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Badanie Ianalumab Versus Placebo jako dodatek do kortykosteroidów pierwszego rzutu w pierwotnej małopłytkowości immunologicznej (ITP) (VAYHIT1)

5 listopada 2026 zaktualizowane przez: Novartis Pharmaceuticals

Randomizowane badanie III fazy z podwójnie ślepą próbą porównujące Ianalumab (VAY736) w porównaniu z placebo jako dodatek do kortykosteroidów pierwszego rzutu w pierwotnej trombocytopenii immunologicznej (VAYHIT1)

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in increasing the rate of stable response off treatment at 12 months (SROT-12) in adult participants with primary ITP.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count <30 G/L) who require first-line standard-of-care corticosteroids.

After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids).

After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.

The efficacy and safety follow-up period will last until treatment failure or up to 39 months after randomization of the last patient, whichever occurs first. Safety follow-up period will be performed for at least 20 weeks and up to 2 years after the last ianalumab/placebo dose.

The primary endpoint was updated in May 2026 to stable response off treatment at 12 months (SROT-12). The previous primary endpoint, time to treatment failure (TTF), remains in the study as a key secondary objective.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

226

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, C1039AAC
        • Novartis Investigative Site
      • Córdoba, Argentyna, 5000
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentyna, C1414DRK
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentyna, C1280AEB
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel Tucuman, Tucumán Province, Argentyna, T4000DPK
        • Novartis Investigative Site
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Novartis Investigative Site
    • Queensland
      • Wooloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
  • Austria
      • Salzburg, Austria, 5020
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Novartis Investigative Site
  • Belgia
      • Brasschaat, Belgia, 2930
        • Novartis Investigative Site
      • Bruges, Belgia, 8000
        • Novartis Investigative Site
    • West Vlaanderen
      • Roeselare, West Vlaanderen, Belgia, 8800
        • Novartis Investigative Site
  • Bułgaria
      • Plovdiv, Bułgaria, 4002
        • Novartis Investigative Site
      • Sofia, Bułgaria, 1431
        • Novartis Investigative Site
  • Chiny
      • Bengbu, Chiny, 233004
        • Novartis Investigative Site
      • Dalian, Chiny, 116000
        • Novartis Investigative Site
      • Tianjin, Chiny, 300020
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100044
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510515
        • Novartis Investigative Site
      • Shenzhen, Guangdong, Chiny, 518037
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Chiny, 050000
        • Novartis Investigative Site
    • Henan
      • Luoyang, Henan, Chiny, 471003
        • Novartis Investigative Site
      • Zhengzhou, Henan, Chiny, 450003
        • Novartis Investigative Site
    • Jiangsu
      • Changzhou, Jiangsu, Chiny, 213004
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, Chiny, 330006
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, Chiny, 650101
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 310006
        • Novartis Investigative Site
  • Czechy
      • Prague, Czechy, 128 08
        • Novartis Investigative Site
      • Prague, Czechy, 100 34
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Czechy, 708 52
        • Novartis Investigative Site
  • Francja
      • Caen, Francja, 14033
        • Novartis Investigative Site
      • Chambéry, Francja, 73000
        • Novartis Investigative Site
      • Le Mans, Francja, 72000
        • Novartis Investigative Site
      • Lille, Francja, 59037
        • Novartis Investigative Site
      • Rennes, Francja, 35033
        • Novartis Investigative Site
  • Hiszpania
      • Barcelona, Hiszpania, 08035
        • Novartis Investigative Site
      • Madrid, Hiszpania, 28009
        • Novartis Investigative Site
      • Murcia, Hiszpania, 30008
        • Novartis Investigative Site
      • Seville, Hiszpania, 41013
        • Novartis Investigative Site
  • Hongkong
      • Hong Kong, Hongkong, 999077
        • Novartis Investigative Site
    • Hong Kong
      • New Territories, Hong Kong, Hongkong, 999077
        • Novartis Investigative Site
  • Indie
    • Gujarat
      • Ahmedabad, Gujarat, Indie, 380013
        • Novartis Investigative Site
    • Uttarakhand
      • Rishikesh, Uttarakhand, Indie, 249203
        • Novartis Investigative Site
  • Japonia
      • Chiba, Japonia, 2600852
        • Novartis Investigative Site
      • Fukuoka, Japonia, 8158555
        • Novartis Investigative Site
      • Gifu, Japonia, 5008513
        • Novartis Investigative Site
      • Osaka, Japonia, 5438555
        • Novartis Investigative Site
    • Aichi-ken
      • Nagakute, Aichi-ken, Japonia, 4801195
        • Novartis Investigative Site
    • Gunma
      • Shibukawa, Gunma, Japonia, 3770280
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japonia, 0608604
        • Novartis Investigative Site
    • Okayama-ken
      • Okayama, Okayama-ken, Japonia, 7011192
        • Novartis Investigative Site
    • Saitama
      • Iruma-gun, Saitama, Japonia, 3500495
        • Novartis Investigative Site
  • Malezja
      • George Town, Malezja, 10050
        • Novartis Investigative Site
      • Johor Bahru, Malezja, 80100
        • Novartis Investigative Site
      • Kuala Selangor, Malezja, 68000
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malezja, 93586
        • Novartis Investigative Site
  • Meksyk
    • Mexico City
      • Mexico City, Mexico City, Meksyk, 06720
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Meksyk, 64460
        • Novartis Investigative Site
  • Niemcy
      • Dresden, Niemcy, 01307
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Niemcy, 60590
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Niemcy, 01307
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Niemcy, 07740
        • Novartis Investigative Site
  • Norwegia
      • Grålum, Norwegia, 1714
        • Novartis Investigative Site
  • Rumunia
      • Bucharest, Rumunia, 030171
        • Novartis Investigative Site
  • Singapur
      • Singapore, Singapur, 119074
        • Novartis Investigative Site
      • Singapore, Singapur, 169608
        • Novartis Investigative Site
  • Stany Zjednoczone
    • Arizona
      • Yuma, Arizona, Stany Zjednoczone, 85364
        • Yuma Regional Medical Center
    • California
      • Clovis, California, Stany Zjednoczone, 93611
        • Community Cancer Institute
      • Fountain Valley, California, Stany Zjednoczone, 92708
        • Compassionate Care Res Group Inc
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Anschutz
    • Florida
      • Margate, Florida, Stany Zjednoczone, 33063
        • DH Cancer Research Center LLC
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60637
        • Uni of Chi Medi Ctr Hema and Onco
    • Indiana
      • Fort Wayne, Indiana, Stany Zjednoczone, 46845
        • Parkview Research Center
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stany Zjednoczone, 02215
        • Beth Israel Deaconess Med Center
    • Minnesota
      • Rochester, Minnesota, Stany Zjednoczone, 55905
        • Mayo Clinic Rochester
    • New York
      • Nyack, New York, Stany Zjednoczone, 10960
        • Hematology Oncology Association of Rockland
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02903
        • Rhode Island Hospital
    • Texas
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Mays Cancer Ctr Uthsa Mdacc
    • Utah
      • Ogden, Utah, Stany Zjednoczone, 84405
        • Community Cancer Trials of Utah
  • Tajlandia
      • Bangkok, Tajlandia, 10330
        • Novartis Investigative Site
      • Bangkok, Tajlandia, 10700
        • Novartis Investigative Site
      • Chiang Mai, Tajlandia, 50200
        • Novartis Investigative Site
  • Turcja (Türkiye)
    • Atakum
      • Samsun, Atakum, Turcja (Türkiye), 55200
        • Novartis Investigative Site
    • Efeler
      • Aydin, Efeler, Turcja (Türkiye), 09100
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turcja (Türkiye), 34098
        • Novartis Investigative Site
  • Wietnam
      • Hanoi, Wietnam, 100000
        • Novartis Investigative Site
      • Ho Chi Minh City, Wietnam, 70000
        • Novartis Investigative Site
  • Węgry
      • Budapest, Węgry, 1083
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Węgry, 4032
        • Novartis Investigative Site
  • Włochy
    • BO
      • Bologna, BO, Włochy, 40138
        • Novartis Investigative Site
    • FI
      • Florence, FI, Włochy, 50134
        • Novartis Investigative Site
    • RM
      • Roma, RM, Włochy, 00168
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Włochy, 34129
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Włochy, 36100
        • Novartis Investigative Site
  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo, W12 0HS
        • Novartis Investigative Site
      • Nottingham, Zjednoczone Królestwo, NG5 1PB
        • Novartis Investigative Site
    • West Midlands
      • Birmingham, West Midlands, Zjednoczone Królestwo, B15 2TH
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 100 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Signed informed consent prior to participation in the study.
  • Male or female participants aged 18 years and older on the day of signing informed consent
  • Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
  • Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
  • Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.

Key Exclusion Criteria:

  • Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible)
  • Current life-threatening bleeding
  • Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
  • Prior use of B-cell depleting therapy (e.g., rituximab).
  • Absolute neutrophil count below 1.0 G/L at randomization
  • Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ianalumab Lower dose

Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Biologiczny: Ianalumab

Intravenous infusion, prepared from concentrate solution

Inne nazwy:
  • VAY736
Lek: Corticosteroids

Oral or parental (if clinically justified)
Eksperymentalny: Ianalumab Higher dose

Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Biologiczny: Ianalumab

Intravenous infusion, prepared from concentrate solution

Inne nazwy:
  • VAY736
Lek: Corticosteroids

Oral or parental (if clinically justified)
Komparator placebo: Placebo

Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Lek: Corticosteroids

Oral or parental (if clinically justified)

Lek: Placebo

Intravenous infusion, prepared from matching placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Rate of Stable Response off treatment at 12 months (SROT-12)
Ramy czasowe: 12 months after last patient completed treatment

A participant will be considered in SROT-12 if at least 75% of the platelet counts collected between visits Week 53 Day 1 and Week 65 Day 1 (Study Days 352 and 463) qualify as Response. Response is any platelet counts of at least 50 G/L in the absence of rescue treatment or new immune thrombocytopenia (ITP) treatment).
12 months after last patient completed treatment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint)
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient

Time to Treatment Failure (TTF) is defined as the time from randomization until the first of the following events/situation indicative of treatment failure: platelet count below 30 G/L later than 8 weeks from randomization, need for a rescue treatment later than 8 weeks from randomization, intake of rescue treatment (e.g., corticosteroids, Intravenous immunoglobulins (IVIG), or platelet transfusion) given later than 8 weeks from randomization, start of new Immune Thrombocytopenia (ITP) treatment whenever it occurs, death (whatever the cause).
Randomization to end of study (up to 39 months after randomization of last patient
Complete Response (CR) rate in each treatment group
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Complete Response (CR) rate at each timepoint defined as the proportion of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment.
Randomization to end of study (up to 39 months after randomization of last patient)
Response (R) rate in each treatment group
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Response (R) rate at each timepoint defined as the proportion of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment.
Randomization to end of study (up to 39 months after randomization of last patient)
Time to complete response in each treatment group
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Time from randomization to date of first complete response.
Randomization to end of study (up to 39 months after randomization of last patient)
Duration of response in each treatment group
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Time from achievement of complete response to loss of complete response
Randomization to end of study (up to 39 months after randomization of last patient)
Stable response at 6 months
Ramy czasowe: At 6 months

Percentage of participants with at least 2 platelet count collected at month 6 (between study dates 107 and 183) and at least 66% of platelet counts qualified as a response
At 6 months
Stable response at 1 year
Ramy czasowe: At 1 year

Percentage of participants with at least 2 platelet counts collected at year 1 (between study days 296 and 379) and at least 66% of platelet counts qualified as a response
At 1 year
Percentage of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

This is to assess the incidence and severity of bleeding in each treatment arm
Randomization to end of study (up to 39 months after randomization of last patient)
Number of participants with bleeding events overall and by World Health Organization (WHO) bleeding scale severity
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

This is to assess the number and severity of bleeding in each treatment arm
Randomization to end of study (up to 39 months after randomization of last patient)
Number of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

This is to assess the number of participants receiving rescue treatment.
Randomization to end of study (up to 39 months after randomization of last patient)
Percentage of participants receiving rescue treatment (cummulative dose/duration of steroids exposure)
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

This is to assess the need of rescue treatment in each treatment group by percentage.
Randomization to end of study (up to 39 months after randomization of last patient)
Cumulative dose/duration of steroids exposure
Ramy czasowe: From screening to end of study (up to 39 months after randomization of last patient)

Duration of exposure to corticosteroids calculated from randomization (first dose) to end of study or last last contact date (if the participant is lost to follow-up).
From screening to end of study (up to 39 months after randomization of last patient)
Change from baseline on T scores of the PROMIS SF v1.0 Fatigue 13a
Ramy czasowe: From screening (baseline) till end of study (up to 39 months after randomization of last patient)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue
From screening (baseline) till end of study (up to 39 months after randomization of last patient)
Change from baseline in ITP-PAQ domain scores
Ramy czasowe: From screening (baseline) till end of study (up to 39 months after randomization of last patient)

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, and Overall QoL. Each item is rated on a Likert type scale
From screening (baseline) till end of study (up to 39 months after randomization of last patient)
Change from baseline in frequency of CD19+ B cell counts
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Post baseline frequency (%within the CD45) of CD19+ B cell counts compare to baseline.
Randomization to end of study (up to 39 months after randomization of last patient)
Change from baseline in absolute number of CD19+ B cell counts
Ramy czasowe: Randomization to end of study (up to 39 months after randomization of last patient)

Post baseline absolute number of CD19+ B cell counts compare with baseline
Randomization to end of study (up to 39 months after randomization of last patient)
Time to first occurrence of B-cell recovery
Ramy czasowe: Randomization to end of study (up to 39 months after randomized of last patient)

B-cell recovery is defined as ≥80% of baseline and ≥LLOQ, or ≥50 cells/μL
Randomization to end of study (up to 39 months after randomized of last patient)
Change from baseline in inmmunoglobulins
Ramy czasowe: Randomization to end of study (up to 39 months after last randomized patients)

Change from baseline in immunoglobulin levels
Randomization to end of study (up to 39 months after last randomized patients)
PK parameters: AUClast
Ramy czasowe: After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)

AUClast: area under the curve from time zero till the last measurable concentration sampling time (tlast)
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
PK parameter: AUCtau
Ramy czasowe: After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)

Area under the curve calculated to the end of a dosing interval (tau)
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
PK parameters: Cmax
Ramy czasowe: After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)

Maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
PK parameters: Tmax
Ramy czasowe: After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)

Time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
PK parameters: Accumulation ratio Racc
Ramy czasowe: After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)

Accumulation ratio calculated using AUC values obtained between the last and first dose
After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Ramy czasowe: Up to Week 33

Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Up to Week 33
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Ramy czasowe: Up to Week 33

Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assess the immunogenicity of ianalumab
Up to Week 33

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Śledczy

  • Dyrektor Studium: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

3 lutego 2023

Zakończenie podstawowe (Szacowany)

29 października 2026

Ukończenie studiów (Szacowany)

5 stycznia 2029

Daty rejestracji na studia

Pierwszy przesłany

23 listopada 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 grudnia 2022

Pierwszy wysłany (Rzeczywisty)

16 grudnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CVAY736I12301
  • 2024-511704-17-00 (Identyfikator rejestru: EU CTIS)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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