title: A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

summary: The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

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

lead_sponsor: Amgen

location_country:
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
United States
France
Germany

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi


type: EudraCT Number

type: Other Identifier

title: A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

summary: This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Hong Kong
Spain
Australia
Korea, Republic of
United States
France
Japan
Singapore

location_facility: University of Chicago Pritzker School of Medicine

location_facility: South Texas Accelerated Research Therapeutics, LLC

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study

acronym: ELITE

summary: Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.

status: Active, not recruiting

design_allocation: Non-Randomized

enrollment_type: Actual

lead_sponsor: MedtronicNeuro

location_country:
United Kingdom
Canada
Switzerland
Puerto Rico
United States
France
Netherlands

location_facility: Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Louisiana State University Health Sciences Center New Orleans

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

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Centre Hospitalier Universitaire De Rennes

intervention_type: Device


ipd_sharing: Yes

status: Completed

acronym: AARDVARC

title: A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

study_completion_date_type: Actual

lead_sponsor: AstraZeneca

source: euctr

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.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Korea, Republic of
United States
France
Belgium

summary: This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

status_simplified: Completed


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

summary: The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

design_allocation: Randomized

lead_sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
Serbia
Spain
United Kingdom
Austria
Australia
Canada
United States
France
Belgium
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Dept of Veterans Affairs Greater Los Angeles Healthcare System

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH

location_facility: LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin

location_facility: The University of California San Francisco

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: University of New Mexico Health Sciences Center

location_facility: Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: New York Presbyterian Hospital - Weill Cornell Medicine

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Hospital Universitario Marqués de Valdecilla


title: Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

acronym: DEFINE GPS

summary: Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

status: Enrolling by invitation

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
Switzerland
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

location_facility: Tampa Cardiovascular Innovations and Research

location_facility: Hospital Universitario Marqués de Valdecillas

location_facility: Central Arkansas Veterans Healthcare System (CAVHS)

location_facility: Baylor Scott & White, The Heart Hospital Plano

intervention_type: Procedure

status_simplified: Unknown


title: A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

acronym: BE MOVING

summary: The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

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.

lead_sponsor: UCB Biopharma SRL

location_country:
Poland
Spain
United Kingdom
Netherlands
Hungary
United States
France
China
Turkey
Belgium
Japan
Germany
Bulgaria
Czechia


acronym: COMMODORE 2

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

lead_sponsor: Hoffmann-La Roche

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).

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
Romania
Philippines
Japan
South Africa
Poland
Hong Kong
Portugal
Australia
Argentina
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
China
Germany
Taiwan
Greece
Thailand
Korea, Republic of
France
Netherlands

location_facility: Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: Global Trial Research Center S.A. de C.V.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Ege University Medical Faculty; Hematology

location_facility: The Chinese University of Hong Kong; Department of Medicine & Therapeutics

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Kings College Hospital; Kings Clinical Research Facility

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Institution; Cardiology

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Hospital Universitario Central de Asturias

location_facility: Philippine General Hospital; Pulmonary Medicine

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Szpital Uniwersytecki nr2 im. dr J. Biziela

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria; Servicos Farmaceuticos

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Singapore General Hospital; Department of Haematology

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Affiliated Hospital of Nantong University; Nephrology

summary: A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.


title: Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP

lead_sponsor: Boehringer Ingelheim

ReferenceType: derived

ReferenceCitation: Morita A, Choon SE, Bachelez H, Anadkat MJ, Marrakchi S, Zheng M, Tsai TF, Turki H, Hua H, Rajeswari S, Thoma C, Burden AD. Design of Effisayil™ 2: A Randomized, Double-Blind, Placebo-Controlled Study of Spesolimab in Preventing Flares in Patients with Generalized Pustular Psoriasis. Dermatol Ther (Heidelb). 2022 Nov 5. doi: 10.1007/s13555-022-00835-6. [Epub ahead of print]

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Spain
Italy
United States
Belgium
Philippines
Japan
South Africa
Russian Federation
Argentina
Tunisia
Turkey
Mexico
Malaysia
China
Germany
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Washington University School of Medicine

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: National Hospital of Dermatology and Venereology

location_facility: Affiliated Hospital of Tianjin institute of Chinese medicine

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: General Hospital of Thessaloniki "Ippokrateio"

location_facility: Chang Gung Medical Foundation (CGMF) - Linkou Bran

location_facility: Uludag University Medicine Faculty Departmant of Dermatology

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Centro de Investigación de Enfermedades Autoinmunes S.C.

location_facility: FSBEI HE "Kirov State Medical University"

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: The First Hospital of Chinese Medical University

location_facility: Center for Skin Research, Testing and Product Development

location_facility: LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

location_facility: Bezmi Alem Valide Sultan Vakif Gureba Egitim ve Arastirma Hastanesi

location_facility: Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

summary:
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups.

Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine.

Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants.

If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.


intervention_type: Biological

title: A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
Italy
Austria
Australia
United Kingdom
Finland
Switzerland
United States
France
Singapore
Belgium
Germany
Czechia

location_facility: University of Pittsburgh Cancer Institute HIllman Cancer Center

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med

location_facility: Emory University School of Medicine/Winship Cancer Institute

summary: The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.


title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

summary: The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 ("escalation"), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 ("expansion").

lead_sponsor: Genmab

location_country:
Denmark
Spain
United Kingdom
United States
France
Belgium
Netherlands

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: University of Iowa Holden Comprehensive Cancer Center

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Medical University of South Carolina (MUSC)

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Pennsylvania School of Medicine

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals


title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.

summary: This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

study_type: Observational

time_perspective: Prospective

lead_sponsor: InnFocus Inc.

location_country:
United Kingdom
Italy
Spain
United States
France

location_facility: UCLA Medical Center Jules Stein Eye Institute

location_facility: Arizona Advance Eye Research Institute, LLC.

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: Glaucoma Consultants of the Capital Region

location_facility: Stiles Eye Care Excellence & Glaucoma Institute

location_facility: A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: Pôle Ophtalmologique de la Clinique Mutualiste

location_facility: University of California at Davis Eye Center

location_facility: Pole Ophtalmologique de la Clinique Mutualiste


intervention_type: Other

title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF 06939926 FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

lead_sponsor: Pfizer

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

location_country:
Taiwan
Spain
Italy
Russian Federation
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
Israel
Belgium
Japan

location_facility: KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Fairway

location_facility: State Autonomous Healthcare Institution of Sverdlovsk Region Children's City Clinical Hospital No 9

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Great Ormond Street Institute of Child Health

location_facility: University of Iowa Hospitals and Clinics

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Children's Specialty Group, PLLC Division of Child & Adolescent Neurology

location_facility: National Center of Neurology and Psychiatry

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Children's Hospital - London Health Sciences Centre

location_facility: Pusan National University Yangsan Hospital

location_facility: Hadassah University Medical Center, Ein Kerem

location_facility: University of Kansas Hospital - Pediatric and Pediatric ICU - Operating Room

location_facility: Inselspital, University Children's Hospital Berne

location_facility: KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Rainbow

location_facility: Saint Petersburg State Paediatric Medical University

location_facility: Hyogo College of Medicine College Hospital

location_facility: University of Kansas Hospital - Investigational Pharmacy

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Schneider Children's Medical Center of Israel

summary: The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.


title: A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

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:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Latvia
Korea, Republic of
France
Netherlands

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: AKH - Gastroenterologie und Hepatologie - Interne Medizin III

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

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

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Private Practice - Dr. Korczowski Bartosz

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

location_facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: Eskisehir Osmangazi University Gastroenterology

location_facility: University Medical Center "Bezanijska kosa"

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: L2IP - Instituto de Pesquisas Clinicas Ltda.

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Oblastni nemocnice Nachod-Endoskopicke centrum

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: Gastroenterology Associates of Orangeburg

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

location_facility: Hatay Namik Kemal University Hospital Gastroenterology

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Unidad de Atención Médica e Investigación en Salud (UNAMIS)

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv

location_facility: The Third Xiangya Hospital of Central South University

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

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

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

location_facility: University Hospitals Cleveland Medical Center

location_facility: Medical Center Ok!Clinic of Intl Inst of Clinical Trials LLC

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: Kharkiv Regional Council Regional Clinical Hospital

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: The First People's Hospital of Changzhou

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu

location_facility: West China Hospital of Sichuan University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: St. Vincent's Hospital Research Ethics Committiee

location_facility: LLC Multidisciplinary Medical Clinic Anthurium

location_facility: Xiangya Hospital, Central South University

location_facility: PanAmerican Clinical Research Mexico S.A. de C.V.

location_facility: NonState Healthcare Institution Central Clinical Hospital

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Private Practice - Dr. Stephane M. Gauthier

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Gastroenterology and internal medicine research institute

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Hacettepe University Faculty of Medicine

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: Woodholme Gastroenterology Associates - Glen Burnie

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: Health Pharma Professional Research S.A. de C.V:

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: Gastroenterology Consultants of Clearwater

location_facility: The Second Xiangya Hospital of Central South University

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

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

summary: The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.


title: Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

acronym: AMEND-CRT

summary: Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

ipd_sharing_description: Available upon reasonable request after acceptance of publications.

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country: Poland Belgium France Romania Germany

location_facility: Groupements des hôpitaux de l'institut catholique de Lille

lead_sponsor_type: academique


title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

summary: Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

lead_sponsor: Edwards Lifesciences

location_country:
United States
Switzerland
Canada
France

location_facility: Hospital of the University of Pennsylvania

location_facility: CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

location_facility: Columbia University Irving Medical Center / NYPH

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)


title: SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

summary: This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

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

location_country:
Poland
Portugal
Spain
Italy
Georgia
Russian Federation
United Kingdom
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany


title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

lead_sponsor: Shire

type: Registry Identifier

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

location_country:
Poland
Spain
Italy
Netherlands
Canada
Hungary
United States
France
Japan
Germany

location_facility: DAI di Medicina Interna, Immunologia Clinica, Patologia Clinica, Malattie Infettive

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: "ALL-MED" Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

location_facility: Klinikum rechts der Isar der TUM, HNO Klinik und Poliklinik

location_facility: Allergy and Asthma Clinical Research Inc

location_facility: University of South Florida Asthma, Allergy & Immunology

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: NZOZ Homeo Medicus, Poradnia Alergologiczna

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: Clinique Specialisee en Allergie de la Capitale

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Service médecine interne, hôpital Saint Antoine

location_facility: Jay M Kashkin, MD Allergy, Asthma and Immunology

location_facility: Institute for Asthma & Allergy - Chevy Chase

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: CHU Grenoble Alpes, service de médecine interne, bureau de recherche clinique

summary:
The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections.

Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.


title: The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

summary:
To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device.

The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device.

The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061.

ReferenceCitation: Chow DH, Bieliauskas G, Sawaya FJ, Millan-Iturbe O, Kofoed KF, Søndergaard L, De Backer O. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure. Open Heart. 2017 Jun 30;4(2):e000627. doi: 10.1136/openhrt-2017-000627. eCollection 2017.

ReferenceCitation: Korsholm K, Jensen JM, Nielsen-Kudsk JE. Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2198-2206. doi: 10.1016/j.jcin.2017.06.057. Epub 2017 Aug 30.

ReferenceCitation: Otton JM, Spina R, Sulas R, Subbiah RN, Jacobs N, Muller DW, Gunalingam B. Left Atrial Appendage Closure Guided by Personalized 3D-Printed Cardiac Reconstruction. JACC Cardiovasc Interv. 2015 Jun;8(7):1004-6. doi: 10.1016/j.jcin.2015.03.015.

ReferenceCitation: de Jaegere P, Rocatello G, Prendergast BD, de Backer O, Van Mieghem NM, Rajani R. Patient-specific computer simulation for transcatheter cardiac interventions: what a clinician needs to know. Heart. 2019 Mar;105(Suppl 2):s21-s27. doi: 10.1136/heartjnl-2018-313514. Review.

ReferenceCitation: Rocatello G, El Faquir N, De Santis G, Iannaccone F, Bosmans J, De Backer O, Sondergaard L, Segers P, De Beule M, de Jaegere P, Mortier P. Patient-Specific Computer Simulation to Elucidate the Role of Contact Pressure in the Development of New Conduction Abnormalities After Catheter-Based Implantation of a Self-Expanding Aortic Valve. Circ Cardiovasc Interv. 2018 Feb;11(2):e005344. doi: 10.1161/CIRCINTERVENTIONS.117.005344.

ReferenceCitation: Bavo AM, Wilkins BT, Garot P, De Bock S, Saw J, Søndergaard L, De Backer O, Iannaccone F. Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure. J Cardiovasc Comput Tomogr. 2020 Mar - Apr;14(2):149-154. doi: 10.1016/j.jcct.2019.08.010. Epub 2019 Aug 20.

ReferenceCitation: Swaans MJ, Huijboom MFM, Boersma LVA. Fluoroscopic Guidance: An Echo From the Past? JACC Cardiovasc Interv. 2021 Aug 23;14(16):1827-1829. doi: 10.1016/j.jcin.2021.07.003.

