Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Un estudio observacional para evaluar la eficacia y seguridad de la combinación de avelumab + axitinib en participantes con aRCC (AVION)

20 de mayo de 2026 actualizado por: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Evaluación real de la eficacia y la seguridad con avelumab (BAVENCIO®) + axitinib (INLYTA®) en pacientes con aRCC en varios países de la UE (AVION)

El objetivo principal de este estudio es ampliar el conocimiento sobre la eficacia de la infusión intravenosa de Avelumab en combinación con Axitinib como terapia de primera línea en pacientes con carcinoma de células renales avanzado (aRCC), además de la seguridad y tolerabilidad en condiciones de rutina diaria. Práctica clinica.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

105

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Amberg, Alemania
        • Klinikum St. Marien Amberg
      • Aschaffenburg, Alemania
        • Klinikum Aschaffenburg Medizinische Klinik
      • Berlin, Alemania
        • Zentrum für urologische Onkologie
      • Biberach an der Riss, Alemania
        • Biberach
      • Bielefeld, Alemania
        • Evangelisches Klinikum Bethel
      • Bielefeld, Alemania
        • Evangelisches Krankenhaus Bielefeld
      • Braunschweig, Alemania
        • Urologie im Schlosscarree
      • Deggendorf, Alemania
        • Donauisar Klinikum Deggendorf
      • Dresden, Alemania
        • Urologische Gemeinschaftspraxis
      • Eisenach, Alemania
        • St. Georg Klinikum Eisenach gGmbH
      • Erlangen, Alemania
        • Universitätsklinikum Erlangen
      • Essen, Alemania
        • Universitaetsklinikum Essen Uroonkologie
      • Friedrichshafen, Alemania
        • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee
      • Fürth, Alemania
        • Onkologische GP Dres. Wilke/Wagner/Petzoldt
      • Fürth, Alemania
        • Onkologische SP Praxis Fürth
      • Goslar, Alemania
        • MVZ Onkologische Kooperation Harz GbR
      • Halberstadt, Alemania
        • Praxis Dr. Maas
      • Hamburg, Alemania
        • Universitätsklinikum Hamburg-Eppendorf
      • Hanover, Alemania
        • Medizinische Hochschule Hannover
      • Hanover, Alemania
        • Vinzenzkrankenhaus Hannover
      • Heinsberg, Alemania
        • Praxis Kretz
      • Jena, Alemania
        • Universitätskinderklinik Jena
      • L.-Eisleben, Alemania
        • Urologische Praxis Dr. Ralf Eckert
      • Luckenwalde, Alemania
        • Urologische Praxis Dipl.-Med. Susanne Kloß
      • Lübeck, Alemania
        • Universitatsklinik Schleswig-Holstein
      • Magdeburg, Alemania
        • Schwerpunktpraxis für Hämatologie und Onkologie
      • Minden, Alemania
        • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)
      • Münster, Alemania
        • University of Munster
      • Münster, Alemania
        • Uniklinikum Münster
      • Osnabrück, Alemania
        • Marienhospital Osnabrück - Standort Natruper Holz
      • Osnabrück, Alemania
        • Paracelsus Klinik Osnabrück
      • Osnabrück, Alemania
        • Klinikum Osnabrück GmbH
      • Ostfildren, Alemania
        • medius Klinik Ostfildern-Ruit
      • Rostock, Alemania
        • Wissenschaftskontor Nord GmbH & Co. KG
      • Rüsselsheim am Main, Alemania
        • GPR Klinikum Rüsselsheimg GmbH
      • Sigmaringen, Alemania
        • SRH Kliniken Landkreis Sigmaringen (DEU)
      • Stolberg, Alemania
        • Hämatologie und Onkologie Stolberg
      • Troisdorf, Alemania
        • Praxis Troisdorf
      • Westerstede, Alemania
        • Medizinische Studiengesellschaft Nord-West GmbH
      • Wetzlar, Alemania
        • Lahn Dill Kliniken GmbH
  • Bélgica
      • Bonheiden, Bélgica
        • Imelda Ziekenhuis
      • Brasschaat, Bélgica
        • AZ Klina
      • Bruges, Bélgica
        • AZ Sint-Jan
  • 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
  • Rusia
      • Irkutsk, Rusia
        • Regional Oncology Dispensary - Irkutsk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Los participantes con un diagnóstico confirmado de RCC avanzado serán observados en este estudio.

Descripción

Criterios de inclusión:

  • Participantes con el estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) 0, 1 o 2
  • Participantes con un diagnóstico confirmado histológicamente de RCC con cualquier origen histológico
  • Participantes con una enfermedad localmente avanzada/metastásica (es decir, [es decir], RCC en estadio 4 recientemente diagnosticado por el Comité Conjunto Estadounidense sobre el Cáncer) o tiene una enfermedad recurrente
  • Los participantes han recibido 1 o 2 ciclos de tratamiento con Avelumab más Axitinib como terapia de primera línea de acuerdo con el Resumen de características del producto (SmPC) aprobado
  • Participantes dispuestos a firmar el formulario de consentimiento informado (ICF) por escrito para participar en este estudio

Criterio de exclusión:

  • Participantes con contraindicaciones para Avelumab o Axitinib según la ficha técnica aprobada
  • Participantes que hayan participado en cualquier estudio clínico de intervención de un fármaco o dispositivo dentro de los 28 días anteriores al inicio de Avelumab más Axitinib

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Avelumab + Axitinib
No habrá ninguna intervención específica del estudio en este estudio. Se observarán los participantes con CCR avanzado que reciban 800 miligramos (mg) de Avelumab por vía intravenosa cada 2 semanas en combinación con 5 mg de Axitinib por vía oral dos veces al día de acuerdo con los términos de la autorización de comercialización para la terapia de primera línea según la práctica clínica actual. durante 24 meses en este estudio.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival Rate
Periodo de tiempo: 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])

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Colaboradores

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

Investigadores

  • Director de estudio: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de agosto de 2021

Finalización primaria (Actual)

8 de agosto de 2024

Finalización del estudio (Actual)

30 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2021

Publicado por primera vez (Actual)

28 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MS100070_0110

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir