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Undersøgelse for at sammenligne Bictegravir/Lenacapavir versus nuværende terapi hos mennesker med HIV-1, som er behandlet med Biktarvy (ARTISTRY-2)

15. oktober 2026 opdateret af: Gilead Sciences

Fase 3 dobbeltblind multicenter randomiseret aktivt kontrolleret undersøgelse til evaluering af sikkerheden og effektiviteten af ​​Bictegravir/Lenacapavir versus Biktarvy® (Bictegravir/Emtricitabin/Tenofovir Alafenamid) hos virologisk undertrykte mennesker med HIV-1

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH) who are successfully treated with B/F/TAF (virologically suppressed).

The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) FDC tablets versus continuing on B/F/TAF (50/200/25 mg) FDC tablets in virologically suppressed PWH.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

577

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, C1141ACG
        • Helios Salud S.A.
      • Buenos Aires, Argentina, C1202ABB
        • Fundacion Huesped
      • Santa Fe, Argentina, S2000PBJ,
        • Instituto CAICI SRL
  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2011
        • Taylor Square Private Clinic
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Alfred Hospital(Alfred Health)
      • South Yarra, Victoria, Australien, 3141
        • Prahran Market Clinic
  • Canada
      • Decarie Montreal, Canada, H4A 3J1
        • Chronic Viral Illness Service/McGill University Health Centre (MUHC)
      • Montreal, Canada, H2L 4P9
        • Clinique Médicale l'Actuel
      • Ottawa, Canada, K1H 8L6
        • The Ottawa Hospital - General Campus
      • Regina, Canada, S4P 0W5
        • Regina General Hospital
      • Vancouver, Canada, V6Z1Y6
        • St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
      • Victoria, Canada, V8W 1M8
        • Cool Aid Community Health Centre
  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
      • London, Det Forenede Kongerige, WC1E 6JB
        • Mortimer Market Centre
      • London, Det Forenede Kongerige, SE5 9RS
        • King's College Hospital, Weston Education Centre
      • London, Det Forenede Kongerige, SW109NH
        • Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
      • London, Det Forenede Kongerige, W2 1NY
        • St Mary's Hospital - PPDS
  • Dominikanske republik
      • Santo Domingo, Dominikanske republik
        • Instituto Dominicano de Estudios Virologicos - IDEV
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85015
        • Pueblo Family Physicians
    • California
      • Berkeley, California, Forenede Stater, 48072
        • Be Well Medical Center
      • Beverly Hills, California, Forenede Stater, 90211
        • Pacific Oaks Medical Group
      • Los Angeles, California, Forenede Stater, 90036
        • Ruane Clinical Research Group Inc.
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
      • Palm Springs, California, Forenede Stater, 92262
        • BIOS Clinical Research
      • San Diego, California, Forenede Stater, 92103
        • UCSD Anti Viral Research Centre (AVRC)
      • Torrance, California, Forenede Stater, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
      • West Hollywood, California, Forenede Stater, 90046
        • Mills Clinical Research
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
        • Public Health Institute at Denver Health
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale University School of Medicine (study visits)
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • Midland Florida Infectious Diseases Specialists, PL - Orange City
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Therafirst Medical Center
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • CAN Community Health
      • Ft. Pierce, Florida, Forenede Stater, 34982
        • Midway Immunology and Research Center
      • Miami, Florida, Forenede Stater, 33133
        • AIDS Healthcare Foundation - The Kinder Medical Group
      • Miami, Florida, Forenede Stater, 33136
        • Schiff Center for liver Diseases/University of Miami
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Floridian Clinical Research
      • Orlando, Florida, Forenede Stater, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Forenede Stater, 32806
        • Bliss Healthcare
      • Pensacola, Florida, Forenede Stater, 32503
        • AHF Pensacola
      • Sarasota, Florida, Forenede Stater, 34237
        • CAN community Health
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Triple O Research Institute, P.A.
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, Forenede Stater, 31201
        • Mercer University, Department of Internal Medicine
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01105
        • Claudia T Martorell MD LLC dba The Research Institute
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • KC Care health Center
      • St Louis, Missouri, Forenede Stater, 63139
        • Southampton Community Healthcare, Inc.
    • New Jersey
      • Hillsborough, New Jersey, Forenede Stater, 08844
        • ID Care, LLC
      • Newark, New Jersey, Forenede Stater, 07102
        • Saint Michael's Medical Center
      • Newark, New Jersey, Forenede Stater, 07103
        • New Jersey Medical School - Clinical Research Center
      • Somers Point, New Jersey, Forenede Stater, 08244
        • South Jersey Infectious Disease
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • AXCES Research Group, LLC
    • New York
      • Flushing, New York, Forenede Stater, 11355
        • New York-Presbyterian Queens
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27858
        • The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Rosedale Health and Wellness
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Philadelphia FIGHT Community Health Centers
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina (MUSC) Research Nexus
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Central Texas Clinical Research
      • Bellaire, Texas, Forenede Stater, 77401
        • St Hope Foundation, Inc.
      • Dallas, Texas, Forenede Stater, 75208
        • AIDS Arms, Inc. DBA Prism Health North Texas
      • Dallas, Texas, Forenede Stater, 75246
        • North Texas Infectious Diseases Consultants, PA
      • El Paso, Texas, Forenede Stater, 79902
        • AXCES Research Group, LLC
      • Fort Worth, Texas, Forenede Stater, 76104
        • Texas Centers for Infectious Disease Associates
      • Houston, Texas, Forenede Stater, 77098
        • The Crofoot research Center, INC.
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • AXCES Research Group, LLC
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Peter Shalit MD
      • Tacoma, Washington, Forenede Stater, 98405
        • Community Health care
  • Italien
      • Brescia, Italien, 25123
        • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
      • Foggia, Italien, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
      • Milan, Italien, 20127
        • IRCCS Ospedale San Raffaele
      • Monza, Italien, 20090
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
      • Pavia, Italien, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Roma, Italien, 00168
        • Fondazione Policlinico Universitario A Gemelli-Rome
      • Roma, Italien, 00149
        • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
  • Japan
      • Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Tokyo, Japan, 162-0052
        • Center Hospital of the National Center for Global Health and Medicine
  • Mexico
      • Mexico City, Mexico, 6170
        • ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
      • Mérida, Mexico, 97070
        • Unidad de Atencion Medica e Investigacion en Salud
  • Puerto Rico
    • PR
      • San Juan, PR, Puerto Rico, 00935
        • Proyecto ACTU
      • San Juan, PR, Puerto Rico, 00909
        • HOPE Clinical Research
  • Spanien
      • Badalona Barcelona, Spanien, 8916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spanien, 08036
        • Hospital Clinic de Barcelona
      • Madrid, Spanien, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz - PPDS
      • Seville, Spanien, 4103
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spanien, 46014
        • Consorcio Hospital General Universitario de Valencia
  • Sydkorea
      • Daegu, Sydkorea, 41944
        • Kyungpook National University Hospital
      • Seoul, Sydkorea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Sydkorea, *04564
        • National Medical Center
      • Seoul, Sydkorea, 137-701
        • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 33004
        • Taoyuan General Hospital, Ministry of Health and Welfare
  • Tyskland
      • Aachen, Tyskland, 52062
        • Praxis Dr. Knechten
      • Berlin, Tyskland, 10117
        • Novopraxis Berlin
      • Cologne, Tyskland, 50668
        • Praxis am Ebertplatz
      • Frankfurt, Tyskland, 60590
        • Universitätsklinikum Frankfurt
      • Hamburg, Tyskland, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Munich, Tyskland, 80336
        • LMU Klinikum der Universität
      • München, Tyskland, 81675
        • Klinikum rechts der Isar der Technischen Universitaet Muenchen

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  • Currently receiving B/F/TAF for at least 6 months prior to screening.
  • If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
  • At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
  • No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
  • Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Key Exclusion Criteria:

  • Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.

  • Breastfeeding (nursing).

  • Prior use of, or exposure to, LEN.

  • Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.

  • Active tuberculosis infection.

  • Acute hepatitis < 30 days before randomization.

  • Chronic hepatitis B virus (HBV) infection, as determined by either:

    • Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
    • Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.

  • Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.

  • History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).

  • Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.

  • Active malignancy requiring acute systemic therapy.

  • Any of the following laboratory values at screening:

    • Alanine aminotransferase > 5 × upper limit of normal (ULN).
    • Direct bilirubin > 1.5 × ULN.
    • Platelets < 50,000/mm^3.
    • Hemoglobin < 8.0 g/dL.

  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.

  • Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.

  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Eksperimentel: Blinded Phase: Treatment Group 1: BIC/LEN 75/50 mg

Participants will switch from bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablets to bictegravir/lenacapavir (BIC/LEN) 75/50 mg FDC tablets + placebo-to-match (PTM) B/F/TAF tablets, administered orally, once daily up to 48 weeks. Participants will also receive a 2-day oral pharmacokinetic (PK) loading dose of LEN 600 mg on Days 1 and 2, in addition to the daily doses of BIC/LEN 75/50 mg and PTM B/F/TAF tablets starting on Day 1.

At the end of blinded treatment (EBT) participants will enter the open label (OL) phase and continue to receive BIC/LEN 75 mg/50 mg FDC tablets through at least 48 weeks in the OL phase. At the OL Week 48, participants will be given an option to continue to receive BIC/LEN FDC tablets.
Medicin: Lenacapavir

Tablets administered orally without regard to food

Andre navne:
  • GS-6207
Medicin: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Andre navne:
  • Bixlenvo™
Medicin: Placebo to match B/F/TAF

Tablets administered orally without regard to food
Aktiv komparator: Blinded Phase: Treatment Group 2: B/F/TAF 50/200/25 mg

Participants will continue with their B/F/TAF 50/200/25 mg tablets and start PTM BIC/LEN tablets on Day 1 administered orally, once daily up to 48 weeks. Participants will receive PTM oral LEN PK loading tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2).

Participants who complete the EBT will be given an option to enter the OL phase to receive BIC/LEN FDC tablets.
Medicin: B/F/TAF

Tablets administered orally without regard to food

Andre navne:
  • Biktarvy®
Medicin: Placebo to match BIC/LEN FDC

Tablets administered orally without regard to food

Medicin: Placebo to match Lenacapavir

Tablets administered orally without regard to food
Eksperimentel: Open-label Phase: BIC/LEN 75/50mg

Participants from Treatment Group 1 will receive BIC/LEN FDC tablets through at least OL Week 48. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets. Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets. Participants from Treatment Group 2 who enter the OL phase will also receive a 2-day oral loading dose of LEN 600 mg (2 × 300 mg LEN on Day 1 and on Day 2).

All participants who enter the OL phase may continue to receive BIC/LEN FDC tablets daily until study drug is available or until Gilead Sciences (Gilead) elects to discontinue the study.
Medicin: Lenacapavir

Tablets administered orally without regard to food

Andre navne:
  • GS-6207
Medicin: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Andre navne:
  • Bixlenvo™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 48 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm
Tidsramme: Week 48

Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and participants who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than adverse event (AE), death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window was between Days 295 and 378 (inclusively). Percentages were rounded off.
Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
Tidsramme: Week 48

Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 48 analysis window were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.
Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
Tidsramme: Baseline, Week 48
Baseline, Week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Tidsramme: First dose date up to Week 48

An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC/LEN FDC, Treatment Group 1) or 30 days (for B/F/TAF, Treatment Group 2) or any AE leading to study drug discontinuation. Percentages were rounded off.
First dose date up to Week 48
Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm
Tidsramme: Week 96
Week 96
Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by US FDA-Defined Snapshot Algorithm
Tidsramme: Week 96
Week 96
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 96
Tidsramme: Week 96
Week 96
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 96
Tidsramme: First dose date up to Week 96
First dose date up to Week 96
Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-Defined Snapshot Algorithm
Tidsramme: Week 144
Week 144
Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by US FDA-Defined Snapshot Algorithm
Tidsramme: Week 144
Week 144
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 144
Tidsramme: Week 144
Week 144
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 144
Tidsramme: First dose date up to Week 144
First dose date up to Week 144

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

Efterforskere

  • Studieleder: Gilead Study Director, Gilead Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

25. marts 2024

Primær færdiggørelse (Faktiske)

27. oktober 2025

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

20. marts 2024

Først indsendt, der opfyldte QC-kriterier

20. marts 2024

Først opslået (Faktiske)

27. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-621-6290
  • 2023-510022-33 (Anden identifikator: European Medicines Agency)
  • jRCT2051240046 (Registry Identifier: Japan Registry)
  • 2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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