title: A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure

acronym: SEQUOIA

summary: A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Australia
Estonia
Canada
New Zealand
Russian Federation
Ukraine
United Kingdom
Hungary
United States
France
Israel
Germany
Bulgaria

location_facility: Perron Institute for Neurological and Translational Science, QEII Medical Centre

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

location_facility: Fixel Institute for Neurological Diseases

location_facility: Policlinico Umberto I - Universita degli Studi di Roma La Sapienza / Neurologia

location_facility: Parkinson's Disease and Movement Disorders Center

location_facility: Federal State Budgetary Institution National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev of the Ministry of Healthcare of the Russian Federation

location_facility: UMHAT Alexandrovska EAD Clinic of Neurological Diseases

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Universita Gabriele D'Annunzio- Cesi-Met

location_facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

location_facility: Hospital Senhora da Oliveira - Guimaraes, EPE

location_facility: Universitaetsklinikum Freiburg - Klinik fur Neurologie und Neurophysiologie

location_facility: Communal Noncommercial Enterprise City Policlinic #9 of Kharkiv City Council

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Dept of Neurology

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: Azienda Ospedaliero Universitaria Pisana

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

location_facility: Pecsi Tudomanyegyetem, Neurologiai Klinika

location_facility: Alexianer St. Joseph-Krankenhaus Berlin-Weißensee, Klinik für Neurologie

location_facility: Colorado Springs Neurological Associates, PC

location_facility: Gemeinschaftspraxis Dr. med. J. Springub/ W. Schwarz

location_facility: Communal Institution Dnipropetrovsk I.I.Mechnikov RCH

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona Umberto I - G.M. Lancisi - G. Salesi, SOD Clinica di Neuroriabilitazione

location_facility: Communal Institution City Clinical Hospital #6

location_facility: Regional State Budgetary Institution of Healthcare Smolensk Regional Clinical Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: Saint Petersburg State Budgetary Institution of Healthcare City Hospital # 40 of Kurortnyi Region

location_facility: Georgetown University Hospital, Dept. of Neurology

location_facility: The Ohio State University Wexner Medical Center

location_facility: Wilhelminenspital Wien Abteilung fur Neurologie

location_facility: University Health Network - Toronto Western Hospital Movement Disorders Clinic

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Medizinische Universitat Innsbruck Abteilung Fur Neurologie

location_facility: Ospedale San Giovanni Battista del Sovrano Militare Ordine di Malta

location_facility: UMHAT Sveti Georgi EAD Clinic of Neurological Diseases

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

location_facility: State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan

location_facility: Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuous Postgraduate Education of the Ministry of Healthcare of the Russian Federation

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.O.C. Neurologia

location_facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: Charite Universitatsmedizin Berlin - Campus Benjamin Franklin

location_facility: Ospedale San Raffaele I U.O. di Neurologia

location_facility: Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele. - P.O G. Rodolico, Clinica Neurologica

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Charite - Campus Virchow-Klinikum, Klinik fur Neurologie

location_facility: University of Texas Southwestern Medical Center

location_facility: NHI Central Clinical Hospital #2 of JSC Russian Railways N.A. Semashko


type: Other Identifier

type: EudraCT Number

title: A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER

summary: This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Poland
Portugal
Russian Federation
Singapore
Canada
Hungary
China
Germany
Taiwan
Greece
Ireland
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: Florence Nightingale KH der Kaiserwerther Diakonie

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

location_facility: Clinical Hospital of the Russian Academy of Sciences

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: National Hospital Organization - Nagoya Medical Center

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Zhejiang University School of Medicine - The Second Affiliated Hospital

location_facility: Medical Study Company NORD-WEST GmbH Oncology Aurich

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim

location_facility: Fort Wayne Medical Oncology and Hematology

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

location_facility: Ryazan State Medical University n.a. I.P. Pavlov

location_facility: Cancer Specialists of North Florida - Jacksonville

location_facility: Istituto Nazionale Tumori Regina Elena di Roma

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital

location_facility: Norton Healthcare - Norton Cancer Institute

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Sichuan University - West China Hospital

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Fujian Medical University - Fujian Provincial Cancer Hospital

location_facility: Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Hospital General Universitario de Alicante

location_facility: Zhengzhou University (ZZU) - Henan Cancer Hospital

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Bengbu Medical College - First Affiliated Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The First Hospital of Xinjiang Medical University

location_facility: Zhejiang Medical University - Zhejiang Cancer Hospital

location_facility: University of Mississippi Medical Center

location_facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Insular-Maternal and Child University Hospital Complex

location_facility: Seoul National University Bundang Hospital

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Central South University - Xiangya School of Medicine - Hunan Cancer Hospital

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Beijing Cancer Hospital - Beijing Institute for Cancer Research

location_facility: Oncology Institute Professor Doctor Alexandru Trestioreanu

location_facility: Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov

location_facility: Chinese PLA General Hospital / 307 Hospital

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


status: Recruiting

intervention_type: Drug

title: A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).

study_completion_date_type: Anticipated

type: Registry Identifier

source: euctr

enrollment_type: Anticipated

location_country:
Spain
Italy
Netherlands
United States
France
Germany

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt

location_facility: Institute for Pediatric Hematology - Oncology, Leon Berard Cancer Center

summary:
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.

Phase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, [DLBCL, BL, or PMBCL]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.

status_simplified: Ongoing


ipd_sharing: Yes

acronym: DUET

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

lead_sponsor: UCB Biopharma SRL

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Portugal
Australia
Turkey
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
Finland
France

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


title: A Phase 2 Randomized, Multicenter, Double-blind, Vehicle Controlled, 90-Day, Safety, Efficacy & Systemic Exposure Study Followed by a 90-Day Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents With Autosomal Recessive Ichthyosis With Lamellar Scale

summary: This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

ipd_sharing: No

lead_sponsor: Mayne Pharma International Pty Ltd

location_country:
Spain
United Kingdom
Australia
Canada
Ukraine
United States
France
Israel
Germany

location_facility: Ternopil Regional Clinical Dermatovenereological Dispensary

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Medical Center of Private Enterprise "Dzerkalo"

location_facility: Royal London Hospital Barts Health Nhs Trust

location_facility: Community Institution "Zaporizhzhya Regional Dermatovenereology Clinical Hospital"

location_facility: Dnipropetrovsk State Hospital of Dermatovenerology


title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy

summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.

status: Active, not recruiting

ReferenceType: derived

ReferenceCitation: Padilla B, Shields AL, Taylor F, Li X, Mcdonald J, Green T, Boral AL, Lin HM, Akin C, Siebenhaar F, Mar B. Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study. Orphanet J Rare Dis. 2021 Oct 18;16(1):434. doi: 10.1186/s13023-021-02037-3.

lead_sponsor: Blueprint Medicines Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Washington University School of Medicine

location_facility: A.O.U di Bologna - IRCCS, Istituto di Ematologia Lorenzo e Ariosto Seragnoli, Ematologia

location_facility: A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno

location_facility: Oslo Universitetssykehus, Rikshospitalet, Department of Hematology

location_facility: Odense Universitetshospital, ORCA/Allergicentret, Hudafdeling I og Allergicenter

location_facility: Virginia Commonwealth University Medical Center

location_facility: Universitätsklinik Mainz, Universitäts-Hautklinik, Clinical Research Center

location_facility: Michigan Medicine, University of Michigan

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Poloclinico, UOC Ematologia

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHU Toulouse Larrey, CEREMAST, Service de Dermatologie et Allergologie cutanée

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Winship Cancer Institute, Emory University

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Hôpital de la Timone, Service de dermatologie

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre

location_facility: University Medical Center Groningen (UMCG)

location_facility: University Clinic Hamburg Eppendorf, University Cancer Center Hamburg (UCCH)

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: Hôpital Pitié-Salpêtrière, Service de Dermatologie

location_facility: Universitätsmedizin Mannheim, III. Medizinische Klinik

location_facility: Karolinska University Hospital, Hematologimottagningen R51

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


title: A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE OL

summary: The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

location_country:
Denmark
Poland
Brazil
United Kingdom
Austria
Russian Federation
Argentina
Sweden
Hungary
United States
France
Israel
Romania
Germany
Bulgaria

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Washington University School of Medicine

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Federal State Budget Scientific Institution

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda


title: Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

acronym: Protect-NOW

summary: International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

study_type: Observational

time_perspective: Other

lead_sponsor: Octapharma

location_country:
Belarus
Spain
Italy
Russian Federation
Estonia
United Kingdom
Canada
Lithuania
Hungary
United States
France
Turkey
Belgium
Azerbaijan
Germany

location_facility: Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)

location_facility: John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

location_facility: Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

location_facility: Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia

location_facility: McMaster University, Division of Pediatric Hematology/Oncology Room 3N27

location_facility: Cure 4 The Kids Foundation Children's Specialty Center

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology

location_facility: Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"

location_facility: Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

location_facility: Heim Pál National Pediatric Institute Department of Oncology and Hematology

location_facility: CHRU Hopital Nord, Secretariat de pediatre

location_facility: Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Republican Scientific Center for Radiation Medicine and Human Ecology

location_facility: Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

location_facility: University of Debrecen Department of Pediatrics

location_facility: Department of Hematology Research Research Transition Facility

location_facility: Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

location_facility: Hospital General Universitario de Alicante Hematología y Hemoterapia

location_facility: Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"

location_facility: CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

location_facility: Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain


title: A Phase Ib Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, To Patients With Advanced Platinum-sensitive Ovarian Cancer

summary:
The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2).

The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2).

Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1.

Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer.

All patients will continue to receive study treatment until disease progression (according to "Response Evaluation Criteria in Solid Tumors" (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.

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

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Italy
Spain
France

location_facility: Stephenson Cancer Center Investigational Pharmacy

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Hospital Universitari Vall dHebron; Oncology

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: University of Arizona Cancer Center, North

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: VCU Massey Cancer Center, Dalton Oncology Clinic

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Medical College of Wisconsin; Department of Obstetrics and Gynecology

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Fondazione Policlinico Universitario "A. Gemelli"; Unità di Fase 1: Unità di Farmacologia Clinica

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Medical College of Georgia; Obstetrics & Gynecolog

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Florida Hospital Cancer Institute; Clinical Research Department

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative


title: A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Double Lung Transplant

summary: The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.

lead_sponsor: Zambon SpA

location_country:
Spain
United Kingdom
Austria
United States
France
Israel
Belgium
Germany

location_facility: University of Kentucky Albert B. Chandler Hospital


status: Completed

primary_purpose: Prevention

intervention_type: Biological

title: A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation From Living CMV-Seropositive Donors (D+).

lead_sponsor: Hookipa Biotech GmbH

location_country:
Denmark
United Kingdom
United States
France
Norway
Germany

location_facility: Thomas E. Starzl Transplantation Institute

location_facility: University of Cincinnati (UC) - College of Medicine

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin

summary: HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).

status_simplified: Completed


title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

acronym: RADIANCE-II

summary: The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

lead_sponsor: ReCor Medical, Inc.

location_country:
United Kingdom
Ireland
Netherlands
Switzerland
United States
France
Belgium
Germany

location_facility: Cardiology Associates of North Mississippi

location_facility: Hôpital Européen Georges-Pompidou (HEGP)

location_facility: The University of North Carolina at Chapel Hill

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Centre Hospitalier Universitaire Saint-Pierre

location_facility: The Cardiothoracic Centre Basildon University Hospital

location_facility: University Hospitals Dorset NHS Foundation Trust

location_facility: University of Pennsylvania Health System

location_facility: The University of Tennessee Health Science Center

intervention_type: Procedure


title: A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

lead_sponsor: CymaBay Therapeutics, Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Canada
Hungary
Germany
Greece
New Zealand
Korea, Republic of
France
Chile
Netherlands

location_facility: Center for Liver Disease and Transplantation

location_facility: Southern Therapy and Advance Research (STAR) LLC

location_facility: Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Consultorio de la Doctora Maria Sarai Gonzalez Huezo

location_facility: Centro de Investigaciones Clínicas Vina del Mar

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: University of Minnesota Medical Center, Fairview

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Pius Brinzeu Emergency Clinical County Hospital

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Schiff Center for Liver Diseases University of Miami

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Yale School of Medicine Digestive Diseases, Internal Medicine

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

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: ifi-Institute for Interdisciplinary Medicine

location_facility: Penn State Milton S Hershey Medical Center

location_facility: The Newcastle Upon Tyne Hospital NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: American Research Corporation at Texas Liver Institute

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of California Davis Medical Center

location_facility: University General Hospital of Heraklion

location_facility: Asheville Gastroenterology Associates, a Division of Digestive Health Partners, P.A.

location_facility: University of Texas Southwestern Medical Center

location_facility: Univeristy of Colorado Denver and Hospital

location_facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo

location_facility: Gastroenterologisch Hepatologisches Zentrum Kiel

summary:
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.


acronym: PURSUIT 2

title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Korea, Republic of
France
United States
Israel
Belgium
Netherlands

location_facility: Children's Center for Digestive Health Care

location_facility: University of North Carolina at Chapel Hill

location_facility: Children's Hospital Colorado and University of Colorado

location_facility: Wojewodzki Specjalistyczny Szpital Dziecięcy im. Prof. Stanislawa Popowskiego

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Emma Children's Hospital Academic Medical Center

location_facility: Azienda USL di Bologna - Ospedale Maggiore

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Rocky Mountain Pediatric Gastroenterology

location_facility: Universitair Kinderziekenhuis Koningin Fabiola

summary: The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric participants with moderately to severely active UC will be assessed.


title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

summary: The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

ReferenceType: result

ReferenceCitation: Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.

ReferenceCitation: Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

lead_sponsor: Shockwave Medical, Inc.

location_country:
Germany
United States
United Kingdom
France

location_facility: Clinique des Domes - Pole Sante Republique

location_facility: Hospital of the University of Pennsylvania

location_facility: New York University (NYU) Langone Medical Center

location_facility: Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss

location_facility: Advocate Health and Hospitals Corporation - Edward Hospital

location_facility: Universitaetsklinikum Giessen and Marburg GmbH

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Pinnacle Health Cardiovascular Institute Inc.

location_facility: Charleston Area Medical Center (CAMC) - Health Education & Research Institute

location_facility: St. Vincent Heart Center of Indiana, LLC

intervention_type: Device


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

lead_sponsor: Idorsia Pharmaceuticals Ltd.

ReferenceType: background

ReferenceCitation: Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.

ReferenceCitation: Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1. Erratum in: Lancet Neurol. 2022 Jan 20;:. Lancet Neurol. 2022 Jun;21(6):e6.

location_country:
Canada
Finland
Sweden
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Bulgaria
Czechia

location_facility: Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck

location_facility: Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu

location_facility: Fleming Island Center for Clinical Research

location_facility: B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu

location_facility: Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset

location_facility: Clinique beau soleil - Department Sleep and Neurology

location_facility: University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring

location_facility: Dm Clinical Research / Martin Diagnostic Clinic

location_facility: 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu

location_facility: 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu

location_facility: Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

location_facility: 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu

location_facility: 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu

location_facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu

location_facility: Baptist Health Center for Clinical Research

location_facility: Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)

location_facility: CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique

location_facility: Fakultní nemocnice Ostrava, Spánková laboratoř

location_facility: Artemis Institute For Clinical Research - Riverside

location_facility: Acibadem City Clinic Tokuda Hospital EAD

location_facility: Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory

location_facility: Wesley Neurology Clinic Pc (Multiple Sclerosis)

location_facility: Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin

location_facility: Jacksonville Center for Clinical Research

location_facility: Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar

location_facility: Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg

location_facility: Clinical Research Group of St. Petersburgh

location_facility: HOSPITAL AZ SINT-JAN_Neurology department

location_facility: B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu

location_facility: 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu

location_facility: Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály

location_facility: Hospital UZ Leuven_ Pneumology Department

location_facility: Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University

summary: The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.


acronym:
JAVELIN BRCA/ATM

 JAVELIN BRCA/ATM

title: A PHASE 2 STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH TALAZOPARIB IN PATIENTS WITH BRCA OR ATM MUTANT TUMORS JAVELIN BRCA/ATM

lead_sponsor: Pfizer

ReferenceCitation: Schram AM, Colombo N, Arrowsmith E, Narayan V, Yonemori K, Scambia G, Zelnak A, Bauer TM, Jin N, Ulahannan SV, Colleoni M, Aftimos P, Donoghue MTA, Rosen E, Rudneva VA, Telli ML, Domchek SM, Galsky MD, Hoyle M, Chappey C, Stewart R, Blake-Haskins JA, Yap TA. Avelumab Plus Talazoparib in Patients With BRCA1/2- or ATM-Altered Advanced Solid Tumors: Results From JAVELIN BRCA/ATM, an Open-Label, Multicenter, Phase 2b, Tumor-Agnostic Trial. JAMA Oncol. 2022 Nov 17. doi: 10.1001/jamaoncol.2022.5218. [Epub ahead of print]

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:
Denmark
Spain
Italy
United Kingdom
United States
France
Belgium
Japan
Netherlands

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico

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

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: Amsterdam University Medical Centre, location VUmc

location_facility: Washington University School of Medicine

location_facility: Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B

location_facility: Memorial Sloan Kettering Cancer Center- Westchester

location_facility: Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo

location_facility: Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Washington University Infusion Center Pharmacy

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori

location_facility: Magee-Women's Hospital Women's Cancer Center

location_facility: Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital of the University of Pennsylvania/Penn Investigational Drug Services

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: Northside Hospital, Inc. - GCS/Northside

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.


acronym: CONQUER

title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Ailani J, Andrews JS, Tockhorn-Heidenreich A, Wenzel R, Rettiganti M. Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis. Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5.

ReferenceCitation: Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.

ReferenceCitation: Tepper SJ, Ailani J, Ford JH, Nichols RM, Li LQ, Kemmer P, Hand AL, Tockhorn-Heidenreich A. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clin Drug Investig. 2022 Mar;42(3):263-275. doi: 10.1007/s40261-021-01115-5. Epub 2022 Jan 18. Erratum in: Clin Drug Investig. 2022 Mar 7;:.

ReferenceCitation: Okonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.

ReferenceCitation: Reuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20.

ReferenceCitation: Citrome L, Sánchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.

ReferenceCitation: Kuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7.

ReferenceCitation: Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w.

ReferenceCitation: Mulleners WM, Kim BK, Láinez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. Epub 2020 Sep 16.

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

location_country:
Spain
United Kingdom
Netherlands
Canada
Hungary
Korea, Republic of
France
United States
Puerto Rico
Belgium
Japan
Germany
Czechia

location_facility: Higashi Sapporo Neurology and Neurosurgery Clinic

location_facility: Michigan Head, Pain and Neurological Institute

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Severance Hospital Yonsei University Health System

location_facility: Medical corporation Shinmatsudakai Atago Hospital

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Neurologicka ambulance, Neurologie Brno s.r.o.

summary: The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.


title: An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

location_country:
Poland
Spain
Italy
Lithuania
Hungary
United States
France

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Debreceni Egyetem Klinikai Központ; Gyermekklinika

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

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

location_facility: East Carolina University; Brody School of Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Children'S Mercy Hospital; Pediatric Nephrology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Emory University School of Med; Pediatrics

summary: Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.


title: A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability Pharmacokinetics Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects With Advanced Solid Tumors.

summary: The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: MedImmune LLC

location_country:
Taiwan
Portugal
Spain
Italy
Australia
Korea, Republic of
United States
France
Netherlands


title: Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

summary:
The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).

The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26.

At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.

ReferenceCitation: Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. Erratum in: Ann Intern Med. 2011 Sep 20;155(6):408.

ipd_sharing_description: Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.

lead_sponsor: Grünenthal GmbH

location_country:
Spain
Australia
New Zealand
Korea, Republic of
United States
France
Germany

location_facility: DE010 - Klinische Forschung Hannover Mitte

location_facility: US045 - Holland Center for Family Health

location_facility: US030 - Gulfcoast Clinical Research Center

location_facility: US038 - DiGiovanna Institute For Medical Education

location_facility: DE013 - Klinik und Poliklinik für Neurologie Universitätsmedizin Mainz

location_facility: ES006 - Hospital Infanta Luisa Rheumatology

location_facility: Nz001 - Bay of Plenty Clinical Trials Unit, Bay of Plenty District Health Board

location_facility: US018 - Carolinas Center for Advanced Management of Pain

location_facility: KR002 - Seoul National University Hospital

location_facility: ES008 - Hospital Lluis Alcanyis Anesthesiology and Pain Unit

location_facility: US049 - Orange County Research Institute

location_facility: DE006 - Center for Clinical Research Dr. med. I. Schoel

location_facility: US007 - Neurology Offices of South Florida

location_facility: US044 - The Helm Center for Pain Management

location_facility: US046 - Clinical Research of West Florida, Inc.

location_facility: FR002 - L'Hôpital Privé du Confluent Département d'évaluation et traitement de la douleur

location_facility: DE011 - Klinische Forschung Berlin Mitte GmbH

location_facility: NZ002 - Southern Clinical Trials Group Ltd

location_facility: KR007 - Konkuk University Medical Center

location_facility: US005 - Hometown Urgent Care and Research

location_facility: DE002 - Klinische Forschung Hamburg GmbH

location_facility: ES007 - Hospital Clínico Universitario de Valencia

location_facility: DE005 - Klinische Forschung Schwerin GmbH

location_facility: US041 - Better Health Clinical Research, Inc.

location_facility: US047 - The Center for Clinical Research

location_facility: AU002 - Royal North Shore Hospital Michael J Cousins Pain Management and Research Centre

location_facility: DE009 - BAG Anästhesie, Schmerztherapie, Palliativmedizin

location_facility: FR004 - Centre Hospitalier Universitaire Amiens Picardie

location_facility: ES004 - Hospital Universitario Puerto Real Unidad de Anestesiologia

location_facility: KR008 - Chungnam National University Hospital

location_facility: FR001 - Centre Hospitalier Universitaire Grenoble Alpes Centre de la douleur

location_facility: US015 - Tennessee Valley Pain Consultants

location_facility: KR003 - Seoul National University Bundang Hospital

location_facility: ES005 - Hospital Sanitas La Moraleja Pain Unit

location_facility: AU001 - The Avenue Cardiovascular Centre Level 1 Masada Private Hospital

location_facility: ES002 - Hospital de la Santa Creu i Sant Pau


title: Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

lead_sponsor: Novo Nordisk A/S

design_allocation: Non-Randomized

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Japan
Portugal
Australia
Puerto Rico
Israel
Turkey
Norway
Malaysia
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

summary: This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.


title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer

summary:
This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.

Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab.

The study will be done in two parts:

Part 1 is to identify the recommended dose to use for treatment.
Part 2 is to find out how well the combination works, and how safe and tolerable it is.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium
Germany

location_facility: Tennessee Oncology - Sara Cannon Research Institute

location_facility: University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario Ramon y Cajal Madrid

location_facility: Azienda Ospedaliera Universitaria Senese U.O.C. Immunoterapia Oncologica

location_facility: Levine Cancer Institute Carolinas Healthcare System


ipd_sharing: Undecided

acronym: TANDEM

title: A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Pedrosa M, Seyedkazemi S, Francque S, Sanyal A, Rinella M, Charlton M, Loomba R, Ratziu V, Kochuparampil J, Fischer L, Vaidyanathan S, Anstee QM. A randomized, double-blind, multicenter, phase 2b study to evaluate the safety and efficacy of a combination of tropifexor and cenicriviroc in patients with nonalcoholic steatohepatitis and liver fibrosis: Study design of the TANDEM trial. Contemp Clin Trials. 2020 Jan;88:105889. doi: 10.1016/j.cct.2019.105889. Epub 2019 Nov 13.

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22.

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:
Egypt
Spain
Italy
Latvia
Russian Federation
United Kingdom
Argentina
Canada
United States
France
India
Israel
Belgium
Singapore
Germany
Turkey
Czechia

summary: The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.


title: OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI

summary: The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

ReferenceCitation: Ali Z, Landmesser U, Karimi Galougahi K, Maehara A, Matsumura M, Shlofmitz RA, Guagliumi G, Price MJ, Hill JM, Akasaka T, Prati F, Bezerra HG, Wijns W, Mintz GS, Ben-Yehuda O, McGreevy RJ, Zhang Z, Rapoza RR, West NEJ, Stone GW. Optical coherence tomography-guided coronary stent implantation compared to angiography: a multicentre randomised trial in PCI - design and rationale of ILUMIEN IV: OPTIMAL PCI. EuroIntervention. 2021 Jan 20;16(13):1092-1099. doi: 10.4244/EIJ-D-20-00501.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
Taiwan
Hong Kong
Portugal
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
New Zealand
Switzerland
Sweden
United States
France
India
Singapore
Belgium
Japan
Germany

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: University of North Carolina at Chapel Hill

location_facility: Centennial Heart Cardiovascular Consultants

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Via Christi Regional Medical Center - St. Francis Campus

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Eastern Heart Clinic - Prince of Wales Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Massachusetts Medical Center

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Cardiovascular Research Institute of Kansas

location_facility: University of California - Davis Medical Center

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: New York Presbyterian Hospital/Columbia University

location_facility: The Cardiac & Vascular Institute Research Foundation, LLC

location_facility: Montefiore Medical Center - Moses Division

location_facility: Sahlgrenska University Hospital - Gothenburg

location_facility: University of California at San Diego (UCSD) Medical Center

location_facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension

ReferenceCitation: Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, Meyenberg C, Wiese T, Deol-Bhullar G, Wandel C, Ashford E, Anagnostou E. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet Psychiatry. 2022 Mar;9(3):199-210. doi: 10.1016/S2215-0366(21)00429-6. Epub 2022 Feb 10.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: Southwest Autism Research & Resource Center

location_facility: Hospital Universitario Rio Hortega; Departamento de Psiquiatria

location_facility: University of California , Los Angeles (UCLA); Child, Adolescent Psychiatry

location_facility: University of California at San Francisco

location_facility: Yale University / Yale-New Haven Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Psiquiatria del niño y del adolescente

location_facility: Hospital Mutua de Terrassa; Departamento de Psiquiatria

location_facility: Hospices Civils de Lyon; Centre d'Investigation Clinique Pédiatrique

location_facility: Vanderbilt University Medical Center; Department of Psychiatry

location_facility: Hospital Universitari Vall d'Hebron; Sevicio de Psiquiatría

location_facility: ASL TO2; Centro Pilota Regione Piemonte - Dip. Salute Mentale

location_facility: Queen Elizabeth University Hospital; Clinical Research Facility

location_facility: Kings College Hospital; Kings Clinical Research Facility

location_facility: Center for Autism and the Developing Brain

location_facility: A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti

location_facility: University of Minnesota Medical Center-Fairview

location_facility: RE:Cognition Health; RE:Cognition Health

location_facility: Uni of Chicago; Centre For Advanced Medicine

location_facility: ASST di Pavia; Dip. di Scienze del Sistema Nervoso e del Comportamento

location_facility: Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre

location_facility: McGill University Health Centre - Glen Site

location_facility: AUSL di Piacenza; Psichiatria di Collegamento

location_facility: Western General Hospital; Wellcome Trust CRF

location_facility: Centre hospitalier du Rouvray; CRAHN Centre de Ressources Autisme Haute-Normandie

location_facility: Nathan S. Kline Institute for Psychiatric Research

location_facility: UPMC Western Psychiatric Institute and Clinic

location_facility: Hopital Charles Perrens; Centre de Ressources Autisme Aquitaine

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of 10 mg of oral administration balovaptan once a day (QD) compared with matching placebo in adults (18 years and older) with autism spectrum disorder (ASD).


title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms

lead_sponsor: BeiGene

ReferenceCitation: Huiqiang Huang, et al. Tislelizumab (BGB-A317) for relapsed/refractory extranodal NK/T-cell lymphoma: preliminary efficacy and safety results from a phase 2 study. Poster Abstract EP1268, European Hematology Association 2020.

ReferenceCitation: Pier Luigi Zinzani, et al. Tislelizumab (BGB-A317) for relapsed/refractory peripheral T-cell lymphomas: Safety and efficacy results from a phase 2 study. Poster Abstract EP1235, European Hematology Association 2020.

location_country: Taiwan Italy Canada France China Germany

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Institut d'hématologie de Basse Normandie

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Fujian Medical University Union Hospital

location_facility: UBC - British Columbia Cancer Agency - The Vancouver Centre

location_facility: Centre hospitalier Universitaire de Limoges

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: The affiliated hospital of Xuzhou medical university

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Ospedale Policlinico San Martino - IRCCS per l'Oncologia

location_facility: West China Hospital of Sichuan University

location_facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

summary:
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:

Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type)
Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)
Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS)

Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).


title: A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension

lead_sponsor: Actelion

location_country:
Poland
Taiwan
Belarus
Serbia
United Kingdom
Russian Federation
Canada
Ukraine
Hungary
United States
France
China
Israel
Belgium
Malaysia
Germany

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: Federal State Budget Scientific Institution

location_facility: Institut Za Zdravstvenu Zaštitu Majke I Deteta Srbije ''Dr Vukan Čupić''

location_facility: Children'S Hospital Cardiac Care Center University Of Colorado

location_facility: Health Institution 4Th City Children'S Clinical Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: State Institution Of The Ministry Of Health Of Ukraine

location_facility: State Institution Republican Scientific And Practical Center For Pediatric Surgery

location_facility: Municipal Institution Of The Zaporizhzhya Regional Council

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

location_facility: Municipal Enterprise Of The Dnipropetrovsk Regional Council

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies

summary: The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.


acronym: PLATforM

title: A Randomized, Open-label, Phase II Open Platform Study Evaluating the Efficacy and Safety of Novel Spartalizumab (PDR001) Combinations in Previously Treated Unresectable or Metastatic Melanoma

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

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

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

location_facility: The Angeles Clinic and Research Institute

location_facility: Massachusetts General Hospital Massachusetts Gen. Hospital CC

location_facility: NYU Laura and Isaac Perlmutter Cancer Center Perlmutter Cancer Center

location_facility: Georgetown University/Lombardi Cancer Center CERL080AUS67

summary: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma


title: Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

summary: The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Portugal
Spain
United Kingdom
Russian Federation
Mexico
Canada
Ukraine
Hungary
France
United States
Belgium
Germany
Czechia

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E

location_facility: State Institution Institute of Otolaryngology n.a. Prof. O.S.

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: Medical University of South Carolina Hospital

location_facility: Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov

location_facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique

location_facility: Vital Prospects Clinical Research Institute PC - CRN

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of Missouri Health Care System

location_facility: Fakultni nemocnice Hradec Kralove, Chirurgicka klinika

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Central Clinical Hospital With Polyclinic of President Administration of RF

location_facility: Banner University of Arizona Medical Center

location_facility: Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection

location_facility: Centro Hospitalar do Algarve - Hospital de Portimao

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Synexus Affiliate - Clinic Med s.j. Bialystok

location_facility: Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde

location_facility: Municipal Institution "City Clinical Hospital #3"

location_facility: Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos

location_facility: CHUS - H. Clinico U. de Santiago; Servicio de Farmacia

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Allergy Associates Research Center LLC - CRN


title: An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma

lead_sponsor: Bayer

ReferenceCitation: Grünewald S, Politz O, Bender S, Héroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Spain
Italy
Austria
Korea, Republic of
United States
France
Japan
Germany

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Hospital General Universitario de Valencia

location_facility: Barbara Ann Karmanos Cancer Institute - Detroit

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

summary:
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.

The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.

The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.

Of note, patients who participate in Part A are not allowed to participate in Part B.

Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.

Part B of the study will no longer be conducted.


title: An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

acronym: APeX-S

summary: This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

ReferenceCitation: Riedl MA, Neville D, Cloud B, Desai B, Bernstein JA. Shared decision-making in the management of hereditary angioedema: An analysis of patient and physician perspectives. Allergy Asthma Proc. 2022 Sep 1;43(5):397-405. doi: 10.2500/aap.2022.43.220050. Epub 2022 Jul 12.

ReferenceCitation: Farkas H, Stobiecki M, Peter J, Kinaciyan T, Maurer M, Aygören-Pürsün E, Kiani-Alikhan S, Wu A, Reshef A, Bygum A, Fain O, Hagin D, Huissoon A, Jeseňák M, Lindsay K, Panovska VG, Steiner UC, Zubrinich C, Best JM, Cornpropst M, Dix D, Dobo SM, Iocca HA, Desai B, Murray SC, Nagy E, Sheridan WP. Long-term safety and effectiveness of berotralstat for hereditary angioedema: The open-label APeX-S study. Clin Transl Allergy. 2021 Jun;11(4):e12035. doi: 10.1002/clt2.12035.

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Denmark
Poland
Hong Kong
Serbia
Spain
Italy
Austria
Australia
New Zealand
United Kingdom
Switzerland
Hungary
North Macedonia
Korea, Republic of
United States
France
Israel
South Africa
Germany
Slovakia

location_facility:
Study Center
Study center


title: A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

summary:
This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:

Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1
Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Germany

location_facility: Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

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

location_facility: Hopital Hotel Dieu Et Hme; Clinique Hematologie

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: UO Ematologia, Ospedale S.Maria delle Croci

location_facility: West Virginia University; Health Sciences Center

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

location_facility: Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz


title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

summary: The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Australia
Switzerland
United States
France

location_facility: Sidney kimmel comprehensive cancer center at johns hopkins

location_facility: Washington University School OF Medicine-Siteman Cancer Center


title: A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

acronym: PODO

summary: The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

ReferenceCitation: Beck LH Jr, Berasi SP, Copley JB, Gorman D, Levy DI, Lim CN, Henderson JM, Salant DJ, Lu W. PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. Kidney Int Rep. 2021 Apr 3;6(6):1629-1633. doi: 10.1016/j.ekir.2021.03.892. eCollection 2021 Jun.

location_country:
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Mexico
Japan
Germany
Slovakia
Czechia

location_facility: University of Miami Hospital and Clinics

location_facility: University Hospitals Coventry & Warwickshire NHS Trust

location_facility: Stanford Health Care Investigational Pharmacy

location_facility: The Cleveland Clinic - Investigational Drug Pharmacy

location_facility: University of Miami Katz Family Division of Nephrology

location_facility: Baylor Scott & White Clinic - Temple South Loop

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie

location_facility: Yale Nephrology Clinical Research Clinic

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: University of Cincinnati at DCI McMillan Research Unit

location_facility: The Ohio State University Clinical Research Center

location_facility: UNC Clinical and Translational Research Center

location_facility: Yale Center for Clinical Investigation - Church Street Research Unit

location_facility: University of Cincinnati Gardner Neuroscience Institute

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: Investigational Drug Service Pharmacy UAB Hosptial

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez"

location_facility: Niigata University Medical & Dental Hospital

location_facility: Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

location_facility: UAB Nephrology Research Clinic at Paula Building

location_facility: UCLA Clinical and Translational Research Center

location_facility: The Ohio State University Investigational Drug Services

location_facility: The Kirklin Clinic of University Alabama Birmingham Hospital

location_facility: University of Alberta - Pharmacy Research Office

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: New York University Grossman School of Medicine - CTSI

location_facility: CarePoint East at The Ohio State University

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: St. Paul's Hospital/Providence Health Care

location_facility: Boston Medical Center - Interventional Radiology

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Yale University School of Medicine - Yale-New Haven Hospital

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont

location_facility: The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Vancouver General Hospital/Vancouver Coastal Health

location_facility: Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB


title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Poland
Taiwan
Spain
United Kingdom
Korea, Republic of
United States
France
Belgium
Germany

summary: The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.


title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

lead_sponsor: Enanta Pharmaceuticals, Inc

ReferenceCitation: Ratziu V, Rinella ME, Neuschwander-Tetri BA, Lawitz E, Denham D, Kayali Z, Sheikh A, Kowdley KV, Desta T, Elkhashab M, DeGrauw J, Goodwin B, Ahmad A, Adda N. EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study. J Hepatol. 2022 Mar;76(3):506-517. doi: 10.1016/j.jhep.2021.10.018. Epub 2021 Nov 3.

location_country:
United Kingdom
New Zealand
Canada
Puerto Rico
United States
France

location_facility: Southern California Transplantation Institute Research Foundation

location_facility: UCSD Altman Clinical and Translational Research Institute

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Wasatch Peak Family Practice/Radiant Research, Inc

location_facility: Clinical Research Advantage, Inc. / Colorado Springs Family Practice

location_facility: Fleming Island Center for Clinical Research

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Chronic Viral Illness Service McGill University Health Center/Royal Victoria

location_facility: CHU de Bordeaux - GH Sud - Hoital Haut Leveque

location_facility: Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic

location_facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center

location_facility: CHU de Strasbourg - Nouvel Hôspital Civil

location_facility: Advanced Gastroenterology Associates, LLC

location_facility: Jacksonville Center for Clinical Research

location_facility: Carolinas Medical Center Transplant Center/Center for Liver Disease

location_facility: WestGlen Gastrointestinal Consultants, PA

location_facility: Carolinas Center for Liver Disease / Carolinas Health Care System

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: Mayo Clinic Health System - Franciscan Healthcare

location_facility: Research Associates of South Florida, LLC

location_facility: Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust

location_facility: NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)

location_facility: University of Washington / Harborview Medical Center

location_facility: University Of Tennessee Health Science Center

summary: A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis