title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)

summary:
Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.

Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Netherlands
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University Of Iowa Hospitals And Clinics

location_facility: St. Vincent Indianapolis Hospital And Health Care Center

location_facility: University Of Texas Medical School - Houston

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Columbia University Medical Center (Cumc)


type: Other Identifier

type: EudraCT Number

title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United Kingdom
United States
Costa Rica
Peru
Belgium
Japan
Poland
Portugal
Austria
Australia
Puerto Rico
Turkey
Norway
Malaysia
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Taiwan
Greece
Finland
Korea, Republic of
France
Colombia
Netherlands

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)

location_facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)

location_facility: Hôpital Foch-Urology department ( Site 1351)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0857)

location_facility: Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)

location_facility: Seoul National University Hospital ( Site 0802)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)

location_facility: Urological Research Network ( Site 1106)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0860)

location_facility: UZA University Hospital Antwerp ( Site 0105)

location_facility: Akershus University Hospital ( Site 0553)

location_facility: University Hospital of Larissa ( Site 0301)

location_facility: Universitaetsklinik Salzburg ( Site 0053)

location_facility: Urology Clinics of North Texas, PLLC ( Site 1064)

location_facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)

location_facility: Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)

location_facility: Northwestern Memorial Hospital ( Site 1101)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 1091)

location_facility: Tampere University Hospital [Tampere Finland] ( Site 0201)

location_facility: Hospital Universitario Lucus Augusti ( Site 0852)

location_facility: Urology Associates [Nashville, TN] ( Site 1072)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8003)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)

location_facility: CHU UCL Namur Site de Godinne ( Site 0103)

location_facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)

location_facility: Policlinico Universitario A. Gemelli ( Site 0358)

location_facility: University of California Irvine Medical Center ( Site 1061)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)

location_facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)

location_facility: Hospital São Carlos-Oncocentro Ce ( Site 1558)

location_facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0409)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 0604)

location_facility: 2CA Braga. Centro Clinico Academico ( Site 0705)

location_facility: OHSU Knight Cancer Institute ( Site 1075)

location_facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)

location_facility: Taichung Veterans General Hospital ( Site 1653)

location_facility: Oncomedica S.A.-Oncomedica S.A ( Site 1604)

location_facility: Mayo Clinic in Arizona - Phoenix ( Site 1094)

location_facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10

location_facility: University of Vermont Medical Center ( Site 1057)

location_facility: Exdeo Clinical Research Inc. ( Site 0165)

location_facility: Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)

location_facility: Michigan Institute of Urology ( Site 1077)

location_facility: Carolina Urologic Research Center ( Site 1085)

location_facility: Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)

location_facility: Taipei Veterans General Hospital ( Site 1652)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)

location_facility: University Of Texas Southwestern Medical Center ( Site 1053)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)

location_facility: Osaka Metropolitan University Hospital ( Site 0404)

location_facility: Medical Concierge Centrum Medyczne ( Site 0676)

location_facility: Woodlands Medical Specialists, PA ( Site 8002)

location_facility: Nara Medical University Hospital ( Site 0411)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)

location_facility: Kitasato University Hospital ( Site 0403)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)

location_facility: Administradora Country S.A. - Clinica del Country ( Site 1607)

location_facility: Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)

location_facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)

location_facility: Stavanger universitetssykehus ( Site 0555)

location_facility: Osp Generale Reg di Bolzano ( Site 0355)

location_facility: Korea University Anam Hospital ( Site 0801)

location_facility: Sylvester Comprehensive Cancer Center ( Site 1056)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)

location_facility: Maastricht University Medical Centre ( Site 0453)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 0679)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1059)

location_facility: Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)

location_facility: MD Anderson Cancer Center Madrid ( Site 0859)

location_facility: Univ. Klinik f. Urologie Innsbruck ( Site 0051)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Hospital Universitario Quiron Madrid ( Site 0862)

location_facility: General University Hospital of Patras ( Site 0302)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)

location_facility: Clinica Universitaria de Navarra ( Site 0863)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)

location_facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0854)

location_facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0653)

location_facility: Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 1087)

location_facility: Associated Medical Professionals of NY ( Site 1078)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)

location_facility: Semmelweis University-Urológiai Klinika ( Site 1301)

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)

location_facility: University Hospitals Cleveland Medical Center ( Site 1066)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0357)

location_facility: Clinical Research Center Sp. z o.o. ( Site 0674)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)

location_facility: Osaka International Cancer Institute ( Site 0413)

location_facility: Advance Urology and Laparoscopic Center ( Site 0757)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)

location_facility: University Malaya Medical Centre ( Site 1180)

location_facility: Hemato Oncologos SA-Oncology ( Site 1601)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)

location_facility: Medizinische Universität Wien ( Site 0054)

location_facility: Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)

location_facility: China Medical University Hospital-Department of Urology ( Site 1654)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)

location_facility: Hirosaki University Hospital ( Site 0407)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0265)

location_facility: Princess Margaret Cancer Centre ( Site 0153)

location_facility: Urology San Antonio Research ( Site 1108)

location_facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)

location_facility: Hospital Universitario La Paz ( Site 0866)

location_facility: University of Tsukuba Hospital ( Site 0412)

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

summary:
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.

The study is divided into two parts: single agent FT-2102 followed by combination therapy.

Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored.

Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

enrollment_type: Actual

lead_sponsor: Forma Therapeutics, Inc.

location_country:
Spain
United Kingdom
Australia
Korea, Republic of
United States
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Washington University School of Medicine

location_facility: Northwestern University, Lurie Comprehensive Cancer Center

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: Medical College of Wisconsin, Froedtert Hospital

location_facility: University of Iowa, Holden Comprehensive Cancer Institute

location_facility: University of Miami, Sylvester Comprehensive Cancer Center

location_facility: Centre de Lutte Contre Cancer (CLCC) - Institute Bergonie

status_simplified: Completed


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma

summary: A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

ReferenceCitation: Moss MH, Lugogo NL, Castro M, Hanania NA, Ludwig-Sengpiel A, Saralaya D, Dobek R, Ojanguren I, Vyshnyvetskyy I, Bruey JM, Osterhout R, Tompkins CA, Dittrich K, Raghupathi K, Ortega H; LEDA Investigators. Results of a Phase 2b Trial With GB001, a Prostaglandin D(2) Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma. Chest. 2022 Aug;162(2):297-308. doi: 10.1016/j.chest.2022.02.038. Epub 2022 Mar 3.

ReferenceCitation: Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.

ipd_sharing: No

lead_sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
Poland
Spain
United Kingdom
Austria
Canada
Ukraine
United States
France
Belgium
Germany
Czechia

location_facility: University Hospital Olomouc, Department of Allergology and Clinical Immunology

location_facility: The Lung Centre, Vancouver General Hospital

location_facility: SALK University Hospital Salzburg, State Hospital Salzburg

location_facility: Allergy and Asthma Diagnostic Treatment Center

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1

location_facility: Glasgow Clinical Research Facility, Glasgow Royal Infirmary

location_facility: Allergy and Clinical Immunology Associates

location_facility: State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: MultiCare Institute for Research & Innovation

location_facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel

location_facility: Banner University of Arizona Medical Center

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Institut fuer Allergie - und Asthmaforschung

location_facility: NOUVEL HOPITAL CIVIL - New Civil Hospital

location_facility: Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog

location_facility: Allergy, Asthma & Sinus Consultants, Inc

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)

location_facility: Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council

location_facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

location_facility: Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council

location_facility: Public Institution: City Clinical Hospital #6

location_facility: Outpatient Allergology and Neurology Clinic Kasmed Ltd.

location_facility: UZ Gent - Department of Respiratory Medicine

location_facility: University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy

location_facility: Allergiste & Immunologue - Clinic/Outpatient Facility

location_facility: Allergy and Asthma Associates of Santa Clara Valley Research Center

location_facility: Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal

location_facility: St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology

location_facility: Pulmonary Outpatient Clinic - Dr. Otakar Hokynar

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

location_facility: Public Institution "City Clinical Hospital #4" under Dnipro City Council

location_facility: Allergy & Asthma Medical Group and Research Center, A P.C.

location_facility: Public Enterprise "Hospital #1" under Zhytomyr City Council

location_facility: Berks Schuylkill Respiratory Specialists, Ltd.

location_facility: California Allergy and Asthma Medical Group

location_facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V

location_facility: Pulmonary Outpatient Clinic Rokycany s.r.o.

intervention_type: Drug


title: Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers

acronym: AURA

summary:
Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC).

Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.

status: Active, not recruiting

ReferenceCitation: Martinez Chanza N, Soukane L, Barthelemy P, Carnot A, Gil T, Casert V, Vanhaudenarde V, Sautois B, Staudacher L, Van den Brande J, Culine S, Seront E, Gizzi M, Albisinni S, Tricard T, Fantoni JC, Paesmans M, Caparica R, Roumeguere T, Awada A. Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial). BMC Cancer. 2021 Dec 2;21(1):1292. doi: 10.1186/s12885-021-08990-3.

lead_sponsor: Jules Bordet Institute

location_country: France Belgium

location_facility: Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage

intervention_type: Procedure


title: Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

acronym: INDURE

summary: Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.

ReferenceCitation: Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.

ReferenceCitation: Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729. Review.

ReferenceCitation: Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244.

ReferenceCitation: Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwöger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
France
Belgium
Germany

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona

location_facility: UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie

location_facility: University Hospital Virgen de la Arrixaca

location_facility: L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)

location_facility: Institut de Cardiologie de Montréal, Université de Montréal

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Rennes

intervention_type: Device


title: An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

summary: Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

lead_sponsor: Albireo

location_country:
Poland
Saudi Arabia
Italy
Spain
Australia
Netherlands
Canada
United Kingdom
Sweden
United States
France
Israel
Turkey
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Instytut Pomnik - Centrum Zarowia Dziecka

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Univesitatsklinikum Tubingen Klinik fur Kinder und Jugendmedizin

location_facility: Baylor College of Medicine - Texas Children's Liver Center

location_facility: Kinderklinik Tubingen, Universitatsklinikum Tubingen

location_facility: Universitair Medisch Centrum (UMC) Utrecht

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Riley Hospital for Children - Riley Children's Specialists

location_facility: Hacettepe University Faculty of Medicine

location_facility: Universite Paris SUD - Hpitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Schneider Children's Medical Center Of Israel

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: University and Pediatric Hospital of Lyon

location_facility: Columbia University Medical Center - Presbyterian Hospital Building


title: A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

acronym: Diamond-AFII

summary: The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Canada
United States
France
Germany
Czechia

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Institut Klinicke a Experimentalni Mediciny (IKEM)


status: Terminated

acronym:
Systemic Corticosteroids Avoidance Study in Severe Asthma Patients.

 Étude de réduction des corticoïdes systémiques chez des patients souffrant d'asthme sévère.

title: A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma

lead_sponsor: Novartis Pharmaceuticals

source: euctr

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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
Spain
United Kingdom
United States
Peru
Belgium
Philippines
South Africa
Czechia
Russian Federation
Argentina
Turkey
Slovakia
Hungary
Germany
Bulgaria
Greece
Thailand
Vietnam
France
Chile
Colombia

summary: The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.

status_simplified: Unknown


title: A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

acronym: ASPEN-OLS

summary: Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.

lead_sponsor: Revance Therapeutics, Inc.

location_country:
Poland
Spain
United Kingdom
Austria
Canada
United States
France
Germany
Czechia

location_facility: University Health Network, Toronto Western Hospital

location_facility: Nemocnice Pardubickeho kraje, a.s.; Pardubicka nemocnice

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: The Walton Centre NHS Foundation Trust, Neuroscience Research Centre

location_facility: Rocky Mountain Movement Disorders Center

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Ki Health Partners LLC DBA New England Institute for Clinical Research

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Intrafusion Research Network - Wesley Neurology Clinic

location_facility: Houston Methodist Neurological Institute

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze

location_facility: The University of Vermont Medical Center


intervention_type: Other

title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

location_country:
Poland
Spain
Italy
United Kingdom
Australia
New Zealand
Finland
Canada
Sweden
Hungary
Puerto Rico
United States
France
Israel
Germany
Czechia

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: York Dermatology Clinic and Research Centre

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula

location_facility: Center for Dermatology Clinical Research

location_facility: Southern Illinois University School of Medicine

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University Hospitals Case Medical Center

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Marietta Dermatology & The Skin Cancer Center

location_facility: Artemis Institute for Clinical Research - San Marcos

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: Progressive Clinical Research - San Antonio

location_facility: University of California San Diego Health Systems

location_facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck

location_facility: Dermatology and Skin Surgery Center - Exton

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: ActivMed Practices and Research - Portsmouth

location_facility: Precision Clinical Research - Corporate Office

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: Synexus - Lancashire Clinical Research Centre

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

location_facility: DelRicht Research - New Orleans - Prytania Street

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi

location_facility: Synexus Clinical Research - Saint Petersburg

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

location_facility: Artemis Institute for Clinical Research - San Diego

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: St. George Dermatology & Skin Care Centre

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

summary: The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

summary: This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

location_facility: University Health Network, Toronto Western Hospital

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: Rocky Mountain Movement Disorders Center

location_facility: University of Pennsylvania, Department of Neurology

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: New England Institute for Clinical Research

location_facility: Fakultní nemocnice Ostrava, Neurologicka klinika

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Mazowiecki Szpital Brodnowski Sp. z o.o.

location_facility: Houston Methodist Neurological Institute

location_facility: University of Florida Health Science Center Jacksonville

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Praxis fuer Neurologie im Bismark Karrée

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze


title: An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat

summary: The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.

lead_sponsor: RECORDATI GROUP

location_country:
Poland
Brazil
Spain
Italy
Austria
Russian Federation
Argentina
Canada
Thailand
Korea, Republic of
United States
Costa Rica
China
France
Belgium
India
Germany
Turkey
Bulgaria
Japan

location_facility: Northwestern University SC - LCI699C2301

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: Columbia University Medical Center New York Presbyterian Neuroendocrine Unit

location_facility: University of Pennsylvania Medical Center Univ Penn

location_facility: University of Michigan Comprehensive Cancer Center


primary_purpose: Other

title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SAFETY DATA OF FACTOR IX OR FACTOR VIII PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C≤2%) WHO ARE NEGATIVE FOR NEUTRALIZING nAb TO AAV VECTOR SPARK100 AND MODERATELY SEVERE TO SEVERE HEMOPHILIA A ADULT SUBJECTS (FVIII:C≤1%) WHO ARE NEGATIVE FOR nAb TO AAV VECTOR SB-525 CAPSID (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PH 3 GENE THERAPY STUDIES (See Detailed Description Section for Official Protocol Title)

lead_sponsor: Pfizer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Taiwan
Brazil
Saudi Arabia
Greece
Italy
Australia
Spain
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Japan
Germany

location_facility: Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos - Hemoes

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: General Hospital of Athens "Hippokration"

location_facility: SODc. Malattie Emorragiche e della Coagulazione Centro di Riferimento Regionale per le

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: Indiana Hemophilia & Thrombosis Center, Inc.

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Severance Hospital, Yonsei University Health System

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Kyung Hee University Hospital At Gangdong

location_facility: Centro de Hemoterapia e Hematologia do Para - Fundação HEMOPA

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: IRCCS - AOU di Bologna, Policlinico di Sant'Orsola

location_facility: Ege Universitesi Tip Fakultesi Cocuk Sagligi Ve Hastaliklari Anabilim Dali Pediatric Hematoloji

location_facility: Universität und Universitätsklinikum des Saarlandes

location_facility: Cliniques universitaires Saint-Luc/Unité d'Hématology et Hémostase

location_facility: Akdeniz University Medical Faculty Hospital

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Penn Comprehensive Hemophilia & Thrombosis Program, Hospital of the University of Pennsylvania

location_facility: lnstituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Ege Universitesi Tip Fakultesi Hematoloji BD

location_facility: Clinical and Translational Research Unit (CTRU)

location_facility: National Center for Child Health and Development

location_facility: Mississippi Center for Advanced Medicine

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital Das Clínicas Da Faculdade de Medicina de Ribeirao Preto Da Universidade de Sao Paulo

location_facility: Università degli studi di Roma "La Sapienza"- Policlinico Umberto I

location_facility: Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: The Chaim Sheba Medical Center, The National Hemophilia Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universitatsklinikum Bonn. Anstalt des oeffentlichen Rechts

location_facility: Gaziantep University Sahinbey Training and Research Hospital

location_facility: Acibadem Adana Hospital, Department of Pediatric Hematology

summary:
To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study.

To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study.

The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.


acronym: IMI/REL (MK-7655A) vs. PIP/TAZ for Treatment of Subjects with HABP/VABP

title: A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

type: Registry Identifier

location_country:
Brazil
Romania
Russian Federation
Ukraine
France
China
Mexico
Philippines

location_facility: City Hospital #2 Severodvinsk ( Site 1017)

location_facility: Kiyv city municipal hospital 17 ( Site 1300)

location_facility: ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304)

location_facility: Guangzhou First People's Hospital ( Site 0101)

location_facility: The first people s hospital of Nanning ( Site 0138)

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153)

location_facility: Lung Center of the Philippines ( Site 0903)

location_facility: Tianjin Medical University General Hospital ( Site 0113)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 0102)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0301)

location_facility: People s Hospital of Lishui City ( Site 0137)

location_facility: First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016)

location_facility: Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150)

location_facility: Hunan Provincial People Hospital ( Site 0122)

location_facility: The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130)

location_facility: Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0300)

location_facility: Shanghai Pulmonary Hospital ( Site 0108)

location_facility: Zhujiang Hospital of Southern Medical University ( Site 0148)

location_facility: The First Affiliated Hospital of Zhengzhou University ( Site 0121)

location_facility: Ivano-Frankivsk regional clinical hospital ( Site 1301)

location_facility: Jiangxi Provincial People's Hospital ( Site 0129)

location_facility: Hopital Roger Salengro du Lille ( Site 0601)

location_facility: The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151)

location_facility: General Hospital of Ningxia Medical University ( Site 0135)

location_facility: City Clinical Hospital No13 of Kharkiv City Council ( Site 1303)

location_facility: Shiyan City People's Hospital-Neurosurgery ( Site 0155)

location_facility: Huadong Hospital Affiliated Fudan University ( Site 0103)

location_facility: The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)

location_facility: People's Hospital of Liaocheng City-Neurology ( Site 0154)

location_facility: The First People's Hospital of Changzhou ( Site 0139)

location_facility: Peking University Third Hospital ( Site 0115)

location_facility: Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011)

location_facility: West Visayas State University Medical Center ( Site 0900)

location_facility: Affiliated Hospital of Jiangsu University ( Site 0147)

location_facility: Southern Medical University Nanfang Hospital ( Site 0120)

location_facility: The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)

location_facility: The first people s hospital of Nanning ( Site 0141)

location_facility: The First Affiliated Hospital of China Medical University ( Site 0116)

location_facility: Huashan Hospital of Fudan University ( Site 0105)

location_facility: The First Affiliated Hospital ( Site 0100)

location_facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104)

location_facility: Peking University First Hospital ( Site 0131)

location_facility: Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110)

location_facility: Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804)

location_facility: Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103)

location_facility: First Hospital Affiliated to Suzhou University ( Site 0111)

location_facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)

location_facility: Huizhou Municipal Central Hospital ( Site 0140)

location_facility: Ningbo First Hospital-neurosurgery ( Site 0152)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0123)

location_facility: Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 0132)

summary: This study will evaluate the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) (MK-7655A) compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.


title: Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

acronym: FORMULA-OLS

summary: A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

ipd_sharing: Undecided

lead_sponsor: F2G Biotech GmbH

location_country:
Poland
Brazil
Spain
United Kingdom
Russian Federation
Australia
Netherlands
Thailand
Vietnam
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Germany
Egypt

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

location_facility: Washington University School of Medicine

location_facility: Valley Fever Institute at Kern Medical Center

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: University of Texas MD Anderson Cancer Center

location_facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: University of California San Diego Medical Center

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital da Universidade Federal de Santa Maria CEP/UFSM

location_facility: SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka


title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).

acronym: TRANSFORM

summary:
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).

All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).

Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.

Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

ReferenceCitation: Kamdar M, Solomon SR, Arnason J, Johnston PB, Glass B, Bachanova V, Ibrahimi S, Mielke S, Mutsaers P, Hernandez-Ilizaliturri F, Izutsu K, Morschhauser F, Lunning M, Maloney DG, Crotta A, Montheard S, Previtali A, Stepan L, Ogasawara K, Mack T, Abramson JS; TRANSFORM Investigators. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022 Jun 18;399(10343):2294-2308. doi: 10.1016/S0140-6736(22)00662-6. Erratum in: Lancet. 2022 Jul 16;400(10347):160.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
Netherlands
Switzerland
Sweden
United States
France
Belgium
Japan
Germany

location_facility: Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno

location_facility: Hospital Clinic i Provincial de Barcelona - ICMHO

location_facility: University College Hospital Macmillan Cancer Centre

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Northwestern University-Feinberg School of Medicine

