STARSCAPE-OLE: A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04594707
Collaborator
(none)
700
211
1
88
3.3
0
Study Details
Study Description
Brief Summary
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
700 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date
:
Aug 30, 2021
Anticipated Primary Completion Date
:
Dec 29, 2028
Anticipated Study Completion Date
:
Dec 29, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRM-151 Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293. |
Drug: PRM-151 (Zinpentraxin Alfa)
Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks.
Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Adverse Events (AE) [From baseline until 8 weeks after the final dose]
Severity will be determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]).
- Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest [From baseline until 8 weeks after the final dose]
- Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs [From baseline until 8 weeks after the final dose]
- Change from Baseline in Targeted Clinical Laboratory Test Results [From baseline until 8 weeks after the final dose]
Secondary Outcome Measures
- Annual Rate of Change in Forced Vital Capacity (FVC) (mL) [From baseline until study completion (up tp 4 years)]
- Annual Rate of Change in 6-Minute Walk Distance (6MWD) [From baseline until study completion (up tp 4 years)]
- Annual Rate of Change in FVC% Predicted [From baseline until study completion (up tp 4 years)]
- Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO) [From baseline until study completion (up tp 4 years)]
- Time to Disease Progression [From the time of randomization until disease progression or death (up tp 4 years)]
Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death
- Survival [Every 6 Months and at study completion (up to 4 years)]
- IPF-related Mortality [Every 6 Months and at study completion (up to 4 years)]
- Respiratory-related Mortality [Every 6 Months and at study completion (up to 4 years)]
- Plasma Concentrations of PRM-151 at Specified Timepoints [Days 1, 3 and 5, Weeks 4, 12 and 24]
- Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline [Baseline (Day 1)]
- Percentage of Participants with ADAs During the Study [Weeks 4, 12 and 24]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
-
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
-
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria:
-
Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
-
History of smoking within 3 months prior to the first visit in the OLE.
-
History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
-
History of severe allergic reaction or anaphylactic reaction to PRM-151.
-
Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
-
Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
-
Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Medical Center | San Francisco | California | United States | 94143-0748 |
| 2 | National Jewish Health Medical Center | Denver | Colorado | United States | 80045-2541 |
| 3 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 4 | Meris Clinical Research | Brandon | Florida | United States | 33511-5719 |
| 5 | Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration | Celebration | Florida | United States | 34747-1818 |
| 6 | Sarasota County Public Hospital | Sarasota | Florida | United States | 34239 |
| 7 | Bassetti Medical Research, Inc | Sebring | Florida | United States | 33870-1216 |
| 8 | Renstar Medical Research | Wesley Chapel | Florida | United States | 33544 |
| 9 | Florida Pulmonary Research Institute, LLC | Winter Park | Florida | United States | 32789 |
| 10 | NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
| 11 | University of Iowa Hospitals and Clinics; Investigational Drug Services | Iowa City | Iowa | United States | 52242 |
| 12 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 13 | University of Louisville Health Sciences Center | Louisville | Kentucky | United States | 40202 |
| 14 | University of Minnesota Medical Center | Minneapolis | Minnesota | United States | 29425-8911 |
| 15 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55902 |
