title: Defining Cut-off Values for Widely-used Composite Scores and Patient-reported Outcome Measures in Psoriatic Arthritis Corresponding to Remission and Flare Assessed by the Physician and the Patient

acronym: ReFlaP

summary: The purpose of this study is to define cut-off values of the most widely used composite scores and patient-reported outcomes, for levels corresponding to remission/low disease activity and for changes in levels corresponding to flares, in PsA, when remission/low disease activity and flare are defined from the patient and physician perspective. The ReFlaP (Remission/Flare in PsA) study is a prospective, multicentric international, longitudinal, observational study.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Lucasson F, Kiltz U, Kalyoncu U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ryussen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Richette P, Husni E, Coates LC, de Wit M, Smolen JS, Orbai AM, Gossec L. Disparities in healthcare in psoriatic arthritis: an analysis of 439 patients from 13 countries. RMD Open. 2022 May;8(1). pii: e002031. doi: 10.1136/rmdopen-2021-002031. Erratum in: RMD Open. 2022 May;8(1):.

ReferenceCitation: Coates LC, Robinson DE, Orbai AM, Kiltz U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Meisalu S, Ruyssen-Witrand A, Eder L, de Wit M, Smolen JS, Lubrano E, Gossec L. What influences patients' opinion of remission and low disease activity in psoriatic arthritis? Principal component analysis of an international study. Rheumatology (Oxford). 2021 Nov 3;60(11):5292-5299. doi: 10.1093/rheumatology/keab220.

ReferenceCitation: Orbai AM, Perin J, Gorlier C, Coates LC, Kiltz U, Leung YY, Palominos PE, Canete JD, Scrivo R, Balanescu A, Dernis E, Talli S, Ruyssen-Witrand A, Soubrier M, Aydin S, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, Smolen JS, de Wit M, Gossec L. Determinants of Patient-Reported Psoriatic Arthritis Impact of Disease: An Analysis of the Association With Sex in 458 Patients From Fourteen Countries. Arthritis Care Res (Hoboken). 2020 Dec;72(12):1772-1779. doi: 10.1002/acr.24090.

ReferenceCitation: Gorlier C, Orbai AM, Puyraimond-Zemmour D, Coates LC, Kiltz U, Leung YY, Palominos P, Cañete JD, Scrivo R, Balanescu A, Dernis E, Tälli S, Ruyssen-Witrand A, Soubrier M, Aydin SZ, Eder L, Gaydukova I, Lubrano E, Kalyoncu U, Richette P, Husni ME, de Wit M, Smolen JS, Gossec L. Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis. 2019 Feb;78(2):201-208. doi: 10.1136/annrheumdis-2018-214140. Epub 2018 Nov 15.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_country:
Brazil
Spain
Italy
Austria
Estonia
Russian Federation
Canada
United Kingdom
United States
France
Singapore
Turkey
Romania
Germany

location_facility:
Sibel Aydin
Laure Gossec
Juan Canete
Smolen
Ruyssen-Witrand
Ana- Maria Orbai
Balanescu
Katy Leung
Dernis
Soubrier
Talli
Palominos
Uta Kiltz
Aydin
Lubrano
Eder
Laura Coates
Rossana Scrivo
Husni
Richette
Inna Gaydukova
Kalyoncu

lead_sponsor_type: academique


title: A Phase 3, Multi-center, Open-label, Randomized Study of Oral ABL001 Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

summary:
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.

Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations.

Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Yuda J, Doki N, Matsuoka H, Yokota T, Tomita A, Takahashi N, Matsumura I, Kubo K, Goto T, Kirito K, Maki A, Aoki M, Allepuz A, Minami Y. Asciminib vs bosutinib in CML patients pretreated with ≥2 tyrosine kinase inhibitors: Results from the Japanese subgroup analysis of ASCEMBL study. Cancer Med. 2022 Sep 27. doi: 10.1002/cam4.5212. [Epub ahead of print]

ReferenceCitation: Li YF, Combes FP, Hoch M, Lorenzo S, Sy SKB, Ho YY. Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-Treated Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic and Acute Phases. Clin Pharmacokinet. 2022 Oct;61(10):1393-1403. doi: 10.1007/s40262-022-01148-9. Epub 2022 Jun 28. Erratum in: Clin Pharmacokinet. 2022 Aug 17;:.

ReferenceCitation: Réa D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, Turkina A, Kim DW, Apperley JF, Abdo A, Fogliatto LM, Kim DDH, le Coutre P, Saussele S, Annunziata M, Hughes TP, Chaudhri N, Sasaki K, Chee L, García-Gutiérrez V, Cortes JE, Aimone P, Allepuz A, Quenet S, Bédoucha V, Hochhaus A. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021 Nov 25;138(21):2031-2041. doi: 10.1182/blood.2020009984.

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
United States
Romania
Japan
Czechia
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Korea, Republic of
France
Netherlands

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Michigan Clinical Trials Office Main Site

location_facility: Indiana Blood and Marrow Institute Regulatory - 2

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: Weill Cornell Medicine NewYork Presbyterian Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

intervention_type: Biological

title: A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

study_completion_date_type: Actual

lead_sponsor: Bioverativ, a Sanofi company

type: EudraCT Number

type: Other Identifier

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Belgium
Japan
Germany
Bulgaria

location_facility: Azienda Ospedaliera Pediatrica Santobono Pausillipon

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est)

location_facility: Children's & Women's Health Centre of British Columbia

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: University of Colorado Hemophilia & Thrombosis Center

summary: The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

status_simplified: Completed


title: A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Frances N, Bacac M, Bray-French K, Christen F, Hinton H, Husar E, Quackenbush E, Schäfer M, Schick E, Vyver AV, Richter WF. Novel in Vivo and in Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. J Pharm Sci. 2022 Apr;111(4):1208-1218. doi: 10.1016/j.xphs.2021.12.019. Epub 2021 Dec 22.

ReferenceCitation: Bröske AE, Korfi K, Belousov A, Wilson S, Ooi CH, Bolen CR, Canamero M, Alcaide EG, James I, Piccione EC, Carlile DJ, Dimier N, Umaña P, Bacac M, Weisser M, Dickinson M. Pharmacodynamics and molecular correlates of response to glofitamab in relapsed/refractory non-Hodgkin lymphoma. Blood Adv. 2022 Feb 8;6(3):1025-1037. doi: 10.1182/bloodadvances.2021005954.

ReferenceCitation: Hutchings M, Morschhauser F, Iacoboni G, Carlo-Stella C, Offner FC, Sureda A, Salles G, Martínez-Lopez J, Crump M, Thomas DN, Morcos PN, Ferlini C, Bröske AE, Belousov A, Bacac M, Dimier N, Carlile DJ, Lundberg L, Perez-Callejo D, Umaña P, Moore T, Weisser M, Dickinson MJ. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell-Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial. J Clin Oncol. 2021 Jun 20;39(18):1959-1970. doi: 10.1200/JCO.20.03175. Epub 2021 Mar 19.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Taiwan
Spain
Italy
Australia
New Zealand
Canada
Finland
United States
France
Belgium
Czechia

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Virginia Commonwealth University Medical Center

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Szpital Kliniczny im. Heliodora Święcickiego; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital,

location_facility: Hospital Duran i Reynals L'Hospitalet; Hematology Department

location_facility: Washington University; Wash Uni. Sch. Of Med


title: A Randomized, Open Label, Multi-center, Comparative Trial, to Assess the Efficacy and Safety of Pritelivir Versus Foscarnet for the Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

summary: Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours.

ipd_sharing: No

lead_sponsor: AiCuris Anti-infective Cures AG

location_country:
United Kingdom
Greece
Georgia
Australia
Italy
Argentina
Mexico
Switzerland
United States
France
Belgium
Germany

location_facility: Research Department of Haematology, UCL Cancer Institute

location_facility: Johns Hopkins University School of Medicine

location_facility: University of California, Division of Infectious Diseases

location_facility: Centro de Investigacion Clinica GRAMEL S.C.

location_facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"

location_facility: Yale University School of Medicine - Infectious Diseases

location_facility: Universitaetsmedizin Mannheim, III. Medizinische Klinik

location_facility: Universitaetsspital Basel Ambulantes Studienzentrum

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University Arizona - Department of Medicine Arizona Health Sciences Center

location_facility: Centro de Investigacion Farmaceutica Especializado de Occidente S.C.

location_facility: Department of Medicine J. H. Stroger Hospital of Cook County

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Westmead Hospital, Centre for Infectious Disease and Microbiology

location_facility: Melbourne Health - Royal Melbourne Hospital

location_facility: Regional University General Hospital of Heraklion

location_facility: David H. Koch Center at Memorial Sloan Kettering Cancer Center

location_facility: Multiprofile Clinic Consilium Medulla LTD

location_facility: Clinical Research Institute Saltillo S.A de C.V

location_facility: Midway Immunology and Research Center (MIRC)

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: CHU Limoges - Centre national de reference des Herpes virus


title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

lead_sponsor: AbbVie

ReferenceType: background

ReferenceCitation: Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, Kim I, Stevens DA, Fiedler W, Pagoni M, Samoilova O, Hu Y, Anagnostopoulos A, Bergeron J, Hou JZ, Murthy V, Yamauchi T, McDonald A, Chyla B, Gopalakrishnan S, Jiang Q, Mendes W, Hayslip J, Panayiotidis P. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020 Jun 11;135(24):2137-2145. doi: 10.1182/blood.2020004856.

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

ReferenceCitation: Wei AH, Panayiotidis P, Montesinos P, Laribi K, Ivanov V, Kim I, Novak J, Stevens DA, Fiedler W, Pagoni M, Bergeron J, Ting SB, Hou JZ, Anagnostopoulos A, McDonald A, Murthy V, Yamauchi T, Wang J, Chyla B, Sun Y, Jiang Q, Mendes W, Hayslip J, DiNardo CD. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). Blood Cancer J. 2021 Oct 1;11(10):163. doi: 10.1038/s41408-021-00555-8. Erratum in: Blood Cancer J. 2021 Oct 26;11(10):171.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Norway
Brazil
Canada
Hungary
China
Germany
Taiwan
Greece
Ireland
New Zealand
Korea, Republic of
France

location_facility: Centre Hospitalier de la Cote /ID# 159697

location_facility: University Hospital Limerick /ID# 162735

location_facility: Debreceni Egyetem Klinikai Koz /ID# 158178

location_facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 162991

location_facility: Universitaetsklinikum Hamburg /ID# 161760

location_facility: Nanfang Hospital of Southern Medical University /ID# 170147

location_facility: Kinki University -Osakasayama Campus /ID# 160777

location_facility: City Clinical Hospital Botkina /ID# 164086

location_facility: Tri-Service General Hospital /ID# 161683

location_facility: The First Hosp of Jilin Univ /ID# 167512

location_facility: Almazov North-West Federal Med /ID# 162170

location_facility: Gen Univ Hosp Alexandroupolis /ID# 157868

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157869

location_facility: University Gen Hosp of Patra /ID# 157871

location_facility: Hopital Sacre Coeur Montreal /ID# 160982

location_facility: Nizhniy Novgorod regional clinical hospital named N. A. Semashko /ID# 163186

location_facility: Netcare Pretoria East Hospital /ID# 157373

location_facility: Blood disease hosp of Chinese Academy of Med Sciences(Institute of Hematology) /ID# 167509

location_facility: Ruijin Hospital, Shanghai Jiaotong /ID# 167325

location_facility: University Hospital of Wales /ID# 162726

location_facility: Pusan National University Hosp /ID# 158725

location_facility: Yamagata University Hospital /ID# 161223

location_facility: Qilu Hospital of Shandong Univ /ID# 167507

location_facility: Yaroslavl Regional Clinic Hosp /ID# 162172

location_facility: Saint Petersburg State Institu /ID# 162171

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 157867

location_facility: General Hospital of Athens Laiko /ID# 157870

location_facility: Fujian Medical Univ Union Hosp /ID# 167321

location_facility: Saitama Med Univ Int Med Ctr /ID# 161308

location_facility: National Hospital Organization Mito Medical Center /ID# 162988

location_facility: VA Caribbean Healthcare System /ID# 158999

location_facility: Juntendo University Hospital /ID# 159781

location_facility: Hospital Universitario y Politecnico La Fe /ID# 161181

location_facility: Casa de Saúde Santa Marcelina /ID# 163413

location_facility: University of Fukui Hospital /ID# 159770

location_facility: University of Alberta Hospital /ID# 159646

location_facility: Tokyo Metropolitan Komagome Hospital /ID# 160759

location_facility: Chungnam National University Hospital /ID# 158726

location_facility: Dél-pesti Centrumkórház- Országos Hematológiai és Infektológiai Intézet /ID# 159127

location_facility: Seoul National University Hospital /ID# 162253

location_facility: Jiangsu Province People's Hospital /ID# 167511

location_facility: Hospital Maisonneuve-Rosemont /ID# 159780

location_facility: Samara State Medical Universit /ID# 164173

location_facility: Osaka City University Hospital /ID# 159722

location_facility: Dokkyo Medical University Hosp /ID# 159650

location_facility: Kaohsiung Medical University /ID# 161693

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 160597

location_facility: Centro de Invest Clin Chapulte /ID# 162625

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 158724

location_facility: Centro de Pesquisas Oncologicas /ID# 163567

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167515

location_facility: Semmelweis Egyetem I. Belklini /ID# 158180

location_facility: Instituto Nacional de Cancerol /ID# 159269

location_facility: Hospital de Cancer de Barretos /ID# 163568

location_facility: Nagasaki University Hospital /ID# 160233

location_facility: Universitair Ziekenhuis Antwerpen /ID# 159566

location_facility: Haukeland University Hospital /ID# 165630

location_facility: Fakult Nem Kralovske Vinohrady /ID# 159248

location_facility: Cliniques Universitaires Saint Luc /ID# 159567

location_facility: Hosp. Univ. Dr. Jose E. Gonz /ID# 159268

location_facility: The First Affiliated Hospital,College of Medicine, Zhejiang University /ID# 167324

location_facility: Hospital do Cancer Mae de Deus /ID# 163416

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 163126

location_facility: Petz Aladar Megyei Oktato Korh /ID# 161739

summary: The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer

summary:
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body.

In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.

lead_sponsor: Seagen Inc.

location_country:
Spain
Italy
United States
France
Belgium

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Providence Regional Medical Center Everett

location_facility: University of Iowa Hospitals and Clinics

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: Hôpital Franco-Britannique - Fondation Cognacq-Jay

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Florida Cancer Specialists - South Region

location_facility: Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara

location_facility: Florida Cancer Specialists - North Region

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Keck Medical Center / University of Southern California

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Lombardi Cancer Center / Georgetown University Medical Center


acronym: Pembrolizumab or placebo in combination with chemoradiation in subjects with locally advanced HNSCC

title: A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Figueiredo Lima IP, Pointreau Y, M Hughes BG, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Israel
Turkey
Brazil
Canada
Germany
Taiwan
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)

location_facility: Hadassah Ein Karem Jerusalem ( Site 0902)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0052)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)

location_facility: Peter MacCallum Cancer Centre ( Site 0300)

location_facility: University of Rochester - James P. Wilmot Cancer Center ( Site 0255)

location_facility: Centro Regional Integrado de Oncologia ( Site 0002)

location_facility: Centro de Investigacion Clinica del Country ( Site 0155)

location_facility: UZ Leuven Campus Gasthuisberg ( Site 0652)

location_facility: Clinique et Maternite Sainte-Elisabeth ( Site 0653)

location_facility: Istituto Europeo di Oncologia ( Site 0953)

location_facility: Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)

location_facility: Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)

location_facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0356)

location_facility: University of Michigan Hospital and Health Systems ( Site 0267)

location_facility: Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)

location_facility: Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Chungbuk National University Hospital ( Site 0454)

location_facility: Medizinische Hochschule Hannover ( Site 0807)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)

location_facility: Taichung Veterans General Hospital ( Site 0506)

location_facility: Hokkaido University Hospital ( Site 0351)

location_facility: Azienda Ospedaliera San Paolo ( Site 0952)

location_facility: St. Francis Hospital Cancer Center ( Site 1461)

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)

location_facility: Texas Oncology-Arlington North ( Site 8005)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1201)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0001)

location_facility: Rush University Medical Center ( Site 0260)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1001)

location_facility: Erasmus University Medical Center ( Site 1354)

location_facility: Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)

location_facility: Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)

location_facility: Oncology Hematology Care, Inc. ( Site 8003)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0156)

location_facility: Chungnam National University Hospital ( Site 0455)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)

location_facility: Hospital Clinico San Carlos ( Site 1051)

location_facility: St. Luke's Cancer Center - Anderson ( Site 0251)

location_facility: St. Joseph Heritage Healthcare ( Site 0254)

location_facility: Osaka International Cancer Institute ( Site 0355)

location_facility: University Hospital Southampton NHS Foundation Trust ( Site 1203)

location_facility: Fondazione IRCCS - Policlinico San Matteo ( Site 0960)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1015)

location_facility: Princess Alexandra Hospital ( Site 0305)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)

location_facility: Royal Brisbane and Women s Hospital ( Site 0302)

location_facility: Hiroshima University Hospital ( Site 0352)

location_facility: Zachodniopomorskie Centrum Onkologii ( Site 1013)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 1350)

location_facility: Fakultni Nemocnice Hradec Kralove ( Site 0705)

location_facility: Universitätsklinikum Erlangen ( Site 0801)

location_facility: Medipol Universite Hastanesi ( Site 1104)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0357)

location_facility: Taipei Veterans General Hospital ( Site 0504)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)

location_facility: Medical Park Izmir Hastanesi ( Site 1109)

location_facility: McGill University Health Centre ( Site 0061)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0955)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1056)

location_facility: University of California San Francisco ( Site 0274)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0272)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 0400)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)

location_facility: London Health Sciences Centre ( Site 0055)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0286)

location_facility: The Royal Marsden Foundation Trust ( Site 1200)

location_facility: Hospital Gral Universitario de Valencia ( Site 1050)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: University Hospital of North Staffordshire ( Site 1202)

location_facility: Klinikum der Universitaet Munchen ( Site 0810)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)

location_facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0005)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 0502)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 0501)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0304)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)

location_facility: Texas Oncology-Austin Central ( Site 8002)

location_facility: Universitares Cancer Center Hamburg - UCCH ( Site 0811)

location_facility: University of Massachusetts Memorial Medical Center ( Site 0285)

location_facility: University of Virginia Health System ( Site 0261)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1106)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1101)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0256)

location_facility: Tel Aviv Sourasky Medical Center ( Site 0900)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0011)

location_facility: Severance Hospital Yonsei University Health System ( Site 0452)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1055)

location_facility: C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)

location_facility: Institut De Cancerologie De Lorraine ( Site 0758)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)

location_facility: Seoul National University Bundang Hospital ( Site 0453)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0602)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)

location_facility: National Cancer Center Hospital East ( Site 0350)

summary: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).


acronym: Jewelfish

title: An Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Risdiplam (RO7034067) in Adult and Pediatric Patients With Spinal Muscular Atrophy

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
United Kingdom
Italy
Netherlands
Switzerland
United States
France
Belgium
Germany

location_facility: Universitätsklinikum Essen; Klinik für Kinderheilkunde I

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Hopital des Enfants; Unite de Neurologie Pediatrique

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

summary: This is a multi-center, exploratory, non-comparative, and open-label study to investigate the safety, tolerability, PK, and PK/PD relationship of risdiplam in adults, children and infants with Spinal Muscular Atrophy (SMA) previously enrolled in Study BP29420 (Moonfish) with the splicing modifier RO6885247 or previously treated with nusinersen, olesoxime or AVXS-101.


acronym: MORPHO

title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

lead_sponsor: Astellas Pharma Global Development, Inc.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Denmark
Poland
Taiwan
Spain
Greece
Italy
Australia
New Zealand
Canada
United Kingdom
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: University of Wisconsin Hospital and Clinics

location_facility: University Hospitals of Cleveland Medical Center

location_facility: University of Minnesota School of Medicine

summary: The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.


title: A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease

summary: To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

status: Terminated

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
United Kingdom
Spain
United States
Chile
France

intervention_type: Other

status_simplified: Unknown


title: A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies

summary: In this four-part study, NKTR-214 will be administered in combination with nivolumab in Part 1, in combination with nivolumab with or without various chemotherapies in Part 2, and with nivolumab in Parts 3 & 4. In Part 1, the Recommended Phase 2 Dose (RP2D) of NKTR-214 in combination with nivolumab will be determined. In Part 2, NKTR-214 with nivolumab at the RP2D will be evaluated as first-line therapy and/or as second or third line therapy in select patients with Melanoma, Renal Cell Carcinoma (RCC), Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), triple negative Breast Cancer (TNBC), HR+/HER2- breast cancer, gastric cancer, and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the doublet combination of NKTR-214 plus nivolumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the doublet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

ReferenceCitation: Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. Eur Urol. 2022 Oct;82(4):365-373. doi: 10.1016/j.eururo.2022.05.002. Epub 2022 May 25.

ReferenceCitation: Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. J Clin Oncol. 2021 Sep 10;39(26):2914-2925. doi: 10.1200/JCO.21.00675. Epub 2021 Jul 13.

ReferenceCitation: Veatch JR, Singhi N, Jesernig B, Paulson KG, Zalevsky J, Iaccucci E, Tykodi SS, Riddell SR. Mobilization of pre-existing polyclonal T cells specific to neoantigens but not self-antigens during treatment of a patient with melanoma with bempegaldesleukin and nivolumab. J Immunother Cancer. 2020 Dec;8(2). pii: e001591. doi: 10.1136/jitc-2020-001591. Erratum in: J Immunother Cancer. 2021 Feb;9(2):.

ipd_sharing: Undecided

lead_sponsor: Nektar Therapeutics

location_country:
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Belgium

location_facility: Assistance Publique Hopitaux de Marseille - Hopital Nord

location_facility: Washington University School of Medicine in St. Louis

location_facility: New York University Langone Medical Center - NYU Cancer Institute

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)

location_facility: Loyola University Medical Center, Chicago

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Institute for Cancer Research and Treatment (IRCC)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Indiana University Health Melvin & Bren Simon Cancer Center

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza


primary_purpose: Prevention

acronym: rVWF IN PROPHYLAXIS

title: A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

lead_sponsor: Takeda

ReferenceCitation: Leebeek FWG, Peyvandi F, Escobar M, Tiede A, Castaman G, Wang M, Wynn T, Baptista J, Wang Y, Zhang J, Mellgård B, Özen G. Recombinant von Willebrand factor prophylaxis in patients with severe von Willebrand disease: phase 3 study results. Blood. 2022 Jul 14;140(2):89-98. doi: 10.1182/blood.2021014810.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Spain
Italy
Russian Federation
Netherlands
Canada
United States
France
Turkey
Germany

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of Florida College of Medicine

location_facility: FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Bleeding and Clotting Disorders Institute

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Comprehensive Cancer Center of Wake Forest Unversity

summary: The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).


title: A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)

summary: This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

ReferenceCitation: Levy C, Kendrick S, Bowlus CL, Tanaka A, Jones D, Kremer AE, Mayo MJ, Haque N, von Maltzahn R, Allinder M, Swift B, McLaughlin MM, Hirschfield GM; GLIMMER Study Group. GLIMMER: A randomized Phase 2b dose-ranging trial of linerixibat in primary biliary cholangitis patients with pruritus. Clin Gastroenterol Hepatol. 2022 Nov 4. pii: S1542-3565(22)01021-7. doi: 10.1016/j.cgh.2022.10.032. [Epub ahead of print]

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Japan
Germany


title: An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.

summary: The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Poland
Taiwan
Belgium
Spain
Italy
Russian Federation
Australia
Mexico
Canada
Thailand
United Kingdom
Hungary
Korea, Republic of
United States
France
Turkey
Colombia
Japan

location_facility: Texas Scottish Rite Hospital for Children SC

location_facility: University of Colorado School of Medicine

location_facility: Cincinnati Children s Hospital Medical Center SC-2


title: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)

acronym: SOLVE-CRT

summary: This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.

