Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Studio per confrontare Bictegravir/Lenacapavir con la terapia attuale in persone con HIV-1 trattate con successo con Biktarvy (ARTISTRY-2)

15 ottobre 2026 aggiornato da: Gilead Sciences

Studio di fase 3 multicentrico randomizzato con controllo attivo, in doppio cieco, per valutare la sicurezza e l'efficacia di Bictegravir/Lenacapavir rispetto a Biktarvy® (Bictegravir/Emtricitabina/Tenofovir Alafenamide) in persone con HIV-1 soppresse virologicamente

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

577

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Lenacapavir

Tablets administered orally without regard to food

Altri nomi:
  • GS-6207
Droga: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Altri nomi:
  • Bixlenvo™
Droga: Placebo to match B/F/TAF

Tablets administered orally without regard to food
Comparatore attivo: 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.
Droga: B/F/TAF

Tablets administered orally without regard to food

Altri nomi:
  • Biktarvy®
Droga: Placebo to match BIC/LEN FDC

Tablets administered orally without regard to food

Droga: Placebo to match Lenacapavir

Tablets administered orally without regard to food
Sperimentale: 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.
Droga: Lenacapavir

Tablets administered orally without regard to food

Altri nomi:
  • GS-6207
Droga: Bictegravir/Lenacapavir (BIC/LEN) FDC

Tablets administered orally without regard to food

Altri nomi:
  • Bixlenvo™

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm
Lasso di tempo: 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
Lasso di tempo: Baseline, Week 48
Baseline, Week 48
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 48
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 96
Week 96
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 96
Lasso di tempo: Week 96
Week 96
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 96
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 144
Week 144
Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 144
Lasso di tempo: Week 144
Week 144
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 144
Lasso di tempo: First dose date up to Week 144
First dose date up to Week 144

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Investigatori

  • Direttore dello studio: Gilead Study Director, Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 marzo 2024

Completamento primario (Effettivo)

27 ottobre 2025

Completamento dello studio (Stimato)

1 dicembre 2029

Date di iscrizione allo studio

Primo inviato

20 marzo 2024

Primo inviato che soddisfa i criteri di controllo qualità

20 marzo 2024

Primo Inserito (Effettivo)

27 marzo 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GS-US-621-6290
  • 2023-510022-33 (Altro identificatore: European Medicines Agency)
  • jRCT2051240046 (Identificatore di registro: Japan Registry)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi