A Study to Test Whether BI 1819479 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Last updated: April 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

2

Condition

Pulmonary Fibrosis

Cystic Fibrosis

Lung Injury

Treatment

Placebo matching BI 1819479

BI 1819479

Clinical Study ID

NCT06335303
1462-0004
U1111-1302-4283
2023-508395-11-00
  • Ages > 40
  • All Genders

Study Summary

This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study.

Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff.

At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients ≥40 years old at the time of signed informed consent.

  2. Signed and dated written informed consent in accordance with ICH-GCP and locallegislation prior to admission to the trial.

  3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)

  4. On stable treatment with nintedanib or pirfenidone for at least 12 weeks or not ontreatment with either nintedanib or pirfenidone for at least 12 weeks

  5. Forced Vital Capacity (FVC) ≥45% of predicted normal.

  6. Diffusion capacity of the lung for carbon monoxide (DLCO) ≥25% of predicted normalcorrected for hemoglobin (Hb).

  7. Women of childbearing potential (WOCBP) must use highly effective methods of birthcontrol with low user dependency and additional barrier contraception for malepartners (use of condom) until end of follow-up period.

  8. Male trial participants with WOCBP partners must use contraception (condom) to avoidexposure via seminal fluid. Female partners of male trial participants must usehighly effective methods of contraception during treatment until end of follow-upperiod.

Exclusion

Exclusion Criteria:

  1. Acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within at least 12 weeksprior to screening and/or during the screening period (investigator-determined).

  2. Treated with immunosuppressive medications (other than oral corticosteroids) orprednisone >15 mg/day or equivalent for respiratory or pulmonary reasons.

  3. Patients who must or wish to continue the intake of restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.

  4. The patient is currently enrolled in another investigational device or drug trial,or their Visit 1 occurs less than 30 days or 5 half-lives (whichever is longer)after completing a previous investigational device or drug trial or receiving otherinvestigational treatments.

  5. Patients with a significant disease or condition other than the IPF under study,which in the opinion of the investigator, may put the patient at risk because ofparticipation, interfere with trial procedures, or cause concern regarding thepatient's ability to participate in the trial or any medical condition which couldlead to a life expectancy <12 months.

  6. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1second (FEV1)/forced vital capacity (FVC) <0.7).

  7. In the opinion of the Investigator, other clinically significant pulmonaryabnormalities.

  8. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.

Further exclusion criteria apply.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo matching BI 1819479
Phase: 2
Study Start date:
September 05, 2024
Estimated Completion Date:
February 03, 2026

Connect with a study center

  • Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

    C.a.b.a, C1027AAP
    Argentina

    Active - Recruiting

  • CEDIC - Centro de Investigacion Clinica

    Caba, C1060ABN
    Argentina

    Active - Recruiting

  • Centro de Investigación Clinica Belgrano

    Caba, 1425
    Argentina

    Active - Recruiting

  • Hospital Britanico de Buenos Aires

    Caba, 1280AEB
    Argentina

    Active - Recruiting

  • Consultorios Médicos del Buen Ayre

    Capital Federal, 1425
    Argentina

    Active - Recruiting

  • Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Launceston Respiratory & Sleep Centre

    Launceston, Tasmania 7250
    Australia

    Site Not Available

  • Lung Research Victoria

    Footscray, Victoria 3011
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Institute for Respiratory Health

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Macquarie University

    Macquarie Park, 2109
    Australia

    Active - Recruiting

  • Medical University of Graz State Hospital - University Hospital Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Krems University Hospital

    Krems, 3500
    Austria

    Active - Recruiting

  • Hospital Elisabethinen Linz

    Linz,
    Austria

    Active - Recruiting

  • Kepler Univ. Klinikum Linz

    Linz, 4020
    Austria

    Site Not Available

  • Clinic Floridsdorf

    Vienna, 1210
    Austria

    Active - Recruiting

  • Klinik Penzing SMZ Baumgartner Hoehe

    Vienna, 1140
    Austria

    Active - Recruiting

  • Standort Penzing der Klinik Ottakring

    Vienna, 1140
    Austria

    Active - Recruiting

  • Klinikum Wels - Grieskirchen GmbH

    Wels, 4600
    Austria

    Active - Recruiting

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • Liège - HOSP CHR de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Serviços Medicos Respirar Sul Fluminense

    Barra Mansa, 27323240
    Brazil

    Active - Recruiting

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, 18618-687
    Brazil

    Site Not Available

  • Hospital das Clínicas da UFG - EBSERH

    Goiania, 74605-050
    Brazil

    Active - Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074
    Brazil

    Active - Recruiting

  • COE Sao Jose dos Campos

    SJC, 122241-660
    Brazil

    Site Not Available

  • Pesquisare

    Santo André, 09080-110
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz

    Sao Paulo, 01327-001
    Brazil

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Active - Recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 3A7
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2N2
    Canada

    Active - Recruiting

  • McGill University Health Centre (MUHC)

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Beijing Chao-Yang Hospital

    Beijing, 100020
    China

    Completed

  • The Second Xiangya Hospital Of Central South University

    Changsha, 410011
    China

    Site Not Available

  • People's Hospital of Sichuan Province

    Chengdu, 610072
    China

    Site Not Available

  • West China Hospital

    Chengdu, 610041
    China

    Site Not Available

  • First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120
    China

    Completed

  • Hangzhou First People's Hospital

    Hangzhou, 310006
    China

    Completed

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, 310016
    China

    Site Not Available

  • Zhejiang Hospital

    Hangzhou, 310013
    China

    Completed

  • Anhui Provincial Hospital

    Hefei, 230001
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, 210008
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, 200030
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, 200433
    China

    Site Not Available

  • China Shenyang Chest Hospital

    Shenyang, 110000
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 30052
    China

    Completed

  • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

    Wuhan, 430022
    China

    Site Not Available

  • Affiliated Hospital, Xuzhou Medical college

    Xuzhou, 221009
    China

    Site Not Available

  • Thomayer University Hospital

    Prague, 140 59
    Czechia

    Active - Recruiting

  • University Hospital Bulovka

    Prague, 18081
    Czechia

    Site Not Available

  • Rigshospitalet-København Ø-69883

    København Ø, 2100
    Denmark

    Active - Recruiting

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00029
    Finland

    Active - Recruiting

  • Oulun yliopistollinen keskussairaala

    Oulu, 90220
    Finland

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, 33520
    Finland

    Active - Recruiting

  • TYKS

    Turku, 20520
    Finland

    Active - Recruiting

  • HOP d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • HOP Avicenne

    Bobigny, 93000
    France

    Site Not Available

  • HOP Louis Pradel

    Bron, 69677
    France

    Active - Recruiting

  • HOP CHU Caen

    Caen, 14033
    France

    Active - Recruiting

  • HOP Côte de Nacre

    Caen, 14033
    France

    Active - Recruiting

  • INS Coeur Poumon

    Lille, 59037
    France

    Active - Recruiting

  • HOP Nord

    Marseille, 13915
    France

    Active - Recruiting

  • HOP Nord-Marseille-61673

    Marseille, 13915
    France

    Site Not Available

  • HOP Pasteur

    Nice, 06001
    France

    Active - Recruiting

  • HOP Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • HOP Charles Nicolle

    Rouen, 76031
    France

    Site Not Available

  • Pneumologische Praxis Dr. Löh

    Bad Homburg, 61350
    Germany

    Site Not Available

  • Charite Universitätsmedizin Berlin KöR

    Berlin, 10117
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Bonn AöR

    Bonn, 53127
    Germany

    Active - Recruiting

  • Caritas-Krankenhaus St. Maria gGmbH

    Donaustauf, 99093
    Germany

    Active - Recruiting

  • Klinikum Fulda gAG

    Fulda, 36043
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475
    Germany

    Active - Recruiting

  • Klinikum Region Hannover GmbH

    Hannover, 30459
    Germany

    Active - Recruiting

  • Lungenklinik Hemer

    Hemer, 58675
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Active - Recruiting

  • Klinikum Konstanz

    Konstanz, 78464
    Germany

    Active - Recruiting

  • Universität Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Klinikum der Universität München AÖR

    München, 81377
    Germany

    Active - Recruiting

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500
    Greece

    Site Not Available

  • Univ. Gen. Hosp. of Patras

    Patras, 26504
    Greece

    Site Not Available

  • Hospital of Heraklion (PAGNI)

    Voutes, 71500
    Greece

    Active - Recruiting

  • Koranyi National Institute For Pulmonolgy

    Budapest, 1121
    Hungary

    Site Not Available

  • University of Debrecen Clinical Centre

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • A. O. Universitaria Careggi

    Firenze, 50137
    Italy

    Active - Recruiting

  • Ospedale Colonnello D Avanzo

    Foggia, 71100
    Italy

    Site Not Available

  • Ospedale G.B. Morgagni

    Forli', 47121
    Italy

    Site Not Available

  • Ospedale G.B. Morgagni - L. Pierantoni AUSL Forlì

    Forli', 47121
    Italy

    Site Not Available

  • Azienda Ospedaliera San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • Osp. S. Giuseppe Fatebenefratelli

    Milano, 20123
    Italy

    Active - Recruiting

  • Ospedale Classificato San Giuseppe

    Milano, 20123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, 00168
    Italy

    Site Not Available

  • Pol. Universitario Tor Vergata

    Roma, 00133
    Italy

    Active - Recruiting

  • Poli Univ A. Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Tosei General Hospital

    Aichi, Seto, 489-8642
    Japan

    Site Not Available

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563
    Japan

    Active - Recruiting

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051
    Japan

    Active - Recruiting

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555
    Japan

    Active - Recruiting

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192
    Japan

    Active - Recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503
    Japan

    Active - Recruiting

  • Kyorin University Hospital

    Tokyo, Mitaka, 181-8611
    Japan

    Active - Recruiting

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-8541
    Japan

    Active - Recruiting

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655
    Japan

    Site Not Available

  • National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8655
    Japan

    Site Not Available

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon, 14647
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Inje University Sanggye Paik Hospital

    Seoul, 01757
    Korea, Republic of

    Completed

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401
    Korea, Republic of

    Active - Recruiting

  • Hospital Sultan Idris Shah Serdang

    Kajang, 43000
    Malaysia

    Site Not Available

  • Institut Perubatan Respiratori

    Kuala Lumpur, 53000
    Malaysia

    Active - Recruiting

  • Sarawak General Hospital

    Kuching, Sarawak, 93586
    Malaysia

    Site Not Available

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Active - Recruiting

  • Greenlane Clinical Centre

    One Tree Hill, Auckland, 1051
    New Zealand

    Active - Recruiting

  • Middlemore Clinical Trials

    Papatoetoe, 2025
    New Zealand

    Site Not Available

  • Haukeland Universitetssykehus

    Bergen, N-5021
    Norway

    Active - Recruiting

  • Akershus Universitetssykehus HF

    Lørenskog, 1478
    Norway

    Active - Recruiting

  • University Clinical Hospital in Bialystok I

    Bialystok, 15-540
    Poland

    Site Not Available

  • Norbert Barlicki University Clinical Hospital No.1, Lodz

    Lodz, 90-153
    Poland

    Site Not Available

  • Clin.Hosp.Med.Univ.Marcinkowski in Poznan

    Poznan, 60-569
    Poland

    Active - Recruiting

  • Alergopneuma Medical Center

    Swidnik, 21040
    Poland

    Active - Recruiting

  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

    Warsaw, 01-138
    Poland

    Site Not Available

  • Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa

    Warszawa, 01-138
    Poland

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Active - Recruiting

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de Galdakao

    Galdakao, 48960
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Active - Recruiting

  • Hospital Virgen de la Victoria

    Malaga, 29010
    Spain

    Active - Recruiting

  • Hospital Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37
    Sweden

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital(Linkou)

    TaoYuan, 333
    Taiwan

    Active - Recruiting

  • Chulalongkorn Hospital

    Bangkok, 10330
    Thailand

    Active - Recruiting

  • Songklanagarind Hospital

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Srinagarind Hospital

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • Ramathibodi Hospital

    Ratchathewi, 10400
    Thailand

    Active - Recruiting

  • Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • Castle Hill Hospital

    Cottingham, Hull, HU16 5JQ
    United Kingdom

    Active - Recruiting

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital, Wonford

    Exeter, EX2 5DW
    United Kingdom

    Active - Recruiting

  • Royal Lancaster Infirmary

    Lancaster, LA1 4RP
    United Kingdom

    Active - Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Active - Recruiting

  • Wythenshawe Hospital

    Manchester, M23 9LT
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, OX3 7LJ
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • The Medical Research Group

    Fresno, California 93720
    United States

    Site Not Available

  • Critical Care, Pulmonary and Sleep Associates

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • St. Francis Medical Institute

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Clinical Research Specialists LLC

    Kissimmee, Florida 34746
    United States

    Active - Recruiting

  • SEC Clinical Research

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The Iowa Clinic, PC

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Advanced Pulmonary Research

    Warren, Michigan 48088
    United States

    Active - Recruiting

  • Memorial Hospital Gulfport

    Gulfport, Mississippi 39501
    United States

    Active - Recruiting

  • Singing River Health

    Ocean Springs, Mississippi 39564
    United States

    Site Not Available

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Southeastern Research Center-Winston Salem-69289

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania 15801
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • University of Utah Health Sciences Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia 23230
    United States

    Site Not Available

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