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

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

intervention_type: Genetic


acronym: PEDFIC 1

title: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

ReferenceCitation: Thompson RJ, Arnell H, Artan R, Baumann U, Calvo PL, Czubkowski P, Dalgic B, D'Antiga L, Durmaz Ö, Fischler B, Gonzalès E, Grammatikopoulos T, Gupte G, Hardikar W, Houwen RHJ, Kamath BM, Karpen SJ, Kjems L, Lacaille F, Lachaux A, Lainka E, Mack CL, Mattsson JP, McKiernan P, Özen H, Rajwal SR, Roquelaure B, Shagrani M, Shteyer E, Soufi N, Sturm E, Tessier ME, Verkade HJ, Horn P. Odevixibat treatment in progressive familial intrahepatic cholestasis: a randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):830-842. doi: 10.1016/S2468-1253(22)00093-0. Epub 2022 Jul 1.

location_facility: Washington University School of Medicine

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Universite Paris SUD - Hopitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: Baylor College of Medicine - Texas Children's Liver Center

location_facility: Columbia University Medical Center - Presbyterian Hospital Building

location_facility: Universitair Medisch Centrum (UMC) Utrecht

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Hacettepe University Faculty of Medicine

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Schneider Children's Medical Center Of Israel

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: University and Pediatric Hospital of Lyon

location_facility: Kinderklinik Tübingen, Universitätsklinikum Tübingen

summary: Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

summary: A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

lead_sponsor: Hoffmann-La Roche

location_country:
Australia
Switzerland
Korea, Republic of
United States
France

location_facility: Centre Georges François Leclerc; Pharmacie des Essais Cliniques

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: City of Hope Comprehensive Cancer Center


title: A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

acronym: SAVAL

summary: Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

ReferenceCitation: Kolte D, Kennedy KF, Shishehbor MH, Abbott JD, Khera S, Soukas P, Mamdani ST, Hyder ON, Drachman DE, Aronow HD. Thirty-Day Readmissions After Endovascular or Surgical Therapy for Critical Limb Ischemia: Analysis of the 2013 to 2014 Nationwide Readmissions Databases. Circulation. 2017 Jul 11;136(2):167-176. doi: 10.1161/CIRCULATIONAHA.117.027625. Epub 2017 May 2.

ReferenceCitation: Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review.

ReferenceCitation: Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989.

ReferenceCitation: Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, de Vries JP, Vos JA, de Borst GJ, Vonken EJ, Wever JJ, Statius van Eps RG, Mali WP, van Overhagen H. Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376. doi: 10.1161/CIRCINTERVENTIONS.114.002376.

ReferenceCitation: Kinlay S. Management of Critical Limb Ischemia. Circ Cardiovasc Interv. 2016 Feb;9(2):e001946. doi: 10.1161/CIRCINTERVENTIONS.115.001946.

ReferenceCitation: Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008. Review.

ReferenceCitation: Conte MS. Critical appraisal of surgical revascularization for critical limb ischemia. J Vasc Surg. 2013 Feb;57(2 Suppl):8S-13S. doi: 10.1016/j.jvs.2012.05.114. Review.

ReferenceCitation: Gray BH, Diaz-Sandoval LJ, Dieter RS, Jaff MR, White CJ; Peripheral Vascular Disease Committee for the Society for Cardiovascular Angiography and Interventions. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):539-45. doi: 10.1002/ccd.25395. Epub 2014 Jul 18.

ReferenceCitation: Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34.

ReferenceCitation: Popplewell MA, Davies HOB, Narayanswami J, Renton M, Sharp A, Bate G, Patel S, Deeks J, Bradbury AW. A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial. Eur J Vasc Endovasc Surg. 2017 Aug;54(2):195-201. doi: 10.1016/j.ejvs.2017.04.020. Epub 2017 Jun 8.

ReferenceCitation: Sadaghianloo N, Jean-Baptiste E, Declemy S, Mousnier A, Brizzi S, Hassen-Khodja R. Percutaneous angioplasty of long tibial occlusions in critical limb ischemia. Ann Vasc Surg. 2013 Oct;27(7):894-903. doi: 10.1016/j.avsg.2013.02.008.

ReferenceCitation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

ReferenceCitation: Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, de Borst GJ, Vonken EPA, Bijlstra OD, Wever JJ, Statius van Eps RG, Mali WPTM, van Overhagen H. Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia. J Am Heart Assoc. 2017 Apr 14;6(4). pii: e004877. doi: 10.1161/JAHA.116.004877.

ReferenceCitation: de Weger VA, Beijnen JH, Schellens JH. Cellular and clinical pharmacology of the taxanes docetaxel and paclitaxel--a review. Anticancer Drugs. 2014 May;25(5):488-94. doi: 10.1097/CAD.0000000000000093. Review. Erratum in: Anticancer Drugs. 2015 Feb;26(2):240.

ReferenceCitation: Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. Eur J Clin Invest. 2015 Mar;45(3):333-45. doi: 10.1111/eci.12407. Epub 2015 Feb 14. Review.

ReferenceCitation: Dake MD, Van Alstine WG, Zhou Q, Ragheb AO. Polymer-free paclitaxel-coated Zilver PTX Stents--evaluation of pharmacokinetics and comparative safety in porcine arteries. J Vasc Interv Radiol. 2011 May;22(5):603-10. doi: 10.1016/j.jvir.2010.12.027. Epub 2011 Mar 17.

ReferenceCitation: Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig MS, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Armstrong EJ, Jeon-Slaughter H, Brilakis ES, Bhatt DL. Femoropopliteal Artery Stent Thrombosis: Report From the Excellence in Peripheral Artery Disease Registry. Circ Cardiovasc Interv. 2016 Feb;9(2):e002730. doi: 10.1161/CIRCINTERVENTIONS.115.002730. Erratum in: Circ Cardiovasc Interv. 2016 Oct;9(10 ):.

ReferenceCitation: Federman DG, Ladiiznski B, Dardik A, Kelly M, Shapshak D, Ueno CM, Mostow EN, Richmond NA, Hopf HW. Wound Healing Society 2014 update on guidelines for arterial ulcers. Wound Repair Regen. 2016 Jan-Feb;24(1):127-35. doi: 10.1111/wrr.12395. Review.

lead_sponsor: Boston Scientific Corporation

location_country:
United States
France
Belgium
Japan
Netherlands

location_facility: Washington University School of Medicine

location_facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Cardiovascular Institute of the South Clinical Research Corporation

location_facility: Advanced Cardiac & Vascular Centers for Amputation Prevention

location_facility: Tokyo Bay Urayasu Ichikawa Medical Center

location_facility: HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)

location_facility: Willis Knighton Bossier Medical Center - Grace Research, LLC

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: Amputation Prevention Center of North Carolina

location_facility: Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital

intervention_type: Combination Product


title: Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

acronym: STAGED-PKD

summary:
Primary Objective:

To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2).

Secondary Objectives:

To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2).
To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2).
To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2).
Safety/tolerability objectives:
To characterize the safety profile of venglustat (Stages 1 and 2).
To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2).
To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).

ReferenceCitation: Perrone RD, Hariri A, Minini P, Ahn C, Chapman AB, Horie S, Knebelmann B, Mrug M, Ong ACM, Pei YPC, Torres VE, Modur V, Gansevoort RT. The STAGED-PKD 2-Stage Adaptive Study With a Patient Enrichment Strategy and Treatment Effect Modeling for Improved Study Design Efficiency in Patients With ADPKD. Kidney Med. 2022 Aug 27;4(10):100538. doi: 10.1016/j.xkme.2022.100538. eCollection 2022 Oct.

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Canada
China
Germany
Denmark
Taiwan
Korea, Republic of
France
Netherlands

location_facility:
Investigational Site Number 8400003
Investigational Site Number 6160002
Investigational Site Number 0360003
Investigational Site Number 8400027
Investigational Site Number 8400019
Investigational Site Number 2760003
Investigational Site Number 8400020
Investigational Site Number 8400007
Investigational Site Number 8400004
Investigational Site Number 3920001
Investigational Site Number 0400004
Investigational Site Number 0360002
Investigational Site Number 3920005
Investigational Site Number 6420002
Investigational Site Number 3920008
Investigational Site Number 7240001
Investigational Site Number 6420004
Investigational Site Number 2500004
Investigational Site Number 2030002
Investigational Site Number 8400015
Investigational Site Number 3920010
Investigational Site Number 3800001
Investigational Site Number 8260001
Investigational Site Number 7920002
Investigational Site Number 5280001
Investigational Site Number 3920009
Investigational Site Number 2030001
Investigational Site Number 2500003
Investigational Site Number 2760011
Investigational Site Number 1560003
Investigational Site Number 0560001
Investigational Site Number 6160003
Investigational Site Number 0560002
Investigational Site Number 3800002
Investigational Site Number 6200005
Investigational Site Number 1580001
Investigational Site Number 5280002
Investigational Site Number 2760007
Investigational Site Number 3920003
Investigational Site Number 1240003
Investigational Site Number 1560002
Investigational Site Number 8400005
Investigational Site Number 6200001
Investigational Site Number 1560001
Investigational Site Number 8400017
Investigational Site Number 1240001
Investigational Site Number 3920004
Investigational Site Number 8400002
Investigational Site Number 8400006
Investigational Site Number 2760009
Investigational Site Number 3800003
Investigational Site Number 2760005
Investigational Site Number 2080001
Investigational Site Number 0360001
Investigational Site Number 3920006
Investigational Site Number 1580002
Investigational Site Number 2760012
Investigational Site Number 2760001
Investigational Site Number 1560005
Investigational Site Number 1560009
Investigational Site Number 4100002
Investigational Site Number 7920003
Investigational Site Number 3920002
Investigational Site Number 3760002
Investigational Site Number 8400021
Investigational Site Number 1560008
Investigational Site Number 8400010
Investigational Site Number 8400016
Investigational Site Number 8400011
Investigational Site Number 0320001
Investigational Site Number 2760010
Investigational Site Number 4100001
Investigational Site Number 2080002
Investigational Site Number 1240002
Investigational Site Number 2760004
Investigational Site Number 2500002
Investigational Site Number 6420001
Investigational Site Number 3760003
Investigational Site Number 0400001
Investigational Site Number 8400008
Investigational Site Number 0320003
Investigational Site Number 5280003
Investigational Site Number 2500001
Investigational Site Number 8400014
Investigational Site Number 2760002
Investigational Site Number 7920001
Investigational Site Number 1560004
Investigational Site Number 3920007
Investigational Site Number 6200004
Investigational Site Number 7240003
Investigational Site Number 8400001
Investigational Site Number 1560006
Investigational Site Number 7240002
Investigational Site Number 6160001
Investigational Site Number 1560007


title: A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy, in Combination With mFOLFOX6 (With or Without Nivolumab) and in Combination With Pembrolizumab in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Whose Tumors Have High or Intermediate Claudin (CLDN) 18.2 Expression

acronym: ILUSTRO

summary: The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.

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.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Taiwan
Italy
Korea, Republic of
United States
France
Japan

location_facility: The Angeles Clinic and Research Institute


acronym: REFALS

title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

lead_sponsor: Orion Corporation, Orion Pharma

ReferenceCitation: Cudkowicz M, Genge A, Maragakis N, Petri S, van den Berg L, Aho VV, Sarapohja T, Kuoppamäki M, Garratt C, Al-Chalabi A; REFALS investigators. Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2021 Oct;20(10):821-831. doi: 10.1016/S1474-4422(21)00242-8.

location_country:
Spain
Ireland
Austria
Australia
Italy
Canada
Finland
Netherlands
United Kingdom
Sweden
United States
France
Belgium
Germany

location_facility: Centre De Recherche Du Centre Hospitalier de l'Universite de Montreal - Hopital Notre-Dame

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Neuromuscular Research Center and Neuromuscular Clinic of Arizona

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

location_facility: Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Neurologian Poliklinikka - Meilahden Tornisairaala 3

location_facility: University of Florida Health - Jacksonville

location_facility: The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

location_facility: Hospital of the University of Pennsylvania

location_facility: Universitair Medisch Centrum Utrecht - Rudolf Magnus Instituut voor Neurowetenschappen

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Centre Hospitalier Affilie Universitaire de Quebec

location_facility: University of Utah - Imaging & Neurosciences Center

location_facility: Colorado Springs Neurological Associates

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Moncton Hospital, Southeast Regional Health Authority

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Kentucky Chandler Medical Center

location_facility: Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau

location_facility: Alberta Health Services - Neuromuscular Clinic

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

location_facility: Wake Forest University Baptist Medical Center

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Neurosciences Institute - Neurology Charlotte

summary: This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.


title: Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure

acronym: ROADSAVER

summary: Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

ReferenceCitation: Kedev S, Müller-Hülsbeck S, Langhoff R. "Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)". Cardiovasc Intervent Radiol. 2022 Mar;45(3):277-282. doi: 10.1007/s00270-021-03051-5. Epub 2022 Jan 18.

lead_sponsor: Terumo Europe N.V.

location_country:
Poland
Portugal
Serbia
Spain
Latvia
Netherlands
Hungary
North Macedonia
France
Belgium
Germany
Slovakia
Czechia

location_facility: Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg

location_facility: Polyclinique Louis Pasteur Essey Les Nancy

location_facility: Hospital Universitario Girona Josep Trueta

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Szpital Uniwersytecki nr.2 im. Dr J. Biziela w Bydgoszczy

location_facility: GCS Centre de Cardiologie du Pays Basque

location_facility: Paul Stradins Clinical University Hospital

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Hospital Universitario Clínico de Valladolid

location_facility: Szent György Fejér County - University Teaching Hospital

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Universitäts und Rehabilitationskliniken Ulm

location_facility: City General Hospital 8th September Skopje


title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

acronym: PULSAR

summary: Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 6 months in the Placebo-Controlled Treatment Period, and then will be eligible to enroll into an 18- month Extension Period during which all participants will receive sotatercept. All treated patients will be also undergo follow-up period after last study drug treatment.

ReferenceCitation: Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.

lead_sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

location_country:
Brazil
Spain
United Kingdom
Australia
United States
France
Israel
Germany

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Banner-University Medical Center Phoenix

location_facility: University of California, San Francisco Medical Center

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden


acronym: innovaTV 207

title: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors

lead_sponsor: Seagen Inc.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik

location_facility: Oncologia Medica, Ospedale Civile S. Maria delle Croci

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

location_facility: Ingalls Cancer Care / Ingalls Memorial Hospital

location_facility: Shands Cancer Center / University of Florida

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: University of Alberta / Cross Cancer Institute

location_facility: Seconda Università degli Studi di Napoli, AOU

location_facility: Wake Forest Baptist Medical Center / Wake Forest University

summary:
This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. There are four parts to this study.

In Part A, the treatment will be given to participants every 3 weeks (3-week cycles).
In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle.
In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 4-week cycle.

In Part D, participants will be given treatment on Day 1 of every 3-week cycle. Participants in Part D will get tisotumab vedotin with either:

Pembrolizumab or,
Pembrolizumab and carboplatin, or
Pembrolizumab and cisplatin


title: ThRombosis ExclUsion STudy

acronym: TRUST

summary: The purpose of this study is to demonstrate the ability of new D-Dimer assay combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.

lead_sponsor: Diagnostica Stago

location_country:
Spain
Italy
United States
France
Belgium

location_facility: Duke Hemostasis and Thrombosis Research Center


acronym: EXPLORER-HCM

title: A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

lead_sponsor: MyoKardia, Inc.

ReferenceCitation: Nassif M, Fine JT, Dolan C, Reaney M, Addepalli P, Allen VD, Sehnert AJ, Gosch K, Spertus JA. Validation of the Kansas City Cardiomyopathy Questionnaire in Symptomatic Obstructive Hypertrophic Cardiomyopathy. JACC Heart Fail. 2022 Aug;10(8):531-539. doi: 10.1016/j.jchf.2022.03.002. Epub 2022 May 4.

ReferenceCitation: Reaney M, Addepalli P, Allen V, Spertus JA, Dolan C, Sehnert AJ, Fine JT. Longitudinal Psychometric Analysis of the Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ) Using Outcomes from the Phase III EXPLORER-HCM Trial. Pharmacoecon Open. 2022 Jul;6(4):575-586. doi: 10.1007/s41669-022-00340-8. Epub 2022 Jun 20.

ReferenceCitation: Hegde SM, Lester SJ, Solomon SD, Michels M, Elliott PM, Nagueh SF, Choudhury L, Zemanek D, Zwas DR, Jacoby D, Wang A, Ho CY, Li W, Sehnert AJ, Olivotto I, Abraham TP. Effect of Mavacamten on Echocardiographic Features in Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. 2021 Dec 21;78(25):2518-2532. doi: 10.1016/j.jacc.2021.09.1381.

ReferenceCitation: Xie J, Wang Y, Xu Y, Fine JT, Lam J, Garrison LP. Assessing health-related quality-of-life in patients with symptomatic obstructive hypertrophic cardiomyopathy: EQ-5D-based utilities in the EXPLORER-HCM trial. J Med Econ. 2022 Jan-Dec;25(1):51-58. doi: 10.1080/13696998.2021.2011301.

ReferenceCitation: Burstein Waldman C, Owens A. A plain language summary of the EXPLORER-HCM study: mavacamten for obstructive hypertrophic cardiomyopathy. Future Cardiol. 2021 Oct;17(7):1269-1275. doi: 10.2217/fca-2021-0044. Epub 2021 May 21.

ReferenceCitation: Spertus JA, Fine JT, Elliott P, Ho CY, Olivotto I, Saberi S, Li W, Dolan C, Reaney M, Sehnert AJ, Jacoby D. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 26;397(10293):2467-2475. doi: 10.1016/S0140-6736(21)00763-7. Epub 2021 May 15.

ReferenceCitation: Olivotto I, Oreziak A, Barriales-Villa R, Abraham TP, Masri A, Garcia-Pavia P, Saberi S, Lakdawala NK, Wheeler MT, Owens A, Kubanek M, Wojakowski W, Jensen MK, Gimeno-Blanes J, Afshar K, Myers J, Hegde SM, Solomon SD, Sehnert AJ, Zhang D, Li W, Bhattacharya M, Edelberg JM, Waldman CB, Lester SJ, Wang A, Ho CY, Jacoby D; EXPLORER-HCM study investigators. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Epub 2020 Aug 29. Erratum in: Lancet. 2020 Sep 12;396(10253):758.

ReferenceCitation: Ho CY, Olivotto I, Jacoby D, Lester SJ, Roe M, Wang A, Waldman CB, Zhang D, Sehnert AJ, Heitner SB. Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy. Circ Heart Fail. 2020 Jun;13(6):e006853. doi: 10.1161/CIRCHEARTFAILURE.120.006853. Epub 2020 Jun 5.

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Netherlands
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of Texas Houston Medical School

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University Of Iowa Hospitals And Clinics

location_facility: University of Pittsburgh Medical Center Presbyterian

location_facility: University of Pennsylvania (Penn Heart and Vascular Center)

location_facility: Cedars-Sinai Medical Center (Smidt Heart Institute)

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: University of Texas Southwestern Medical Center

location_facility: Charité Campus Buch - Experimental and Clinical Research Center

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

summary: This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.


title: A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus

summary: To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).

primary_purpose: Basic Science

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Germany
Poland
United States
France

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne

location_facility: Medycyna Kliniczna Marzena Waszczak - Jeka


title: A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

summary: This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

lead_sponsor: Genentech, Inc.

location_country:
Denmark
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
Singapore
Belgium
Japan
Netherlands

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Fundacion Jimenez Diaz; Servicio de Farmacia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Hospital Universitario Quironsalud Madrid; Servicio de Farmacia

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

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


acronym: Morpheus-TNBC

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC)

location_country:
Spain
United Kingdom
Australia
Korea, Republic of
United States
Israel
France
Germany

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: NYU Langone Medical Center; NYU Perlmutter Cancer Center

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Fiona Stanley Hospital - Medical Oncology

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: University of Ulsan College of Medicine - Asan Medical Center

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: University of California San Diego Medical Center; Moores Cancer Center

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Vanderbilt University Medical Center; Vanderbilt University

summary:
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations in patients with metastatic or inoperable locally advanced TNBC.

The study will be performed in two stages. During Stage 1, two cohorts will be enrolled in parallel in this study: one cohort will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort), and one cohort will consist of participants who had disease progression during or following 1L treatment with chemotherapy (e.g., paclitaxel, nab-paclitaxel, carboplatin) and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). In addition, participants in the 2L CIT-naive cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.


title: A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease

summary: The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).

location_country:
United States
France
Belgium

location_facility: University of Colorado School of Medicine


title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

summary: The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Highlands Oncology Group-Research Department

location_facility: Sidney kimmel comprehensive cancer center at johns hopkins

location_facility: Willamette Valley Cancer Institute And Research Center

location_facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Columbia University Medical Center (Cumc)

location_facility: Winship Cancer Institute of Emory University


title: A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
Australia
United States
United Kingdom
France

location_facility:
Investigational Site
Investigative Site

summary: This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.