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En studie av EDP-938 hos ikke-innlagte voksne med RSV som har høy risiko for komplikasjoner. (RSVHR)

28. juli 2026 oppdatert av: Enanta Pharmaceuticals, Inc

En fase 2b, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til EDP-938 hos ikke-innlagte voksne med akutt respiratorisk syncytial virusinfeksjon som har høy risiko for komplikasjoner

Dette er en fase 2b, randomisert, dobbeltblind, placebokontrollert studie av EDP-938 administrert oralt for behandling av ikke-innlagte voksne personer med bekreftet RSV-infeksjon som har høy risiko for komplikasjoner etter RSV-infeksjon.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

187

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Instituto Medico Platense
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Centro de Investigaciones Medica Mar del Plata
      • Munro, Buenos Aires, Argentina, B1605
        • Clínica Privada Independencia
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • Instituto Medico Rio Cuarto
    • Santa Fe Province
      • Santa Fe, Santa Fe Province, Argentina, 3000
        • Instituto Del Buen Aire
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000NWB
        • Clínica Mayo de U.M.C.B. S.R.L
  • Bulgaria
      • Haskovo, Bulgaria, 6305
        • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
      • Veliko Tarnovo, Bulgaria, 5006
        • Medical Center Neuromedix EOOD
    • Blagoevgrad
      • Blagoevgrad, Blagoevgrad, Bulgaria, 2700
        • Multiprofile Hospital for Active Treatment Puls AD - PPDS
    • Burgas
      • Burgas, Burgas, Bulgaria, 8000
        • Medical Center For Life EOOD
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Diagnostic Consultative Center-1-Sevlievo EOOD
    • Kozloduy
      • Kozloduy, Kozloduy, Bulgaria, 3320
        • Medical Center Zdrave-1 OOD
    • Kyustendil
      • Kyustendil, Kyustendil, Bulgaria, 2500
        • Medical Center Hera - Kyustendil EOOD
    • Lovech
      • Troyan Municipality, Lovech, Bulgaria, 5600
        • Specialized Hospital for Active Treatment of Pulmonary Diseases
    • Montana
      • Lom, Montana, Bulgaria, 3600
        • Diagnostic Consultative Center 1- Lom EOOD
      • Montana, Montana, Bulgaria, 3400
        • Medical Center Hera EOOD, Montana
    • Pernik
      • Pernik, Pernik, Bulgaria, 2300
        • Specialized Hospital for Active Treatment of Pulmonary Diseases- Pernik EOOD
    • Ruse
      • Rousse, Ruse, Bulgaria, 7002
        • Medical Center Prolet EOOD
    • Sevlievo
      • Sevlievo, Sevlievo, Bulgaria, 5400
        • Medical Center Hipocrena
    • Sofia
      • Sofia, Sofia, Bulgaria, 1202
        • Medical Center Hera EOOD
      • Sofia, Sofia, Bulgaria, 1750
        • University Multiprofile Hospital for Active Treatment Sofiamed OOD
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1431
        • Medical Center Sanador M EOOD
    • Varna
      • Varna, Varna, Bulgaria
        • Medical Centre Pratia Clinic EOOD Varna
    • Veliko Tarnovo
      • Veliko Tarnovo, Veliko Tarnovo, Bulgaria, 5000
        • Medical Center Tara OOD
  • Colombia
      • Barranquilla, Colombia, 080020
        • Oinsamed S.A.S - Clinica Misericordia
      • Medellín, Colombia, 050021
        • Fundacion Centro de Investigacion Clinica CIC
    • Antioquia
      • Medellín, Antioquia, Colombia, 50021
        • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura Industriales Medellin
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Clinica de la Costa Ltda - PPDS
    • Cundinamarca
      • Chía, Cundinamarca, Colombia, 250001
        • Clínica Universidad De la Sabana
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660003
        • Fundación Centro De Investigaciones Clinicas Ips Cardiomet Pereira
  • Forente stater
    • Arizona
      • Tempe, Arizona, Forente stater, 85282-2455
        • Voyage Medical
    • California
      • Fresno, California, Forente stater, 93701
        • Ucsf Fresno
      • Lomita, California, Forente stater, 90717
        • Torrance Clinical Research Institute
      • Los Angeles, California, Forente stater, 90017
        • Downtown LA Research Center Inc - ClinEdge - PPDS
      • Westminster, California, Forente stater, 92683
        • Allianz Research Institute Inc
    • Colorado
      • Aurora, Colorado, Forente stater, 80014
        • Allianz Research Institute - Colorado
    • Florida