ReferenceCitation: Singh JP, Abraham WT, Auricchio A, Delnoy PP, Gold M, Reddy VY, Sanders P, Lindenfeld J, Rinaldi CA. Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial. Am Heart J. 2019 Nov;217:13-22. doi: 10.1016/j.ahj.2019.04.002. Epub 2019 Apr 9.

lead_sponsor: EBR Systems, Inc.

location_country:
United Kingdom
Italy
Australia
Netherlands
United States
France
Germany

location_facility: Penn State Health, Hershey Medical Center

location_facility: CHU Grenoble - Hopital Michallon Service de Cardiologie

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

location_facility: University of Illinois Hospital & Health Sciences System

location_facility: St. Vincent's Hospital and Healthcare Center

location_facility: Methodist Physicians Clinic Heart Consultants

location_facility: Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ)

location_facility: The University of Texas Health Science Center at Houston

intervention_type: Device


title: A Phase II Single Arm Clinical Trial of a Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma

acronym: TITAN-RCC

summary: TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab "boost" cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC.

lead_sponsor: AIO-Studien-gGmbH

location_country:
Spain
Italy
Austria
United Kingdom
France
Belgium
Germany
Czechia

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Universitätsklinikum Jena und Poliklinik für Urologie

location_facility: Azienda USL8 Arezzo U.O.C. Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: AKH Wien Universitätsklinik für Innere Medizin I

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario Central de Asturias

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: Universität des Saarlandes Medizinische Fakultät

location_facility: Hospital Universitario Marques de Valdecilla


title: A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)

lead_sponsor: Merus N.V.

location_country:
Taiwan
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Sweden
Korea, Republic of
United States
France
Israel
Norway
Belgium
Japan
Germany
Singapore

location_facility: START Hospital Universitario Madrid Sanchinarro

location_facility: Seoul National University College of Medicine

location_facility: National Cancer Centre of Singapore PTE LTD

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Vall D'Hebron Institute of Oncology (VHIO)

location_facility: Severance Hospital- Yonsei Cancer Center

summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)


acronym: SUNFISH

title: A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients

ReferenceCitation: Mercuri E, Deconinck N, Mazzone ES, Nascimento A, Oskoui M, Saito K, Vuillerot C, Baranello G, Boespflug-Tanguy O, Goemans N, Kirschner J, Kostera-Pruszczyk A, Servais L, Gerber M, Gorni K, Khwaja O, Kletzl H, Scalco RS, Staunton H, Yeung WY, Martin C, Fontoura P, Day JW; SUNFISH Study Group. Safety and efficacy of once-daily risdiplam in type 2 and non-ambulant type 3 spinal muscular atrophy (SUNFISH part 2): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2022 Jan;21(1):42-52. doi: 10.1016/S1474-4422(21)00367-7. Erratum in: Lancet Neurol. 2022 Feb;21(2):e2. Lancet Neurol. 2022 Mar;21(3):e3. Lancet Neurol. 2022 May;21(5):e5.

location_country:
Croatia
Poland
Brazil
Serbia
Spain
Italy
Russian Federation
United Kingdom
Canada
United States
France
China
Turkey
Belgium
Japan
Germany

location_facility: Clinical Medical Center Zagreb; University Hospital Rebro Department of Paediatrics

location_facility: University of Oxford; Department of Paediatrics

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Hospital Yeditepe University Kozyatagi; Pediatry

location_facility: London Health Sciences Centre; Children's Hospital; Pediatrics

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"; UO di Neurologia dello Sviluppo

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: National Center Of Neurology And Psychiatry Hospital

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

location_facility: Columbia University Medical Center; The Neurological Institute of New York

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Reumatologia

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: Alberta Children's Hospital Division of Pediatric Neurology

location_facility: Hôpital Necker-Enfants Malades; Service de neuropédiatrie

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen

location_facility: McGill University Health Centre - Glen Site

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

location_facility: Hacettepe University, School of Medicine; Pediatrics Department; Pediatrics Child Neurology Unit

location_facility: Russian Children Neuromuscular Center of Veltischev

location_facility: Szpital Kliniczny im. H. Swiecickiego U.M. w Poznaniu; Od. Kliniczny Neurologii Dzieci i Młodziezy

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: Szpital Gdanskiego Uniwersytetu Medycznego; Clinic of developmental neurology

summary: Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.


acronym: PSO-LONG

title: LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

lead_sponsor: LEO Pharma

ReferenceCitation: Guenther L, Takhar A, Megna M, Sebastian M, Nyholm N, Thoning H, Levin LÅ. Impact of fixed-dose combination Cal/BD foam on the work productivity of patients with psoriasis: results from the 52-week randomized, double-blind, PSO-LONG trial. J Eur Acad Dermatol Venereol. 2022 Jul;36(7):1054-1063. doi: 10.1111/jdv.18053. Epub 2022 Mar 28.

ReferenceCitation: Lebwohl MG, Papp KA, Mørch MH, Bernasconi MYJ, Warren RB. Long-Term Proactive Treatment of Plaque Psoriasis with Calcipotriene/Betamethasone Dipropionate Foam Prolongs Remission and Reduces Relapses Irrespective of Patient Baseline Characteristics. Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.

ReferenceCitation: Stein Gold L, Alonso-Llamazares J, Lacour JP, Warren RB, Tyring SK, Kircik L, Yamauchi P, Lebwohl M; PSO-LONG Trial Investigators. PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis. Adv Ther. 2020 Nov;37(11):4730-4753. doi: 10.1007/s12325-020-01497-6. Epub 2020 Sep 23.

location_country:
Poland
United Kingdom
Canada
United States
France
Germany

location_facility: The Guenther Dermatology Research Centre

location_facility: Psoriasis Treatment Center of Central NJ

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie

location_facility: C.H.U. de nice, Hôpital de l'Archet II, Service de Dermatologie-Vénérologie

location_facility: Center for Dermatology Clinical Research

location_facility: Rivergate Dermatology Clinical Research Center

location_facility: Henry Ford Medical Center - New Center One

location_facility: C.H.U. de Saint-Etienne Service de Dermatologie

location_facility: Kliniczny Szpital Wojewódzki, Klinika Dermatologii

summary:
A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.


title: Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

lead_sponsor: Sanofi

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Switzerland
Hungary
United States
France
Israel
Turkey
Belgium
Czechia

location_facility:
Investyigator Site 1
Investigator Site
Investigator Site 2
Investigator site 2
Investigator Site 1
Investigator site 1
Investigator site

summary: The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).


title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

lead_sponsor: Jazz Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Australia
New Zealand
Canada
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Japan
Germany

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Medical University of South Carolina - PPDS

location_facility: Acibadem Universitesi Tip Fakultesi Atakent Hastanesi

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Medical Hospital Tokyo Medical and Dental University

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopôle

location_facility: Centre Hospitalier Universitaire du Sart Tilman

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Severance Hospital at Yonsei University Health System

location_facility: Hospital General Universitario Morales Meseguer

location_facility: 11. Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G M Lancisi G Salesi

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Akdeniz University Medical Faculty Department of Pediatrics

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Schneider Children Medical Center of Israel

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

summary: This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.


title: A Prospective, Non-interventional Study Measuring Quality of Life, Treatment Preference and Treatment Satisfaction of Autosomal Dominant Polycystic Kidney Disease Patients in Europe

acronym: ACQUIRE

summary: This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.

status: Unknown status

ReferenceCitation: Joly D, Quinn J, Mokiou S, O'Reilly K, Sánchez-Covisa J, Wang-Silvanto J, Doll H. Rationale and study protocol of ACQUIRE, a prospective, observational study measuring quality of life, treatment preference and treatment satisfaction of autosomal dominant polycystic kidney disease (ADPKD) patients in Europe. BMC Nephrol. 2020 Jul 24;21(1):298. doi: 10.1186/s12882-020-01927-1.

lead_sponsor: Otsuka Pharmaceutical Europe Ltd

location_country:
Spain
United Kingdom
Austria
Switzerland
France
Belgium
Germany

location_facility: University Medical Center Schleswig-Holstein

location_facility: CHU Liège - Domaine Universitaire du Sart Tilman


title: A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

acronym: SIDEROS

summary: The purpose of the study is to assess the efficacy of idebenone in delaying the loss of respiratory function in patients with DMD receiving concomitant glucocorticoid steroids

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

ReferenceCitation: McDonald CM, Meier T, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Spagnolo P, Buyse GM; DELOS Study Group. Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2016 Aug;26(8):473-80. doi: 10.1016/j.nmd.2016.05.008. Epub 2016 May 12.

ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CS, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, Rummey C, Leinonen M, Mayer OH, Spagnolo P, Meier T, McDonald CM; DELOS Study Group. Treatment effect of idebenone on inspiratory function in patients with Duchenne muscular dystrophy. Pediatr Pulmonol. 2017 Apr;52(4):508-515. doi: 10.1002/ppul.23547. Epub 2016 Aug 29.

lead_sponsor: Santhera Pharmaceuticals

location_country:
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Bulgaria

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin

location_facility: Scientific Coordinator Nemo Sud Clinical Center

location_facility: Great Ormond Street Hospital for Children

location_facility: John Walton Muscular Dystrophy Research Centre

location_facility: Reparto Di Neurologia dell'Osperdale Di Padova

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital

location_facility: Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital

location_facility: Centre de Référence Neuromusculaire, CHR Citadelle

location_facility: Institute of Neurology at Schneider Children's Medical Center of Israel

location_facility: Banner University of Arizona Medical Center

location_facility: Servizio di Cardiomiologia e Genetica Medica, AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System

location_facility: Dipartimento di Clinica Neurologica e Psichiatrica dell'Età Evolutiva della Fondazione IRCCS "C. Mondino" di Pavia

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Semmelweis University 2nd Department of Paediatrics

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Gillette Children's Specialty Healthcare

location_facility: Universitätsklinikum Heidelberg Zentrum für Kinder- und Jugendmedizin

location_facility: UCL, National Hospital for Neurology and Neurosurgery

location_facility: Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: Oxford University hospitals NHS Foundation Trust

location_facility: UC Davis Department of Physical Medicine and Rehabilitation

location_facility: I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20

location_facility: Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre


title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

summary: The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).

ReferenceCitation: Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Spain
Greece
Italy
Netherlands
United Kingdom
Finland
Canada
United States
France
Belgium
Germany

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: New England Institute for Clinical Research

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Walton Centre for Neurology and Neurosurgery


title: A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors

summary: This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

lead_sponsor: Genentech, Inc.

location_country:
Spain
Australia
Canada
Korea, Republic of
United States
France
Japan

location_facility: Uni of Pittsburgh Cancer Inst. ; Oncology

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Rhode Island Hospital; Pharmacy Department


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

acronym: SUNRISE 1

summary: This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

ReferenceCitation: Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.

ReferenceCitation: Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82. pii: 20m13795. doi: 10.4088/JCP.20m13795.

ReferenceCitation: Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150.

ReferenceCitation: Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254. Erratum in: JAMA Netw Open. 2020 Apr 1;3(4):e206497. JAMA Netw Open. 2021 Aug 2;4(8):e2127643.

lead_sponsor: Eisai Inc.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: Clinical Research Group of St Petersburg Inc

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Medical University of South Carolina - PPDS

location_facility: Orange County Neuropsychiatric Research Center, LLC

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Quest Pharmaceutical Services-Miami Research Associates, LLC (QPS MRA)

location_facility: Artemis Institute For Clinical Research LLC

location_facility: Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Sleep Medicine Centers of Western New York

location_facility: Saint Francis Sleep Allergy and Lung Institute

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Zentralinstitut für Seelische Gesundheit

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fleming Island Center For Clinical Research


title: A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

summary: This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

ReferenceCitation: Lonial S, Popat R, Hulin C, Jagannath S, Oriol A, Richardson PG, Facon T, Weisel K, Larsen JT, Minnema MC, Abdallah AO, Badros AZ, Knop S, Stadtmauer EA, Cheng Y, Amatangelo M, Chen M, Nguyen TV, Amin A, Peluso T, van de Donk NWCJ. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lancet Haematol. 2022 Nov;9(11):e822-e832. doi: 10.1016/S2352-3026(22)00290-3. Epub 2022 Oct 6.

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Israel
Japan
Germany

location_facility: Loyola University Medical Center LUMC - Cardinal Bernardin Cancer Center CBCC

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: McGill University Health Center - Royal Victoria Hospital

location_facility: Robert H Lurie Comprehensive Cancer Center NW Univ

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of Washington-Seattle Cancer Care Alliance

location_facility: "Regional" - Oncology Hematology West, PC dba Nebraska Cancer Specialist

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: The Blavatnik Family- Chelsea Medical Center at Mount Sinai

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Winship Cancer Institute of Emory University

location_facility: "Bergan"- Oncology Hematology West, PC dba Nebraska Cancer Specialist

location_facility: Icahn School of Medicine at Mount Sinai Medical Center

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: New York Presbyterian Hospital Weil Cornell Medical College

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

location_facility: "Grand Island"- Oncology Hematology West, PC dba Nebraska Cancer Specialist

location_facility: "Methodist"- Oncology Hematology West, PC dba Nebraska Cancer Specialist

location_facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: "Papillion"- Oncology Hematology West, PC dba Nebraska Cancer Specialist

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Texas Southwestern Medical Center


acronym: VENICE I

title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)

lead_sponsor: AbbVie

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Portugal
Austria
Puerto Rico
Israel
Turkey
Norway
Sweden
Canada
Switzerland
Germany
Denmark
Greece
Ireland
Finland
France
Netherlands

location_facility: Hanusch Krankenhaus der WGKK /ID# 147548

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 147503

location_facility: Sunnybrook Health Sciences Ctr /ID# 147462

location_facility: CHRU de Brest - Hopital Morvan /ID# 147485

location_facility: Vehbi Koc vakfi Amerikan Hasta /ID# 147325

location_facility: Southampton General Hospital /ID# 147646

location_facility: Albert Schweitzer Ziekenhuis /ID# 147495

location_facility: The Royal Wolverhampton NHS Tr /ID# 147945

location_facility: General Hospital of Athens Laiko /ID# 147517

location_facility: Cliniques Universitaires Saint Luc /ID# 147388

location_facility: Hospital Santa Creu i Sant Pau /ID# 151230

location_facility: Hospital Clinico Univ de Salamanca /ID# 147392

location_facility: Onkologische Schwerpunktpraxis /ID# 147516

location_facility: Skanes Universitetssjukhus Lund /ID# 147439

location_facility: OncoResearch Lerchenfeld GmbH /ID# 164044

location_facility: West Virginia Univ School Med /ID# 151602

location_facility: Univ Hosp Bristol NHS Foundati /ID# 147647

location_facility: Ondokuz mayis University Facul /ID# 147326

location_facility: Istanbul University Istanbul Medical Faculty /ID# 156040

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 151624

location_facility: CHU de Quebec-Universite Laval /ID# 150299

location_facility: Cent fuer Haematologie und Onk /ID# 147511

location_facility: Haukeland University Hospital /ID# 147382

location_facility: Puerto Rico Hematology Oncolog /ID# 150003

location_facility: Hopitaux Universitaires de Geneve /ID# 147930

location_facility: Ospedale Regional Bellinzona e /ID# 151232

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 147505

summary: The purpose of this study is to evaluate the efficacy of venetoclax monotherapy in participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation OR those who have received prior treatment with a B-cell receptor inhibitor.


title: A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors

acronym: Bellini

summary: This is a Phase 3, multicenter, randomized, double blind, placebo-controlled study evaluating the efficacy and safety of venetoclax plus bortezomib and dexamethasone in subjects with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and received 1 to 3 prior lines of therapy for multiple myeloma.

ReferenceCitation: Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Taiwan
Brazil
Spain
Ireland
Italy
Australia
Russian Federation
Canada
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Japan
Germany

location_facility: Bashkir State Medical University /ID# 151206

location_facility: China Medical University Hospital /ID# 154446

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 148948

location_facility: Duplicate_Centre Hospitalier Lyon Sud /ID# 149300

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 149020

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 150895

location_facility: University College London Hospitals NHS Foundation Trust /ID# 149044

location_facility: The Royal Wolverhampton NHS Trust /ID# 149043

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 152518

location_facility: Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 152414

location_facility: Hospital Universitario 12 de Octubre /ID# 148981

location_facility: Univ of Colorado Cancer Center /ID# 149130

location_facility: The Cancer Institute Hospital Of JFCR /ID# 150780

location_facility: East Kent Hospitals University NHS Foundation Trust /ID# 149059

location_facility: Kuzbass Regional Clinical Hospital /ID# 148955

location_facility: Japanese Red Cross Medical Center /ID# 149902

location_facility: Seoul National University Bundang Hospital /ID# 150888

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust /ID# 149058

location_facility: National Hospital Organization Shibukawa Medical Center /ID# 150281

location_facility: Nottingham University Hospitals NHS Trust /ID# 149047

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 152411

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 148949

location_facility: Hospital Universitario Dr. Peset /ID# 148986

location_facility: Royal Brisbane and Women's Hospital /ID# 149105

location_facility: Hospital Universitario de la Princesa /ID# 148980

location_facility: Central Clinical Hospital RZHD Medicine /ID# 148954

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 148939

location_facility: Clinical Oncology Dispensary of Omsk /ID# 148953

location_facility: Nagoya City University Hospital /ID# 150943

location_facility: Taipei Veterans General Hosp /ID# 154445

location_facility: Chonnam National University Hospital /ID# 150894

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 148936

location_facility: Duplicate_Yonsei University Health System, Severance hospital. /ID# 150891

location_facility: Gachon University Gil Medical Center /ID# 150893

location_facility: National Cancer Center Hospital /ID# 151039

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 149025

location_facility: Seoul National University Hospital /ID# 150890

location_facility: The Queen Elizabeth Hospital /ID# 149104

location_facility: National Hospital Organization Mito Medical Center /ID# 151051

location_facility: CHRU de Brest - Hopital Morvan /ID# 149299

location_facility: National Taiwan University Hospital /ID# 154444

location_facility: Japanese Red Cross Osaka Hospital /ID# 150716

location_facility: Samara State Medical University /ID# 148952

location_facility: Manchester University NHS Foundation Trust /ID# 149046

location_facility: Concord Repatriation General Hospital /ID# 149106

location_facility: Gabrail Cancer Center Research /ID# 149098

location_facility: A.O.U. Città della Salute e della Scienza di Torino/Ospedale Molinette /ID# 148943

location_facility: King's College Hospital NHS Foundation Trust /ID# 149045

location_facility: Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 156524

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 148956

location_facility: CHU Grenoble - Hopital Michallon /ID# 149301

location_facility: Kobe City Medical Center General Hospital /ID# 150944

location_facility: Hospital das Clinicas da Universidade Federal de Goiás /ID# 149290

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 148942

location_facility: Royal Prince Alfred Hospital /ID# 149108

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 152516

location_facility: Duplicate_Kyoto Prefectural University of Medicine /ID# 150719

location_facility: National Hospital Organization Disaster Medical Center /ID# 150784

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 150242

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust /ID# 149055

location_facility: Liga Norte Riograndense Contra o Câncer /ID# 149023

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 152517

location_facility: JCHO Kyoto Kuramaguchi Medical /ID# 150781

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 149294


title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients

summary:
The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.

lead_sponsor: Debiopharm International SA

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Canada
Hungary
Germany
Taiwan
Thailand
Vietnam
Korea, Republic of
France


title: Prospective, Multi-national, Multicentre, Non-interventional Study to Evaluate the Long Term Safety of Esmya, in Particular Endometrial Safety, and the Current Prescription and Management Patterns of Esmya in a Long Term Treatment Setting.

acronym: Premium

summary: This is a multi-centre, multinational, prospective, non-interventional study in females with a diagnosis of moderate to severe uterine fibroids, and for whom a treatment with Esmya in a long term manner is planned, and in subjects who were previously exposed to UPA in the long term Phase III studies.

lead_sponsor: PregLem SA

location_country:
Denmark
Poland
Portugal
Romania
Spain
Italy
Latvia
Netherlands
United Kingdom
Lithuania
Sweden
Hungary
France
Belgium
Germany
Czechia

location_facility: Szegedi Tudomanyegyetem, Szuleszeti es Nogyogyaszati Klinika

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Royal United Hospital, Bath - Royal United Hospital Bath NHS Trust

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Rosemere Cancer Centre - Royal Preston Hospital

location_facility: Hospital Universitario de Guadalajara (HUG)

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: University ""Magna Graecia"" Of Catanzaro

location_facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

location_facility: Gabinet Lekarski Specjalistyczny "Sonus" Lemieszczuk Boguslaw

location_facility: Unversitaetsklinikum Hamburg Eppendorf - Klinik und Poliklinik fur Gynakologie

location_facility: Royal Stoke University Hospital - University Hospital of North Midlands NHS Trust

location_facility: University of Torino, S. Anna Hospital- City of Health and Science

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Groupement Hospitalier Universitaire Sud CHU Bicetre

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Jessop Wing

location_facility: Praxis fuer Gynaekologie & Geburtshilfe Prof. Dr. Dr. A. Ebert

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

location_facility: Hinchingbrooke Health Care NHS Trust - Hinchingbrooke Hospital

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico Santa Maria Alle Scotte

location_facility: Szent Anna Privat Surgery-Szent Anna Magae¡nrendela

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: ASSIR OSONA (Atencio a la Salut Sexual i Reproductiva) - ICS (Institut Catala de la Salut)

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: PAN-Klinik am Neumarkt-Gemeinschaftspraxis fur Urologie

location_facility: Woman's Health Sciences Department, Gynecologic Section, Hsopital G. Salesi- Polytechnic University of Marche

location_facility: University Hospital Of North Tees - North Tees And Hartlepool Nhs Foundation Trust

location_facility: Elena Doamna Obstetrics and Gynecology Clinical Hospital

location_facility: Karolinska Institutet, Karolinska University Hospital Huddinge

location_facility: Endoskopie Und Endometriose-Zentrum Munchen

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Instituto Palacios, Salud y Medicina de la Mujer

location_facility: Hull Royal Infirmary - Hull and East Yorkshire Hospitals NHS Trust

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona


title: A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)

summary: Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

lead_sponsor: Bellerophon Pulse Technologies

location_country:
Croatia
Portugal
Serbia
Spain
Colombia
Austria
Australia
Italy
Canada
Netherlands
United Kingdom
Ukraine
United States
France
Israel
Belgium
Germany
Czechia

location_facility: CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie

location_facility: University of Texas Southwestern Medical Center of Dallas

location_facility: Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires

location_facility: Toronto General Hospital, University Health Network

location_facility: Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1

location_facility: Lawson Clinical Research Services / London Health Sciences Centre - VH

location_facility: University of California, Davis Medical Center

location_facility: Medizinische Hochschule Hannover-Abteilung für Pneumologie

location_facility: Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: National institute of phthisiology and pulmonology

location_facility: Bluhm Cardiovascular Institute, Clinical Trials Unit

location_facility: UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division

location_facility: Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I

location_facility: University of Arizona Sarver Heart Center

location_facility: Montefiore Medical Center - Weiler Division

location_facility: National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE"

location_facility: Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie

location_facility: Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville

location_facility: Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

location_facility: Wellstar Medical Group - Pulmonary Medicine

location_facility: Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B

location_facility: AKH-Vienna, Medical University of Vienna

location_facility: Clinical Center of Serbia Department of Cardiology and Polyclinic

location_facility: Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C)

location_facility: Faculty of Medicine / Peter Lougheed Center / Respiratory Research

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

location_facility: NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine

location_facility: Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie

location_facility: Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep

location_facility: Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II

location_facility: Clinical Center of Nis, Clinic for Cardiovascular Diseases

location_facility: Lviv Regional Clinical Hospital, Department of Intesive Care #2

location_facility: University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department

location_facility: Hospital Universitario Puerta de Hierro - Madrid

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: A.O.U. Policlinico Umberto I- Università La Sapienza

location_facility: Hospital Universitario Marques de Valdecilla (HUMV)

location_facility: Clinical Center of Serbia, Polyclinic, Pulomology Department

location_facility: "Universitätsklinikum Freiburg - Medizinische Universitätsklinik

location_facility: Vseobecna Fakultni Nemocnice v Praze (VFN)