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En undersøgelse for at evaluere effektiviteten og sikkerheden af ​​GSK3915393 hos deltagere med idiopatisk lungefibrose (IPF)

20. august 2026 opdateret af: GlaxoSmithKline

Et fase 2, randomiseret, dobbeltblindt, placebokontrolleret, parallelt gruppestudie (TRANSFORM) for at evaluere effektiviteten og sikkerheden af ​​GSK3915393 hos deltagere med idiopatisk lungefibrose (IPF)

Idiopatisk lungefibrose er en kronisk lungesygdom, der forårsager ardannelse i lungerne og åndedrætsbesvær. GSK3915393 er et nyt lægemiddel, som for første gang testes hos deltagere med IPF. Undersøgelsen vil vurdere sikkerheden og effektiviteten af ​​GSK3915393 hos IPF-deltagere.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

158

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1207AAP
        • GSK Investigational Site
      • Florida, Argentina, B1602DQD
        • GSK Investigational Site
      • La Plata, Argentina, 1900
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Rosario, Argentina, S2000DBS
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • GSK Investigational Site
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
  • Det Forenede Kongerige
      • Edinburgh, Det Forenede Kongerige, EH16 4SA
        • GSK Investigational Site
      • Leeds West Yorkshire, Det Forenede Kongerige, LS9 7TF
        • GSK Investigational Site
      • London, Det Forenede Kongerige, SW3 6HP
        • GSK Investigational Site
  • Forenede Stater
    • California
      • Newport Beach, California, Forenede Stater, 92663
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • GSK Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33704
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-5360
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • GSK Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10065
        • GSK Investigational Site
    • North Carolina
      • Wilmington, North Carolina, Forenede Stater, 28401
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37204
        • GSK Investigational Site
    • Texas
      • Cypress, Texas, Forenede Stater, 77429
        • GSK Investigational Site
  • Frankrig
      • La Tronche, Frankrig, 38700
        • GSK Investigational Site
      • Paris, Frankrig, 75018
        • GSK Investigational Site
      • Pessac, Frankrig, 33604
        • GSK Investigational Site
      • Rennes, Frankrig, 35000
        • GSK Investigational Site
      • Rouen, Frankrig, 76000
        • GSK Investigational Site
      • Toulouse, Frankrig, 31059
        • GSK Investigational Site
  • Holland
      • Eindhoven, Holland, 5623 EJ
        • GSK Investigational Site
      • Rotterdam, Holland, 3015 CE
        • GSK Investigational Site
  • Italien
      • Catania, Italien, 95123
        • GSK Investigational Site
      • Monza MB, Italien, 20900
        • GSK Investigational Site
      • Naples, Italien
        • GSK Investigational Site
      • Padova, Italien, 35128
        • GSK Investigational Site
      • Perugia, Italien, 06132
        • GSK Investigational Site
      • Pisa, Italien, 56124
        • GSK Investigational Site
      • Roma, Italien, 00168
        • GSK Investigational Site
      • Sassari, Italien, 07100
        • GSK Investigational Site
      • Torrette AN, Italien
        • GSK Investigational Site
  • Polen
      • Bialystok, Polen, 15-044
        • GSK Investigational Site
      • Lodz, Polen, 90-153
        • GSK Investigational Site
      • Poznan, Polen, 60-569
        • GSK Investigational Site
  • Spanien
      • Barcelona, Spanien
        • GSK Investigational Site
      • Barcelona, Spanien, 08907
        • GSK Investigational Site
      • Madrid, Spanien, 28006
        • GSK Investigational Site
      • Madrid, Spanien, 28007
        • GSK Investigational Site
      • Oviedo, Spanien, 33011
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr, Spanien, 28223
        • GSK Investigational Site
      • Santander, Spanien, 39011
        • GSK Investigational Site
      • Seville, Spanien, 41013
        • GSK Investigational Site
  • Tyskland
      • Essen, Tyskland, 45293
        • GSK Investigational Site
      • Hanover, Tyskland, 30173
        • GSK Investigational Site
      • Heidelberg, Tyskland, 69126
        • GSK Investigational Site
      • Wuppertal, Tyskland, 42283
        • GSK Investigational 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

Inklusionskriterier:

  • Deltagere med IPF diagnosticeret inden for 5 år før screening baseret på den gældende retningslinje for American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guideline på diagnosetidspunktet.
  • Centralt aflæst brysthøjopløsningscomputertomografi (HRCT) opnået ved screening eller historisk HRCT opnået inden for 12 måneder efter screening, som er i overensstemmelse med sædvanlig interstitiel pneumoni (UIP) eller sandsynlig UIP (hvis ubestemt HRCT-fund, kan IPF bekræftes lokalt ved historisk biopsi) .
  • FVC større end eller lig med (>=) 45 procent (%) af forventet normal.
  • Diffuserende kapacitet (af lunge) for kulilte (DLCO) >=25 % af forventet normal korrigeret for hæmoglobin (Hb).
  • Præbronkodilatator tvungen eksspiratorisk volumen på 1 sekund (FEV1)/FVC ≥ 0,7.
  • Hvis du får antifibrotika, skal du have en stabil dosis af nintedanib eller pirfenidon i mindst 12 uger før screening.
  • Hvis deltageren ikke i øjeblikket får pirfenidon eller nintedanib, skal deltageren have stoppet pirfenidon eller nintedanib i mindst 4 uger før screening.
  • Kropsvægt ≥40 kg (kg) og kropsmasseindeks inden for intervallet 18,5-35 kg pr. kvadratmeter (kg/m2) (inklusive).
  • En kvindelig deltager er berettiget til at deltage, hvis en kvinde i ikke-fertil alder (WONCBP)
  • I stand til at give underskrevet informeret samtykke

Ekskluderingskriterier:

  • Deltagere med interstitiel lungesygdom (ILD) forbundet med andre kendte årsager.
  • Diagnose af sarkoidose eller enhver systemisk autoimmun sygdom (herunder, men ikke begrænset til, sklerodermi, polymyositis/dermatomyositis, systemisk lupus erythematosus og reumatoid arthritis).
  • Akut IPF-eksacerbation inden for 6 måneder før screening og/eller i screeningsperioden (bestemt af investigator).
  • Klinisk signifikant ikke-parenkymal lungesygdom (f.eks. astma, kronisk obstruktiv lungesygdom, kavitære eller pleurasygdomme) ved screening.
  • Diagnose af svær pulmonal hypertension (bestemt af investigator)
  • Omfanget af emfysem er større end omfanget af fibrose ifølge rapporterede resultater fra den seneste HRCT.
  • Anamnese med tidligere lungetransplantation eller nylig større operation (bestemt af investigator) inden for 12 uger før screening eller planlagt i forsøgsperioden. Registrering på venteliste til transplantation er tilladt.
  • Klinisk signifikant luftvejsinfektion (f.eks. aktiv tuberkulose, infektiøs lungebetændelse, Corona virus sygdom 2019 [COVID-19]), der kræver behandling inden for 4 uger før og/eller under screeningsperioden.
  • Cigaretrygning (inklusive e-cigaretter) enten på nuværende tidspunkt eller inden for 3 måneder før screening.
  • Aktuel eller kronisk leversygdom eller kendte lever- eller galdeabnormiteter (med undtagelse af Gilberts syndrom eller asymptomatiske galdesten).
  • Alanintransaminase (ALT), aspartattransaminase (AST), alkalisk fosfatase (ALP) >2x øvre normalgrænse (ULN) og bilirubin >1,5x ULN (isoleret bilirubin >1,5xULN er acceptabelt, hvis bilirubin er fraktioneret og direkte bilirubin mindre end ( <) 35 % ved screening).
  • Klinisk signifikante abnormiteter detekteret på EKG af enten rytme eller ledning, et korrigeret QT-interval (QTc) >450 millisekund (msec) eller QTc > 480msec for deltagere med en bundtgrenblok og/eller en pacemaker, som aktivt ventrikulært pacer under screenings-EKG'et .
  • Deltagere med pacemakere, som ikke pacerer på tidspunktet for screenings-EKG'et, skal have en ikke-pacet QTc <450 msek.

Forudgående/Samtidig terapi-

  • Samtidig brug af pirfenidon og nintedanib ved screening.
  • Modtog systemiske kortikosteroider svarende til prednison >10 mg/dag eller tilsvarende inden for 2 uger efter screeningsperioden.
  • Brug af en af ​​følgende terapier inden for 4 uger før screening og under screeningsperioden eller planlagt under undersøgelsen:
  • Immunmodulerende terapier, herunder men ikke begrænset til azathioprin, mycophenolatmofetil, methotrexat, tacrolimus, cyclophosphamid, imatinib, Tumor Necrosis Factor-Alpha (TNF-α) hæmmere.
  • Medicin, der er under undersøgelse til behandling af IPF, herunder inhaleret treprostinil og Phosphodiesterase-4 (PDE-4) hæmmere. Symptomatisk hostebehandling er tilladt.
  • Nuværende brug af systemiske stærke og moderate inducere eller hæmmere af Cytochrom P450 3A4 (CYP3A4) (se afsnittet om forbudt medicin for yderligere information), som ikke sikkert kan seponeres eller skiftes til et alternativt middel mindst 14 dage før randomisering.
  • Nuværende brug af systemiske CYP3A4-substrater, der har et snævert terapeutisk indeks, som ikke sikkert kan seponeres eller skiftes til et alternativt middel mindst 14 dage før randomisering.

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
Eksperimentel: GSK3915393
Participants received GSK3915393 80 milligrams (mg), orally, twice daily for 26 weeks.
Medicin: GSK3915393
GSK3915393 was administered.
Placebo komparator: Placebo
Participants received matching placebo, orally, twice daily for 26 weeks.
Medicin: Placebo
Placebo was administered.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Tidsramme: Baseline (Day 1) and Week 26
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline (CFB) in FVC at Week 26 was calculated for each participant using the FVC Week 26 result minus the Baseline FVC result. Posterior median CFB and the 95% highest posterior density (HPD) interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change From Baseline in Forced Vital Capacity at Weeks 4, 8, 12 and 18
Tidsramme: Baseline (Day 1) and Weeks 4, 8, 12 and 18
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Posterior median CFB and the 95% HPD interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Weeks 4, 8, 12 and 18
Absolute Change From Baseline in FVC (Percentage [%] Predicted) at Weeks 4, 8, 12, 18 and 26
Tidsramme: Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. The FVC (percentage [%] predicted) result at each timepoint for each participant is calculated using the formula: FVC (% predicted) equals to FVC (mL) divided by Predicted FVC (mL) multiply by 100. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline in FVC (% predicted) at each time point for each participant was calculated by subtracting the Baseline FVC (% predicted) from the FVC (% predicted) at that timepoint.
Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26
Proportion of Participants Who Achieved Relative Decline of Less Than or Equal to (<=) 5% in FVC From Baseline at Week 26
Tidsramme: Baseline (Day 1) and Week 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Relative decline from Baseline in FVC (mL) at the Week 26 visit was calculated using the following formula: relative decline at Week 26 equals to (1 minus Week 26 FVC [mL] divided by Baseline FVC [mL]) multiplied by 100. Participants with relative decline of <=5% at Week 26 were classified as responders; those with greater than (>) 5% decline were non-responders. Participants who died due to disease progression prior to Week 26 were imputed as non-responders. Posterior median and the 95% HPD interval were derived using a Bayesian logistic regression model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Week 26
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Week 29
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or any other situation according to medical or scientific judgment.
Up to Week 29
Number of Participants With Vital Signs Results by Potential Clinical Importance (PCI) Criteria
Tidsramme: Up to Week 29
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate were measured for at least 5 minutes of rest for the participant in a quiet setting. PCI ranges were SBP (low: less than [<]85 millimeter of mercury [mmHg], high: >180 mmHg), DBP (low: <45 mmHg, high: >110 mmHg) and pulse rate (low: <40 beat per minute [bpm], high: >110 bpm). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Number of Participants With Electrocardiogram (ECG) Results by PCI Criteria
Tidsramme: Up to Week 29
Triplicate 12-lead ECGs were obtained after participant has rested in supine position for 5 minutes, using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTc intervals. ECG parameters with PCI ranges were: PR Interval (low: <110 milliseconds[msec], high: >220 msec), QRS Duration (low: <75 msec, high: >120 msec) and QTcF Interval (<=450 msec, >450 msec to <=480 msec, >480 msec to <=500 msec and >500 msec). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Number of Participants With Hematology Laboratory Results by PCI Criteria
Tidsramme: Up to week 29
Hematology parameters with PCI ranges were: hematocrit (low: <0.1 percentage of red blood cells in blood, high: >0.54 percentage of red blood cells in blood), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >800*10^9/L), and white blood cell (WBC) (low: <2*10^9/L and high: >25*10^9/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to week 29
Number of Participants With Hepatobiliary Laboratory Results by PCI Criteria
Tidsramme: Up to week 29
Hepatobiliary parameters with PCI ranges were: Alanine transaminase (ALT) (high: greater than or equal to [>=] 3*upper limit of normal [ULN]), Aspartate aminotransferase (AST) (high: >=3*ULN), Alkaline phosphatase (ALP) (high: >=2*ULN) and total bilirubin (high: >=2*ULN). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to week 29
Number of Participants With Clinical Chemistry Laboratory Results by PCI Criteria
Tidsramme: Up to Week 29
Clinical chemistry parameters with PCI ranges were: glucose (low: <2 millimoles per liter[mmol/L], high: >25 mmol/L), albumin (low: <30 grams per liter[g/L]), creatine phosphokinase (CPK) (high: >1500 international units per liter [IU/L]), potassium (low: <3 mmol/L, high: >6.0 mmol/L), sodium (low: <130 mmol/L, high: >155 mmol/L), blood urea nitrogen (BUN) (high: >14 mmol/L) and calcium corrected for albumin (low: <1.9 mmol/L, high: >3 mmol/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic (PK) analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 4 Hours (AUC [0-4]) of GSK3915393
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Infinity (AUC [0-inf]) of GSK3915393
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

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)

4. april 2024

Primær færdiggørelse (Faktiske)

1. oktober 2025

Studieafslutning (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først indsendt

12. marts 2024

Først indsendt, der opfyldte QC-kriterier

12. marts 2024

Først opslået (Faktiske)

19. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 220929
  • 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
  • 2023-509371-16-00 (Anden identifikator: EU CT Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til anonymiserede data på individuelt patientniveau (IPD) og relaterede undersøgelsesdokumenter fra de kvalificerede undersøgelser via datadelingsportalen. Detaljer om GSK's datadelingskriterier kan findes på: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD-delingstidsramme

Anonymiseret IPD vil blive gjort tilgængelig inden for 6 måneder efter offentliggørelsen af ​​primære, sekundære nøgle- og sikkerhedsresultater for undersøgelser af produkt med godkendte indikationer eller afsluttede aktiv(er) på tværs af alle indikationer.

IPD-delingsadgangskriterier

Anonymiseret IPD deles med forskere, hvis forslag er godkendt af et uafhængigt reviewpanel og efter en datadelingsaftale er på plads. Adgangen gives i en indledende periode på 12 måneder, men en forlængelse kan gives, når det er berettiget, i op til 6 måneder.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Abonner