Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus ihonalaisen nivolumabin ja laskimonsisäisen nivolumabin välillä potilailla, joilla on aiemmin hoidettu kirkassoluinen munuaissyöpä, joka on edennyt tai levinnyt (CheckMate-67T)

keskiviikko 26. elokuuta 2026 päivittänyt: Bristol-Myers Squibb

Vaihe 3, avoin, satunnaistettu, noninferiority-tutkimus nivolumabin ihonalaisesta formulaatiosta vs. suonensisäinen nivolumabi potilailla, joilla on pitkälle edennyt tai metastaattinen kirkassoluinen munuaissolusyöpä ja jotka ovat saaneet aikaisempaa systeemistä hoitoa

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

681

Vaihe

  • Vaihe 3

Laajennettu käyttöoikeus

Ei ole enää käytettävissä kliinisen tutkimuksen ulkopuolella. Katso laajennettu käyttöoikeustietue.

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Argentiina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentiina, C1426ANZ
        • Local Institution - 0038
      • Capital Federal, Buenos Aires, Argentiina, C1419AHN
        • Local Institution - 0095
      • Mar del Plata, Buenos Aires, Argentiina, 7600
        • Local Institution - 0058
      • Pergamino, Buenos Aires, Argentiina, B2700CPM
        • Local Institution - 0037
    • Córdoba Province
      • Parana, Córdoba Province, Argentiina, 5000
        • Local Institution - 0079
      • Río Cuarto, Córdoba Province, Argentiina, 5800
        • Local Institution - 0030
    • Río Negro Province
      • Viedma, Río Negro Province, Argentiina, R8500ACE
        • Local Institution - 0066
    • San Juan Province
      • San Juan, San Juan Province, Argentiina, J5402DIL
        • Local Institution - 0056
  • Brasilia
    • Paraná
      • Curitiba, Paraná, Brasilia, 80520-174
        • Local Institution - 0064
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasilia, 98700-000
        • Local Institution - 0107
      • Porto Alegre, Rio Grande do Sul, Brasilia, 91350-200
        • Local Institution - 0039
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasilia, 20230-130
        • Local Institution - 0090
    • São Paulo
      • Barretos, São Paulo, Brasilia, 014784-000
        • Local Institution - 0071
      • São José do Rio Preto, São Paulo, Brasilia, 15090-000
        • Local Institution - 0070
      • São Paulo, São Paulo, Brasilia, 01246-000
        • Local Institution - 0081
      • São Paulo, São Paulo, Brasilia, 01327-0001
        • Local Institution - 0096
  • Chile
    • Araucania
      • Temuco, Araucania, Chile
        • Local Institution - 0084
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0005
      • Santiago, Santiago Metropolitan, Chile, 7500653
        • Local Institution - 0104
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0076
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0077
  • Espanja
      • Barcelona, Espanja, 08003
        • Local Institution - 0048
      • Barcelona, Espanja, 08035
        • Local Institution - 0102
      • Barcelona, Espanja, 08041
        • Local Institution - 0049
      • Madrid, Espanja, 28026
        • Local Institution - 0072
      • Madrid, Espanja, 28033
        • Local Institution - 0067
      • Madrid, Espanja, 28046
        • Local Institution - 0074
      • Madrid, Espanja, 28050
        • Local Institution - 0075
      • Sabadell, Espanja, 08208
        • Local Institution - 0032
      • Santander, Espanja, 39008
        • Local Institution - 0086
      • Seville, Espanja, 31013
        • Local Institution - 0059
  • Irlanti
    • Dublin
      • Tallaght, Dublin, Irlanti
        • Local Institution - 0060
  • Italia
      • Cremona, Italia, 26100
        • Local Institution - 0033
      • Florence, Italia, 50134
        • Local Institution - 0008
      • Meldola, Italia, 47014
        • Local Institution - 0027
      • Milan, Italia, 20141
        • Local Institution - 0018
      • Milan, Italia, 20133
        • Local Institution
      • Padova, Italia, 35128
        • Local Institution - 0014
      • Parma, Italia, 43126
        • Local Institution - 0082
      • Pavia, Italia, 27100
        • Local Institution - 0092
      • Roma, Italia, 00168
        • Local Institution - 0100
      • Rome, Italia, 00152
        • Local Institution - 0091
      • Terni, Italia, 05100
        • Local Institution - 0057
  • Meksiko
    • Coahuila
      • Torreón, Coahuila, Meksiko, 27010
        • Local Institution - 0101
    • Mexico City
      • Tlalpan, Mexico City, Meksiko, 14080
        • Local Institution - 0089
    • Nuevo León
      • Monterrey, Nuevo León, Meksiko, 64460
        • Local Institution - 0103
      • Monterrey, Nuevo León, Meksiko, 64710
        • Local Institution - 0031
    • Querétaro
      • Querétaro City, Querétaro, Meksiko, 76000
        • Local Institution - 0065
      • Querétaro City, Querétaro, Meksiko, 76090
        • Local Institution - 0085
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Meksiko, 78200
        • Local Institution - 0105
  • Portugali
      • Coimbra, Portugali, 3030-075
        • Local Institution - 0050
      • Lisbon, Portugali, 1500-650
        • Local Institution - 0052
  • Puola
      • Biała Podlaska, Puola, 21-500
        • Local Institution - 0055
      • Bydgoszcz, Puola, 85-796
        • Local Institution - 0062
      • Gdansk, Puola, 80-214
        • Local Institution - 0083
      • Krakow, Puola, 30-688
        • Local Institution - 0021
      • Krakow, Puola, 31-115
        • Local Institution - 0098
      • Poznan, Puola, 60-569
        • Local Institution - 0001
      • Warsaw, Puola, 02-781
        • Local Institution - 0023
  • Ranska
      • Nice, Ranska, 6189
        • Local Institution
      • Suresnes, Ranska, 92151
        • Local Institution - 0051
      • Villejuif, Ranska, 94800
        • Local Institution - 0068
  • Romania
      • Bucharest, Romania, 022238
        • Local Institution - 0024
      • Cluj-Napoca, Romania, 400132
        • Local Institution - 0002
      • Cluj-Napoca, Romania, 400641
        • Local Institution - 0040
      • Craiova, Romania, 200347
        • Local Institution - 0016
  • Suomi
      • Tampere, Suomi, 33521
        • Local Institution - 0017
  • Turkki (Türkiye)
      • Ankara, Turkki (Türkiye), 06230
        • Local Institution - 0026
      • Ankara, Turkki (Türkiye), 06590
        • Local Institution - 0097
      • Istanbul, Turkki (Türkiye), 34098
        • Local Institution - 0019
    • Bagcilar
      • Istanbul, Bagcilar, Turkki (Türkiye), 34284
        • Local Institution - 0035
  • Tšekki
      • Brno, Tšekki, 656 53
        • Local Institution - 0063
      • Hradec Králové, Tšekki, 500 05
        • Local Institution - 0036
      • Olomouc, Tšekki, 77900
        • Local Institution - 0020
      • Ostrava, Tšekki, 708 52
        • Local Institution - 0099
      • Prague, Tšekki, 140 59
        • Local Institution - 0010
      • Praha 8 Liben, Tšekki, 18081
        • Local Institution - 0106
  • Uusi Seelanti
      • Auckland, Uusi Seelanti, 1023
        • Local Institution - 0053
      • Hamilton, Uusi Seelanti, 3204
        • Local Institution - 0041
      • Palmerston North, Uusi Seelanti, 4414
        • Local Institution - 0078
  • Venäjä
      • Chelyabinsk, Venäjä, 454087
        • SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
      • Ivanovo, Venäjä, 153040
        • Ivanovo Regional Oncology Dispensary
      • Moscow, Venäjä, 125284
        • Hertzen Moscow Oncology Research Center
      • Nizghiy Novgorod, Venäjä, 603000
        • Local Institution
      • Omsk, Venäjä, 644013
        • Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
      • Saint Petersburg, Venäjä, 197022
        • LLC Eurocityclinic
  • Yhdysvallat
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Local Institution
    • New York
      • Buffalo, New York, Yhdysvallat, 14263
        • Local Institution - 0025
    • Pennsylvania
      • West Reading, Pennsylvania, Yhdysvallat, 19611
        • Local Institution - 0088

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features
  • Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV)
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization
  • Received no more than 2 prior systemic treatment regimens
  • Intolerance or progression on or after the last treatment regimen received and within 6 months prior to randomization
  • Karnofsky PS ≥ 70 at screening
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Untreated, symptomatic central nervous system (CNS) metastases

  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization

  • Active, known, or suspected autoimmune disease

  • Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if:

    1. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
    2. They continue on ART as clinically indicated while enrolled on study
    3. CD4 counts and viral load are monitored per standard of care by a local health care provider
    4. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally

  • Serious or uncontrolled medical disorders including for example, active severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must have resolved based on investigator clinical judgment and, in consultation with Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment to be eligible

  • Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death ligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

  • Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Käsivarsi A
Biologinen: Nivolumab and rHuPH20

Specified dose on specified days

Muut nimet:
  • BMS-986298
Active Comparator: Käsivarsi B
Biologinen: Nivolumab

Specified dose on specified days

Muut nimet:
  • BMS-936558
  • Opdivo
Kokeellinen: Käsivarsi C
Biologinen: Nivolumab and rHuPH20

Specified dose on specified days

Muut nimet:
  • BMS-986298
Kokeellinen: Käsi D
Biologinen: Nivolumab and rHuPH20

Specified dose on specified days

Muut nimet:
  • BMS-986298

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale
Aikaikkuna: Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)
Adjusted Geometric Mean of Nivolumab Trough Serum Concentration at Steady State (Cminss) on Original Scale
Aikaikkuna: Pre-dose (Day 1 to Day 28)

Plasma samples were collected to assess the serum concentration.
Pre-dose (Day 1 to Day 28)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Objective Response Rate (ORR) Per BICR
Aikaikkuna: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Objective response rate (ORR) is defined as the percentage of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Trough Serum Concentration of Nivolumab at Day 28 (Cmind28)
Aikaikkuna: Pre-dose at Day 28

Blood samples were collected to assess serum concentration.
Pre-dose at Day 28
Maximum Serum Concentration of Nivolumab After the First Dose (Cmax1)
Aikaikkuna: Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Peak Serum Concentration of Nivolumab at Steady State (Cmaxss)
Aikaikkuna: Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Time-averaged Serum Concentration of Nivolumab at Steady State (Cavgss)
Aikaikkuna: Pre-dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre-dose (Day 1 to Day 28)
Trough Serum Concentration of Nivolumab (Ctrough)
Aikaikkuna: Pre-dose at Week 17

Blood samples were collected to assess serum concentration.
Pre-dose at Week 17
Time to Maximum Serum Concentration of Nivolumab at Day 1 (Tmax1)
Aikaikkuna: Post dose (Day 1)

Blood samples were collected to assess serum concentration.
Post dose (Day 1)
Trough Serum Concentration of Nivolumab at Steady State (Cminss)
Aikaikkuna: Pre dose (Day 1 to Day 28)

Blood samples were collected to assess serum concentration.
Pre dose (Day 1 to Day 28)
Number of Participants With Adverse Events, Serious Adverse Events, AEs Leading to Discontinuation and Death
Aikaikkuna: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence at any dose that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, results in a congenital abnormality or birth defect, or is an important medical event that may not result in death, be life-threatening, or require hospitalization, but may require medical or surgical intervention to prevent any of the outcomes listed above.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Number of Participants With Grade 3/4 Laboratory Abnormalities
Aikaikkuna: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

Blood samples were collected for assessment of laboratory test results. All abnormalities were graded as per CTCAE v5.0 on a scale from 1 to 4, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)
Disease Control Rate (ORR) Per BICR
Aikaikkuna: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Disease control rate (DCR) is defined as the percentage of participants who achieve a BOR of confirmed Complete Response (CR), confirmed Partial Response (PR), or stable disease (SD), based on BICR assessments (using RECIST 1.1) divided by the number of all randomized participants. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Time to Response (TTR) Per BICR
Aikaikkuna: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Time to response (TTR) assessed by BICR is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.

CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Duration of Response (DoR) Per BICR
Aikaikkuna: From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)

Duration of Response (DOR) in months is defined as the time from date of the first documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. CR is complete disappearance of all target lesions except nodal disease; all target nodes must decrease to normal size (short axis < 10 mm). PR is ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. Disease progression is defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm.
From first dose to the date of first objectively documented progression, per RECIST v1.1, or death due to any cause, whichever occurred first (up to approximately 26 months)
Overall Survival
Aikaikkuna: From first dose to the date of death (up to approximately 26 months)

Overall survival is defined as the time from the first dosing date (or from randomization/on treatment) to the date of death from any cause.
From first dose to the date of death (up to approximately 26 months)
Number of Participants With Drug-Related Local Injection- or Infusion-Site Reactions
Aikaikkuna: First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
First dose (Day 1) and 100 days after last dose of study therapy (up to approximately 27 months)
Number of Participants With Incidence of Anti-nivolumab Antibodies
Aikaikkuna: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

ADA Positive is a subject with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater [≥]than baseline positive titer) at any time after initiation of treatment.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 25 months)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Bristol-Myers Squibb

Tutkijat

  • Opintojohtaja: Bristol-Myers Squibb, Bristol-Myers Squibb

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 21. toukokuuta 2021

Ensisijainen valmistuminen (Todellinen)

Tiistai 29. heinäkuuta 2025

Opintojen valmistuminen (Arvioitu)

Maanantai 10. toukokuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 16. maaliskuuta 2021

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 19. maaliskuuta 2021

Ensimmäinen Lähetetty (Todellinen)

Maanantai 22. maaliskuuta 2021

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 22. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 26. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CA209-67T
  • 2020-003655-15 (EudraCT-numero)
  • U1111-1255-9514 (Rekisterin tunniste: WHO)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD-jaon aikakehys

See Plan Description

IPD-jaon käyttöoikeuskriteerit

See Plan Description

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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