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A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

Study Purpose

HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no. 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or <70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key Inclusion Criteria in Core Phase: 1. Male or female ≥18 years of age at Screening. 2. Current diagnosis of IPF, as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines and determined by central review; the date of initial diagnosis of IPF should be ≤7 years prior to Screening. 3. No recent changes or planned changes to the dose or regimen for IPF therapy, defined as:

  • - Receiving a stable dose of IPF-approved therapy (i.e., nintedanib or pirfenidone) for a minimum of 3 months prior to Day 1 with no plans to change the background regimen during trial participation, or.
  • - Not currently receiving background IPF-approved therapy at Screening (either naïve to IPF-approved therapy or previously discontinued any IPF-approved therapy at least 4 weeks prior to Day 1 or drug-specific, 5 half-lives elimination period if longer than 4 weeks), and with no current plans to restart treatment during trial participation.
  • - Participants receiving any additional agent for IPF therapy must be on a stable regimen for at least 3 months prior to Day 1 with no current plans to change the treatment regimen during trial participation.
Any previously discontinued therapy used to treat IPF must have been discontinued at least 4 weeks prior to Day 1 or 5 half-lives for that specific therapy must have elapsed, whichever is longer, with no plans to restart the therapy during trial participation. 4. Lung high-resolution computed tomography (HRCT) historically performed within 6 months prior to the Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on participant's HRCT. If an evaluable HRCT is not available within 6 months prior to Screening, an HRCT will be performed at Screening to determine eligibility, according to the same requirements as the historical HRCT. 5. HRCT shows ≥10% to <50% parenchymal fibrosis (reticulation) and the extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (central reviewer determined). 6. Meets all of the following criteria during the Screening Period: 1. FVC ≥45% predicted of normal. 2. forced expiratory volume in 1 second (FEV1)/FVC ≥0.7. 3. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin is ≥25% and ≤90% predicted of normal. 7. Estimated minimum life expectancy of ≥30 months for non-IPF-related disease, in the opinion of the Investigator. 8. Vaccinations are up to date given age, comorbidities and local availability prior to trial drug dosing. 9. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. Key Inclusion Criteria in Extension Phase: 1. Completed the Double-blind Treatment Period (Week 52) of the Core Phase of the trial; subjects prematurely discontinued from trial drug in the Core Phase of the trial for reasons other than safety or tolerability may be included at the discretion of the Investigator after completing scheduled visits, including Week 52 assessments. 2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the Extension Phase of the trial. Key Exclusion Criteria Core Phase: 1. Any of the following cardiovascular diseases: 1. uncontrolled, severe hypertension (≥160/100 mmHg), within 6 months of Screening. 2. myocardial infarction within 6 months of Screening. 3. unstable cardiac angina within 6 months of Screening. 2. Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 [COVID-19]), connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus, Sjogren's, dermatomyositis, scleroderma), exposures (e.g., radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone). 3. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed). The participant must be 3 months beyond any acute infection with COVID-19 if there has been a prior infection. 4. Clinically significant pulmonary hypertension requiring chronic medical therapy. 5. Use of any of the following therapies within 4 weeks prior to Screening, during the Screening Period or planned during the trial: prednisone at steady dose >10 mg/day or equivalent or cyclosporine. Change in regimen or dosage of any immunosuppressant during the Screening Period through the end of trial participation will require consultation with and approval by the trial Medical Monitor. 6. Use of rifampin within 2 weeks prior to Day 1 or planned during the trial. 7. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 8. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug. Females must refrain from egg/ova donation for 4 weeks after the last dose of trial drug and males must refrain from sperm donation for 3 months after the last dose of trial drug. 9. Pregnant or lactating women and women who plan to become pregnant or breast feed during the trial and within 4 weeks after the last dose of trial drug. 10. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject. 11. Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial. 12. Known history of positive test for human immunodeficiency virus (HIV). 13. Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody [anti-HBcAb] and negative hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus [anti-HCV] and positive RNA HCV). 14. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis. 15. Previous organ transplant (including allogeneic and autologous marrow transplant). 16. International normalized ratio >2, prolonged prothrombin time >1.5 × the upper limit of normal (ULN) or partial thromboplastin time >1.5 × ULN at Screening. 17. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 × ULN. 18. Estimated glomerular filtration rate <30 mL/min/1.73 m^2 at Screening. 19. Total bilirubin >1.5 × ULN. Subjects with documented diagnosis of Gilbert's syndrome may be enrolled if their total bilirubin is ≤3.0 mg/dL. 20. Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment according to the Child-Pugh scoring system. 21. Any confirmed Grade 3 or higher laboratory abnormality. 22. Any laboratory abnormality at Screening that, in the opinion of the Investigator, would preclude the participant's entry in the trial. 23. Exposure to an experimental drug (with the exception of HZN-825) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is the longest, prior to Day 1. 24. Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial. Key Exclusion Criteria Extension Phase: 1. Anticipated use of another investigational agent for any condition during the course of the trial. 2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-303 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. Estimated minimum life expectancy ≤18 months, in the opinion of the Investigator.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05032066
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Horizon Therapeutics Ireland DAC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brajesh K Pandey, MD
Principal Investigator Affiliation Horizon Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Canada, Chile, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Part 1 (Core Phase) The overall objective of the Core Phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1), administered orally once daily (QD) or twice daily (BID) for 52 weeks in the treatment of participants with IPF. Part 2 (Extension Phase) The overall objective of the Extension Phase is to investigate the long-term efficacy, safety and tolerability of HZN-825, a selective antagonist of LPAR1, administered at a dose of 300 mg BID orally to participants with IPF in a 52-week open-label extension (OLE) following completion of the Core Phase of the trial. The dose for the Extension Phase may be modified based on the results of the Core Phase. Two types of Baseline are defined for the Extension Phase:

  • - OLE Baseline, defined as the latest measurement prior to the first dose of HZN-825 in the Extension Phase.
  • - HZN-825 Baseline, defined as the latest measurement prior to the first dose of HZN-825 in either the Core Phase or the Extension Phase.
For subjects who received placebo in the Core Phase, OLE Baseline will be the same as HZN-825 Baseline.

Arms & Interventions

Arms

Experimental: HZN-825 300 mg once daily (QD)

Two 150 mg oral tablets given in the morning with a meal and two matching placebo tablets given in the evening with a meal; total daily dose 300 mg HZN-825.

Experimental: HZN-825-300 mg twice daily (BID)

Two 150 mg oral tablets given in the morning with a meal and two 150 mg oral tablets given in the evening with a meal; total daily dose 600 mg HZN-825.

Placebo Comparator: Placebo BID

Matching placebo tablets (2) given in the morning with a meal and matching placebo tablets (2) given in the evening with a meal; total dose 4 placebo tablets.

Interventions

Drug: - HZN-825

Core Phase: Participants will receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally in the morning and evening with a meal for 52 weeks according to randomization schema. Extension Phase: Participants will receive open-label HZN-825 150 mg orally in the morning and evening with a meal for 52 weeks.

Drug: - Placebo

Core Phase: Participants will receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally in the morning and evening with a meal for 52 weeks according to randomization schema. Extension Phase: Participants who received matching placebo in the Core Phase will receive open-label HZN-825 150 mg orally in the morning and evening with a meal for 52 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Site Contact

Brittany Harrison

bnrouse@uabmc.edu

205-934-4440

Palmtree Clinical Research, Palm Springs, California

Status

Recruiting

Address

Palmtree Clinical Research

Palm Springs, California, 92262

Site Contact

Daniel Rangel

drangel@palmtreeclinical.com

760-778-7799

St. Francis Medical Institute, Clearwater, Florida

Status

Completed

Address

St. Francis Medical Institute

Clearwater, Florida, 33765

Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida

Status

Withdrawn

Address

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, 33470

Central Florida Pulmonary Group PA, Orlando, Florida

Status

Recruiting

Address

Central Florida Pulmonary Group PA

Orlando, Florida, 32803

Site Contact

Kathleen Summo

ksummo@cfpulmonary.com

407-841-1100 #225

DBC Research Corp., Tamarac, Florida

Status

Recruiting

Address

DBC Research Corp.

Tamarac, Florida, 33321

Site Contact

Matthew Apelbaum

mapelbaum@dbcresearch.com

954-537-2100

GCP Clinical Research, Tampa, Florida

Status

Recruiting

Address

GCP Clinical Research

Tampa, Florida, 33609

Site Contact

Neelima Nambiar

NeelimaN@gcpclinicalresearch.com

813-240-9734

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Chelsey Aulukh

ckirtley@kumc.edu

913-588-2812

Nebraska Pulmonary Specialties LLC, Lincoln, Nebraska

Status

Completed

Address

Nebraska Pulmonary Specialties LLC

Lincoln, Nebraska, 68510

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756-1000

Site Contact

Laurie Stadler

laurie.p.stadler@hitchcock.org

603-650-3334

Commack, New York

Status

Recruiting

Address

Stony Brook Medicine Advanced Specialty Care

Commack, New York, 11725

Clinical Research of Gastonia, Gastonia, North Carolina

Status

Recruiting

Address

Clinical Research of Gastonia

Gastonia, North Carolina, 28054

Site Contact

Lauren Bargett

lbargett@crgastonia.com

704-675-7144

Shelby Clinical Research, Shelby, North Carolina

Status

Recruiting

Address

Shelby Clinical Research

Shelby, North Carolina, 28150

Southeastern Research Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Southeastern Research Center

Winston-Salem, North Carolina, 27103

The Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Ron Wehrmann

wehrmar@ccf.org

216-445-0574

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Anila Vero

anila.vero@jefferson.edu

215-503-5405

Temple University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University Hospital

Philadelphia, Pennsylvania, 19140-5103

Site Contact

Julie Juhas

julie.juhas@tuhs.temple.edu

215-707-1359

Clinical Research of Rock Hill, Rock Hill, South Carolina

Status

Completed

Address

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732

Franklin, Tennessee

Status

Recruiting

Address

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067

Site Contact

Lindsey Robbs

lrobbs@cttcmidtn.com

615-205-8352

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37204

Site Contact

James Del Greco

james.del.greco@vumc.org

615-343-7068

El Paso Pulmonary Association - Elligo, El Paso, Texas

Status

Recruiting

Address

El Paso Pulmonary Association - Elligo

El Paso, Texas, 79902-1124

Site Contact

Nayomi Aguilera

nayomi.aguilera@elligodirect.com

915-301-2970

McKinney, Texas

Status

Recruiting

Address

Metroplex Pulmonary and Sleep Medicine Center

McKinney, Texas, 75069

Site Contact

Ambreen Ahmed

aahmed@mpsleepcenter.com

972-838-1892

Northwestern Memorial Hospital, Milwaukee, Wisconsin

Status

Recruiting

Address

Northwestern Memorial Hospital

Milwaukee, Wisconsin, 53226-3522

Site Contact

Phillip Cooper

p-cooper@northwestern.edu

312-503-1137

International Sites

STAT Research S.A., Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

STAT Research S.A.

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB

Florencio Varela, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto De Enfermedades Respiratorias E Investigacion Medica

Florencio Varela, Buenos Aires, 1888

Site Contact

Delfina Rios

delfinarios@ierim.com

+541120739884

Instituto Ave Pulmo, Mar Del Plata, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto Ave Pulmo

Mar Del Plata, Buenos Aires, 7600

Site Contact

Felicitas Fernandez Voena

felifv@gmail.com

+542234108383

Instituto De Patologías Respiratorias, San Miguel De Tucumán, Tucumán, Argentina

Status

Recruiting

Address

Instituto De Patologías Respiratorias

San Miguel De Tucumán, Tucumán, 4000

Site Contact

Natalia Verónica Diaz

ipr_nataliadiaz@yahoo.com

+543814314170

Centro Medico Dra de Salvo, Ciudad de Buenos Aires, Argentina

Status

Recruiting

Address

Centro Medico Dra de Salvo

Ciudad de Buenos Aires, , C1426ABP

Site Contact

Claudia Acher

cda1023@yahoo.com.ar

+54114781533118

Instituto Del Buen Aire, Santa Fe, Argentina

Status

Recruiting

Address

Instituto Del Buen Aire

Santa Fe, , 3000

Site Contact

Marion Lencina

marionanlencina@gmail.com

+543425083311

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

Georgia Rendell

georgia.rendell@sa.gov.au

+61870744287

Box Hill Hospital, Box Hill, Victoria, Australia

Status

Recruiting

Address

Box Hill Hospital

Box Hill, Victoria, 3128

Site Contact

Carmen Lo

carmen.lo@monash.edu

+61390952417

Dynamic Drug Advancement Ltd., Ajax, Ontario, Canada

Status

Recruiting

Address

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5

Site Contact

Noorul Ain Fatima

crc3@dynamicdrugadvancement.com

(905) 427-3784

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

Status

Recruiting

Address

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6

Site Contact

Sarah Goodwin

sgoodwin@stjosham.on.ca

(905) 521-6130

Centro de Investigación Curico, Curico, Maule, Chile

Status

Recruiting

Address

Centro de Investigación Curico

Curico, Maule, 3440000

Site Contact

Gabriela Astorga Fuentes

gabrielakaf@cicu.cl

+56992176560

Universidad de Los Andes, Las Condes, Región-MetropolitanadeSantiago, Chile

Status

Recruiting

Address

Universidad de Los Andes

Las Condes, Región-MetropolitanadeSantiago, 7550000

Site Contact

Francisca Aguirre Boza

faguirre@clinicauandes.cl

+56982945040

Enroll SpA, Providencia, Región-MetropolitanadeSantiago, Chile

Status

Recruiting

Address

Enroll SpA

Providencia, Región-MetropolitanadeSantiago, 7500587

Site Contact

Rosario Garcia

rgarcia@biosresearch.cl

+56964790949

Meditek Ltda, Santiago, Región-MetropolitanadeSantiago, Chile

Status

Recruiting

Address

Meditek Ltda

Santiago, Región-MetropolitanadeSantiago, 8330008

Site Contact

Ana Maria Afani

anamariaafani@gmail.com

+56224076288

MIRES/MYF estudios cli-nicos, Ñuñoa, Región-MetropolitanadeSantiago, Chile

Status

Recruiting

Address

MIRES/MYF estudios cli-nicos

Ñuñoa, Región-MetropolitanadeSantiago, 7750495

Site Contact

Gabriela Zurita

gzurita680@gmail.com

+56988193959

Quillota, Valparaíso, Chile

Status

Recruiting

Address

Centro Respiratorio Integral LTDA. (CENRESIN)

Quillota, Valparaíso, 2260000

Site Contact

Paula Ahumada

paulahumada.klga@gmail.com

+56956833929

Centro de Investigacion del Maule, Talca, Chile

Status

Recruiting

Address

Centro de Investigacion del Maule

Talca, , 3465586

Site Contact

Viviana Parra

viviparris@gmail.com

+56995119728

Clinical Research Chile SpA, Valdivia, Chile

Status

Recruiting

Address

Clinical Research Chile SpA

Valdivia, , 8330033

Site Contact

Eduardo Castillo Palma

ecastillo@clinicalresearch.cl

+56940601237

Hopital Nord AP-HM, Marseille, Bouches-du-Rhône, France

Status

Recruiting

Address

Hopital Nord AP-HM

Marseille, Bouches-du-Rhône, 13915

Site Contact

Geneviève Mouton

genevieve.mouton@ap-hm.fr

+33494966145

Hopital Haut Leveque, Pessac, Gironde, France

Status

Recruiting

Address

Hopital Haut Leveque

Pessac, Gironde, 33604

Site Contact

Virginie Hulot

virginie.hulot@chu-bordeaux.fr

+33557656717

Hôpital Bretonneau, Tours, Indre-et-Loire, France

Status

Recruiting

Address

Hôpital Bretonneau

Tours, Indre-et-Loire, 37044

Site Contact

Noemie Bernier

n.bernier@chu-tours.fr

+33247478622

Lungenklinik Hemer, Hemer, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Lungenklinik Hemer

Hemer, Nordrhein-Westfalen, 58675

Site Contact

Sandra Kebekus

sandra.kebekus@lkhemer.de

+4923729082178

University General Hospital of Patras, Patras, Achaïa, Greece

Status

Recruiting

Address

University General Hospital of Patras

Patras, Achaïa, 265 04

Site Contact

Argyris Tzouvelekis

argyris.tzouvelekis@gmail.com

+302613603523

Evangelismos General Hospital of Athens, Athens, Attiki, Greece

Status

Recruiting

Address

Evangelismos General Hospital of Athens

Athens, Attiki, 10676

Athens Medical Center, Marousi, Attiki, Greece

Status

Recruiting

Address

Athens Medical Center

Marousi, Attiki, 151 25

Site Contact

Euaggelos Bouros

iatrikobouros@gmail.com

+302106157002

University General Hospital of Ioannina, Ioannina, Greece

Status

Recruiting

Address

University General Hospital of Ioannina

Ioannina, , 455 00

Site Contact

Apostolis Nikolopoulos

ap.nikolopoulos@gmail.com

+306934251315

University General Hospital of Heraklion, Iraklio, Greece

Status

Recruiting

Address

University General Hospital of Heraklion

Iraklio, , 711 10

Site Contact

Evangelia Stamataki

emstamataki@yahoo.gr

+306937049001

University General Hospital of Larissa, Larisa, Greece

Status

Recruiting

Address

University General Hospital of Larissa

Larisa, , 411 10

Site Contact

Paraskevi Kirgou

paraskevi.kirgou@gmail.com

+306979511663

Forlì, Emilia-Romagna, Italy

Status

Recruiting

Address

Presidio Ospedaliero GB Morgagni L Pierantoni

Forlì, Emilia-Romagna, 47121

Site Contact

Brunella Biondi

brunella.biondi@auslromagna.it

+390543735828

Azienda Ospedaliera Universitaria Senese, Siena, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Senese

Siena, , 53100

Site Contact

Benedetta Benedetta Di Ruggiero

benedettadiruggiero@gmail.com

+390577586710

Himeji-Shi, Hyôgo, Japan

Status

Recruiting

Address

National Hospital Organization Himeji Medical Center

Himeji-Shi, Hyôgo, 670-8520

Site Contact

Saki Takeda

takeda.saki.zy@mail.hosp.go.jp

+81792253211

Naka-Gun, Ibaraki, Japan

Status

Recruiting

Address

National Hospital Organization Ibarakihigashi National Hospital

Naka-Gun, Ibaraki, 319-1113

Site Contact

Fumiko Komukai

fumiko-komukai@iromgroup.co.jp

+81292832778

Yokohama-Shi, Kanagawa, Japan

Status

Recruiting

Address

Kanagawa Cardiovascular and Respiratory Center

Yokohama-Shi, Kanagawa, 235-0041

Site Contact

Momoka Sato

sato.momoka411@eps.co.jp

+81454401227

Hiroshima Prefectural Hospital, Hiroshima, Japan

Status

Recruiting

Address

Hiroshima Prefectural Hospital

Hiroshima, , 734-0004

Site Contact

Rie Yoriki

yoriki.rie144@eps.co.jp

+81825061631

Tokyo, Japan

Status

Recruiting

Address

Medical Hospital of Tokyo Medical and Dental University

Tokyo, , 113-8519

Site Contact

Ayako Kajigaya

kajigaya.ayako796@eps.co.jp

+81338136111

Sakai-Shi, Ôsaka, Japan

Status

Recruiting

Address

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai-Shi, Ôsaka, 591-8025

Site Contact

Sarasa Tanaka

tanaka.sarasa259@eps.co.jp

+81722523021

Seongnam-si, Gyeonggido, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620

Site Contact

Hye-Jin Kim

1012hjkim@naver.com

+82317372365

Korea University Anam Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Korea University Anam Hospital

Seoul, , 02841

Site Contact

MiJa Kim

01692353168@hanmail.net

+8229205439

Asan Medical Center-PPDS, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center-PPDS

Seoul, , 05505

Site Contact

Kyung Mi Choi

rubeadal60@gmail.com

+82220483716

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, ,

Site Contact

Sookyung Park

sk3896.park@samsung.com

+82234101346

CICUM San Miguel, Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

CICUM San Miguel

Guadalajara, Jalisco, 44160

Site Contact

Clara Guadalupe Tellez Rivera

clat@usac.com.mx

+523333364245

Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Nuevo León, 64460

Site Contact

Andrea Rodriguez Semporini

arodriguez@ceprep.mx

+528183482018

Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Unidad de Investigación Clínica En Medicina SC

Monterrey, Nuevo León, 64718

Site Contact

Cristina Noriega Diaz

cristina.noriega@udicem.org

+528181430783

Centro, Oaxaca, Mexico

Status

Recruiting

Address

Oaxaca Site management Organization (OSMO)

Centro, Oaxaca, 68000

Site Contact

Jessica Trujillo Martinez

jessicatrujillo.osmo@gmail.com

+529512085001

Erasmus MC, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, , 3015 GD

Site Contact

Annemarie Geel

a.geel@erasmusmc.nl

+31107032849

Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomorskie,

Site Contact

Angelika Wojtowicz

angwojtowicz@uck.gda.pl

+48725589826

Katowice, Slaskie, Poland

Status

Recruiting

Address

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Katowice, Slaskie, 40-752

Site Contact

Justyna Torbus

justyna.torbus@int.pl

+48790780873

MCM Krakow - PRATIA - PPDS, Kraków, Poland

Status

Recruiting

Address

MCM Krakow - PRATIA - PPDS

Kraków, , 30-510

Site Contact

Karolina Wisniewska

karolina.wisniewska@pratia.com

+48513419044

KwaPhila Health Solutions, Durban, Kwazulu - Natal, South Africa

Status

Recruiting

Address

KwaPhila Health Solutions

Durban, Kwazulu - Natal, 4091

Site Contact

Camellia Lutchmana

camellialutchmana@ecarefoundation.com

+27312611095

Cape Town, Western Cape, South Africa

Status

Not yet recruiting

Address

University of Cape Town Lung Institute (UCTLI)

Cape Town, Western Cape, 7700

Site Contact

Christine Bush

christine.bush@uct.ac.za

+27214066889

Dr. Ismail Abdullah Private Practice, Cape Town, Western Cape, South Africa

Status

Recruiting

Address

Dr. Ismail Abdullah Private Practice

Cape Town, Western Cape, 7764

Site Contact

Mia Nel

mianel86@yahoo.com

+27216334680

Hospital Universitario de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario de Bellvitge

L'Hospitalet De Llobregat, Barcelona, 08907

Site Contact

Gemma Montagut

gmontagut@bellvitgehospital.cat

+34934035807

Pozuelo De Alarcón, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Quironsalud Madrid

Pozuelo De Alarcón, Madrid, 28223

Site Contact

Patricia Gonzalez Cediel

patricia.gonzalezc@quironsalud.es

+34914521900 #30121

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Completed

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Kaohsiung City, Taiwan

Status

Recruiting

Address

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, , 807

Site Contact

Yu-Chiao Cheng

joyjoy609609@gmail.com

+886915149315

China Medical University Hospital - PPDS, Taichung, Taiwan

Status

Recruiting

Address

China Medical University Hospital - PPDS

Taichung, , 404

Site Contact

Shu-Min Peng

psm851202@yahoo.com.tw

+886910726911

Far Eastern Memorial Hospital, Taipei, Taiwan

Status

Recruiting

Address

Far Eastern Memorial Hospital

Taipei, , 220

Site Contact

Huei-Fang Huang

hueifang82587@yahoo.com.tw

+886956182117

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei, ,

Site Contact

Yi-Chen Lin

lynn19970309@outlook.com

+886912596789

Kocaeli University Hospital, Kocaeli, Turkey

Status

Completed

Address

Kocaeli University Hospital

Kocaeli, , 41380

Connolly Hospital Blanchardstown, Liverpool, United Kingdom

Status

Not yet recruiting

Address

Connolly Hospital Blanchardstown

Liverpool, , L9 7AL

Site Contact

Anna Maria O'Brien

annamaria.obrien@hse.ie

+35316466164