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Uno studio osservazionale per valutare l'efficacia e la sicurezza della combinazione Avelumab + Axitinib nei partecipanti con aRCC (AVION)

20 maggio 2026 aggiornato da: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Valutazione nel mondo reale dell'efficacia e della sicurezza con Avelumab (BAVENCIO®) + Axitinib (INLYTA®) in pazienti con aRCC in più paesi dell'UE (AVION)

Lo scopo principale di questo studio è quello di ampliare le conoscenze sull'efficacia dell'infusione endovenosa di Avelumab in combinazione con Axitinib come terapia di prima linea nei partecipanti con carcinoma a cellule renali avanzato (aRCC) oltre alla sicurezza e alla tollerabilità in condizioni di routine della vita quotidiana pratica clinica.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

105

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

  • Belgio
      • Bonheiden, Belgio
        • Imelda Ziekenhuis
      • Brasschaat, Belgio
        • AZ Klina
      • Bruges, Belgio
        • AZ Sint-Jan
  • Germania
      • Amberg, Germania
        • Klinikum St. Marien Amberg
      • Aschaffenburg, Germania
        • Klinikum Aschaffenburg Medizinische Klinik
      • Berlin, Germania
        • Zentrum für urologische Onkologie
      • Biberach an der Riss, Germania
        • Biberach
      • Bielefeld, Germania
        • Evangelisches Klinikum Bethel
      • Bielefeld, Germania
        • Evangelisches Krankenhaus Bielefeld
      • Braunschweig, Germania
        • Urologie im Schlosscarree
      • Deggendorf, Germania
        • Donauisar Klinikum Deggendorf
      • Dresden, Germania
        • Urologische Gemeinschaftspraxis
      • Eisenach, Germania
        • St. Georg Klinikum Eisenach gGmbH
      • Erlangen, Germania
        • Universitätsklinikum Erlangen
      • Essen, Germania
        • Universitaetsklinikum Essen Uroonkologie
      • Friedrichshafen, Germania
        • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
      • Fürth, Germania
        • Onkologische GP Dres. Wilke/Wagner/Petzoldt
      • Fürth, Germania
        • Onkologische SP Praxis Fürth
      • Goslar, Germania
        • MVZ Onkologische Kooperation Harz GbR
      • Halberstadt, Germania
        • Praxis Dr. Maas
      • Hamburg, Germania
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover, Germania
        • Medizinische Hochschule Hannover
      • Hanover, Germania
        • Vinzenzkrankenhaus Hannover
      • Heinsberg, Germania
        • Praxis Kretz
      • Jena, Germania
        • Universitätskinderklinik Jena
      • L.-Eisleben, Germania
        • Urologische Praxis Dr. Ralf Eckert
      • Luckenwalde, Germania
        • Urologische Praxis Dipl.-Med. Susanne Kloß
      • Lübeck, Germania
        • Universitatsklinik Schleswig-Holstein
      • Magdeburg, Germania
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Minden, Germania
        • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
      • Münster, Germania
        • University of Munster
      • Münster, Germania
        • Uniklinikum Münster
      • Osnabrück, Germania
        • Marienhospital Osnabrück - Standort Natruper Holz
      • Osnabrück, Germania
        • Paracelsus Klinik Osnabrück
      • Osnabrück, Germania
        • Klinikum Osnabrück GmbH
      • Ostfildren, Germania
        • medius Klinik Ostfildern-Ruit
      • Rostock, Germania
        • Wissenschaftskontor Nord GmbH & Co. KG
      • Rüsselsheim am Main, Germania
        • GPR Klinikum Rüsselsheimg GmbH
      • Sigmaringen, Germania
        • SRH Kliniken Landkreis Sigmaringen (DEU)
      • Stolberg, Germania
        • Hämatologie und Onkologie Stolberg
      • Troisdorf, Germania
        • Praxis Troisdorf
      • Westerstede, Germania
        • Medizinische Studiengesellschaft Nord-West GmbH
      • Wetzlar, Germania
        • Lahn Dill Kliniken GmbH
  • Grecia
      • Athens, Grecia
        • Gen. Hos. "Alexandra"
      • Athens, Grecia
        • General Hospital of Athens G.Gennimatas
      • Athens, Grecia
        • Henry Dunant Hospital Center
      • Athens, Grecia
        • University Hospital of Athens Sotiria
      • Attiki, Grecia
        • Attikon Hospital
      • Chaïdári, Grecia
        • Attikon
      • Heraklion, Grecia
        • General Hospital "Venizelio"
      • Ioannina, Grecia
        • University Hospital of Ioannina
      • Kavala, Grecia
        • Kavala General Hospital
      • Larissa, Grecia
        • University Hospital of Larissa
      • Piraeus, Grecia
        • Metaxa Hospital
      • Piraeus, Grecia
        • Metropolitan Hospital Greece
      • Pátrai, Grecia
        • General Hospital of Patras "o Agios Andreas"
      • Thessaloniki, Grecia
        • Papageorgiou Hospital
      • Thessaloniki, Grecia
        • Agios Loukas Hospital
      • Thessaloniki, Grecia
        • Bioclinic (GRC)
      • Thessaloniki, Grecia
        • Saint Luke Hospital
  • Russia
      • Irkutsk, Russia
        • Regional Oncology Dispensary - Irkutsk

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

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

In questo studio saranno osservati i partecipanti con una diagnosi confermata di RCC avanzato.

Descrizione

Criterio di inclusione:

  • Partecipanti con performance status ECOG (Eastern Cooperative Oncology Group) 0, 1 o 2
  • - Partecipanti con diagnosi istologicamente confermata di RCC con qualsiasi origine istologica
  • Partecipanti con una malattia localmente avanzata/metastatica (ovvero [cioè] RCC di stadio 4 di nuova diagnosi secondo l'American Joint Committee on Cancer) o con malattia ricorrente
  • - I partecipanti hanno ricevuto 1 o 2 cicli di trattamento con Avelumab più Axitinib come terapia di prima linea secondo il Riassunto delle caratteristiche del prodotto (RCP) approvato
  • - Partecipanti disposti a firmare il modulo di consenso informato scritto (ICF) per partecipare a questo studio

Criteri di esclusione:

  • - Partecipanti con controindicazioni per Avelumab o Axitinib secondo l'RCP approvato
  • Partecipanti che hanno partecipato a qualsiasi studio clinico interventistico di un farmaco o dispositivo entro 28 giorni prima dell'inizio di Avelumab più Axitinib

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

Coorti e interventi

Gruppo / Coorte
Avelumab + Axitinib
Non ci saranno interventi specifici per lo studio in questo studio. Saranno osservati i partecipanti con RCC avanzato che ricevono 800 milligrammi (mg) di Avelumab per via endovenosa ogni 2 settimane in combinazione con 5 mg di Axitinib per via orale due volte al giorno in conformità con i termini dell'autorizzazione all'immissione in commercio per la terapia di prima linea secondo l'attuale pratica clinica per 24 mesi in questo studio.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival Rate
Lasso di tempo: At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
Overall survival rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival Rate
Lasso di tempo: At 24 months after index date (baseline visit as reported in the eCRF)
Overall survival rate was defined as the percentage of participants who are alive at 24 months after the index date. Percentage of participants alive at the time of outcome assessment (24 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
At 24 months after index date (baseline visit as reported in the eCRF)
Duration of Overall Survival
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Duration of overall survival is defined as the time from index date to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date)
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date
Lasso di tempo: up to 24 months after the index date (baseline visit as reported in the eCRF)
Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) as best overall response up to 24 months after the index date. CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date
Lasso di tempo: up to 24 months after the index date (baseline visit as reported in the eCRF)
Disease control rate is defined as the percentage of participants with objective response (complete response [CR] or partial response [PR] or stable disease [SD]) as best overall response up to 24 months after the index date. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Lasso di tempo: up to 24 months after the index date (baseline visit as reported in the eCRF)
DoR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
up to 24 months after the index date (baseline visit as reported in the eCRF)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date)
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score
Lasso di tempo: Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains, Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-12, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed.
Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Number of Participants With Adverse Events Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Severity of TEAEs were evaluated using the NCI-CTCAE version 5.0. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. Number of participants with TEAEs grade greater than or equal to (>=) 3 were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first
Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3
Lasso di tempo: From the index date (baseline visit as reported in the eCRF) up to 24 months
Time to therapy discontinuation due to AE >= grade 3 was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From the index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Axitinib Due to All-Cause AEs >= Grade 3
Lasso di tempo: Time from first dose of study drug up to 24 months
The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. Duration of Avelumab plus Axitinib therapy (days) = (Date of discontinuation of Axitinib - Date of index date + 1). Duration of avelumab plus axitinib therapy among participants who discontinued the Axitinib due to all-cause AEs >= grade 3 was reported.
Time from first dose of study drug up to 24 months
Time to Onset of Treatment - Emergent Adverse Events (TEAEs)
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months
Time to onset of TEAE = Start date TEAE - Index date. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months
Duration of TEAE = (Stop date of TEAE - Start date of TEAE + 1) divided by 7. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants with therapy modifications due to AE related to avelumab plus axitinib therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months after the index date
Percentage of Participants Receiving Later-line Therapy
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months
Percentage of participants receiving later-line therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months
Time to Second-line Therapy Initiation
Lasso di tempo: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Time to second line treatment was calculated as: (second line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.
Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months
Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs
Lasso di tempo: From index date (baseline visit as reported in the eCRF) up to 24 months
Number of participants with patient-reported potential signs and symptoms of immune-related AEs were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
From index date (baseline visit as reported in the eCRF) up to 24 months

Collaboratori e investigatori

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

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaboratori

Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany

Investigatori

  • Direttore dello studio: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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.

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)

9 agosto 2021

Completamento primario (Effettivo)

8 agosto 2024

Completamento dello studio (Effettivo)

30 aprile 2025

Date di iscrizione allo studio

Primo inviato

23 giugno 2021

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2021

Primo Inserito (Effettivo)

28 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MS100070_0110

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 .

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