A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
Двойное слепое рандомизированное плацебо-контролируемое исследование, оценивающее эффективность и безопасность нерандомиласта в течение 26 недель у пациентов с системными аутоиммунными ревматическими заболеваниями, связанными с интерстициальными заболеваниями легких (SARD)
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease.
Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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New South Wales
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Camperdown, Sydney, New South Wales, Австралия, 2050
- Royal Prince Alfred Hospital
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Darlinghurst, New South Wales, Австралия, 2010
- St Vincent's Hospital Sydney
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Queensland
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Chermside, Queensland, Австралия, 4032
- The Prince Charles Hospital
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Victoria
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Heidelberg, Victoria, Австралия, 3084
- Austin Hospital
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Western Australia
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Murdoch, Western Australia, Австралия, 6150
- Fiona Stanley Hospital
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Krems, Австрия, 3500
- Krems University Hospital
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Wels, Австрия, 4600
- Klinikum Wels - Grieskirchen GmbH
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Berlin, Германия, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, Германия, 13125
- Immanuel-Krankenhaus GmbH
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Bonn, Германия, 53127
- Universitätsklinikum Bonn AöR
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Braunschweig, Германия, 38126
- Städtisches Klinikum Braunschweig gGmbH
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Bremen, Германия, 28325
- Gesundheit Nord gGmbH | Klinikverbund Bremen
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Cologne, Германия, 51149
- Krankenhaus Porz am Rhein gGmbH
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Düsseldorf, Германия, 40225
- Universitätsklinikum Düsseldorf
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Essen, Германия, 45239
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Freiburg im Breisgau, Германия, 79106
- Universitätsklinikum Freiburg
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Gommern, Германия, 39245
- Helios Fachklinik Vogelsang-Gommern GmbH
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Hanover, Германия, 30625
- Medizinische Hochschule Hannover
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Herne, Германия, 44649
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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Kirchheim unter Teck, Германия, 73230
- medius Kliniken gGmbH
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Konstanz, Германия, 78464
- Klinikum Konstanz
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Lübeck, Германия, 23538
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Minden, Германия, 32429
- Johannes Wesling Klinikum Minden
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München, Германия, 80336
- Klinikum der Universität München AÖR
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Regensburg, Германия, 93049
- Krankenhaus Barmherzige Brüder Regensburg
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Barcelona, Испания, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Испания, 08026
- Hospital Santa Creu i Sant Pau
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Bilbao, Испания, 48013
- Hospital de Basurto
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Córdoba, Испания, 14004
- Hospital Universitario Reina Sofía
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Huelva, Испания, 21005
- Hospital Juan Ramón Jimenez
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L'Hospitalet de Llobregat, Испания, 08907
- Hospital Universitari de Bellvitge
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Madrid, Испания, 28040
- Fundación Jiménez Díaz
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Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Испания, 28034
- Hospital Universitario Ramon Y Cajal
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Santiago de Compostela, Испания, 15706
- Hospital Clínico de Santiago
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Seville, Испания, 41009
- Hospital Universitario Virgen De La Macarena
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Seville, Испания, 41013
- Hospital Virgen del Rocio
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Valencia, Испания, 46017
- Hospital Dr. Peset
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Vigo, Испания, 36312
- Complejo Hospitalario Universitario de Vigo
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Brescia, Италия, 25123
- ASST degli Spedali Civili di Brescia
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Florence, Италия, 50134
- A. O. Universitaria Careggi
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Milan, Италия, 20132
- Ospedale San Raffaele S.r.l.
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Milan, Италия, 20122
- Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
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Padova, Италия, 35128
- Azienda Ospedaliera Universitaria di Padova
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Pavia, Италия, 27100
- Fondazione IRCCS Policlinico S. Matteo
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Roma, Италия, 00161
- AOU Policlinico Umberto I
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Beijing, Китай, 100730
- Peking Union Medical College Hospital
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Beijing, Китай, 100020
- Beijing Chao-Yang Hospital
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Beijing, Китай, 100029
- China-Japan Friendship Hospital
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Chengdu, Китай, 610041
- West China Hospital, Sichuan University
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Chengdu, Китай, 610072
- Sichuan Provincial People's Hospital
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Guangzhou, Китай, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, Китай, 310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Китай, 310003
- The First Affiliated Hospital, Zhejiang University
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Luoyang, Китай, 471000
- The First Affiliated Hospital of Henan University of Science and Technology
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Macau, Китай, 999078
- University Hospital_Macau University of Science and Technology
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Nanchang, Китай, 330006
- The First Affiliated Hospital of Nanchang University
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Shanghai, Китай, 200040
- Huashan Hospital, Fudan University
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Tianjin, Китай, 30052
- Tianjin Medical University General Hospital
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Wuhan, Китай, 430030
- Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
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Wuhan, Китай, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xiamen, Китай, 361003
- First Affiliated Hospital of Xiamen University
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Zhuzhou, Китай, 412007
- Zhuzhou Central Hospital
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Chihuahua City, Мексика, 31020
- Investigacion y Biomedicina de Chihuahua S.C.
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Guadalajara, Мексика, 44160
- Centro Integral en Reumatologia, SA. de CV.
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Mexico City, Мексика, 14080
- Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City, Мексика, 03650
- Soltmed Smo
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Mexico City, Мексика, 06700
- CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
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Monterrey, Мексика, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Mérida, Мексика, 97070
- Medical Care & Research SA de CV
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Heerlen, Нидерланды, 6419 PC
- Zuyderland Medisch Centrum
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Nieuwegein, Нидерланды, 3435 CM
- St. Antonius Ziekenhuis
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Rotterdam, Нидерланды, 3015
- Erasmus Medisch Centrum-ROTTERDAM-50697
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Nordbyhagen, Норвегия, 1478
- Akershus Universitetssykehus HF
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Skien, Норвегия, N-3710
- Sykehuset Telemark HF, Avd. Skien
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San Juan, Пуэрто-Рико, 00917
- GCM Medical Group, PSC
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Antrim, Соединенное Королевство, BT41 2RL
- Antrim Area Hospital
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Bath, Соединенное Королевство, BA1 3NG
- Royal United Hospital, Bath
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Birmingham, Соединенное Королевство, B9 5SS
- Heartlands Hospital
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Leeds, Соединенное Королевство, LS7 4SA
- Chapel Allerton Hospital
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London, Соединенное Королевство, NW3 2QG
- Royal Free Hospital
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London, Соединенное Королевство, SW17 0QT
- St George's Hospital
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London, Соединенное Королевство, WC1E 6BT
- University College Hospital
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Londonderry, Соединенное Королевство, BT47 6SB
- Altnagelvin Area Hospital
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Luton, Соединенное Королевство, LU4 8RB
- Luton & Dunstable University Hospital
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Preston, Соединенное Королевство, PR2 9HT
- NIHR Lancashire Clinical Research Facility
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Sheffield, Соединенное Королевство, S5 7AU
- Northern General Hospital
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Truro, Соединенное Королевство, TR1 3LJ
- Royal Cornwall Hospital
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Westcliffe-on-Sea, Соединенное Королевство, SS0 0RY
- Southend University Hospital
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35205
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Соединенные Штаты, 85259
- Mayo Clinic-Arizona
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California
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Los Angeles, California, Соединенные Штаты, 90095
- University of California Los Angeles
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San Diego, California, Соединенные Штаты, 92108
- Paradigm Clinical Research - San Diego
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Colorado
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Denver, Colorado, Соединенные Штаты, 80206
- National Jewish Health
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06510
- Yale University School of Medicine
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Florida
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Brandon, Florida, Соединенные Штаты, 33511
- Meris Clinical Research-Brandon-69466
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Miami, Florida, Соединенные Штаты, 33125
- Miami VA Healthcare System
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30309
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
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Augusta, Georgia, Соединенные Штаты, 30912
- Augusta University
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611
- Northwestern University
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Chicago, Illinois, Соединенные Штаты, 60637
- The University of Chicago Medical Center
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Evanston, Illinois, Соединенные Штаты, 60201
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 66160
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Соединенные Штаты, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55455
- University of Minnesota
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Rochester, Minnesota, Соединенные Штаты, 55902
- Mayo Clinic, Rochester
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Nebraska
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Omaha, Nebraska, Соединенные Штаты, 68198-1230
- University of Nebraska Medical Center
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New York
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Great Neck, New York, Соединенные Штаты, 11021
- Northwell Health
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New York, New York, Соединенные Штаты, 10017
- NYU Langone Health
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New York, New York, Соединенные Штаты, 10032
- New York Presbyterian Hospital -Columbia University
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North Carolina
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Salisbury, North Carolina, Соединенные Штаты, 28144
- Onsite Clinical Solutions
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Southeastern Research Center-Winston Salem-69289
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19140
- Temple Lung Center
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- The University of Texas Health Science Center at Houston
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San Antonio, Texas, Соединенные Штаты, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84108
- University of Utah Health Sciences Center
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West Virginia
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Beckley, West Virginia, Соединенные Штаты, 25801
- Rheumatology and Pulmonary Clinic
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53792
- University of Wisconsin
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Angers, Франция, 49933
- HOP d'Angers
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Bordeaux, Франция, 33076
- HOP Pellegrin
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Lille, Франция, 59037
- Hôpital Claude Huriez
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Paris, Франция, 75014
- Hôpital Cochin
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Paris, Франция, 75018
- HOP Bichat
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Rennes, Франция, 35203
- HOP Sud
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Strasbourg, Франция, 67091
- HOP Civil
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Toulouse, Франция, 31059
- Hôpital Rangueil - CHU de Toulouse
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Aarau, Швейцария, CH-5001
- Cantonal Hospital of Aarau
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Basel, Швейцария, 4031
- Universitätsspital Basel
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Geneva, Швейцария, 1205
- Hopitaux Universitaires de Geneve (HUG)
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Neuchâtel, Швейцария, 2000
- Neuchatel Hospital Network
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Sankt Gallen, Швейцария, 9007
- Kantonsspital St.Gallen
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Zurich, Швейцария, 8091
- University Hospital Zurich
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Seongnam, Южная Корея, 13620
- Seoul National University Bundang Hospital
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Seoul, Южная Корея, 03080
- Seoul National University Hospital
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Seoul, Южная Корея, 04401
- Soonchunhyang University Hospital Seoul
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Seoul, Южная Корея, 02447
- Kyung Hee University Hospital
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Aichi, Toyoake, Япония, 470-1192
- Fujita Health University Hospital
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Fukuoka, Kitakyushu, Япония, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Hiroshima, Hiroshima, Япония, 734-8551
- Hiroshima University Hospital
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Hokkaido, Sapporo, Япония, 060-8543
- Sapporo Medical University Hospital
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Hokkaido, Sapporo, Япония, 060-8648
- Hokkaido University Hospital
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Kagawa, Kita-gun, Япония, 761-0793
- Kagawa University Hospital
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Kanagawa, Kawasaki, Япония, 216-8511
- St. Marianna University Hospital
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Kanagawa, Sagamihara, Япония, 252-0375
- Kitasato University Hospital
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Kyoto, Kyoto, Япония, 606-8507
- Kyoto University Hospital
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Nagasaki, Nagasaki, Япония, 852-8501
- Nagasaki University Hospital
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Osaka, Takatsuki, Япония, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Saitama, Iruma-gun, Япония, 350-0495
- Saitama Medical University Hospital
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Tokyo, Bunkyo-Ku, Япония, 113-8431
- Juntendo University Hospital
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Tokyo, Bunkyo-ku, Япония, 113-8603
- Nippon Medical School Hospital
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Tokyo, Shinjuku-ku, Япония, 160-8582
- Keio University Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
- Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
- Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent >10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review
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No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
- No improvement in absolute forced vital capacity (FVC) % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted >5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
- No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)
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FVC ≥45% of predicted normal at Visit 1
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Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1
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Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:
- If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
- If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2
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If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
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In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned
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Further inclusion criteria apply
Exclusion Criteria:
- Organising pneumonia as predominant pattern in the HRCT
- Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1
- Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
- Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
- Any suicidal behaviour in the past 2 years
- Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
- Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
- Further exclusion criteria apply
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast. |
Nerandomilast
Другие имена:
|
|
Плацебо Компаратор: Placebo
Participants with SARD-ILDs will receive placebo. |
Placebo matching nerandomilast |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
Временное ограничение: At baseline and at Week 26
|
QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD [%] is the QILD volume [mL] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease. |
At baseline and at Week 26
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Абсолютное изменение от исходного уровня в сосудисто -объеме [%] на HRCT на 26 неделе
Временное ограничение: На базовом уровне и на 26 неделе
|
На базовом уровне и на 26 неделе
|
|
|
Абсолютное изменение от исходного уровня в дополнительном использовании кислорода во всем исследовании для пользователей кислорода на исходном уровне
Временное ограничение: На исходном уровне и на 52 неделе
|
На исходном уровне и на 52 неделе
|
|
|
Время до первого дополнительного использования кислорода во время исследования для не пользователей кислорода на исходном уровне
Временное ограничение: До 52 недели
|
До 52 недели
|
|
|
Появление нежелательных явлений, связанных с инфекцией (AES) из исходного уровня в течение длительности испытания
Временное ограничение: До 1 года
|
До 1 года
|
|
|
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
Временное ограничение: At baseline and at Week 26
|
QLF will be assessed via qHRCT. QLF are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD [%] is the QILD volume [mL] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease. |
At baseline and at Week 26
|
|
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
Временное ограничение: At baseline and at Week 26
|
QGGO will be assessed via qHRCT. QGGO are quantitative measures of different radiological patterns associated with lung fibrosis. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. A higher QGGO percentage or volume indicates a higher extent of disease. |
At baseline and at Week 26
|
|
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
Временное ограничение: At baseline and at Week 26
|
FVC will be assessed using standardised spirometry equipment which will be provided centrally with supplies of precalibrated disposable flow sensors. Spirometry will be conducted with the participant in a seated position. It is preferable that the same trained individual (i.e. PFT specialist or pulmonologist) performs the PFTs for a given participant. The best of 3 efforts will be defined as the highest FVC obtained on any of three blows meeting the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (with a maximum of eight attempts). Predicted normal values will be calculated according to global lung function initiative (GLI). |
At baseline and at Week 26
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1305-0046
- U1111-1305-5857 (Идентификатор реестра: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-512849-17-00 (Идентификатор реестра: CTIS (EU))
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Once the criteria in section "time frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Сроки обмена IPD
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Критерии совместного доступа к IPD
For study documents -upon signing of a "Document Sharing Agreement". For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .