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Studie Ianalumab versus placebo jako doplněk ke kortikosteroidům první linie u primární imunitní trombocytopenie (ITP) (VAYHIT1)

5. listopadu 2026 aktualizováno: Novartis Pharmaceuticals

Randomizovaná, dvojitě zaslepená studie fáze III Ianalumab (VAY736) versus placebo jako doplněk ke kortikosteroidům první linie u primární imunitní trombocytopenie (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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

226

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 100 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Ianalumab Lower dose

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

Intravenous infusion, prepared from concentrate solution

Ostatní jména:
  • VAY736
Lék: Corticosteroids

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

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

Intravenous infusion, prepared from concentrate solution

Ostatní jména:
  • VAY736
Lék: Corticosteroids

Oral or parental (if clinically justified)
Komparátor placeba: Placebo

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

Oral or parental (if clinically justified)

Lék: Placebo

Intravenous infusion, prepared from matching placebo

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of Stable Response off treatment at 12 months (SROT-12)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novartis Pharmaceuticals

Vyšetřovatelé

  • Ředitel studie: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. února 2023

Primární dokončení (Odhadovaný)

29. října 2026

Dokončení studie (Odhadovaný)

5. ledna 2029

Termíny zápisu do studia

První předloženo

23. listopadu 2022

První předloženo, které splnilo kritéria kontroly kvality

14. prosince 2022

První zveřejněno (Aktuální)

16. prosince 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CVAY736I12301
  • 2024-511704-17-00 (Identifikátor registru: EU CTIS)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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