| 16 | The Lung Research Center | Chesterfield | Missouri | United States | 63017-3625 |
| 17 | Washington University | Saint Louis | Missouri | United States | 63128 |
| 18 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-0600 |
| 19 | Albany Med College | Albany | New York | United States | 12208 |
| 20 | Lenox Hill Hospital | New York | New York | United States | 10075 |
| 21 | American Health Research Inc. | Charlotte | North Carolina | United States | 28277 |
| 22 | Pulmonix Research | Greensboro | North Carolina | United States | 27403-1127 |
| 23 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 24 | Jefferson University Physicians (JUP) - Jefferson Pulmonary | Philadelphia | Pennsylvania | United States | 19107 |
| 25 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
| 26 | SleepMed of South Carolina | Columbia | South Carolina | United States | 29201-2953 |
| 27 | Lowcountry Lung and Critical Care | North Charleston | South Carolina | United States | 29406 |
| 28 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37212 |
| 29 | Metroplex Pulmonology & Sleep Center | McKinney | Texas | United States | 75069 |
| 30 | University Of Utah Hosp & Clin; Investigational Pharmacy | Salt Lake City | Utah | United States | 84132 |
| 31 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22031 |
| 32 | Hospital Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | Argentina | C1284AEB | |
| 33 | Centro de Alergia y Enfermedades Respiratorias | Ciudad Autonoma Buenos Aires | Argentina | C1414AIF | |
| 34 | Fundacion Respirar (Centro Medico Dra. De Salvo) | Ciudad Autonoma Buenos Aires | Argentina | C1426ABP | |
| 35 | Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility | Córdoba | Argentina | X5003DCE | |
| 36 | Hospital Universitario Austral | Derqui-Pilar | Argentina | B1629ODT | |
| 37 | Centro Medico de Enfermedades Respiratorias (CEMER) | Florida | Argentina | ||
| 38 | Centro de estudios respiratorios | Mar Del Plata | Argentina | B7600CLK | |
| 39 | INSARES | Mendoza, Mendoza City | Argentina | M5500CCG | |
| 40 | Fundacion Scherbovsky | Mendoza | Argentina | M5500AYB | |
| 41 | Centro Respiratorio Infantil | Rosario | Argentina | S2000BRH | |
| 42 | Investigaciones en Patologias Respiratorias | San Miguel de Tucuman | Argentina | T4000IAR | |
| 43 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 44 | Cairns Base Hospital; Cancer Care Centre | Cairns | Queensland | Australia | 4870 |
| 45 | Lung Research Queensland | Nundah | Queensland | Australia | 4101 |
| 46 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 47 | The Queen Elizabeth Hospital | Woodville | South Australia | Australia | 5011 |
| 48 | Monash Medical Centre; Medicine | Melbourne | Victoria | Australia | 3186 |
| 49 | The Alfred Hospital | Prahan | Victoria | Australia | 3181 |
| 50 | ULB Hôpital Erasme | Brussels | Belgium | 1070 | |
| 51 | Cliniques Universitaires Saint-Luc; Pharmacy | Bruxelles | Belgium | 1200 | |
| 52 | UZ Leuven | Leuven | Belgium | 3000 | |
| 53 | C. H. U. Sart-Tilman; Laboratory | Liège | Belgium | 4000 | |
| 54 | CHU UCL Namur / site Godinne | Yvoir | Belgium | B5530 | |
| 55 | Kelowna Respiratory and Allergy Clinic | Kelowna | British Columbia | Canada | V1W 1V3 |
| 56 | The Rhema Research Institute | Owen Sound | Ontario | Canada | N4K 6M9 |
| 57 | Peking Union Medical College Hospital; Pharmacy | Beijing City | China | 100730 | |
| 58 | Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Beijing Shi | China | 100050 | |
| 59 | The Second Hospital of Jilin University | Changchun | China | 130041 | |
| 60 | Anhui Provincial Hospital | Hefei | China | 230001 | |
| 61 | Tianjin Medical University General Hospital | Tianjin | China | 300052 | |
| 62 | Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City | China | 430030 | |
| 63 | Wuxi People's Hospital | Wuxi | China | 214023 | |
| 64 | Fakultni nemocnice Brno | Brno | Czechia | 613 00 | |
| 65 | Nemocnice Na Bulovce | Prague | Czechia | 180 01 | |
| 66 | Thomayerova nemocnice; Lekarna - pavilon H | Praha 4 | Czechia | 140 00 | |
| 67 | Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni | Zlin | Czechia | 760 01 | |
| 68 | Hopital Avicenne | Bobigny | France | 93000 | |
| 69 | Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche | Brest | France | 29200 | |
| 70 | Hopital Louis Pradel | Bron | France | 69677 | |
| 71 | CHU Hopitaux de Bordeaux | CHU Hopitaux De Bordeaux | France | 33000 | |
| 72 | CHU Dijon Bourgogne Hôpital François Mitterand | Dijon | France | 21000 | |
| 73 | CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie | La Tronche | France | 38700 | |
| 74 | Centre Hospitalier Regional Universitaire de Lille | Lille | France | ||
| 75 | Servie de Pneumologie et centre de Transplantation Pulmonaire | Marseille | France | 13354 | |
| 76 | CHU Nice - Hôpital Pasteur 2 | Nice | France | 06000 | |
| 77 | Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie | Paris | France | 75018 | |
| 78 | Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche | Reims | France | 51092 | |
| 79 | Centre Hospitalier Universitaire de Rennes | Rennes | France | 35033 | |
| 80 | CHU Tours - Hôpital Bretonneau | Tours | France | 37044 | |
| 81 | Evang. Lungenklinik Berlin Klinik für Pneumologie | Berlin | Germany | 13125 | |
| 82 | Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik | Heidelberg | Germany | 69120 | |
| 83 | Lungenfachklinik Immenhausen | Immenhausen | Germany | 34376 | |
| 84 | Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup | Marburg | Germany | 35037 | |
| 85 | Krankenhaus Bethanien gGmbH | Solingen | Germany | 42699 | |
| 86 | Evangelismos Hospital; Endocrinology, Diabetes & Metabolism | Athens | Greece | 10676 | |
| 87 | National and Kapodistrian University of Athens EKPA Medical School | Athens | Greece | 115 27 | |
| 88 | University Hospital of Ioannina; Pulmonology Department | Ioannina | Greece | 455 00 | |
| 89 | University General Hospital of Larissa | Larissa | Greece | 412 21 | |
| 90 | Athens Medical Center | Marousi | Greece | 151 25 | |
| 91 | University General Hospital of Patras | Patras | Greece | 265 00 | |
| 92 | "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic " | Sotiria Athens | Greece | 115 27 | |
| 93 | Prince of Wales Hospital; Dept. of Medicine & Therapeutics | Hong Kong | Hong Kong | ||
| 94 | The University of Hong Kong; Queen Mary Hospital | Hong Kong | Hong Kong | ||
| 95 | Semmelweis University | Budapest | Hungary | 1081 | |
| 96 | Debreceni Egyetem | Debrecen | Hungary | 4032 | |
| 97 | Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET | Szombathely | Hungary | 9700 | |
| 98 | Szent Borbala Korhaz | Tatabánya | Hungary | 2800 | |
| 99 | Barzilai Medical Center; Neurology Department | Ashkelon | Israel | 7830604 | |
| 100 | Shamir medical center | Be'er Ya'akov | Israel | 0070300 | |
| 101 | Soroka University Medical Center, Psychiatry; Psychiatry | Beer Sheva | Israel | 8410101 | |
| 102 | Rambam Health Care Campus | Haifa | Israel | 3109600 | |
| 103 | Edith Wolfson Medical Center | Holon | Israel | 5822012 | |
| 104 | Hadassah Medical Center | Jerusalem | Israel | 9112000 | |
| 105 | Meir Medical Center | Kfar- Saba | Israel | 4428164 | |
| 106 | Rabin Medical Center | Petach Tiqwa | Israel | 4941492 | |
| 107 | The Chaim Sheba Medical Center | Ramat Gan | Israel | 5211401 | |
| 108 | Kaplan Medical Center | Rehovot | Israel | 7610001 | |
| 109 | Tel Aviv Sourasky Medical Center; Department of Neurology | Tel Aviv | Israel | 6423906 | |
| 110 | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Abruzzo | Italy | 24060 |
| 111 | "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia " | Napoli | Campania | Italy | 80131 |
| 112 | Azienda Ospedaliera Universitaria Federico II | Napoli | Campania | Italy | 80131 |
| 113 | Ospedale Morgagni Pierantoni; Patologia clinica | Forlì | Emilia-Romagna | Italy | 47100 |
| 114 | A.O.U. Policlinico di Modena | Modena | Emilia-Romagna | Italy | 40124 |
| 115 | Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio | Rome | Lazio | Italy | 00133 |
| 116 | Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia | Rome | Lazio | Italy | 00168 |
| 117 | Ospedale San Giuseppe; U.O. di Pneumologia | Milano | Lombardia | Italy | 20123 |
| 118 | Asst Santi Paolo E Carlo | Milano | Lombardia | Italy | 20142 |
| 119 | Fondazione IRCCS Policlinico San Matteo ; Divisione di Ematologia Dipartimento di Onco-Ematologia | Pavia | Lombardia | Italy | 27100 |
| 120 | Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia | Foggia | Puglia | Italy | 71122 |
| 121 | A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale | Sassari | Sardegna | Italy | 07100 |
| 122 | Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele | Catania | Sicilia | Italy | 95123 |
| 123 | Az. Osp. Univ. P. Giaccone; UOC di Pneumologia | Palermo | Sicilia | Italy | 90127 |
| 124 | Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia | Palermo | Sicilia | Italy | 90127 |
| 125 | AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2 | Firenze | Toscana | Italy | 50134 |
| 126 | A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche | Siena | Toscana | Italy | 53100 |
| 127 | Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1 | Padova | Veneto | Italy | 35128 |
| 128 | University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center | Treviso | Veneto | Italy | 31100 |
| 129 | Chiba University Hospital | Chiba | Japan | 260-8677 | |
| 130 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 131 | Kobe City Medical Center General Hospital | Hyogo | Japan | 650-0047 | |
| 132 | National Hospital Organization Himeji Medical Center | Hyogo | Japan | 670-8520 | |
| 133 | Nippon Medical School Musashi Kosugi Hospital | Kawasaki-Shi | Japan | ||
| 134 | Nagasaki University Hospital | Nagasaki | Japan | 852-8501 | |
| 135 | Center Hospital of the National Center for Global Health and Medicine | Tokyo | Japan | 162-0052 | |
| 136 | The Catholic University of Korea Bucheon St. Mary's Hospital | Gyeonggi-do | Korea, Republic of | 14662 | |
| 137 | Gacheon University Gil Medical Center | Namdong-gu | Korea, Republic of | 21565 | |
| 138 | The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology | Seoul | Korea, Republic of | (0)7345 | |
| 139 | Seoul National University Hospital (SNUH) - Medical Oncology Center | Seoul | Korea, Republic of | 03080 | |
| 140 | Soonchunhyang University Hospital | Seoul | Korea, Republic of | 04401 | |
| 141 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 142 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 143 | Unidad Médica para la Salud Integral UMSI | San Nicolás de Los Garza | Nuevo LEON | Mexico | 66465 |
| 144 | Unidad de Investigacion CIMA SC | Chihuahua | Mexico | 31200 | |
| 145 | Centro de Diagnóstico y Tratamiento de Enfermedades Respiratorias, Medica San Isidro | Metepec | Mexico | 52140 | |
| 146 | Centro Respiratorio de México | Mexico | Mexico | 14050 | |
| 147 | INER- Instituto Nacional de Enfermedades Respiratorias"Ismae | Mexico | Mexico | 14080 | |
| 148 | CICC Morelia | Morelia | Mexico | ||
| 149 | Sint Antonius Ziekenhuis, locatie Nieuwegein | Nieuwegein | Netherlands | 3430 EM | |
| 150 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3000 CA | |
| 151 | Auckland City Hospital | Auckland | New Zealand | 1023 | |
| 152 | NZ Respiratory & Sleep Institute | Auckland | New Zealand | 1051 | |
| 153 | University of Otago, Christchurch | Christchurch | New Zealand | 8011 | |
| 154 | Waikato Hospital; Gastro Research | Hamilton | New Zealand | 3240 | |
| 155 | Tauranga Hospital | Tauranga | New Zealand | 3143 | |
| 156 | Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen | Bergen | Norway | 5021 | |
| 157 | Akershus universitetssykehus | Lørenskog | Norway | 1478 | |
| 158 | Oslo University Hospital HF, Rikshospitalet | Oslo | Norway | 0424 | |
| 159 | Hospital de Chancay | Chancay | Peru | 15131 | |
| 160 | Centrum Medycyny Oddechowej Mroz sp. j. | Białystok | Poland | 15-044 | |
| 161 | Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | Poland | 85-312 | |
| 162 | Jagiellonskie Centrum Innowacji | Kraków | Poland | 30-348 | |
| 163 | SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | Poland | 90-153 | |
| 164 | Hospital Senhora da Oliveira - Guimarães, E.P.E | Guimaraes | Portugal | 4835-044 | |
| 165 | CHVNG/E_Unidade 1; Servico de Pneumologia | Vila Nova de Gaia | Portugal | 4434-502 | |
| 166 | Chelyabinsk Regional Clinical Hospital; Hematology | Chelyabinsk | Russian Federation | 454076 | |
| 167 | National University Hospital | Singapore | Singapore | 119074 | |
| 168 | Singapore General Hospital | Singapore | Singapore | 169608 | |
| 169 | Tan Tock Seng Hospital; Oncology | Singapore | Singapore | 308433 | |
| 170 | University of Cape Town Lung Institute; Lung Clinical Research | Cape Town | South Africa | 7700 | |
| 171 | Johese Clinical Research | Centurion | South Africa | 1692 | |
| 172 | Into Research; Life Groenkloof Hospital Medical Centre | Groenkloof | South Africa | 0181 | |
| 173 | Vergelegen Medi-Clinic | Somerset West | South Africa | 7130 | |
| 174 | HUA - Txagorritxu | Vitoria | Alava | Spain | 01009 |
| 175 | Hospital Univ. Central de Asturias | Oviedo | Asturias | Spain | 33006 |
| 176 | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 177 | Hospital Universitario Marques de Valdecilla | Santander | Cantabria | Spain | 39008 |
| 178 | CHUS - H. Clinico U. de Santiago | Santiago de Compostela | LA Coruña | Spain | 15706 |
| 179 | Hospital Universitario del Henares | Coslada | Madrid | Spain | 28850 |
| 180 | Hospital Galdakao-Usansolo | Galdakao | Vizcaya | Spain | 48960 |
| 181 | Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia | Barcelona | Spain | 08025 | |
| 182 | Hospital Clinic I Provincial | Barcelona | Spain | 08036 | |
| 183 | Hospital Germans Trias i Pujol | Barcelona | Spain | 08916 | |
| 184 | Hospital Virgen de las Nieves; Servicio de Neumologia | Granada | Spain | 18014 | |
| 185 | Clinica Universidad de Navarra ; Servicio de Farmacia | Madrid | Spain | 28027 | |
| 186 | Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz | Madrid | Spain | 28029 | |
| 187 | Fundacion Jimenez Diaz-UTE | Madrid | Spain | 28040 | |
| 188 | Hosp. Clinico San Carlos | Madrid | Spain | 28040 | |
| 189 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 190 | Hospital Clinico Universitario de Salamanca | Salamanca | Spain | 37007 | |
| 191 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
| 192 | Buddhist Tzu Chi Dalin General Hospital; Rheumatology | Chia-yi | Taiwan | 622 | |
| 193 | Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital | Kaoshiung City | Taiwan | 807 | |
| 194 | China Medical University Hospital | Taichung | Taiwan | 40447 | |
| 195 | National Cheng Kung University Hospital | Tainan | Taiwan | 70457 | |
| 196 | National Taiwan University Hospital | Taipei | Taiwan | 10002 | |
| 197 | Far Eastern Memorial Hospital; Department of Clinical Pathology | Taipei | Taiwan | 220 | |
| 198 | Veterans General Hospital - Taichung | Xitun Dist. | Taiwan | 40705 | |
| 199 | Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali; Onkologi | Adana | Turkey | 01330 | |
| 200 | Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi | Ankara | Turkey | 06620 | |
| 201 | Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi | Bursa | Turkey | 16059 | |
| 202 | Gaziantep Universitesi Tip Fakultesi | Gaziantep | Turkey | 27310 | |
| 203 | Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi | Istanbul | Turkey | 34020 | |
| 204 | Istanbul Universitesi Onkoloji Enstitüsü Hastanesi | İstanbul | Turkey | 34093 | |
| 205 | Ege Universitesi Tip Fakultesi Hastanesi | Izmir / | Turkey | 35100 | |
| 206 | Dokuz Eylul University Faculty of Medicine; Chest Diseases | Izmir | Turkey | 35340 | |
| 207 | Marmara Universitesi Hastanesi Marmara University Hospital | Maltepe | Turkey | 34854 | |
| 208 | Eriyes universitesi Tıp Fakultesi Hastanesi | Melikgazi/Kayser | Turkey | 38039 | |
| 209 | Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi | Mersin | Turkey | 33110 | |
| 210 | Akdeniz University Faculty of Medicine Department of Pulmonology | Muratpasa/Antalya | Turkey | 07059 | |
| 211 | Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine) | Sariyer | Turkey | 34450 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04594707
Other Study ID Numbers:
- WA42294
- 2020-001429-30
First Posted:
Oct 20, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: