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Studie van Ianalumab versus Placebo naast eerstelijnscorticosteroïden bij primaire immuuntrombocytopenie (ITP) (VAYHIT1)

5 november 2026 bijgewerkt door: Novartis Pharmaceuticals

Een gerandomiseerde, dubbelblinde fase III-studie van Ianalumab (VAY736) versus placebo in aanvulling op eerstelijnscorticosteroïden bij primaire immuuntrombocytopenie (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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

226

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

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 tot 100 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

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

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ianalumab Lower dose

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

Intravenous infusion, prepared from concentrate solution

Andere namen:
  • VAY736
Geneesmiddel: Corticosteroids

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

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

Intravenous infusion, prepared from concentrate solution

Andere namen:
  • VAY736
Geneesmiddel: Corticosteroids

Oral or parental (if clinically justified)
Placebo-vergelijker: Placebo

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

Oral or parental (if clinically justified)

Geneesmiddel: Placebo

Intravenous infusion, prepared from matching placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Stable Response off treatment at 12 months (SROT-12)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Onderzoekers

  • Studie directeur: Novartis Pharmaceuticals, Novartis Pharmaceuticals

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)

3 februari 2023

Primaire voltooiing (Geschat)

29 oktober 2026

Studie voltooiing (Geschat)

5 januari 2029

Studieregistratiedata

Eerst ingediend

23 november 2022

Eerst ingediend dat voldeed aan de QC-criteria

14 december 2022

Eerst geplaatst (Werkelijk)

16 december 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CVAY736I12301
  • 2024-511704-17-00 (Register-ID: EU CTIS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

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 .

Abonneren