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Studie av Ianalumab kontra placebo som tillägg till första linjens kortikosteroider vid primär immun trombocytopeni (ITP) (VAYHIT1)

5 november 2026 uppdaterad av: Novartis Pharmaceuticals

En fas III, randomiserad, dubbelblind studie av Ianalumab (VAY736) kontra placebo som tillägg till första linjens kortikosteroider vid primär immun trombocytopeni (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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

226

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Australien
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australien, 2605
        • Novartis Investigative Site
    • Queensland
      • Wooloongabba, Queensland, Australien, 4102
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Novartis Investigative Site
  • Belgien
      • Brasschaat, Belgien, 2930
        • Novartis Investigative Site
      • Bruges, Belgien, 8000
        • Novartis Investigative Site
    • West Vlaanderen
      • Roeselare, West Vlaanderen, Belgien, 8800
        • Novartis Investigative Site
  • Bulgarien
      • Plovdiv, Bulgarien, 4002
        • Novartis Investigative Site
      • Sofia, Bulgarien, 1431
        • Novartis Investigative Site
  • Frankrike
      • Caen, Frankrike, 14033
        • Novartis Investigative Site
      • Chambéry, Frankrike, 73000
        • Novartis Investigative Site
      • Le Mans, Frankrike, 72000
        • Novartis Investigative Site
      • Lille, Frankrike, 59037
        • Novartis Investigative Site
      • Rennes, Frankrike, 35033
        • Novartis Investigative Site
  • Förenta staterna
    • Arizona
      • Yuma, Arizona, Förenta staterna, 85364
        • Yuma Regional Medical Center
    • California
      • Clovis, California, Förenta staterna, 93611
        • Community Cancer Institute
      • Fountain Valley, California, Förenta staterna, 92708
        • Compassionate Care Res Group Inc
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • University of Colorado Anschutz
    • Florida
      • Margate, Florida, Förenta staterna, 33063
        • DH Cancer Research Center LLC
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • Uni of Chi Medi Ctr Hema and Onco
    • Indiana
      • Fort Wayne, Indiana, Förenta staterna, 46845
        • Parkview Research Center
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Förenta staterna, 02215
        • Beth Israel Deaconess Med Center
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic Rochester
    • New York
      • Nyack, New York, Förenta staterna, 10960
        • Hematology Oncology Association of Rockland
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02903
        • Rhode Island Hospital
    • Texas
      • San Antonio, Texas, Förenta staterna, 78229
        • Mays Cancer Ctr Uthsa Mdacc
    • Utah
      • Ogden, Utah, Förenta staterna, 84405
        • Community Cancer Trials of Utah
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Novartis Investigative Site
    • Hong Kong
      • New Territories, Hong Kong, Hong Kong, 999077
        • Novartis Investigative Site
  • Indien
    • Gujarat
      • Ahmedabad, Gujarat, Indien, 380013
        • Novartis Investigative Site
    • Uttarakhand
      • Rishikesh, Uttarakhand, Indien, 249203
        • Novartis Investigative Site
  • Italien
    • BO
      • Bologna, BO, Italien, 40138
        • Novartis Investigative Site
    • FI
      • Florence, FI, Italien, 50134
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00168
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italien, 34129
        • Novartis Investigative Site
    • VI
      • Vicenza, VI, Italien, 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
  • Kina
      • Bengbu, Kina, 233004
        • Novartis Investigative Site
      • Dalian, Kina, 116000
        • Novartis Investigative Site
      • Tianjin, Kina, 300020
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100044
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Novartis Investigative Site
      • Shenzhen, Guangdong, Kina, 518037
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050000
        • Novartis Investigative Site
    • Henan
      • Luoyang, Henan, Kina, 471003
        • Novartis Investigative Site
      • Zhengzhou, Henan, Kina, 450003
        • Novartis Investigative Site
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213004
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Novartis Investigative Site
    • Yunnan
      • Kunming, Yunnan, Kina, 650101
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310006
        • Novartis Investigative Site
  • Malaysia
      • George Town, Malaysia, 10050
        • Novartis Investigative Site
      • Johor Bahru, Malaysia, 80100
        • Novartis Investigative Site
      • Kuala Selangor, Malaysia, 68000
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • 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
  • Norge
      • Grålum, Norge, 1714
        • Novartis Investigative Site
  • Rumänien
      • Bucharest, Rumänien, 030171
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien, 08035
        • Novartis Investigative Site
      • Madrid, Spanien, 28009
        • Novartis Investigative Site
      • Murcia, Spanien, 30008
        • Novartis Investigative Site
      • Seville, Spanien, 41013
        • Novartis Investigative Site
  • Storbritannien
      • London, Storbritannien, W12 0HS
        • Novartis Investigative Site
      • Nottingham, Storbritannien, NG5 1PB
        • Novartis Investigative Site
    • West Midlands
      • Birmingham, West Midlands, Storbritannien, B15 2TH
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
  • Tjeckien
      • Prague, Tjeckien, 128 08
        • Novartis Investigative Site
      • Prague, Tjeckien, 100 34
        • Novartis Investigative Site
    • Poruba
      • Ostrava, Poruba, Tjeckien, 708 52
        • Novartis Investigative Site
  • Turkiet (Türkiye)
    • Atakum
      • Samsun, Atakum, Turkiet (Türkiye), 55200
        • Novartis Investigative Site
    • Efeler
      • Aydin, Efeler, Turkiet (Türkiye), 09100
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkiet (Türkiye), 34098
        • Novartis Investigative Site
  • Tyskland
      • Dresden, Tyskland, 01307
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60590
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Tyskland, 07740
        • Novartis Investigative Site
  • Ungern
      • Budapest, Ungern, 1083
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Ungern, 4032
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 70000
        • Novartis Investigative Site
  • Österrike
      • Salzburg, Österrike, 5020
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Österrike, 6020
        • Novartis Investigative Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ianalumab Lower dose

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

Intravenous infusion, prepared from concentrate solution

Andra namn:
  • VAY736
Läkemedel: Corticosteroids

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

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

Intravenous infusion, prepared from concentrate solution

Andra namn:
  • VAY736
Läkemedel: Corticosteroids

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

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

Oral or parental (if clinically justified)

Läkemedel: Placebo

Intravenous infusion, prepared from matching placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of Stable Response off treatment at 12 months (SROT-12)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time from randomization to Treatment Failure (TTF) (Key Secondary Endpoint)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Utredare

  • Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 februari 2023

Primärt slutförande (Beräknad)

29 oktober 2026

Avslutad studie (Beräknad)

5 januari 2029

Studieregistreringsdatum

Först inskickad

23 november 2022

Först inskickad som uppfyllde QC-kriterierna

14 december 2022

Första postat (Faktisk)

16 december 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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