ReferenceCitation: Garot P, Iriart X, Aminian A, Kefer J, Freixa X, Cruz-Gonzalez I, Berti S, Rosseel L, Ibrahim R, Korsholm K, Odenstedt J, Nielsen-Kudsk JE, Saw J, Sondergaard L, De Backer O. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study. Open Heart. 2020 Aug;7(2). pii: e001326. doi: 10.1136/openhrt-2020-001326.

lead_sponsor: Rigshospitalet, Denmark

location_country: Denmark Spain Italy Canada France Belgium Sweden

location_facility: Hopital Civil Marie Curie CHU de Charleroi

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467

summary: This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

status: Terminated

lead_sponsor: AbbVie

location_country:
Taiwan
Spain
Australia
United States
Israel
France
Japan

location_facility: National Taiwan University Hospital /ID# 209322

location_facility: China Medical University Hosp /ID# 209323

location_facility: Prisma Health Cancer Institute-Faris Road /ID# 219076

location_facility: National Cancer Center Hospital East /ID# 214697

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214756

location_facility: Nagoya City University Hospital /ID# 214696

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214672

location_facility: Hospital Universitario Vall d'Hebron /ID# 214690

location_facility: St Vincent's Hospital Melbourne /ID# 222066

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170

location_facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215480

location_facility: University of Arizona Cancer Center - North Campus /ID# 219102

location_facility: National Cancer Center Hospital /ID# 214801

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739


title: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System

summary: This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

lead_sponsor: Abbott Medical Devices

location_country:
Saudi Arabia
Italy
Spain
Netherlands
Canada
United States
Israel
France
Japan
Germany

location_facility: University of California - Davis Medical Center

location_facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: Hudson Valley Cardiovascular Practice, P.C.

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz

location_facility: Hospital Alvaro Cunqueiro Dept of Interventional Cardiology

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: The Sakakibara Heart Insitute of Okayama

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Medizinische Einrichtungen der Universitat zu Koln


title: A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

lead_sponsor: Amgen

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

location_country:
Spain
Italy
Russian Federation
Canada
France
United States
Israel
Belgium
Czechia

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: Azienda Ospedaliero Universitaria Di Cagliari

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: National Medical Research Center for Children's Health

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

location_facility: Hospital Infantil Universitario Nino Jesus

summary:
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.

The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.


title: An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

summary: The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

lead_sponsor: BeiGene

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
New Zealand
United Kingdom
Korea, Republic of
United States
France
China
Germany
Czechia

location_facility: The affiliated Hospital of Xuzhou Medical University

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Beatson West of Scotland Cancer Centre - Oncology

location_facility: The first Bethune Hospital of Jilin University

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Tongji Hospital of Tongji Medical College

location_facility: University of Michigan Health System - Oncology

location_facility: Barwon Health, University Hospital Geelong

location_facility: Fujian Medical University Union Hospital

location_facility: Churchill Hospital - Oxford University Hospital NHS Trust

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Florida Cancer Specialists and Research Institute - South

location_facility: Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy

location_facility: Florida Cancer Specialists and Research Institute - North

location_facility: Brisbane Clinic for Lymphoma, Myeloma and Leukaemia

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Banner MD Anderson Cancer Center - Critical Care

location_facility: Institut Catala d'Oncologia-Hospital Universitari Germans Trias i Pujol

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Nottingham University Hospitals NHS Trust

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation

location_facility: Nanfang hospital of Southern Medical University

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Xia Hua Hospital Affiliated to Shanghai Jiao Tong University School of medicine

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

location_facility: Institute of Hematology and Hospital of Blood Disease


title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

acronym: MERGE

summary: Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

lead_sponsor: Mirum Pharmaceuticals, Inc.

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

location_facility: The Children's Memorial Health Institute

location_facility: Hospital Universitario La Paz- Hospital Materno Infantil

location_facility: Paediatric Liver Center, Kings College Hospital

location_facility: Baylor College of Medicine/Texas Children's Hospital


title: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.

location_country:
Spain
Italy
Australia
Korea, Republic of
United States
Chile
France
Israel
South Africa
Norway
Germany

location_facility: Clinical Research Unit - University of Pretoria ( Site 0102)

location_facility: CHU de Grenoble Hopital Nord ( Site 2027)

location_facility: Severance Hospital Yonsei University Health System ( Site 1993)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 2005)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0090)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 2039)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0060)

location_facility: Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001)

location_facility: Centre Georges Francois Leclerc ( Site 2025)

location_facility: Little Company of Mary Hospital ( Site 0100)

location_facility: Seoul National University Hospital ( Site 1992)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0040)

location_facility: The Queen Elizabeth Hospital ( Site 0143)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0104)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0005)

location_facility: Northwest Medical Specialties, PLLC ( Site 0006)

location_facility: Universitaetsklinikum Regensburg ( Site 2007)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0042)

location_facility: Istituto Europeo di Oncologia ( Site 2040)

location_facility: Clinica Universitaria de Navarra. ( Site 0082)

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0002)

summary: This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.


title: A Phase II Multi-center, Single Arm, Safety and Efficacy Study of MBG453 in Combination With Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy

summary: This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax.

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:
Taiwan
Spain
Italy
Australia
Canada
Korea, Republic of
United States
France
Japan
Germany

location_facility: MD Anderson Cancer Center/University of Texas MD Anderson

location_facility: Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga

location_facility: Dana Farber Cancer Institute Dana Farber Cancer Int

location_facility: University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic

location_facility: Levine Cancer Insitute Carolinas Healthcare System

location_facility: Weill Cornell Medicine NewYork Presbyterian Hospital


title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

acronym: PROTECTED TAVR

summary: To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

ReferenceCitation: Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messé SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Oct 6;387(14):1253-1263. doi: 10.1056/NEJMoa2204961. Epub 2022 Sep 17.

ipd_sharing: Undecided

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Italy
Australia
United States
France
Germany

location_facility: Wake Forest University School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Methodist Healthcare System of San Antonio dba Methodist Hospital

location_facility: Kaiser Foundation Hospital - San Francisco

location_facility: South Denver Cardiology Associates PC and Swedish medical center

location_facility: University of California, Davis Medical Center


title: A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

acronym: MATIC

summary: A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

ReferenceCitation: Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4. Review.

lead_sponsor: ALK-Abelló A/S

location_country:
Poland
Spain
Russian Federation
Canada
Lithuania
Ukraine
United States
France
Germany
Bulgaria
Slovakia

location_facility: Regional Children's Clinical Hospital of Vinnytsia Regional Council

location_facility: City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department

location_facility: Centrum Alergologii Teresa Hofman Sp. z o.o.

location_facility: Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

location_facility: Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk

location_facility: Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

location_facility: Allergy & Asthma Specialists Medical Group and Research Center

location_facility: City Children's Clinic № 16" of Kharkiv City Council

location_facility: Rostov-on-Don Clinical Diagnostic Center Zdorovie

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases

location_facility: State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine

location_facility: The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital

location_facility: Multiprofile Hospital for active treatment, Department of Pediatrics

location_facility: Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center

location_facility: Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center

location_facility: O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear

location_facility: Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.

location_facility: Scientific Medical Center for General Therapy and Pharmacology

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics

location_facility: Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

location_facility: Allergy & Asthma Associates of Monmouth City

location_facility: Medical Research Centre of Maimi ll, Inc.

location_facility: Regional Children Clinical Hospital, Infectious-Diagnostic Department

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: Aeroallergy Research Labs of Savannah, Inc.

location_facility: Allergy, Asthma & Clinical Research Center

location_facility: Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse

location_facility: Clinique spécialisée en allergie de la capitale

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

location_facility: Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics

location_facility: Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology

location_facility: Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin

location_facility: Kingston General Hospital - Division of Allergy & Immunology

location_facility: Dnipro City Children's Municipal Clinical Hospital #2

location_facility: Odesa Regional Children's Clinical Hospital" of Odesa Regional Council

location_facility: City Children's Clinical Hospital # 19" of Kharkiv City Council

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie

location_facility: Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Children's Clinical Hospital of Poltava Regional Council

location_facility: Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center

location_facility: All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel

location_facility: Center of Allergy Diagnosis and Treatment

location_facility: Allergy Partners of Western North Carolina

location_facility: Joel Liem Medicine Professional Corporation

location_facility: West Ashley office: Charleston Allergy & Asthma

location_facility: North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation

location_facility: Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

location_facility: Ambulancia klinickej imunologie a alergologie

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

location_facility: CHU de Montpellier - Service Pneumologie et Addictologie

location_facility: Multiprofile Hospital for Active Treatment, Department of Pediatrics

location_facility: University of South Florida Asthma, Allergy and Immunology

location_facility: I.P. Pavlov Ryazan State Medical University

location_facility: California Allergy and Asthma Medical Group

location_facility: Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine

location_facility: Vital Prospects Clinical Research Institute, P.C.


primary_purpose: Prevention

acronym: RSV MAT-004

title: A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

lead_sponsor: GlaxoSmithKline

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

location_country:
Spain
Australia
New Zealand
Finland
Canada
United States
France
Panama
South Africa

summary: The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.


title: A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

summary: This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

time_perspective: Other

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

lead_sponsor: Ethicon, Inc.

location_country:
United Kingdom
Netherlands
Korea, Republic of
United States
France
Singapore
Germany

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: University of Miami, Miller School of Medicine


title: A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Japan
Germany

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: The Children's Hospital for Cancer and Blood Disorders

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: University of Chicago - Comer Children's Hospital

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Hospital Infantil Universitario Niño Jesús

summary: The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.


title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

summary:
The main aims of the study are:

To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
To check what dose range provides adequate relief of narcolepsy symptoms.
To check how much TAK-994 stays in the blood of participants, over time.

The study will have 4 parts. Participants can only join 1 of the parts.

A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.

B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.

C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.

D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

lead_sponsor: Takeda

location_country:
Spain
Italy
Finland
Canada
Hungary
Korea, Republic of
United States
France
China
Japan
Netherlands
Czechia

location_facility: Sleep Medicine Specialists of South Florida

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: Ospedale San Raffaele (San Raffaele Turro)

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

location_facility: Hospital Universitario Araba Sede Santiago

location_facility: Medical University of South Carolina (MUSC)

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

location_facility: Hospital Vithas Nuestra Senora de America

location_facility: Neurocare, Inc., dba Neurocare Center for Research

location_facility: Stichting Epilepsie Instelling Nederland, Heemstede

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: Delta Waves Sleep Disorders and Research Center

location_facility: University of Kansas Medical Center Research Institute, Inc.

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

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic


acronym: InPedILD®

title: A Double Blind, Randomised, Placebo-controlled Trial to Evaluate the Dose-exposure and Safety of Nintedanib Per os on Top of Standard of Care for 24 Weeks, Followed by Open Label Treatment With Nintedanib of Variable Duration, in Children and Adolescents (6 to 17 Year-old) With Clinically Significant Fibrosing Interstitial Lung Disease

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Deterding R, Griese M, Deutsch G, Warburton D, DeBoer EM, Cunningham S, Clement A, Schwerk N, Flaherty KR, Brown KK, Voss F, Schmid U, Schlenker-Herceg R, Verri D, Dumistracel M, Schiwek M, Stowasser S, Tetzlaff K, Clerisme-Beaty E, Young LR. Study design of a randomised, placebo-controlled trial of nintedanib in children and adolescents with fibrosing interstitial lung disease. ERJ Open Res. 2021 Jun 21;7(2). pii: 00805-2020. doi: 10.1183/23120541.00805-2020. eCollection 2021 Apr.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Mexico
Norway
Brazil
Canada
Hungary
Denmark
Greece
Finland
France

location_facility: Independent Public Teaching Children's Hospital

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: General Hospital of Thessaloniki "Ippokrateio"

location_facility: Children's Hematology,Oncology&Immunology na Rogachev,Moscow

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: St. Petersburg State Pediatric University

location_facility: Hospital de Pediatría " Prof. Dr. Juan P. Garrahan"

location_facility: Teaching Hospital Motol, Oncology Clinic

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Regional Children Clinical Hospital, Pulmonology, Kharkiv

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Serviços Medicos Respirar Sul Fluminense

location_facility: Regional clinical children hospital, Zaporizhya

location_facility: Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky

summary: The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).


title: Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study

summary: The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.

lead_sponsor: Medtronic Cardiovascular

location_country:
Spain
Ireland
Italy
Australia
United Kingdom
Canada
United States
France
Israel
Belgium
Sweden

location_facility: St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.

location_facility: Laval University Institute of Cardiology and Respirology of Quebec

location_facility: Royal Victoria Hospital - Belfast Health and Social Care Trust

location_facility: Dixie Regional Medical Center Intermountain

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: University of Alabama at Birmingham Hospital

location_facility: Hôpitaux Universitaires - Hôpital Henri Mondor

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: California Pacific Medical Center - Sutter Health

location_facility: Hospital Universitario Central de Asturas

location_facility: New York Presbyterian - Columbia University Medical Center

location_facility: St. John's Hospital/Prarie Education and Research Cooperative


acronym: DEVOTE

title: Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

lead_sponsor: Biogen

ReferenceCitation: Finkel RS, Ryan MM, Pascual Pascual SI, Day JW, Mercuri E, De Vivo DC, Foster R, Montes J, Gurgel-Giannetti J, MacCannell D, Berger Z. Scientific rationale for a higher dose of nusinersen. Ann Clin Transl Neurol. 2022 Jun;9(6):819-829. doi: 10.1002/acn3.51562. Epub 2022 May 13.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Japan
Poland
Russian Federation
Australia
Israel
Mexico
Brazil
Lebanon
Canada
Hungary
Germany
Taiwan
Greece
Ireland
Estonia
Latvia
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Great Ormond Street Hospital for Children

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: London Health Sciences Centre (LHSC) - Children's Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: The University of Texas Southwestern Medical Center

location_facility: HC-UFMG - Hospital das Clinicas da Universidade Federal de Minas Gerais

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Tokyo Women's Medical University Hospital

location_facility: Fondazione Serena Onlus - Centro Clinico Nemo

location_facility: Saint George University Hospital Medical Center

location_facility: Russian Children Neuromuscular Center of Veltischev

location_facility: Fundacion Hospitalaria San Vicente de Paul

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz

summary:
The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C).

The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).


title: Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study

summary: Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

ReferenceCitation: Mehra MR, Crandall DL, Gustafsson F, Jorde UP, Katz JN, Netuka I, Uriel N, Connors JM, Sood P, Heatley G, Pagani FD. Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial. Eur J Heart Fail. 2021 Jul;23(7):1226-1237. doi: 10.1002/ejhf.2275. Epub 2021 Jul 1. Review.

ipd_sharing_description: To be determined

location_country:
United Kingdom
Italy
Austria
Australia
Canada
Kazakhstan
United States
France
Czechia

location_facility: University of North Carolina at Chapel Hill

location_facility: National Research Center for Cardiac Surgery

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Minnesota Medical Center Fairview

location_facility: California Pacific Medical Center - Van Ness Campus

location_facility: New York-Presbyterian/Columbia University Medical Center

location_facility: Miami Transplant Institute - Jackson Memorial

location_facility: Montefiore Medical Center - Moses Division


title: A Phase 1b/2, Open-label, Multicenter Study of Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First-line Therapy in Metastatic Microsatellite-stable Colorectal Cancer (COLUMBIA-1)

summary: COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC).

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:
Spain
Australia
Canada
United States
France


title: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

summary: This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess ziftomenib (KO-539), a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML).

ReferenceCitation: Sasca D, Guezguez B, Kühn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673. Review.

ReferenceCitation: Jiménez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.

lead_sponsor: Kura Oncology, Inc.

location_country:
United States
Spain
France

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center


title: Extravascular ICD Pivotal Study (EV ICD)

acronym: EV ICD

summary:
Pivotal Summary:

The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Continued Access Summary:

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

primary_purpose: Other

ReferenceCitation: Friedman P, Murgatroyd F, Boersma LVA, Manlucu J, O'Donnell D, Knight BP, Clémenty N, Leclercq C, Amin A, Merkely BP, Birgersdotter-Green UM, Chan JYS, Biffi M, Knops RE, Engel G, Muñoz Carvajal I, Epstein LM, Sagi V, Johansen JB, Sterliński M, Steinwender C, Hounshell T, Abben R, Thompson AE, Wiggenhorn C, Willey S, Crozier I; Extravascular ICD Pivotal Study Investigators. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med. 2022 Oct 6;387(14):1292-1302. doi: 10.1056/NEJMoa2206485. Epub 2022 Aug 28.

ReferenceCitation: Crozier I, O'Donnell D, Boersma L, Murgatroyd F, Manlucu J, Knight BP, Birgersdotter-Green UM, Leclercq C, Thompson A, Sawchuk R, Willey S, Wiggenhorn C, Friedman P. The extravascular implantable cardioverter-defibrillator: The pivotal study plan. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2371-2378. doi: 10.1111/jce.15190. Epub 2021 Aug 5.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Poland
Hong Kong
Saudi Arabia
Italy
Austria
Australia
Netherlands
Canada
New Zealand
Spain
Switzerland
United Kingdom
Hungary
United States
France
Belgium
Norway
Germany

location_facility: Continued Access: North Shore University Hospital

location_facility: Continued Access: Medstar Washington Hospital Center

location_facility: Continued Access: Saint Luke's Mid America Heart Institute

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: London Health Sciences Centre - University Campus

location_facility: University of Washington (UW) Medical Center

location_facility: OhioHealth Research and Innovation Institute (OHRI)

location_facility: University Hospitals Cleveland Medical Center

location_facility: The College of Medicine & King Khalid University Hospital, King Saud University

location_facility: AdventHealth Cardiovascular Research Institute

location_facility: Kepler Universitätsklinikum Med Campus III.

location_facility: HonorHealth Cardiac Arrhythmia Group - Osborn

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

location_facility: University of California San Diego (UCSD)

location_facility: Prairie Education & Research Cooperative

location_facility: Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego


acronym: FREESIA

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

lead_sponsor: Janssen Sciences Ireland UC

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 Data Access (YODA) Project site at yoda.yale.edu

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Japan
Malaysia
Bulgaria

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

location_facility: MD Anderson Cancer Center - University of Texas

location_facility: Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

location_facility: Japanese Red Cross Society Nagano Hospital

location_facility: Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: Henry Ford Hospital - Hematology/oncology

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

summary: The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.


acronym: STEADFAST

title: A Phase II, Multicenter, Randomized, Open Label Two Arm Study Evaluating the Effect of Crizanlizumab + Standard of Care and Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy (STEADFAST)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Spain
Ireland
Greece
Lebanon
United Kingdom
United States
France
Panama
Turkey
Netherlands

location_facility: University of Texas Health Science Center at Houston

location_facility: East Carolina University BrodySchool of Med. (3)

