|
Days 1, 3, 5, 9 and 14
|
|
|
Time to RSV RNA Viral Load TND for the mITT Population
Tidsramme: Day 1 through Day 14
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Time to RSV viral load TND is defined as the time between the date of first dose to the first date of achieving viral load TND.
|
Day 1 through Day 14
|
|
Safety as Measured by Frequency of Adverse Events (AEs)
Tidsramme: Up to Day 33
|
Number of subjects experiencing any Treatment-Emergent Adverse Events (TEAEs)
|
Up to Day 33
|
|
Time to Resolution of RSV Infection Symptoms by Patient Global Impression of Severity (PGI-S) Scale Score for the mITT Population
Tidsramme: Day 1 through Day 33
|
PGI-S is a 7-point patient-reported scale ranging from 1 (normal/none) to 7 (among the most extremely ill); lower scores indicate less severe disease. Time to resolution is defined as time from the first dose to first of two consecutive timepoints where the response assessed by PGI-S is 'None'. Time to resolution is calculated as: date/time of resolution - date/time of first dose with conversion to days. |
Day 1 through Day 33
|
|
Incidence of New Antibiotic Use, or New or Increased Use of Bronchodilators, Systemic or Inhaled Corticosteroids, or Oxygen Supplementation for the mITT Population
Tidsramme: Day 1 through Day 33
|
Incidence was defined as the number of subjects with new antibiotic, bronchodilators, inhaled corticosteroids or oxygen use
|
Day 1 through Day 33
|
|
Incidence of Unscheduled Medically Attended Visits for RSV Infection or Other Causes for the mITT Population
Tidsramme: Day 1 through Day 33
|
Incidence was defined as the number of subjects with unscheduled medically attended visits for RSV infection or other causes.
|
Day 1 through Day 33
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, 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)
29. november 2022
Primær færdiggørelse (Faktiske)
23. juni 2025
Studieafslutning (Faktiske)
23. juni 2025
Datoer for studieregistrering
Først indsendt
3. oktober 2022
Først indsendt, der opfyldte QC-kriterier
3. oktober 2022
Først opslået (Faktiske)
6. oktober 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EDP 938-104
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 .