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

Tutkimus ianalumabin tehosta ja turvallisuudesta verrattuna plaseboon eltrombopagin lisäksi primaari-immuunitrombosytopeniapotilailla, jotka eivät saaneet steroideja (VAYHIT2)

torstai 5. marraskuuta 2026 päivittänyt: Novartis Pharmaceuticals

Kolmannen vaiheen satunnaistettu, kaksoissokkotutkimus ianalumabista (VAY736) verrattuna lumelääkkeeseen eltrombopagin lisäksi potilailla, joilla on primaarinen immuunitrombosytopenia (ITP) ja joilla oli riittämätön vaste tai uusiutuminen ensimmäisen linjan steroidihoidon jälkeen (VAYHIT2)

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count <30 G/L) who failed previous first-line treatment with corticosteroids.

After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

152

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

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

Opiskelupaikat

  • Alankomaat
      • Utrecht, Alankomaat, 3584 CX
        • Novartis Investigative Site
    • South Holland
      • Leiden, South Holland, Alankomaat, 2333 ZA
        • Novartis Investigative Site
  • Argentiina
      • CABA, Argentiina, C1181ACH
        • Novartis Investigative Site
  • Belgia
    • Namur
      • Yvoir, Namur, Belgia, 5530
        • Novartis Investigative Site
    • West Vlaanderen
      • Roeselare, West Vlaanderen, Belgia, 8800
        • Novartis Investigative Site
  • Espanja
      • Salamanca, Espanja, 37007
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Espanja, 15706
        • Novartis Investigative Site
  • Etelä -Korea
      • Jeollanam, Etelä -Korea, 519763
        • Novartis Investigative Site
      • Seoul, Etelä -Korea, 06591
        • Novartis Investigative Site
  • Filippiinit
      • Makati City, Filippiinit, 1229
        • Novartis Investigative Site
      • Quezon, Filippiinit, 1102
        • Novartis Investigative Site
  • Intia
    • Uttarakhand
      • Rishikesh, Uttarakhand, Intia, 249203
        • Novartis Investigative Site
    • West Bengal
      • Kolkata, West Bengal, Intia, 700014
        • Novartis Investigative Site
  • Italia
    • BO
      • Bologna, BO, Italia, 40138
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italia, 00168
        • Novartis Investigative Site
      • Roma, RM, Italia, 00133
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italia, 34129
        • Novartis Investigative Site
  • Itävalta
      • Vienna, Itävalta, 1090
        • Novartis Investigative Site
  • Japani
      • Kumamoto, Japani, 8600008
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japani, 4538511
        • Novartis Investigative Site
    • Osaka
      • Osaka, Osaka, Japani, 5400006
        • Novartis Investigative Site
      • Suita, Osaka, Japani, 5650871
        • Novartis Investigative Site
    • Yamanashi
      • Kofu, Yamanashi, Japani, 4008506
        • Novartis Investigative Site
  • Kiina
      • Beijing, Kiina, 100730
        • Novartis Investigative Site
      • Jinan, Kiina, 250012
        • Novartis Investigative Site
      • Tianjin, Kiina, 300020
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kiina, 510515
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kiina, 430022
        • Novartis Investigative Site
    • Shandong
      • Binzhou, Shandong, Kiina, 256603
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kiina, 310003
        • Novartis Investigative Site
  • Malesia
      • George Town, Malesia, 10050
        • Novartis Investigative Site
      • Johor Bahru, Malesia, 80100
        • Novartis Investigative Site
      • Kuala Selangor, Malesia, 68000
        • Novartis Investigative Site
    • Pulau Pinang
      • George Town, Pulau Pinang, Malesia, 10450
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, Malesia, 88586
        • Novartis Investigative Site
    • Selangor
      • Subang Jaya, Selangor, Malesia, 47500
        • Novartis Investigative Site
  • Meksiko
    • Coahuila
      • Saltillo, Coahuila, Meksiko, 25230
        • Novartis Investigative Site
    • Michoacán
      • Morelia, Michoacán, Meksiko, 58260
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Meksiko, 64460
        • Novartis Investigative Site
  • Ranska
      • Blois, Ranska, 41000
        • Novartis Investigative Site
      • Le Mans, Ranska, 72000
        • Novartis Investigative Site
  • Romania
      • Timișoara, Romania, 300079
        • Novartis Investigative Site
    • Dolj
      • Craiova, Dolj, Romania, 200136
        • Novartis Investigative Site
  • Saksa
      • Dresden, Saksa, 01307
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Saksa, 50937
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Saksa, 01307
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Saksa, 07740
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Thaimaa
      • Bangkok, Thaimaa, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thaimaa, 50200
        • Novartis Investigative Site
  • Turkki (Türkiye)
      • Izmir, Turkki (Türkiye), 35100
        • Novartis Investigative Site
    • Atakum
      • Samsun, Atakum, Turkki (Türkiye), 55200
        • Novartis Investigative Site
    • Bilkent Cankaya
      • Ankara, Bilkent Cankaya, Turkki (Türkiye), 06800
        • Novartis Investigative Site
    • Efeler
      • Aydin, Efeler, Turkki (Türkiye), 09100
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkki (Türkiye), 34098
        • Novartis Investigative Site
  • Tšekki
      • Brno, Tšekki, 625 00
        • Novartis Investigative Site
      • Prague, Tšekki, 128 08
        • Novartis Investigative Site
      • Prague, Tšekki, 100 34
        • Novartis Investigative Site
  • Unkari
      • Budapest, Unkari, 1083
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Unkari, 4032
        • Novartis Investigative Site
  • Yhdistynyt kuningaskunta
      • London, Yhdistynyt kuningaskunta, W12 0HS
        • Novartis Investigative Site
      • London, Yhdistynyt kuningaskunta, E1 1BB
        • Novartis Investigative Site
      • Oxford, Yhdistynyt kuningaskunta, OX3 7LE
        • Novartis Investigative Site
  • Yhdysvallat
    • Arizona
      • Yuma, Arizona, Yhdysvallat, 85364
        • Yuma Regional Medical Center
    • Colorado
      • Aurora, Colorado, Yhdysvallat, 80045
        • University of Colorado Anschutz
    • Illinois
      • Evanston, Illinois, Yhdysvallat, 60201
        • Endeavor Health
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02215
        • Boston Medical Center
      • Worcester, Massachusetts, Yhdysvallat, 01665
        • UMASS Memorial Medical Center
    • Michigan
      • Farmington Hills, Michigan, Yhdysvallat, 48334
        • Michigan Center of Medical Research
    • Montana
      • Billings, Montana, Yhdysvallat, 59102
        • St Vincent Frontier Cancer Center
    • New York
      • Nyack, New York, Yhdysvallat, 10960
        • Hematology Oncology Association of Rockland
      • The Bronx, New York, Yhdysvallat, 10461
        • Montefiore Medical Center

