Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

keskiviikko 30. marraskuuta 2016 päivittänyt: AstraZeneca

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

2508

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Argentiina
      • Buenos Aires, Argentiina
        • Research Site
      • Caba, Argentiina
        • Research Site
      • Ciudad Autónoma de Bs. As., Argentiina
        • Research Site
      • Ciudad de Buenos Aires, Argentiina
        • Research Site
      • Concepción del Uruguay, Argentiina
        • Research Site
      • Corrientes, Argentiina
        • Research Site
      • Córdoba, Argentiina
        • Research Site
      • Florida, Argentiina
        • Research Site
      • Godoy Cruz, Argentiina
        • Research Site
      • La Plata, Argentiina
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      • Mar del Plata, Argentiina
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      • Mendoza, Argentiina
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      • Ranelagh, Argentiina
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      • Rosario, Argentiina
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      • San Miguel de Tucuman, Argentiina
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  • Chile
      • Concepcion, Chile
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      • Quillota, Chile
        • Research Site
      • Santiago, Chile
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      • Talcahuano, Chile
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  • Filippiinit
      • Iloilo City, Filippiinit
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      • Quezon City, Filippiinit
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  • Japani
      • Asahi-shi, Japani
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      • Chiyoda-ku, Japani
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      • Chuo-ku, Japani
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      • Fukuoka-shi, Japani
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      • Itabashi-ku, Japani
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      • Sagamihara-shi, Japani
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      • Sakaide-shi, Japani
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      • Sapporo-shi, Japani
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      • Sendai-shi, Japani
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      • Setagaya-ku, Japani
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      • Takamatsu-shi, Japani
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      • Toshima-ku, Japani
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      • Tsukubo-gun, Japani
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      • Yokohama-shi, Japani
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  • Kanada
      • Quebec, Kanada
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    • Alberta
      • Calgary, Alberta, Kanada
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      • Sherwood Park, Alberta, Kanada
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    • British Columbia
      • Vancouver, British Columbia, Kanada
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      • Moncton, New Brunswick, Kanada
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    • Ontario
      • Burlington, Ontario, Kanada
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    • Quebec
      • Montreal, Quebec, Kanada
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      • St Charles Borromee, Quebec, Kanada
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  • Puola
      • Aleksandrów Łódzki, Puola
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      • Białystok, Puola
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      • Bielsko Biala, Puola
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      • Bydgoszcz, Puola
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      • Bystra Śląska, Puola
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      • Gdańsk, Puola
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      • Gorzów Wlkp, Puola
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      • Karczew, Puola
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      • Katowice, Puola
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      • Koszalin, Puola
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      • Kraków, Puola
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      • Lubin, Puola
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      • Lublin, Puola
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      • Ostrów Wielkopolski, Puola
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      • Poznań, Puola
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      • Ruda Slaska, Puola
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      • Rzeszów, Puola
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      • Skierniewice, Puola
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      • Szczecin, Puola
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      • Tarnów, Puola
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      • Toruń, Puola
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      • Trzebnica, Puola
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      • Warszawa, Puola
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      • Wieluń, Puola
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      • Wroclaw, Puola
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      • Wrocław, Puola
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      • Zabrze, Puola
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      • Łódź, Puola
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      • Łęczna, Puola
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      • Żnin, Puola
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  • Romania
      • Bragadiru, Romania
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      • Brasov, Romania
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      • Bucharest, Romania
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      • Constanta, Romania
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      • Deva, Romania
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      • Iasi, Romania
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      • Timisoara, Romania
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  • Ruotsi
      • Goteborg, Ruotsi
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      • Luleå, Ruotsi
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      • Lund, Ruotsi
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  • Saksa
      • Aschaffenburg, Saksa
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      • Bamberg, Saksa
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      • Berlin, Saksa
        • Research Site
      • Bonn, Saksa
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      • Frankfurt, Saksa
        • Research Site
      • Frankfurt/Main, Saksa
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      • Geesthacht, Saksa
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      • Gelsenkirchen, Saksa
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      • Hamburg, Saksa
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      • Hannover, Saksa
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      • Herford, Saksa
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      • Leipzig, Saksa
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      • Mainz, Saksa
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      • München, Saksa
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      • Neu-Isenburg, Saksa
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      • Rostock, Saksa
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      • Rüdersdorf, Saksa
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      • Witten, Saksa
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  • Ukraina
      • Chernivtsi, Ukraina
        • Research Site
      • Dnipropetrovsk, Ukraina
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      • Ivano-Frankivsk, Ukraina
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      • Kharkiv, Ukraina
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      • Kyiv, Ukraina
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      • Lutsk, Ukraina
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      • Mykolayiv, Ukraina
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      • Uzhgorod, Ukraina
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      • Vinnytsia, Ukraina
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      • Vinnytsya, Ukraina
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      • Zaporizhzhia, Ukraina
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      • Zaporozhye, Ukraina
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  • Yhdysvallat
    • Alabama
      • Andalusia, Alabama, Yhdysvallat
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      • Birmingham, Alabama, Yhdysvallat
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    • Arizona
      • Flagstaff, Arizona, Yhdysvallat
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      • Glendale, Arizona, Yhdysvallat
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      • Phoenix, Arizona, Yhdysvallat
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      • Tucson, Arizona, Yhdysvallat
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    • California
      • Alhambra, California, Yhdysvallat
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      • Anaheim, California, Yhdysvallat
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      • Beverly Hills, California, Yhdysvallat
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      • Garden Grove, California, Yhdysvallat
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      • Lakewood, California, Yhdysvallat
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      • North Hollywood, California, Yhdysvallat
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      • Northridge, California, Yhdysvallat
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      • Palmdale, California, Yhdysvallat
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      • Rancho Mirage, California, Yhdysvallat
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      • Redondo Beach, California, Yhdysvallat
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      • Rolling Hills Estate, California, Yhdysvallat
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      • Sacramento, California, Yhdysvallat
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      • Stockton, California, Yhdysvallat
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      • Thousand Oaks, California, Yhdysvallat
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      • Upland, California, Yhdysvallat
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      • Ventura, California, Yhdysvallat
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      • Walnut Creek, California, Yhdysvallat
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      • Westminister, California, Yhdysvallat
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      • Woodland, California, Yhdysvallat
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    • Colorado
      • Centennial, Colorado, Yhdysvallat
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      • Colorado Springs, Colorado, Yhdysvallat
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      • Wheat Ridge, Colorado, Yhdysvallat
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    • Florida
      • Celebration, Florida, Yhdysvallat
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      • Fort Lauderdale, Florida, Yhdysvallat
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      • Hialeah, Florida, Yhdysvallat
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      • Homestead, Florida, Yhdysvallat
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      • Jacksonville, Florida, Yhdysvallat
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      • Lehigh Acres, Florida, Yhdysvallat
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      • Miami, Florida, Yhdysvallat
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      • Ocala, Florida, Yhdysvallat
        • Research Site
      • Orlando, Florida, Yhdysvallat
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      • Ormond Beach, Florida, Yhdysvallat
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      • Virginia Gardens, Florida, Yhdysvallat
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    • Georgia
      • Gainesville, Georgia, Yhdysvallat
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      • Smyrna, Georgia, Yhdysvallat
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    • Idaho
      • Eagle, Idaho, Yhdysvallat
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    • Illinois
      • Shiloh, Illinois, Yhdysvallat
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    • Kansas
      • Lenexa, Kansas, Yhdysvallat
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    • Kentucky
      • Fort Mitchell, Kentucky, Yhdysvallat
        • Research Site
    • Louisiana
      • Covington, Louisiana, Yhdysvallat
        • Research Site
    • Maine
      • Bangor, Maine, Yhdysvallat
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, Yhdysvallat
        • Research Site
      • Flint, Michigan, Yhdysvallat
        • Research Site
      • Traverse City, Michigan, Yhdysvallat
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    • Minnesota
      • Minneapolis, Minnesota, Yhdysvallat
        • Research Site
    • Missouri
      • St Louis, Missouri, Yhdysvallat
        • Research Site
    • Nevada
      • Las Vagas, Nevada, Yhdysvallat
        • Research Site
    • New Jersey
      • Union, New Jersey, Yhdysvallat
        • Research Site
    • New York
      • Bronx, New York, Yhdysvallat
        • Research Site
    • North Carolina
      • Durham, North Carolina, Yhdysvallat
        • Research Site
      • Wilmington, North Carolina, Yhdysvallat
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Yhdysvallat
        • Research Site
      • Columbus, Ohio, Yhdysvallat
        • Research Site
      • Dayton, Ohio, Yhdysvallat
        • Research Site
      • Middleburg Heights, Ohio, Yhdysvallat
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat
        • Research Site
    • Oregon
      • Corvallis, Oregon, Yhdysvallat
        • Research Site
      • Portland, Oregon, Yhdysvallat
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, Yhdysvallat
        • Research Site
      • Pittsburgh, Pennsylvania, Yhdysvallat
        • Research Site
    • South Carolina
      • Indian Land, South Carolina, Yhdysvallat
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, Yhdysvallat
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, Yhdysvallat
        • Research Site
    • Texas
      • Arlington, Texas, Yhdysvallat
        • Research Site
      • Austin, Texas, Yhdysvallat
        • Research Site
      • Boerne, Texas, Yhdysvallat
        • Research Site
      • Dallas, Texas, Yhdysvallat
        • Research Site
      • Houston, Texas, Yhdysvallat
        • Research Site
      • San Antonio, Texas, Yhdysvallat
        • Research Site
    • Utah
      • Midvale, Utah, Yhdysvallat
        • Research Site
      • Murray, Utah, Yhdysvallat
        • Research Site
    • Virginia
      • Fairfax, Virginia, Yhdysvallat
        • Research Site
      • Falls Church, Virginia, Yhdysvallat
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, Yhdysvallat
        • Research Site
      • Milwaukee, Wisconsin, Yhdysvallat
        • Research Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta - 75 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
  4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Exclusion criteria:

  1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)

  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the patient throughout the study
    • Influence the findings of the studies or their interpretations
    • Impede the patient's ability to complete the entire duration of study
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
  4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kolminkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Benralitsumabi 30 mg q.4 viikkoa
Benralitsumabi annetaan ihon alle 4 viikon välein
Biologinen: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Kokeellinen: Benralitsumabi 30 mg q.8 viikkoa
Benralitsumabi annetaan ihon alle 8 viikon välein
Biologinen: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo Comparator: Plasebo
Plaseboa ihon alle
Biologinen: Placebo
Placebo subcutaneously on study week 0 until study week 52 inclusive.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Change in Asthma Rescue Medication Use
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Immediately following the first administration of study drug through Study Week 56.
Home Lung Function Assessments Based on PEF
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
Immediately following the first administration of study drug through Study Week 56.
Proportion of Nights With Awakening Due to Asthma
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Number of Patients With >=1 Asthma Exacerbation
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Time to First Asthma Exacerbation
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56.
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
Immediately following the first administration of study drug through Study Week 56.
Pharmacokinetics of Benralizumab
Aikaikkuna: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Mean PK Concentration at each visit
Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Immunogenicity of Benralizumab
Aikaikkuna: Pre-treatment until end of follow-up
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Pre-treatment until end of follow-up
Extent of Exposure
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
Extent of exposure is defined as the duration of treatment in days
Immediately following the first administration of study drug through Study Week 56
Mean Change From Baseline to Week 56 in AQLQ(S)+12
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.
Immediately following the first administration of study drug through Study Week 56
Change From Baseline to Week 56 in EQ-5D-5L VAS
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
Immediately following the first administration of study drug through Study Week 56
Mean Work Productivity Loss Due to Asthma
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.
Immediately following the first administration of study drug through Study Week 56
Mean Productivity Loss Due to Asthma in Classroom
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.
Immediately following the first administration of study drug through Study Week 56
Number of Participants That Utilized Health Care Resources
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Patient and Clinician Assessment of Response to Treatment
Aikaikkuna: Immediately following the first administration of study drug through Study Week 56
CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
Immediately following the first administration of study drug through Study Week 56

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AstraZeneca

Tutkijat

  • Päätutkija: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Torstai 1. elokuuta 2013

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. maaliskuuta 2016

Opintojen valmistuminen (Todellinen)

Tiistai 1. maaliskuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 31. heinäkuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 31. heinäkuuta 2013

Ensimmäinen Lähetetty (Arvio)

Perjantai 2. elokuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Keskiviikko 25. tammikuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 30. marraskuuta 2016

Viimeksi vahvistettu

Tiistai 1. marraskuuta 2016

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • D3250C00018

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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