Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8 april 2022 bijgewerkt door: Prof Evangelos Terpos, National and Kapodistrian University of Athens
Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health.
Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
Studietype
Observationeel
Inschrijving (Verwacht)
600
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ioanna Charitaki
- Telefoonnummer: +30 6976156403
- E-mail: j.charitaki@gmail.com
Studie Locaties
-
-
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Athens, Griekenland
- Werving
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Contact:
- Evangelos Terpos, MD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine.
In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health.
The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease.
Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.
Beschrijving
Inclusion Criteria:
- Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
- Age ≥ 18 years old
Exclusion Criteria:
- Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
|
Cohort 2
People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up).
This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50).
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Day 50 (28 days after the second dose of the vaccine)
|
Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations
|
Day 50 (28 days after the second dose of the vaccine)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Day 1
|
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Day 22
|
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Month 3
|
Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Month 6
|
Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Month 9
|
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Neutralizing antibodies against SARS-CoV-2
Tijdsspanne: Month 18
|
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Day 1
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Day 22
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Day 36
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Day 50
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Month 3
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Month 6
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Month 9
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Month 12
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tijdsspanne: Month 18
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Day 36
|
According to antibody responses on day 36
|
Day 36
|
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Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory B-cells against SARS-CoV-2
Tijdsspanne: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
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Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory T-cells against SARS-CoV-2
Tijdsspanne: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of monocytes (CD14+, CD16+)
Tijdsspanne: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
Tijdsspanne: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tijdsspanne: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Tijdsspanne: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Tijdsspanne: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Tijdsspanne: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Tijdsspanne: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Tijdsspanne: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Tijdsspanne: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Tijdsspanne: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Tijdsspanne: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Tijdsspanne: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Tijdsspanne: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
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TNF-a levels
Tijdsspanne: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Tijdsspanne: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
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Day 1
|
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CRP levels
Tijdsspanne: Day 8
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CRP blood level measurements on day 8
|
Day 8
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CRP levels
Tijdsspanne: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Tijdsspanne: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
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CRP levels
Tijdsspanne: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Tijdsspanne: Day 50
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CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Tijdsspanne: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
Tijdsspanne: Month 6
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Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
Tijdsspanne: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
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CRP levels
Tijdsspanne: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
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CRP levels
Tijdsspanne: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Evangelos Terpos, National and Kapodistrian University of Athens
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241.
- Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 januari 2021
Primaire voltooiing (Verwacht)
1 augustus 2022
Studie voltooiing (Verwacht)
1 december 2022
Studieregistratiedata
Eerst ingediend
3 februari 2021
Eerst ingediend dat voldeed aan de QC-criteria
5 februari 2021
Eerst geplaatst (Werkelijk)
8 februari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 april 2022
Laatste update ingediend die voldeed aan QC-criteria
8 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Neoplasmata
- Longontsteking, viraal
- Longontsteking
- Longziekten
- Neoplasmata per site
- Ziekte attributen
- Hematologische ziekten
- COVID-19
- Hematologische neoplasmata
- Chronische ziekte
Andere studie-ID-nummers
- 900/24-12-2020
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
At the end of the study, the results will be announced in medical conferences or medical journals.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .