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En undersøgelse, der evaluerer effektiviteten og sikkerheden af ​​Lebrikizumab hos voksne patienter med let til moderat astma

19. juni 2026 opdateret af: Hoffmann-La Roche

ET FASE III, RANDOMISERET, DOBBELT-BLINDT, PLACEBO-KONTROLLERET UNDERSØGELSE TIL EVALUERING AF EFFEKTIVITETEN OG SIKKERHEDEN AF LEBRIKIZUMAB HOS VOKSNE PATIENTER MED LÆG TIL MODERAT ASTMA

Dette fase III, randomiserede, dobbeltblindede, placebokontrollerede, multicenterstudie vil vurdere effektiviteten og sikkerheden af ​​lebrikizumab hos voksne patienter med mild til moderat astma behandlet med korttidsvirkende beta-agonist (SABA) behandling alene. Patienterne vil blive randomiseret i forholdet 1:1:1 til at modtage enten blindet lebrikizumab eller placebobehandling ved subkutan (SC) injektion (hver 4. uge for i alt 3 doser) eller åben behandling med Singulair (Montelukast; 10 mg dagligt) ). Tid på studiebehandling vil vare 12 uger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

313

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90020-090
        • Santa Casa de Misericórdia de Porto Alegre
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brasilien, 88040-970
        • Ufsc - Nupaiva
    • São Paulo
      • Santo André, São Paulo, Brasilien, 09080-000
        • Pesquisare Saúde Sociedade Simples
      • Santo André, São Paulo, Brasilien, 09060-650
        • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
  • Bulgarien
      • Gabrovo, Bulgarien, 5300
        • SHATPD ? Gabrovo EOOD; Department of pneumology
      • Razgrad, Bulgarien, 7200
        • MHAT "Sv. Ivan Rilski" ? Razgrad AD; Department of pnemology and phthisiatry
      • Rousse, Bulgarien, 7002
        • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
      • Sofia, Bulgarien, 1000
        • Medical Center Excelsior OOD
      • Varna, Bulgarien, 9000
        • Medical Center Researchexpert OOD
      • Veliko Tarnovo, Bulgarien, 5000
        • Medical Center Tara OOD
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K. Gupta Medicine Professional Corporation
  • Det Forenede Kongerige
      • Manchester, Det Forenede Kongerige, M23 9QZ
        • The Medicines Evaluation Unit
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Clinical Research Center of Alabama, LLC
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Allergy & Asthma Immunology Associates
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Anaheim Clinical Trials
      • Los Angeles, California, Forenede Stater, 90025
        • CA Allergy & Asthma Med Grp; Medical Group, Inc.
      • Los Angeles, California, Forenede Stater, 90048
        • Southern California Institute For Respiratory
      • Napa, California, Forenede Stater, 94558
        • North Bay Clinical Trials
      • Rancho Mirage, California, Forenede Stater, 92270
        • Advances in Medicine
      • Redwood City, California, Forenede Stater, 94063
        • Allergy & Asthma Consultants
      • Riverside, California, Forenede Stater, 92506
        • Integrated Research Group Inc
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Storms Clinical Research; Institute
      • Denver, Colorado, Forenede Stater, 80206
        • National Jewish Health
    • Florida
      • Winter Park, Florida, Forenede Stater, 32789
        • Florida Pulmonary Research Institute, LLC
    • Georgia
      • Duluth, Georgia, Forenede Stater, 30096
        • In-Quest Medical Research, LLC
    • Illinois
      • Normal, Illinois, Forenede Stater, 61761
        • Sneeze, Wheeze, & Itch Associates
      • River Forest, Illinois, Forenede Stater, 60305
        • Asthma & Allergy Center of Chicago, S.C.
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40223
        • Family Allergy & Asthma
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63141
        • Midwest Clinical Research LLC
      • St Louis, Missouri, Forenede Stater, 63141
        • The Clinical Research Ctr
    • Nebraska
      • Papillion, Nebraska, Forenede Stater, 68046
        • Asthma & Allergy Center, P.C.
    • Nevada
      • Reno, Nevada, Forenede Stater, 89511
        • Advanced Research Institute
    • New Jersey
      • Ocean City, New Jersey, Forenede Stater, 07712
        • Atlantic Research Center, LLC
    • New York
      • The Bronx, New York, Forenede Stater, 10459
        • Urban Health Plan, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Allergy, Asthma & Clinical Research Center
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Clinical Research Inst. of Southern Oregon, Pc
      • Portland, Oregon, Forenede Stater, 97202
        • Allergy Associates Research Center LLC - CRN
    • South Carolina
      • Greer, South Carolina, Forenede Stater, 29651
        • Mountainview Clinical Research
    • Texas
      • Boerne, Texas, Forenede Stater, 78006
        • TTS Research
      • Dallas, Texas, Forenede Stater, 75231
        • Pharmaceutical Research & Consulting, Inc.
      • Dallas, Texas, Forenede Stater, 75231
        • Allergy Asthma Research Assoc
      • Houston, Texas, Forenede Stater, 77034
        • Texas Institute of chest and Sleep Disorder
      • McKinney, Texas, Forenede Stater, 75069
        • Metroplex Pulmonology & Sleep Center
      • San Antonio, Texas, Forenede Stater, 78249
        • Bandera Family Health Care
      • San Antonio, Texas, Forenede Stater, 78207
        • Quality Assurance Research Center
      • San Antonio, Texas, Forenede Stater, 78251
        • South Texas Allergy and Asthma Medical Professionals
      • Waco, Texas, Forenede Stater, 76712
        • Allergy & Asthma Center
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22030
        • O & O Alpan, LLC
      • Richmond, Virginia, Forenede Stater, 23220
        • Clinical Research Partners, LLC
    • Wisconsin
      • Greenfield, Wisconsin, Forenede Stater, 53228
        • Allergy Asthma & Sinus Center
  • New Zealand
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials
      • Beckenham, New Zealand, 8024
        • Southern Clinical Trials, Ltd
  • Polen
      • Bialystok, Polen, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika Alergologii i Chorob Wewnetrznych
      • Krakow, Polen, 31-023
        • Grazyna Pulka Specjalistyczny Osrodek ALL-MED
      • Krakow, Polen, 31-159
        • GRA?YNA JASIENIAK-PINIS ATOPIA Niepubliczny Zak?ad Opieki Zdrowotnej Poradnie Specjalistyczne
      • Poznan, Polen, 60-693
        • Specjalistyczny Niepubliczny Zespol Opieki Zdrowotnej; Alergologia Plus Osrodek Diagnostyki.
      • Poznan, Polen, 60-823
        • NZOZ Alergo-Med. Specjalistyczna Przychodnia Lekarska; Poradnia Alergologiczna
      • Tarnów, Polen, 33-100
        • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o
      • Wroclaw, Polen, 53-201
        • NZOZ ALL-MED Specjalistyczna Opieka Medyczna
  • Rumænien
      • Bucharest, Rumænien, 030303
        • Compartiment Pneumologie; Fundatia Dr. Victor Babes
      • Craiova, Rumænien, 200446
        • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes; Sectia Pneumologie II
      • Iași, Rumænien, 700115
        • Spitalul Clinic de Pneumoftiziologie Iasi; Sectia Clinica I Pneumoftiziologie
      • Oradea, Rumænien, 410176
        • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea; Sectia Pneumologie I
  • Rusland
      • Saint Petersburg, Rusland, 190068
        • LLC Medical Center "Alliance-Biomedical - Russian Group"
      • Saint Petersburg, Rusland, 194295
        • LLC Medical Center"REAVITA"
      • Saint Petersburg, Rusland, 194354
        • Multiple-discipline City Hospital #2
      • Saratov, Rusland, 410053
        • Regional Clinical Hospital
      • Yekaterinburg, Rusland, 620109
        • Ural State Medical University; Pulmonology
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Rusland, 390026
        • Ryazan State Medical University named after I.P.Pavlov
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusland, 197706
        • City Hospital #40 of Resort Administrative District
      • Saint Petersburg, Sankt-Peterburg, Rusland, 197022
        • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
      • Saint Petersburg, Sankt-Peterburg, Rusland, 197089
        • St. Petersburg State Medical University n.a. I.P. Pavlov
  • Sydafrika
      • Cape Town, Sydafrika, 7700
        • University of Cape Town Lung Institute; Lung Clinical Research
      • Cape Town, Sydafrika, 7530
        • Tiervalei Trial Centre
      • Johannesburg, Sydafrika, 2113
        • Newtown Clinical Research
      • Lyttleton, Sydafrika, 0157
        • I Engelbrecht Research
      • Pretoria Gauteng Province, Sydafrika, 0087
        • Syzygy Clinical Research; ?Unit 3 to 7
      • Soweto, Sydafrika, 1818
        • Soweto Clinical Trial Centre
  • Tjekkiet
      • Jind?ich?v Hradec, Tjekkiet, 377 01
        • MediTrial s.r.o.
      • Karlovy Vary ? Stará Role, Tjekkiet, 360 17
        • Pneumo - KV; Ordinace pneumologie a diagnostiky plicních funkcí
      • Strakonice, Tjekkiet, 38601
        • Ordinace pro tuberkulozu a respiracni nemoci

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alder 18-75 år ved studiestart
  • Astmadiagnose i >/= 12 måneder før studiestart
  • Bronkodilatatorrespons ved screening
  • Præ-bronkodilatator FEV1 på 60 % - 85 % forudsagt ved både screeningsbesøg 2 og 3
  • Ingen anden klinisk signifikant lungesygdom bekræftet ved røntgen af ​​thorax eller computertomografi (CT) scanning
  • Stabil og symptomatisk astma i screeningsperioden
  • Brug af effektiv prævention, som defineret af protokollen, indtil 24 uger efter sidste dosis

Ekskluderingskriterier:

  • Vedligeholdelse af kortikosteroidbehandling, defineret som daglig eller alternativ-dages oral corticosteroid vedligeholdelsesbehandling inden for 3 måneder før studiestart
  • Behandling med systemiske eller inhalerede kortikosteroider inden for 4 uger før studiestart eller under screeningsperioden uanset årsag, herunder en akut forværring.
  • Behandling med en leukotrienreceptorantagonist (LTRA), langtidsvirkende beta-agonist (LABA) langtidsvirkende muskarinantagonist (LAMA), zileuton, roflumilast eller theophyllin inden for 2 uger før studiestart
  • Dokumenteret tidligere behandlingssvigt med Montelukast
  • Behandling med intraartikulære kortikosteroider inden for 4 uger før studiestart eller i screeningsperioden eller forventet behov for intraartikulære kortikosteroider i løbet af undersøgelsen
  • Enhver infektion, der kræver hospitals-, IV- eller im-antibiotisk behandling eller enhver luftvejsinfektion inden for 4 uger efter studiestart. Enhver infektion, der kræver oral antibiotikabehandling inden for 2 uger efter studiestart, eller enhver parasitisk infektion inden for 6 måneder efter studiestart
  • Klinisk signifikant abnormitet fundet under screening eller klinisk signifikant medicinsk sygdom, der er ukontrolleret på trods af behandling, der efter investigators opfattelse sandsynligvis vil påvirke patientens evne til at deltage i undersøgelsen eller påvirke undersøgelsens vurderinger
  • Anamnese med interstitiel lungesygdom, kronisk obstruktiv lungesygdom (KOL) eller anden klinisk signifikant lungesygdom bortset fra astma
  • Anamnese med alkohol- eller stofmisbrug, der ville forringe eller risikere patientens fulde deltagelse i undersøgelsen, efter investigators mening
  • Aktuel eller historie med rygning (> 10 pakke-år), eller manglende vilje til at holde sig fra at ryge i hele undersøgelsens varighed
  • Tidligere og/eller nuværende brug af enhver anti-IL-13 eller anti-IL4/IL-13 behandling, inklusive lebrikizumab
  • Brug af et licenseret eller forsøgsmæssigt monoklonalt antistof andet end anti-IL-13 eller anti-IL-4/IL-13, herunder, men ikke begrænset til, omalizumab, anti-IL-5 eller anti-IL-17, inden for 6 måneder eller 5 lægemiddelhalveringstider før besøg 1 (alt efter hvad der er længst) eller under screening
  • Anvendelse af en systemisk immunmodulerende eller immunsuppressiv terapi inden for 3 måneder eller 5 lægemiddelhalveringstider før studiestart eller under screening
  • Brug af anden forsøgsbehandling inden for 4 uger eller 5 lægemiddelhalveringstider før studiestart (alt efter hvad der er længst) eller under screening
  • Påbegyndelse af eller ændring i allergenimmunterapi inden for 3 måneder før studiestart eller under screening
  • Modtagelse af en levende svækket vaccine inden for 4 uger før studiestart eller under screening
  • Graviditet eller amning
  • Body mass index > 38 kg/m2
  • Kropsvægt < 40 kg
  • Historien om bronchial termoplastik

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Andet: Placebo
Lebrikizumab-matched placebo SC injection given on Days 1, 29, and 57
Aktiv komparator: Montelukast
Medicin: Montelukast
10 mg tablet given orally once daily for 12 weeks, according to the approved label.
Andre navne:
  • Singulair
Eksperimentel: Lebrikizumab
Medicin: Lebrikizumab
Lebrikizumab 125 mg subcutaneous (SC) injection given on Days 1, 29, and 57
Andre navne:
  • RO5490255

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Tidsramme: Baseline through Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the second for the montelukast vs. placebo sensitivity comparison.
Baseline through Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lebrikizumab vs. Placebo: Change From Baseline in Asthma Reliever Medication Use at Week 12
Tidsramme: Baseline through Week 12
Participants could only receive SABA therapy for asthma treatment as asthma reliever medication (<10 puffs daily). SABA use was recorded in the eDiary. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the comparison between the double-blind lebrikizumab and placebo study arms.
Baseline through Week 12
Lebrikizumab vs. Placebo: Change From Baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) Overall Score at Week 12
Tidsramme: Baseline through Week 12
The AQLQ[S] was used to assess the participant's asthma-specific health-related quality of life. The 32-item questionnaire contains four domains: activity limitations, symptoms, emotional function, and environmental stimuli. The AQLQ[S] has a recall specification of 2 weeks. Participants were asked to think about how they had been during the previous 2 weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all; 1 = severely impaired). An increase in the AQLQ score indicates a better quality of life. The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. A mixed-effect model of repeated measures (MMRM) was used to estimate the change from baseline values.
Baseline through Week 12
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Montelukast vs. Placebo: Change Fom Baseline in Morning Pre-bronchodilator Peak Expiratory Flow (PEF) at Week 12
Tidsramme: Baseline through Week 12
PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to this secondary outcome measure of PEF. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the sensitivity comparison between montelukast (open-label, active comparator) and placebo study arms.
Baseline through Week 12
Lebrikizumab vs. Placebo: Change From Baseline in Morning Pre-bronchodilator PEF at Week 12
Tidsramme: Baseline through Week 12
Peak expiratory flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. A mixed-effect model of repeated measures (MMRM) was used to estimate the absolute change from baseline values for the comparison between the double-blind lebrikizumab and placebo study arms.
Baseline through Week 12
Lebrikizumab vs. Placebo: Number of Participants With Treatment Failure
Tidsramme: Baseline up to Week 12
Treatment failure was defined as a worsening of asthma symptoms (per investigator's assessment of participant report) in association with either relative decline in pre-bronchodilator FEV1 >=20%; or >=20% decline in morning pre-bronchodilator PEF on 2 consecutive days compared with baseline; or use of >=10 puffs of albuterol metered dose inhaler (MDI); or >=2 additional administrations (or any new use) of nebulized short-acting β-agonist (SABA) therapy within any calendar day; or need for any inhaled, oral, or parenteral corticosteroid or for a controller medication. The hazard ratio from the Cox Proportional Hazards model compared the risk of treatment failure for the lebrikizumab-treated and placebo participants.
Baseline up to Week 12
Lebrikizumab vs. Placebo: Time to Treatment Failure
Tidsramme: Basleine up to Week 12
Treatment failure was defined as a worsening of asthma symptoms (per investigator's assessment of participant report) in association with either relative decline in pre-bronchodilator FEV1 >=20%; or >=20% decline in morning pre-bronchodilator PEF on 2 consecutive days compared with baseline; or use of >=10 puffs of albuterol metered dose inhaler (MDI); or >=2 additional administrations (or any new use) of nebulized short-acting β-agonist (SABA) therapy within any calendar day; or need for any inhaled, oral, or parenteral corticosteroid or for a controller medication. Time to treatment failure was estimated using Kaplan-Meier method.
Basleine up to Week 12
Change From Baseline in Blood Eosinophil Count at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Change From Baseline in Serum Periostin at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Change From Baseline in Total Immunoglobulin E (IgE) Levels at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Change From Baseline in C-C Motif Chemokine Ligand 13 (CCL-13) Levels at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Change From Baseline in CCL-17 Levels at Week 12
Tidsramme: Baseline, Week 12
Baseline, Week 12
Maximum Serum Lebrikizumab Concentration (Cmax) After the First Dose
Tidsramme: Predose on Day 0 and post-Day 1 dose on Day 7
According to the protocol and statistical analysis plan, a single PK sample was collected per participant after the first dose at the expected time of the maximum serum lebrikizumab concentration.
Predose on Day 0 and post-Day 1 dose on Day 7
Time to Reach Maximum Lebrikizumab Concentration After the First Dose (Tmax)
Tidsramme: Post-Day 1 dose on Day 7
According to the protocol and statistical analysis plan, the Tmax, Week1 (first dose) value was estimated on the basis of a single pharmacokinetic (PK) timepoint per participant after the first dose, which was taken at the expected time of the maximum serum lebrikizumab concentration.
Post-Day 1 dose on Day 7
Elimination Half-Life (t1/2) of Lebrikizumab
Tidsramme: Predose on Days 0, 28, and 56, and on Days 7, 84, 112, and 140
According to the protocol and statistical analysis plan, the t1/2 was estimated based on the seven total PK samples collected per participant.
Predose on Days 0, 28, and 56, and on Days 7, 84, 112, and 140
Predose Serum Lebrikizumab Concentration (Cmin) at Week 4
Tidsramme: Predose on Day 28 (Week 4)
Predose on Day 28 (Week 4)
Serum Lebrikizumab Concentration at Week 12
Tidsramme: On Day 84 (Week 12)
On Day 84 (Week 12)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juni 2014

Primær færdiggørelse (Faktiske)

22. januar 2016

Studieafslutning (Faktiske)

22. januar 2016

Datoer for studieregistrering

Først indsendt

26. marts 2014

Først indsendt, der opfyldte QC-kriterier

2. april 2014

Først opslået (Anslået)

4. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WA29249
  • 2013-004625-81 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner