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Eine Beobachtungsstudie zur Bewertung der Wirksamkeit und Sicherheit der Kombination Avelumab + Axitinib bei Teilnehmern mit aRCC (AVION)

Bewertung der Wirksamkeit und Sicherheit unter realen Bedingungen mit Avelumab (BAVENCIO®) + Axitinib (INLYTA®) bei Patienten mit aRCC in mehreren EU-Ländern (AVION)

Der Hauptzweck dieser Studie besteht darin, das Wissen über die Wirksamkeit der intravenösen Infusion von Avelumab in Kombination mit Axitinib als Erstlinientherapie bei Teilnehmern mit fortgeschrittenem Nierenzellkarzinom (aRCC) zusätzlich zur Sicherheit und Verträglichkeit unter täglichen Routinebedingungen zu erweitern klinische Praxis.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

105

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Teilnehmer mit einer bestätigten Diagnose von fortgeschrittenem RCC werden in dieser Studie beobachtet.

Beschreibung

Einschlusskriterien:

  • Teilnehmer mit dem Leistungsstatus 0, 1 oder 2 der Eastern Cooperative Oncology Group (ECOG).
  • Teilnehmer mit einer histologisch bestätigten RCC-Diagnose jeglichen histologischen Ursprungs
  • Teilnehmer mit einer lokal fortgeschrittenen/metastasierten Erkrankung (d. h. neu diagnostiziertem RCC im Stadium 4 gemäß dem American Joint Committee on Cancer) oder einer rezidivierenden Erkrankung
  • Die Teilnehmer haben 1 oder 2 Zyklen einer Behandlung mit Avelumab plus Axitinib als Erstlinientherapie gemäß der genehmigten Zusammenfassung der Merkmale des Arzneimittels (SmPC) erhalten.
  • Teilnehmer, die bereit sind, die schriftliche Einverständniserklärung (ICF) zur Teilnahme an dieser Studie zu unterzeichnen

Ausschlusskriterien:

  • Teilnehmer mit Kontraindikationen für Avelumab oder Axitinib gemäß der genehmigten Fachinformation
  • Teilnehmer, die innerhalb von 28 Tagen vor Beginn der Behandlung mit Avelumab plus Axitinib an einer interventionellen klinischen Studie zu einem Arzneimittel oder Gerät teilgenommen haben

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Avelumab + Axitinib
In dieser Studie wird es keine studienspezifischen Interventionen geben. Teilnehmer mit fortgeschrittenem RCC, die 800 Milligramm (mg) Avelumab intravenös alle 2 Wochen in Kombination mit 5 mg Axitinib oral zweimal täglich gemäß den Bedingungen der Marktzulassung für die Erstlinientherapie gemäß der aktuellen klinischen Praxis erhalten, werden beobachtet für 24 Monate in dieser Studie.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival Rate
Zeitfenster: 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])

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival Rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. August 2021

Primärer Abschluss (Tatsächlich)

8. August 2024

Studienabschluss (Tatsächlich)

30. April 2025

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2021

Zuerst gepostet (Tatsächlich)

28. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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