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: University of Illinois Hospital and Health Sciences System

summary: The goal of the study is to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.


title: A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

summary:
Primary Objectives:

To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
To evaluate the pharmacokinetics (PK) of SC and IV isatuximab

Secondary Objectives:

To estimate absolute bioavailability of SC and IV isatuximab
To measure receptor occupancy (RO) after isatuximab SC versus IV administration
To assess efficacy of isatuximab after SC and IV administration
To assess patient expectations prior to and patient experience and satisfaction after SC administration
To evaluate potential immunogenicity of SC or IV isatuximab

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

lead_sponsor: Sanofi

location_country:
Spain
Australia
United States
France
Belgium
Japan

location_facility:
Investigational Site Number :7240002
Investigational Site Number :0360002
Investigational Site Number :8400005
Investigational Site Number :0360003
Investigational Site Number :3920002
Investigational Site Number :2500001
Investigational Site Number :0560001
Investigational Site Number :0360004
Investigational Site Number :3920001
Investigational Site Number :8400002
Investigational Site Number :7240001
Investigational Site Number :7240003
Investigational Site Number :2500002
Investigational Site Number :0360001
Investigational Site Number :8400001


title: An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria

summary: The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.

lead_sponsor: Dicerna Pharmaceuticals, Inc.

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

location_facility:
Clinical Trial Site
Clinical Research Site


acronym: UNITE

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

location_country:
Poland
Spain
Greece
Italy
Russian Federation
United Kingdom
Finland
Ukraine
United States
France
Israel
Germany
Czechia

location_facility:
Teva Investigational Site 30242
Teva Investigational Site 30232
Teva Investigational Site 58319
Teva Investigational Site 35267
Teva Investigational Site 50480
Teva Investigational Site 32731
Teva Investigational Site 14332
Teva Investigational Site 50481
Teva Investigational Site 14338
Teva Investigational Site 54183
Teva Investigational Site 35265
Teva Investigational Site 14345
Teva Investigational Site 14339
Teva Investigational Site 54185
Teva Investigational Site 53446
Teva Investigational Site 32736
Teva Investigational Site 14333
Teva Investigational Site 14334
Teva Investigational Site 14341
Teva Investigational Site 40055
Teva Investigational Site 31272
Teva Investigational Site 63075
Teva Investigational Site 63076
Teva Investigational Site 80175
Teva Investigational Site 14335
Teva Investigational Site 32737
Teva Investigational Site 63077
Teva Investigational Site 53445
Teva Investigational Site 14342
Teva Investigational Site 50482
Teva Investigational Site 54184
Teva Investigational Site 80173
Teva Investigational Site 80177
Teva Investigational Site 54190
Teva Investigational Site 32732
Teva Investigational Site 32733
Teva Investigational Site 54186
Teva Investigational Site 80172
Teva Investigational Site 80178
Teva Investigational Site 53448
Teva Investigational Site 32734
Teva Investigational Site 50483
Teva Investigational Site 31274
Teva Investigational Site 58321
Teva Investigational Site 14411
Teva Investigational Site 53447
Teva Investigational Site 14340
Teva Investigational Site 30234
Teva Investigational Site 58320
Teva Investigational Site 31276
Teva Investigational Site 31273
Teva Investigational Site 34254
Teva Investigational Site 14331
Teva Investigational Site 30235
Teva Investigational Site 30236
Teva Investigational Site 14336
Teva Investigational Site 30237

summary:
The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult patients with migraine and major depressive disorder (MDD)

The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult patients with migraine and MDD on the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult patients with migraine and MDD.

The total duration of patient participation in the study is planned to be approximately 28 weeks.


title: A Phase III, Extension Clinical Trial to Demonstrate Efficacy and Safety of Liposomal Cyclosprine A Via the PARI Investigational eFlow® Device and SoC in Treating Bronchiolitis Obliterans in Patients Post Single or Double Lung Transplant

lead_sponsor: Zambon SpA

location_country:
Spain
Austria
United States
Israel
France
Germany

location_facility:
CHU Hopital Nord
Complexo Hospitalario de A Coruna
Waehringer Guertel
Hospital Marques de Valdecilla
UK Albert B. Chandler Hospital
University of Pittsburgh Medical Center
Indiana University
Columbia University Medical Center
Rabin Medical Center
Houston Methodist Hospital
Johns Hopkins University Hospital
University of Maryland
Baylor University Medical Center
Hospital Universitari Vall d'Hebron
Hannover Medical School
LMU Klinikum Groshadern
Barnes-Jewish Hospital
Hopitaux Universitaires de Strasbourg
UCSF

summary: The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.