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 - 100 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Key Inclusion criteria

  1. Male or female patients aged 18 years and older on the day of signing the informed consent.
  2. A signed informed consent must be obtained prior to participation in the study.
  3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
  4. Patient with platelet count <30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag

Key Exclusion criteria

  1. ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
  2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
  3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
  4. Patients with current or history of life-threatening bleeding
  5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
  6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
  7. Patients with hepatic impairment
  8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
  9. Nursing (breast feeding) or pregnant women

Other protocol-defined inclusion/exclusion criteria may 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: Treatment arm 1 - Lower dose

Participants will receive eltrombopag and ianalumab lower dose
Biologinen: Ianalumab

Concentrate for solution for infusion for intravenous use

Muut nimet:
  • VAY736
Lääke: Eltrombopag

Film-coated tablet for oral use

Muut nimet:
  • ETB115
Kokeellinen: Treatment arm 2 - Higher dose

Participants will receive eltrombopag and ianalumab higher dose
Biologinen: Ianalumab

Concentrate for solution for infusion for intravenous use

Muut nimet:
  • VAY736
Lääke: Eltrombopag

Film-coated tablet for oral use

Muut nimet:
  • ETB115
Placebo Comparator: Treatment arm 3 - Placebo

Participants will receive eltrombopag and placebo
Lääke: Eltrombopag

Film-coated tablet for oral use

Muut nimet:
  • ETB115
Lääke: Placebo

Concentrate for solution for infusion for intravenous use.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Time from randomization until treatment failure
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure:

  • platelet count below 30 G/L
  • start of a new ITP treatment
  • need for a rescue treatment
  • ineligibility to taper or inability to discontinue eltrombopag
  • death
Randomization to until end of study (up to 39 months after randomization of last participant)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Stable response at 6 months (Key Secondary Endpoint)
Aikaikkuna: At 6 months

Percentage of participants with at least 3 platelet count collected at month 6 (between study days 121 and 183 and at least 75% of platelet counts qualified as a response).
At 6 months
Complete Response rate at each timepoint
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment
Randomization to until end of study (up to 39 months after randomization of last participant)
Response rate at each timepoint
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment
Randomization to until end of study (up to 39 months after randomization of last participant)
Best response rate across all timepoints
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Percentage of participants with a best response rate of either response or complete response
Randomization to until end of study (up to 39 months after randomization of last participant)
Time to first response/time to first complete response
Aikaikkuna: Time from randomization up to the longest observed treatment period duration

