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Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma (DREAM)

18 stycznia 2018 zaktualizowane przez: GlaxoSmithKline

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

621

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, 1425
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentyna, C1426ABP
        • GSK Investigational Site
      • Mendoza, Argentyna, M5500CCG
        • GSK Investigational Site
      • Tucuman, Argentyna, 4000
        • GSK Investigational Site
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentyna, B7600FZN
        • GSK Investigational Site
  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
      • Talcahuano, Chile, 4270918
        • GSK Investigational Site
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2341131
        • GSK Investigational Site
  • Federacja Rosyjska
      • Barnaul, Federacja Rosyjska, 656 045
        • GSK Investigational Site
      • Chelyabinsk, Federacja Rosyjska, 454106
        • GSK Investigational Site
      • Kazan, Federacja Rosyjska, 420015
        • GSK Investigational Site
      • Moscow, Federacja Rosyjska, 105 077
        • GSK Investigational Site
      • Moscow, Federacja Rosyjska, 115478
        • GSK Investigational Site
      • Moscow, Federacja Rosyjska, 123 182
        • GSK Investigational Site
      • Saint-Petersburg, Federacja Rosyjska, 194354
        • GSK Investigational Site
      • St. Petersburg, Federacja Rosyjska, 198216
        • GSK Investigational Site
      • Tomsk, Federacja Rosyjska, 634001
        • GSK Investigational Site
  • Francja
      • Clamart, Francja, 92140
        • GSK Investigational Site
      • Marseille cedex 20, Francja, 13915
        • GSK Investigational Site
      • Montpellier, Francja, 34295
        • GSK Investigational Site
      • Nantes, Francja, 44093
        • GSK Investigational Site
      • Saint Pierre cedex, Francja, 97448
        • GSK Investigational Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4Z6
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Kanada, L5A 3V4
        • GSK Investigational Site
      • Mississauga, Ontario, Kanada, L5M 2V8
        • GSK Investigational Site
    • Quebec
      • Quebec City, Quebec, Kanada, G1V 4G5
        • GSK Investigational Site
  • Niemcy
      • Berlin, Niemcy, 10367
        • GSK Investigational Site
      • Berlin, Niemcy, 10717
        • GSK Investigational Site
      • Berlin, Niemcy, 14050
        • GSK Investigational Site
      • Berlin, Niemcy, 12203
        • GSK Investigational Site
    • Brandenburg
      • Ruedersdorf, Brandenburg, Niemcy, 15562
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Niemcy, 60596
        • GSK Investigational Site
      • Frankfurt am Main, Hessen, Niemcy, 60596
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Niemcy, 55131
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Niemcy, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Niemcy, 23552
        • GSK Investigational Site
  • Polska
      • Bialystok, Polska, 15-276
        • GSK Investigational Site
      • Lodz, Polska, 90-153
        • GSK Investigational Site
      • Warszawa, Polska, 01-138
        • GSK Investigational Site
      • Wroclaw, Polska, 54-239
        • GSK Investigational Site
      • Zawadzkie, Polska, 47-120
        • GSK Investigational Site
      • Zgierz, Polska, 95-100
        • GSK Investigational Site
  • Republika Korei
      • Bucheon-si,, Republika Korei, 420-767
        • GSK Investigational Site
      • Cheongju, Chungcheongbuk-do, Republika Korei, 361-711
        • GSK Investigational Site
      • Seoul, Republika Korei, 152-703
        • GSK Investigational Site
      • Seoul, Republika Korei, 133--792
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Republika Korei, 443-721
        • GSK Investigational Site
  • Rumunia
      • Bucharest, Rumunia, 050159
        • GSK Investigational Site
      • Bucuresti, Rumunia, 70000
        • GSK Investigational Site
      • Iasi, Rumunia, 700115
        • GSK Investigational Site
      • Targu Mures, Rumunia, 540143
        • GSK Investigational Site
  • Stany Zjednoczone
    • California
      • Long Beach, California, Stany Zjednoczone, 90808
        • GSK Investigational Site
      • Los Angeles, California, Stany Zjednoczone, 90095
        • GSK Investigational Site
      • Riverside, California, Stany Zjednoczone, 92506
        • GSK Investigational Site
      • San Diego, California, Stany Zjednoczone, 92103-8415
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, Stany Zjednoczone, 80206
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, Stany Zjednoczone, 06510
        • GSK Investigational Site
    • Georgia
      • Albany, Georgia, Stany Zjednoczone, 31707
        • GSK Investigational Site
      • Columbus, Georgia, Stany Zjednoczone, 31904
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, Stany Zjednoczone, 40508
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, Stany Zjednoczone, 27103
        • GSK Investigational Site
    • Ohio
      • Canton, Ohio, Stany Zjednoczone, 44718
        • GSK Investigational Site
      • Cleveland, Ohio, Stany Zjednoczone, 44195
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73103
        • GSK Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, PA 15213
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone, 29406
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, Stany Zjednoczone, 37203
        • GSK Investigational Site
    • Texas
      • Boerne, Texas, Stany Zjednoczone, 78006
        • GSK Investigational Site
      • Houston, Texas, Stany Zjednoczone, 77054
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, Stany Zjednoczone, 53792
        • GSK Investigational Site
  • Ukraina
      • Cherkassy, Ukraina, 18009
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49006
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49051
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraina, 49027
        • GSK Investigational Site
      • Donetsk, Ukraina, 83003
        • GSK Investigational Site
      • Donetsk, Ukraina, 83099
        • GSK Investigational Site
      • Kharkiv, Ukraina, 61035
        • GSK Investigational Site
      • Kiev, Ukraina, 03680
        • GSK Investigational Site
      • Kyiv, Ukraina, 03038
        • GSK Investigational Site
      • Kyiv, Ukraina, 03115
        • GSK Investigational Site
      • Mykolayiv, Ukraina, 54003
        • GSK Investigational Site
  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo, E1 2AT
        • GSK Investigational Site
      • London, Zjednoczone Królestwo, SW3 6HP
        • GSK Investigational Site
      • Manchester, Zjednoczone Królestwo, M23 9LT
        • GSK Investigational Site
      • Southampton, Zjednoczone Królestwo, SO16 6YD
        • GSK Investigational Site
    • Leicestershire
      • Leicester, Leicestershire, Zjednoczone Królestwo, LE3 9QP
        • GSK Investigational Site

Kryteria uczestnictwa

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

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 65 lat (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Male or female
  • Aged 12 to 65 years inclusive
  • Minimum weight 45kg
  • Clinical features of severe refractory asthma
  • Well documented requirement for high dose inhaled corticosteroids (ICS) [i.e. >= 880mcg/day fluticasone propionate or equivalent daily] for at least 12 months
  • Using additional controller medication in addition to high dose ICS for at least 12 months
  • Persistent airflow obstruction indicated by a pre-bronchodilator FEV1<80% predicted at visit 1 or 2 or peak flow diurnal variability of >20% on 3 or more days during the run-in
  • Airway inflammation which is likely to be eosinophilic in nature demonstrated by either raised peripheral blood eosinophils (>=300/microL), sputum eosinophils (>=3%), exhaled nitric oxide (>=50ppb) or prompt deterioration of asthma control following a <=25% reduction in regular maintenance dose of inhaled or oral corticosteroids (OCS)
  • History of 2 or more exacerbations requiring systemic corticosteroids in the previous 12 months
  • Evidence of asthma documented by airway reversibility, airway hyperresponsiveness or airflow variability
  • ECG assessment demonstrating QTc<450msec or QTc<480msec for patients with bundle branch block
  • Liver function tests demonstrating ALT<2xUpper Limit of Normal (ULN), AST<2xULN, Alk Phos <=1.5xULN, bilirubin <=1.5xULN
  • Female of non-child-bearing potential or child-bearing potential with a negative pregnancy test at screening and prepared to agree to an acceptable method of contraception
  • Able to give written informed consent
  • Able to read, comprehend and write at a sufficient level to complete study materials

Exclusion Criteria:

  • Current smokers or smoking history of >=10 pack years
  • Clinically important lung condition other than asthma
  • Diagnosis of malignancy or in the process of investigation
  • Unstable liver disease
  • Churg-Strauss syndrome
  • Using methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine or any experimental anti-inflammatory therapy within 3 months of screening
  • Omalizumab (Xolair) or any other biological for the treatment of inflammatory disease within 6 months of Visit 1
  • Regular use of oral or systemic corticosteroids for diseases other than asthma within 12 months or any intra-articular, short-acting intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroid within 3 months
  • Allergy/intolerance to the excipients in the mepolizumab formulation
  • Any investigational drug within 30 days or 5 terminal half-lives, whichever is longer
  • Pregnant or breastfeeding or planning to become pregnant
  • Clinically significant disease which is uncontrolled with standard treatment
  • History of alcohol misuse or substance abuse
  • Parasitic infestation within previous 6 months
  • Known immunodeficiency
  • Unable to follow instructions, use the electronic diary or peak flow meter
  • Known evidence of lack of adherence to controller medications and/or follow physician's recommendations
  • Previous participation in a study of mepolizumab and received study medication within 90 days

Plan studiów

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

Jak projektuje się badanie?

Szczegóły projektu

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

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Mepolizumab 750mg
Mepolizumab 750mcg i.v. every 4 weeks
Biologiczny: Mepolizumab 750
Mepolizumab 750mg every four weeks by i.v.
Aktywny komparator: Mepolizumab 250mg
Mepolizumab 250mcg i.v. every 4 weeks
Biologiczny: Mepolizumab 250
Mepolizumab 250mg every four weeks by i.v.
Aktywny komparator: Mepolizumab 75mg
Mepolizumab 75mcg i.v. every 4 weeks
Biologiczny: Mepolizumab 75
Mepolizumab 75mg every four weeks by i.v.
Komparator placebo: Placebo
Placebo saline every 4 weeks i.v.
Lek: Placebo saline
Placebo saline every four weeks by i.v.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Clinically Significant Exacerbations of Asthma Per Year
Ramy czasowe: From randomization (Week 0) to Week 52 or early withdrawal (EW)
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable
From randomization (Week 0) to Week 52 or early withdrawal (EW)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit
Ramy czasowe: From randomization (Week 0) to Week 52 or EW
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
From randomization (Week 0) to Week 52 or EW
Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year
Ramy czasowe: From randomization (Week 0) to Week 52 or EW
The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.
From randomization (Week 0) to Week 52 or EW
Time to First Exacerbation Requiring Hospitalization or ED Visit
Ramy czasowe: From randomization (Week 0) to Week 52 or EW
Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).
From randomization (Week 0) to Week 52 or EW
Number of All Recorded Exacerbations Per Year
Ramy czasowe: From randomization (Week 0) to Week 52 or EW
Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.
From randomization (Week 0) to Week 52 or EW
Time to First All Recorded Exacerbation
Ramy czasowe: From randomization (Week 0) to Week 52 or EW
All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).
From randomization (Week 0) to Week 52 or EW
Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period
Ramy czasowe: From Baseline up to Week 52 or EW
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.
From Baseline up to Week 52 or EW
Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period
Ramy czasowe: From Baseline up to Week 52 or EW
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment
From Baseline up to Week 52 or EW
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period
Ramy czasowe: From Baseline up to Week 52 or EW
The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.
From Baseline up to Week 52 or EW

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

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

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2009

Zakończenie podstawowe (Rzeczywisty)

23 marca 2012

Ukończenie studiów (Rzeczywisty)

23 marca 2012

Daty rejestracji na studia

Pierwszy przesłany

22 października 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 października 2009

Pierwszy wysłany (Oszacować)

23 października 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 stycznia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 stycznia 2018

Ostatnia weryfikacja

1 stycznia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 112997

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Badanie danych/dokumentów

  1. Formularz zgłoszenia przypadku z adnotacjami
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formularz świadomej zgody
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Plan analizy statystycznej
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Protokół badania
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Specyfikacja zestawu danych
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  7. Raport z badania klinicznego
    Identyfikator informacji: 112997
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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