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En utvidelsesstudie av forsøkspersoner som fikk et Avalyn inhalert antifibrotisk middel (seil) (SAIL)

3. november 2026 oppdatert av: Avalyn Pharma Inc.

En multinasjonal, langsiktig, sikkerhet og tolerabilitet, åpen utvidelsesstudie av forsøkspersoner som har deltatt i Avalyn Pharma-studier av inhalerte antifibrotiske midler (AP-LTE-008 [SAIL])

This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System.

The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug.

A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.

Studietype

Intervensjonell

Registrering (Antatt)

340

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1056ABI
        • Rekruttering
        • CINME
        • Hovedetterforsker:
          • Maria Otaola
        • Ta kontakt med:
          • Maria Otaola
        • Ta kontakt med:
      • Buenos Aires, Argentina, 7600
        • Rekruttering
        • Instituto Ave Pulmo, Fundacion Enfisema
        • Hovedetterforsker:
          • Luis Wehbe
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1199ABH
      • Buenos Aires, Argentina, 1842
        • Rekruttering
        • Clinica Monte Grande
        • Ta kontakt med:
      • Buenos Aires, Argentina, B1878
      • Buenos Aires, Argentina, 1427
        • Rekruttering
        • Fundación Respirar
        • Hovedetterforsker:
          • Pablo Doreski
        • Ta kontakt med:
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
        • Rekruttering
        • CIMER Centro Integral de Medicina Respiratoria
        • Hovedetterforsker:
          • Hector Altieri
        • Ta kontakt med:
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAP
        • Rekruttering
        • Investigaciones En Patologias Respiratorias
        • Hovedetterforsker:
          • Ramon Angel Rosas
        • Ta kontakt med:
  • Australia
      • Chermside, Australia
      • Footscray, Australia
        • Rekruttering
        • Lung & Sleep Victoria
        • Hovedetterforsker:
          • Ian Glaspole
        • Ta kontakt med:
      • Kent Town, Australia
        • Rekruttering
        • Respiratory Clinical Trials PTY Ltd
        • Hovedetterforsker:
          • Michael Chia
        • Ta kontakt med:
      • Kingston, Australia
      • Nedlands, Australia
        • Rekruttering
        • Univ of Western Australia / Institute for Respiratory Health
        • Hovedetterforsker:
          • Vidya Navaratnam
        • Ta kontakt med:
      • New Lambton Heights, Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Macquarie Park, New South Wales, Australia, 2113
      • Westmead, New South Wales, Australia, 2145
        • Rekruttering
        • Westmead Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jimmy Chien
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Rekruttering
        • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
        • Hovedetterforsker:
          • Daniel Chambers
        • Ta kontakt med:
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Aktiv, ikke rekrutterende
        • The Queen Elizabeth Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Rekruttering
        • Alfred Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jun Keng Khoo
  • Canada
    • Ontario
      • Ajax, Ontario, Canada
        • Rekruttering
        • Dynamic Drug Advancement
        • Hovedetterforsker:
          • George Philteos
        • Ta kontakt med:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Rekruttering
        • Research Institute McGill University Health Center
        • Hovedetterforsker:
          • Deborah Assayag
        • Ta kontakt med:
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Rekruttering
        • CIC Mauricie
        • Hovedetterforsker:
          • Emilie Millaire
        • Ta kontakt med:
    • Vancouver
      • Vancouver, Vancouver, Canada, V5Z1M9
        • Rekruttering
        • Centre for Lung Health
        • Hovedetterforsker:
          • Daniel Marinescu
        • Ta kontakt med:
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Rekruttering
        • University of Alabama at Birmingham
        • Hovedetterforsker:
          • Tejaswini Kulkarni
        • Ta kontakt med:
    • California
      • Los Angeles, California, Forente stater, 90033
        • Rekruttering
        • University of Southern California
        • Hovedetterforsker:
          • Toby Maher
        • Ta kontakt med:
      • Newport Beach, California, Forente stater, 92663
        • Rekruttering
        • Newport Native MD, Inc.
        • Hovedetterforsker:
          • Ryan Klein
        • Ta kontakt med:
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • University of Colorado, Anschutz Medical Campus
        • Hovedetterforsker:
          • Joyce Lee, MD
        • Ta kontakt med:
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06030
        • Rekruttering
        • UConn Health
        • Ta kontakt med:
          • Ameer Rasheed
        • Hovedetterforsker:
          • Ameer Rasheed
      • New Haven, Connecticut, Forente stater, 06519
        • Rekruttering
        • Yale University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mridu Gulati
    • Florida
      • Ocala, Florida, Forente stater, 34470
        • Rekruttering
        • Renstar Medical Research
        • Hovedetterforsker:
          • Raj Karunakara, MD
        • Ta kontakt med:
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Rekruttering
        • Piedmont Healthcare, Inc.
        • Hovedetterforsker:
          • Amy Case, MD
        • Ta kontakt med:
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Rekruttering
        • The University of Kansas Medical Center
        • Hovedetterforsker:
          • Mark Hamblin
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
      • Baltimore, Maryland, Forente stater, 21205
        • Rekruttering
        • Johns Hopkins Asthma and Allergy Center
        • Hovedetterforsker:
          • Matthew Lammi, MD
        • Ta kontakt med:
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Rekruttering
        • Mayo Clinic Rochester
        • Ta kontakt med:
          • Sam Nascak
        • Hovedetterforsker:
          • Andrew Limper, MD
        • Ta kontakt med:
    • Missouri
      • Hannibal, Missouri, Forente stater, 63401
        • Rekruttering
        • Hannibal Regional Healthcare System, Inc.
        • Hovedetterforsker:
          • Humam Farah, MD
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Hovedetterforsker:
          • Maria Padilla, MD
        • Ta kontakt med:
      • New York, New York, Forente stater, 10032
        • Rekruttering
        • Columbia University
        • Hovedetterforsker:
          • Claire McGroder, MD
        • Ta kontakt med:
      • New York, New York, Forente stater, 10021
        • Rekruttering
        • Weill Cornell
        • Hovedetterforsker:
          • Anna Podolanczuk
        • Ta kontakt med:
    • North Carolina
      • Statesville, North Carolina, Forente stater, 28625
      • Winston-Salem, North Carolina, Forente stater, 27103
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • Rekruttering
        • University of Cincinnati
        • Hovedetterforsker:
          • Nishant Gupta, MD
        • Ta kontakt med:
    • Oregon
      • Bend, Oregon, Forente stater, 97701
        • Rekruttering
        • Summit Health
        • Hovedetterforsker:
          • Jeremy Feldman, MD
        • Ta kontakt med:
      • Portland, Oregon, Forente stater, 97220
        • Rekruttering
        • The Oregon Clinic Pulmonary East
        • Hovedetterforsker:
          • David Hotchkin
        • Ta kontakt med:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Rekruttering
        • Temple University Hospital
        • Hovedetterforsker:
          • Gerard Criner, MD
        • Ta kontakt med:
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Rekruttering
        • Thomas Jefferson University
        • Hovedetterforsker:
          • Ross Summer, MD
        • Ta kontakt med:
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Rekruttering
        • Medical University of South Carolina
        • Hovedetterforsker:
          • Timothy Whelan, MD
        • Ta kontakt med:
      • Charleston, South Carolina, Forente stater, 29406
        • Rekruttering
        • Lowcountry Lung and Critical Care, PA
        • Hovedetterforsker:
          • Thomas Kaelin, Jr., DO
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37204
        • Rekruttering
        • Vanderbilt University Medical Center
        • Hovedetterforsker:
          • Justin Hewlett, MD
        • Ta kontakt med:
    • Texas
      • El Paso, Texas, Forente stater, 79902
        • Rekruttering
        • El Paso Pulmonary Association, P.A.
        • Hovedetterforsker:
          • Carlo Hatem, MD
        • Ta kontakt med:
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Baylor College of Medicine
        • Hovedetterforsker:
          • Ivan Rosas
        • Ta kontakt med:
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Rekruttering
        • Intermountain Medical Center
        • Hovedetterforsker:
          • Peter Crossno, MD
        • Ta kontakt med:
      • Salt Lake City, Utah, Forente stater, 84108
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • Rekruttering
        • University of Washington
        • Hovedetterforsker:
          • Suha Kadura
        • Ta kontakt med:
  • Frankrike
      • Angers, Frankrike, 49933
        • Rekruttering
        • Centre Hospitalier Universitaire d'Angers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Frederick Gagnadoux
    • Montpellier
      • Montrevel-en-Bresse, Montpellier, Frankrike, 34090
        • Rekruttering
        • University of Montpellier
        • Hovedetterforsker:
          • Arnaud Bourdin
        • Ta kontakt med:
  • Italia
      • Milan, Italia, 20123
        • Rekruttering
        • Ospedale San Giuseppe/ MultiMedica SPA
        • Hovedetterforsker:
          • Sergio Harari
        • Ta kontakt med:
      • Milan, Italia, 20089
        • Rekruttering
        • HUMANITAS Research Hospital
        • Hovedetterforsker:
          • Francesco Amati
        • Ta kontakt med:
    • Lombardy
      • Pavia, Lombardy, Italia, 27100
        • Rekruttering
        • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
        • Hovedetterforsker:
          • Angelo Guido Corsico
        • Ta kontakt med:
  • Nederland
      • Nieuwegein, Nederland
      • Rotterdam, Nederland, 3015
        • Rekruttering
        • Erasmus University Medical Center
        • Ta kontakt med:
          • Thomas Koudstaal
        • Hovedetterforsker:
          • Thomas Koudstaal
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Aktiv, ikke rekrutterende
        • Dunedin Hospital
      • Hamilton, New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand
        • Rekruttering
        • Greenlane Clinical Centre
        • Hovedetterforsker:
          • Margaret Wilsher
        • Ta kontakt med:
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
    • Tauranga
      • Tauranga, Tauranga, New Zealand, 3112
        • Rekruttering
        • Bay of Plenty Clinical Trials Unit
        • Hovedetterforsker:
          • Suzanne Poole
        • Ta kontakt med:
  • Polen
      • Gdansk, Polen, 80211
        • Rekruttering
        • Uniwersyteckie Centrum Kliniczne
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amelia Szymanowska-Narloch
      • Lodz, Polen, 90315
        • Rekruttering
        • Department of Pneumology of the University Hospital No 1
        • Hovedetterforsker:
          • Wojciech Piotrowski
        • Ta kontakt med:
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-602
        • Rekruttering
        • Prywatny Gabinet Lekarski Ginekologia I Połoznictwo Ultrasonografia
        • Ta kontakt med:
        • Hovedetterforsker:
          • Izabela Grabska- Kobylecka
  • Spania
      • Málaga, Spania, 29010
        • Rekruttering
        • Hospital Universitario Virgen de la Victoria
        • Hovedetterforsker:
          • Jose Luis Velasco Garrido
        • Ta kontakt med:
    • Andalusia
      • Granada, Andalusia, Spania, 18014
        • Rekruttering
        • Hospital Universitario Virgen de las Nieves
        • Hovedetterforsker:
          • Ana Dolores Romero Ortiz
        • Ta kontakt med:
    • Barcelona
      • Barcelona, Barcelona, Spania, 08908
        • Rekruttering
        • Hospital Universitary de Bellvitge
        • Ta kontakt med:
        • Hovedetterforsker:
          • Maria Molina
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Rekruttering
        • Hospital Universitario Marqués de Valdecilla
        • Ta kontakt med:
        • Hovedetterforsker:
          • José Cifrian
    • Madrid
      • Madrid, Madrid, Spania, 28034
      • Madrid, Madrid, Spania, 28034
        • Rekruttering
        • Hospital Universitario Ramón y Cajal
        • Ta kontakt med:
          • Juan Rigual
      • Madrid, Madrid, Spania
        • Rekruttering
        • Hospital Gregorio Marañon
        • Hovedetterforsker:
          • Luis Puente Maestu
        • Ta kontakt med:
  • Storbritannia
      • Cambridge, Storbritannia, CB2 0AY
        • Rekruttering
        • Royal Papworth Hospital NHS Foundation Trust
        • Ta kontakt med:
        • Hovedetterforsker:
          • Helen Parfrey
      • Leicester, Storbritannia
        • Rekruttering
        • Leicester Biomedical Research Centre
        • Hovedetterforsker:
          • Charlotte Swales
        • Ta kontakt med:
      • London, Storbritannia, SW17 0RE
        • Rekruttering
        • St. George's University Hospitals NHS Foundation Trust
        • Hovedetterforsker:
          • Aul Raminder
        • Ta kontakt med:
    • Devon
      • Exeter, Devon, Storbritannia, EX2 5DW
        • Rekruttering
        • Royal Devon
        • Ta kontakt med:
          • Michael Gibbons
        • Hovedetterforsker:
          • Michael Gibbons
    • East Yorkshire
      • Cottingham, East Yorkshire, Storbritannia, HU16 5JQ
        • Rekruttering
        • Hull University Teaching Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Simon Hart
    • London
      • London, London, Storbritannia, SW3 6NP
        • Har ikke rekruttert ennå
        • Royal Brompton Hospital
        • Ta kontakt med:
          • Peter George
        • Hovedetterforsker:
          • Peter George
    • South East England
      • Oxford, South East England, Storbritannia, OX3 7LE
        • Rekruttering
        • Oxford University Hospitals NHS Foundation Trust
        • Hovedetterforsker:
          • Rachel Hoyles
        • Ta kontakt med:
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, Storbritannia, ST4 6QG
        • Har ikke rekruttert ennå
        • University Hospitals of North Midlands NHS Trust
        • Hovedetterforsker:
          • Helen Stone
        • Ta kontakt med:
          • Helen Stone
    • West Midlands
      • Birmingham, West Midlands, Storbritannia, B15 2GW
        • Rekruttering
        • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
        • Hovedetterforsker:
          • Anjali Crawshaw
        • Ta kontakt med:
    • Yorkshire
      • Leeds, Yorkshire, Storbritannia, LS9 7TF
        • Rekruttering
        • St James University Hospital
        • Ta kontakt med:
          • Paul Beirne
  • Tsjekkia
      • Praha Klanovice, Tsjekkia
        • Rekruttering
        • Fakultni Thomayerove nemocnice
        • Hovedetterforsker:
          • Martina Sterclova
        • Ta kontakt med:
  • Tyskland
      • Frankfurt, Tyskland, 60389
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Rekruttering
        • Medizinische Hochschule Hannover
        • Hovedetterforsker:
          • Jonas Schupp
        • Ta kontakt med:
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 12351
        • Rekruttering
        • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sven Gläser

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.

Previous participation is defined as: Having completed the final visit of the Treatment Period on the full dose of study drug (either active or placebo).

  • Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.

Exclusion Criteria:

  • Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
  • Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
  • Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
  • Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
  • History of hypersensitivity and/or allergic reaction to pirfenidone or the excipients to be used in this study.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Open-label AP01 treatment arm

All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability.
Kombinasjonsprodukt: AP01

AP01 will be administered open-label via the eFlow Nebulizer System

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
Tidsramme: Through end of study; average of 6 years

The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.
Through end of study; average of 6 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated.
Tidsramme: Through end of study; average of 6 years

FVC will be evaluated via spirometry.
Through end of study; average of 6 years
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease.
Tidsramme: Through end of study; average of 6 years

Stabilization of disease will be based on computational analysis of quantitative high-resolution computed tomography (HRCT) to assess the extent and pattern of interstitial lung disease present on the HRCT scans (methodologies developed by Qureight).
Through end of study; average of 6 years
To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL).
Tidsramme: Through end of study; average of 6 years

This outcome will evaluate the change from baseline in the 'Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire' (L-PF) total score. The L-PF is a 23-point questionnaire with lower scores equating to 'less symptomatic' and higher scores equating to 'more symptomatic.'
Through end of study; average of 6 years

Samarbeidspartnere og etterforskere

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

Sponsor

Avalyn Pharma Inc.

Etterforskere

  • Studieleder: Avalyn Pharma, Inc., Avalyn Pharma 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)

17. april 2025

Primær fullføring (Antatt)

31. desember 2031

Studiet fullført (Antatt)

31. desember 2031

Datoer for studieregistrering

Først innsendt

8. april 2025

Først innsendt som oppfylte QC-kriteriene

22. april 2025

Først lagt ut (Faktiske)

30. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AP-LTE-008
  • ACTRN12625000246482 (Registeridentifikator: Australian New Zealand Clinical Trials Registry)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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