Time from randomization to date of first response and time from randomization to date of first complete response
Time from randomization up to the longest observed treatment period duration
Duration of response
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Time from achievement of response to treatment failure.
Randomization to until end of study (up to 39 months after randomization of last participant)
Stable response at 1 year
Aikaikkuna: At 1 year

Percentage of participants with at least 2 platelet count collected at year 1 (between study days 296 and 379 and at least 66% of platelet counts qualified as a response).
At 1 year
Duration of complete response
Aikaikkuna: Randomization to end of study (up to 39 months after randomization of last participant)

Time from achievement of complete response to loss of complete response stable response at 1 year period
Randomization to end of study (up to 39 months after randomization of last participant)
Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm
Aikaikkuna: up to week 24

Probability to be treatment failure-free (as defined for the primary efficacy endpoint)
up to week 24
Percentage of participants with bleeding events according to World Health Organization (WHO)
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Percentage of participants reporting bleeding events according to WHO bleeding scale
Randomization to until end of study (up to 39 months after randomization of last participant)
Number of participants receiving rescue treatment
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Number of participants who are in need of rescue treatment in each treatment arm
Randomization to until end of study (up to 39 months after randomization of last participant)
Percentage of participants receiving rescue treatment
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Percentage of participants who are in need of rescue treatment
Randomization to until end of study (up to 39 months after randomization of last participant)
Change from baseline in the frequency of CD19+ B-cell counts
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Post-baseline frequency of CD19+ B-cell counts (percentage within CD45) compared to baseline
Randomization to until end of study (up to 39 months after randomization of last participant)
Change from baseline in the absolute number of CD19+ B-cell counts
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Post-baseline absolute number of CD19+ B-cell counts compared to baseline
Randomization to until end of study (up to 39 months after randomization of last participant)
Change from baseline on T-score of the PROMIS SF v1.0 Fatigue 13a
Aikaikkuna: From screening (baseline) until end of study (up 39 months after randomization of last participant)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults.
From screening (baseline) until end of study (up 39 months after randomization of last participant)
Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity
Aikaikkuna: From screening (baseline) until end of study (up 39 months after randomization of last participant)

The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women´s Reproductive Health, overall QoL. Each item is rated on a Likert type scale. Each scale is scored from 0 to 100. Higher scores represent better HRQoL.
From screening (baseline) until end of study (up 39 months after randomization of last participant)
Time to first occurence of B-cell recovery defined as ≥80% of baseline ≥50 cells/µL
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Time to B-cell recovery defined as ≥80% of baseline or ≥50 cells/µL
Randomization to until end of study (up to 39 months after randomization of last participant)
Change from baseline in immunoglobulins
Aikaikkuna: Randomization to until end of study (up to 39 months after randomization of last participant)

Change from baseline in immunoglobulin levels
Randomization to until end of study (up to 39 months after randomization of last participant)
PK parameters: AUClast
Aikaikkuna: After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)

AUClast: Area under the curve from time zero to the last measurable concentration sampling time (tlast)
After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)
PK parameters: AUCtau
Aikaikkuna: After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)

AUCtau: Area under the curve calculated to the end of a dosing interval (tau)
After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)
PK parameters: Cmax
Aikaikkuna: After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)

Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)
PK parameters: Tmax
Aikaikkuna: After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)

Time to reach maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
After first dose (pre-dose, EOI, 168, 336 and 504 hours post dose) and after last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)
PK parameters: Accumulation ratio Racc
Aikaikkuna: After last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)

Accumulation ratio calculated using AUC values obtained after the last and first dose
After last dose (pre-dose, EOI, 336, 672, 2016, 3360 hours post dose)
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Aikaikkuna: up to week 33

Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
up to week 33
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Aikaikkuna: up to week 33

Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
up to week 33

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Novartis Pharmaceuticals

Tutkijat

  • Opintojohtaja: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Julkaisuja ja hyödyllisiä linkkejä

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

Yleiset julkaisut

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)

Torstai 2. helmikuuta 2023

Ensisijainen valmistuminen (Todellinen)

Torstai 19. kesäkuuta 2025

Opintojen valmistuminen (Arvioitu)

Lauantai 8. huhtikuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 23. marraskuuta 2022

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 14. joulukuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Perjantai 16. joulukuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 9. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 5. marraskuuta 2026

Viimeksi vahvistettu

Sunnuntai 1. marraskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CVAY736Q12301
  • 2024-512890-28-00 (Muu tunniste: EU CTIS)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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