      • Bay Pines, Florida, Forente stater, 33744
        • Bay Pines VA Healthcare System
      • Cape Coral, Florida, Forente stater, 33990
        • C&A Clinical Trials Corp
      • Cutler Bay, Florida, Forente stater, 33157
        • Beautiful Minds Clinical Research Center
      • Hialeah, Florida, Forente stater, 33015
        • Dinamo Research & Diagnostic Center, LLC
      • Kissimmee, Florida, Forente stater, 34741
        • I.H.S Health LLC
      • Miami, Florida, Forente stater, 33144
        • Dynamic Medical Research, LLC
      • Miami, Florida, Forente stater, 33179-2537
        • Floridian Research Institute
      • Orlando, Florida, Forente stater, 32827
        • Orlando VA Healthcare System
      • Ormond Beach, Florida, Forente stater, 32174
        • Ormond Beach Clinical Research
      • Port Saint Lucie, Florida, Forente stater, 34952
        • CDC Research Institute, LLC
      • Tampa, Florida, Forente stater, 33615
        • Santos Research Center
      • Tampa, Florida, Forente stater, 33607
        • Research Bay, Inc.
    • Georgia
      • East Point, Georgia, Forente stater, 30344
        • Covenant Pulmonary Criticial Care and Research Ins
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • Snake River Research
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • University of Louisville
    • Montana
      • Butte, Montana, Forente stater, 59701
        • Mercury Street Medical
    • New York
      • Syracuse, New York, Forente stater, 13210-1685
        • Global Health Institute
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Progressive Medicine of the Triad, LLC
    • Ohio
      • Toledo, Ohio, Forente stater, 43617
        • Toledo Institute of Clinical Research
    • Texas
      • Austin, Texas, Forente stater, 78704-7507
        • IMA Clinical Research - Austin - PPDS
      • Fort Worth, Texas, Forente stater, 76164-9041
        • Valley Institute of Research
      • Houston, Texas, Forente stater, 77022
        • HDH Research, Inc.
      • McKinney, Texas, Forente stater, 75069
        • Metroplex Pulmonary and Sleep Medicine Center-4833 Medical Center Dr Unit 6B
      • Mesquite, Texas, Forente stater, 75149
        • SMS Clinical Research, LLC
    • Washington
      • Redmond, Washington, Forente stater, 98052
        • Eastside Research Associates
  • Malaysia
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Hospital Miri
  • Mexico
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization - Clinic - OSMO - PPDS
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • CICUM San Miguel
      • Guadalajara, Jalisco, Mexico, 44100
        • Instituto Jalisciense de Investigación Clínica Sa de Cv
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Investigación Clinica Médica y Farmacoló
      • Guadalajara, Jalisco, Mexico, 45235
        • Hospital Civil Fray Antonio Alcalde
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06760
        • Centro de Atención e Investigación Médica S.A. - México - CAIMED - PPDS
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 31000
        • Accelerium, S. de R.L. de C.V. - PPDS
      • Monterrey, Nuevo León, Mexico
        • Camacho Ortiz, Adrian
    • Veracruz
      • Veracruz, Veracruz, Mexico, 91020
        • Centro de Alta Especialidad Dr. Rafael Lucio
      • Veracruz, Veracruz, Mexico, 91700
        • FAICIC
  • Polen
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 91-463
        • Centrum Medyczne PROFAMILIA
  • Slovakia
      • Spišská Nová Ves, Slovakia, 052 01
        • Plucna ambulancia Hrebenar, s.r.o.
  • Spania
      • Santiago de Compostela, Spania, 15706
        • CHUS - H. Clinico U. de Santiago
    • Alicante
      • Alicante, Alicante, Spania, 03010
        • Hospital General Universitario Dr. Balmis
    • Cordoba
      • Cabra, Cordoba, Spania, 14940
        • Centro de salud Cabra Matrona Antonia Mesa Fernández
  • Sør-Afrika
      • Johannesburg, Sør-Afrika, 2001
        • Newtown Clinical Research Centre
      • Paarl, Sør-Afrika, 7646
        • Be Part Yoluntu Centre
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
  • Tsjekkia
      • Nový Knín, Tsjekkia, 262 03
        • Res Medica s.r.o.
    • Liberec Region
      • Liberec, Liberec Region, Tsjekkia, 460 14
        • MUDr. Jakub Strincl, s.r.o.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Minst én av følgende tilstander som disponerer dem for komplikasjoner etter RSV-infeksjon:

    1. Alder ≥65 år
    2. Kongestiv hjertesvikt (CHF)
    3. Astma
    4. Kronisk obstruktiv lungesykdom (KOLS)
  • Forsøkspersonen har en ny debut av et eller flere av følgende symptom(er) eller forverring av allerede eksisterende symptom(er) forenlig med en luftveisinfeksjon ikke mer enn 72 timer før administrering av den første dosen av studiemedikamentet: feberfølelse , hodepine, nakkesmerter, tretthet, tap av matlyst, avbrutt søvn, kroppssmerter, sår hals, tett nese, hoste, hoste med slim, tungpustethet eller kortpustethet.
  • Personen rapporterer minst 2 av følgende symptomer, hvorav ett må rapporteres som minst "moderat" alvorlighetsgrad: hoste, hoste med slim, hvesing eller kortpustethet
  • Forsøkspersonen har testet positivt for RSV-infeksjon ved bruk av en NAAT (polymerasekjedereaksjon [PCR] eller annet) på en nasal/nasofaryngeal vattpinneprøve.
  • En kvinne i fertil alder som er seksuelt aktiv med en mann, må godta å bruke to effektive prevensjonsmetoder fra screeningsdatoen til 30 dager etter siste dose av studiemedikamentet.
  • En mannlig forsøksperson som ikke har gjennomgått en vasektomi og er seksuelt aktiv med en kvinne i fertil alder, må godta å bruke effektiv prevensjon fra screeningsdatoen til 90 dager etter hans siste dose av studiemedikamentet.

Ekskluderingskriterier:

  • Forsøkspersonen har et forventet behov for sykehusinnleggelse innen 24 timer etter signering av studie ICF
  • Pasienten mottar systemisk antiviral, antibakteriell, antifungal eller antimykobakteriell terapi innen 7 dager før signering av studiens ICF
  • Pasienten har samtidige luftveisinfeksjoner som er virale (annet enn RSV, men inkludert influensa), bakterielle eller soppinfeksjoner, inkludert systemiske bakterielle eller soppinfeksjoner, innen 7 dager før signering av studie ICF
  • Forsøkspersonen har et SARS-CoV-2-testresultat som er positivt innen 28 dager før signering av studiens ICF
  • Forsøkspersonen har KOLS med spirometriresultater (oppnådd innen 1 år før signering av studiens ICF) FEV1 ≤35 %
  • Individet har en kjent positiv human immunsviktvirusinfeksjon, aktiv hepatitt A-virusinfeksjon, kronisk hepatitt B-virusinfeksjon og/eller nåværende hepatitt C-virus (HCV)-infeksjon; Personer med en historie med HCV-infeksjon som har oppnådd en dokumentert vedvarende virologisk respons 12 uker etter fullført HCV-behandling, kan bli registrert.
  • Personen har en av følgende hjertesykdommer: enhver medfødt hjertesykdom, medfødt lang QT-syndrom eller enhver klinisk manifestasjon som resulterer i forlengelse av QT-intervallet
  • Personen har immunkompromittert status
  • Personen bor i institusjon eller omsorgsbolig og mottar også akuttbehandling for enhver luftveistilstand; Merk: Selvstendige leiligheter regnes ikke som institusjonsomsorg eller omsorgsbolig

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: EDP-938
EDP-938 800 mg, én gang daglig
Legemiddel: EDP-938
Subjects took EDP-938 once daily for 5 days
Placebo komparator: Placebo
Matchende placebo, én gang daglig
Legemiddel: Placebo
Subjects took matching placebo, once daily for 5 days

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma PK-konsentrasjoner av EDP-938
Tidsramme: Frem til dag 5
Frem til dag 5
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
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
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
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.
Day 1 through Day 33
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
Percentage of Subjects Requiring Hospitalization for RSV or Other Causes
Tidsramme: Day 1 through Day 33
Day 1 through Day 33
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
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
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Enanta Pharmaceuticals, Inc

Etterforskere

  • Studieleder: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. november 2022

Primær fullføring (Faktiske)

23. juni 2025

Studiet fullført (Faktiske)

23. juni 2025

Datoer for studieregistrering

Først innsendt

3. oktober 2022

Først innsendt som oppfylte QC-kriteriene

3. oktober 2022

Først lagt ut (Faktiske)

6. oktober 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EDP 938-104

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere