primary_purpose: Supportive Care

acronym: TRANSITION

title: A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Bao W, Noè A, Schwende H, Butylin D, Prescott MF; TRANSITION Investigators. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study. JACC Heart Fail. 2020 Oct;8(10):822-833. doi: 10.1016/j.jchf.2020.05.012. Epub 2020 Aug 12.

ReferenceCitation: Senni M, Wachter R, Witte KK, Straburzynska-Migaj E, Belohlavek J, Fonseca C, Mueller C, Lonn E, Chakrabarti A, Bao W, Noe A, Schwende H, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur J Heart Fail. 2020 Feb;22(2):303-312. doi: 10.1002/ejhf.1670. Epub 2019 Dec 9.

ReferenceCitation: Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bøhmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noè A, Schwende H, Bao W, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J Heart Fail. 2019 Aug;21(8):998-1007. doi: 10.1002/ejhf.1498. Epub 2019 May 27.

ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Belohlavek J, Noè A, Carr D, Butylin D. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs. post-discharge initiation of sacubitril/valsartan. ESC Heart Fail. 2018 Apr;5(2):327-336. doi: 10.1002/ehf2.12246. Epub 2017 Dec 14.

location_country:
Poland
Portugal
Saudi Arabia
Italy
Russian Federation
Lebanon
Spain
Argentina
Canada
Switzerland
United Kingdom
Sweden
France
Turkey
Belgium
Norway
Germany
Slovakia
Czechia

summary: To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.


type: EudraCT Number

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

summary: The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Italy
Australia
Finland
Canada
Sweden
United States
France
Norway
Germany

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound Eltanexor (KPT-8602) in Patients With Newly Diagnosed and Relapsed/Refractory Cancer Indications

summary:
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS.

Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Lee S, Mohan S, Knupp J, Chamoun K, de Jonge A, Yang F, Baloglu E, Shah J, Kauffman MG, Shacham S, Bhatnagar B. Oral eltanexor treatment of patients with higher-risk myelodysplastic syndrome refractory to hypomethylating agents. J Hematol Oncol. 2022 Aug 3;15(1):103. doi: 10.1186/s13045-022-01319-y.

ipd_sharing: Undecided

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Spain
Canada
United States
France
China

location_facility: Sarah Cannon Cancer Center - (Colorado Blood Cancer Institute)

location_facility: Sarah Cannon Cancer Center (HCA Midwest KC)

location_facility: John Theurer Cancer Center at Hackensack UMC

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: University of Pennsylvania Abramson Cancer Center Clinical Research Unit

location_facility: Clinical Universidad de Navarra (Madrid site)

location_facility: Oncology Institute of Hope and Innovation

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Rocky Mountain Regional VA Medical Center

location_facility: Ohio State University, The James Cancer Hospital and Solove Research Institute

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

acronym: CheckMate 274

summary: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

status: Active, not recruiting

ReferenceCitation: Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. Erratum in: N Engl J Med. 2021 Aug 26;385(9):864.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

intervention_type: Biological


title: A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

acronym: ReGIFT

summary: The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

primary_purpose: Prevention

lead_sponsor: Quark Pharmaceuticals

location_country:
Brazil
Spain
Australia
Netherlands
Argentina
Canada
United States
France
Belgium
Germany
Czechia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier - Universitaire de Liège

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: University Hospital Schleswig Holstein, Campus Kiel

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Hospital Universitari Germans Trias i Pujol

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

location_facility: University of Florida Health, Shands Hospital

location_facility: Integris Nazih Zuhdi Transplant Institute

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

location_facility: Fundação Oswaldo Ramos - Hospital do Rim

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto de Nefrología Trasplante Renal y Renopancreatico

intervention_type: Other


acronym: Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)

title: A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy

lead_sponsor: Bayer

source: euctr

ReferenceCitation: Kindler HL, Novello S, Bearz A, Ceresoli GL, Aerts JGJV, Spicer J, Taylor P, Nackaerts K, Greystoke A, Jennens R, Calabrò L, Burgers JA, Santoro A, Cedrés S, Serwatowski P, Ponce S, Van Meerbeeck JP, Nowak AK, Blumenschein G Jr, Siegel JM, Kasten L, Köchert K, Walter AO, Childs BH, Elbi C, Hassan R, Fennell DA. Anetumab ravtansine versus vinorelbine in patients with relapsed, mesothelin-positive malignant pleural mesothelioma (ARCS-M): a randomised, open-label phase 2 trial. Lancet Oncol. 2022 Apr;23(4):540-552. doi: 10.1016/S1470-2045(22)00061-4.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Finland
Canada
Korea, Republic of
United States
France
Turkey
Belgium
Netherlands

summary:
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).

210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.

Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.

Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.


type: Other Identifier

title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

acronym: CHRYSALIS

summary: The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

ReferenceCitation: Jatkoe T, Wang S, Odegaard JI, Velasco Roth AM, Osgood D, Martinez G, Lucas P, Curtin JC, Karkera J. Clinical Validation of Companion Diagnostics for the Selection of Patients with Non-Small Cell Lung Cancer Tumors Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutations for Treatment with Amivantamab. J Mol Diagn. 2022 Nov;24(11):1181-1188. doi: 10.1016/j.jmoldx.2022.07.003. Epub 2022 Aug 10.

ReferenceCitation: Park K, Haura EB, Leighl NB, Mitchell P, Shu CA, Girard N, Viteri S, Han JY, Kim SW, Lee CK, Sabari JK, Spira AI, Yang TY, Kim DW, Lee KH, Sanborn RE, Trigo J, Goto K, Lee JS, Yang JC, Govindan R, Bauml JM, Garrido P, Krebs MG, Reckamp KL, Xie J, Curtin JC, Haddish-Berhane N, Roshak A, Millington D, Lorenzini P, Thayu M, Knoblauch RE, Cho BC. Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study. J Clin Oncol. 2021 Oct 20;39(30):3391-3402. doi: 10.1200/JCO.21.00662. Epub 2021 Aug 2.

ReferenceCitation: Köhler J, Jänne PA. Amivantamab: Treating EGFR Exon 20-Mutant Cancers With Bispecific Antibody-Mediated Receptor Degradation. J Clin Oncol. 2021 Oct 20;39(30):3403-3406. doi: 10.1200/JCO.21.01494. Epub 2021 Aug 2.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
China
Japan

location_facility: Washington University School of Medicine

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Sir Bobby Robson Unit, Northern Centre for Cancer Care

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Sanford Cancer Center - Sanford Hematology Oncology

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: The First Bethune Hospital of Jilin University

location_facility: The first affiliated hospital of xiamen university

location_facility: University of Michigan - Rogel Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Samuel Oschin Comprehensive Cancer Center Cedars-Sinai Medical Center

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


title: A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

summary: The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

ReferenceType: result

ReferenceCitation: Daar ES, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, Rockstroh JK, Molina JM, Koenig E, Liu YP, Custodio J, Andreatta K, Graham H, Cheng A, Martin H, Quirk E. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e347-e356. doi: 10.1016/S2352-3018(18)30091-2. Epub 2018 Jun 18.

ReferenceCitation: Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum in: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Spain
Dominican Republic
Italy
Australia
United Kingdom
Canada
Puerto Rico
United States
France
Belgium
Germany


title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

acronym: COBRA-REDUCE

summary: The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

status: Unknown status

ReferenceCitation: Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2022 Jan;34:17-24. doi: 10.1016/j.carrev.2021.01.022. Epub 2021 Jan 22.

ipd_sharing: No

lead_sponsor: CeloNova BioSciences, Inc.

location_country:
Denmark
Italy
Latvia
Switzerland
United States
France
Belgium
Germany

location_facility: Paula Stradins Clinical University Hospital

location_facility: Sentara Heart Hospital (Sentara Cardiovascular Research Institute)

location_facility: Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois

location_facility: University of Maryland St. Joseph Medical Center

location_facility: Rutgers Robert Wood Johnson Medical Schoo

intervention_type: Device

status_simplified: Unknown


title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Czechia
Poland
Portugal
Russian Federation
Australia
Mexico
Norway
Sweden
Canada
Hungary
Germany
Greece
Ireland
Latvia
New Zealand
Finland
France
Netherlands

location_facility: University Diabetes and Endocrine Consultants

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)

location_facility: "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

location_facility: APDP - Associação Protectora dos Diabéticos de Portugal

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Diabetes Endocrinology Research Center of Western New York

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: VSV Centrs, Stalte Private Practice, Talsi

location_facility: Medical Academy named after I. Mechnikov, St. Petersburg

location_facility: Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin

location_facility: Endo-Diabesidad-Clínica Durán & Asociados

location_facility: Eagle's Landing Diabetes and Endocrinology

location_facility: Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases

location_facility: SC Medical Centre "Sanatatea Ta" SRL, Bucharest

location_facility: DiaGolfova s.r.o., Department Diabetology, Prague

location_facility: Richmond Road and Diagnostic Treatment Centre

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Clinical Research Center Medicome, Oswiecim

location_facility: P. Stradins Clinical University Hospital, Riga

location_facility: SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.

location_facility: University of Maryland School of Medicine

location_facility: Diabetes-Klinik Bad Mergentheim GmbH & Co. KG

location_facility: HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

location_facility: A. Lucenko's Internist & Endocrinologist Doctor's Practice

location_facility: Oslo Universitetssykehus HF, Lipidklinikken

location_facility: NorCal Endocrinology and Internal Medicine

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: AIDIN VK s.r.o.,Department Diabetology, Hranice

location_facility: Osp. S. Giovanni Calibita Fatebenefratelli

location_facility: Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.

location_facility: Applied Medical Informatics Research INC.

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Zala Country Hospital, Diabetic Outpatient Clinic

location_facility: Dace Teterovska Doctor's Practice in Endocrinology,Ogre

location_facility: Strand Physician Specialists dba Carolina Health Specialists

location_facility: Endocrine-Diabetes Care and Resource Center

location_facility: Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.

location_facility: Desert Endocrinology Clinical Research Center

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: Institut für Diabetesforschung Münster GmbH

location_facility: City Hospital Saint Elizaveta, Dept. Endocrinology

location_facility: Milan Kvapil s.r.o.,Diabetology ambulance,Prague

summary: The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin


acronym:
Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF

 Innocuité, tolérance et PK du nintedanib combiné avec la pirfénidone dans la PFI

title: A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

ReferenceCitation: Vancheri C, Kreuter M, Richeldi L, Ryerson CJ, Valeyre D, Grutters JC, Wiebe S, Stansen W, Quaresma M, Stowasser S, Wuyts WA; INJOURNEY Trial Investigators. Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis. Results of the INJOURNEY Trial. Am J Respir Crit Care Med. 2018 Feb 1;197(3):356-363. doi: 10.1164/rccm.201706-1301OC.

location_country:
Italy
Netherlands
Canada
United States
France
Germany

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

summary:
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.


status: Terminated

acronym: GALILEO

title: Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes

ReferenceCitation: Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchétché D, Möllmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schäfer U, Wöhrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.

ReferenceCitation: Dangas GD, Tijssen JGP, Wöhrle J, Søndergaard L, Gilard M, Möllmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimarães AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schäfer U, Seeger J, Tchétché D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.

ReferenceCitation: Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8.

ReferenceCitation: Windecker S, Tijssen J, Giustino G, Guimarães AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Sweden
Korea, Republic of
United States
France
Belgium
Norway
Germany
Czechia

summary:
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).

To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.


title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated Rejection in Kidney Transplant Patients

summary: The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

ReferenceCitation: Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24.

ipd_sharing_description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
Spain
Netherlands
Canada
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Kidney Transplant Research Office at UCLA

location_facility: University Of Colorado School Of Medicine

location_facility: University of Pennsylvania Health System

location_facility: University of Utah Health Sciences Center

location_facility: Providence Health Care Research Institute

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: INTEGRIS Nazih Zuhdi Transplant Institute

location_facility: Hospital Universitario Germans Trias i Pujol


title: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

summary: To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

lead_sponsor: Calibra Medical, Inc.

location_country:
Germany
United States
United Kingdom
France

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Royal United Hospital, Diabetes & Lipid Research Wolfson Centre

location_facility: University Diabetes and Endocrine Consultants

location_facility: Texas Diabetes & Endocrinology, P.A.- Austin

location_facility: Diabetes Research Institute Mills-Peninsula Health Service

location_facility: Lapeyronie Hospital, University Hospital Montpellier

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Forth Valley Royal Hospital Dept. of Diabetes

location_facility: John H. Stroger, Jr. Hospital of Cook County Diabetes Center

location_facility: Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications

location_facility: Advanced Metabolic Care & Research Institute, Inc. (AMCR)

location_facility: BAG Unterm Heilig Kreuz Unterm Heilig Kreuz

location_facility: Rocky Mountain Diabetes and Osteoporosis Center PA

location_facility: Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust

location_facility: Leicester General Hospital Leicester Diabetes Centre

location_facility: Park Nicollet Institute International Diabetes Center

location_facility: Ninewells Hospital & Medical School Diabetes Support Unit

location_facility: Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.


title: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

lead_sponsor: Arena Pharmaceuticals

location_country:
Spain
United Kingdom
Lithuania
Ukraine
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Canada
Hungary
Germany
Bulgaria
Latvia
New Zealand
Korea, Republic of
France

location_facility:
Arena 1403
Arena 1458
Arena 1411
Arena 1210
Arena 1432
Arena 1116
Arena 1601
Arena 1607
Arena 1106
Arena 1113
Arena 1477
Arena 1478
Arena 1107
Arena 1455
Arena 1489
Arena 1703
Arena 1505
Arena 1472
Arena 1206
Arena 1484
Arena 1459
Arena 1128
Arena 1490
Arena 1497
Arena 1414
Arena 1506
Arena 1410
Arena 1474
Arena 1493
Arena 1610
Arena 1209
Arena 1605
Arena 1101
Arena 1416
Arena 1462
Arena 1443
Arena 1457
Arena 1454
Arena 1444
Arena 1441
Arena 1469
Arena 1465
Arena 1702
Arena 1208
Arena 1491
Arena 1706
Arena 1109
Arena 1303
Arena 1127
Arena 1121
Arena 1445
Arena 1420
Arena 1479
Arena 1123
Arena 1451
Arena 1475
Arena 1466
Arena 1119
Arena 1614
Arena 1424
Arena 1433
Arena 1460
Arena 1409
Arena 1115
Arena 1111
Arena 1438
Arena 1143
Arena 1112
Arena 1302
Arena 1428
Arena 1407
Arena 1408
Arena 1501
Arena 1473
Arena 1615
Arena 1430
Arena 1498
Arena 1494
Arena 1504
Arena 1448
Arena 1204
Arena 1138
Arena 1456
Arena 1103
Arena 1500
Arena 1202
Arena 1437
Arena 1118
Arena 1102
Arena 1705
Arena 1139
Arena 1464
Arena 1419
Arena 1114
Arena 1105
Arena 1141
Arena 1131
Arena 1470
Arena 1476
Arena 1108
Arena 1418
Arena 1421
Arena 1130
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Arena 1405
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Arena 1136
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Arena 1481
Arena 1431
Arena 1425
Arena 1406
Arena 1304
Arena 1137


title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

summary: This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

ReferenceCitation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8:CD003919. doi: 10.1002/14651858.CD003919.pub3. Review.

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

lead_sponsor: AbbVie

location_country:
Denmark
Poland
United Kingdom
Russian Federation
Australia
New Zealand
Canada
United States
France
Israel
Philippines
Germany

location_facility: Imperial College Healthcare NHS Trust /ID# 234777

location_facility: Cincinnati Eye Institute- Edgewood /ID# 236714

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 235966

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 235929

location_facility: Manchester University NHS Foundation Trust /ID# 237318

location_facility: Medical Center Ophthalmology Associates /ID# 235016

location_facility: Duplicate_Cornerstone Eye Care /ID# 235047

location_facility: Levenson Eye Associates Inc. /ID# 235021

location_facility: Northern New Jersey Eye Institute PA /ID# 234944

location_facility: Emerson Clinical Research Institute /ID# 235977

location_facility: ATX Clinical Trials Inc. dba Keystone Research /ID# 235869

location_facility: Carolinas Centers for Sight,PC /ID# 237017

location_facility: West Virginia University Eye Institute /ID# 235174

location_facility: California Center for Clin Res /ID# 237412

location_facility: North Bay Eye Associates Inc. /ID# 235429

location_facility: Clinique Honore Cave - Pharmacie /ID# 235925

location_facility: The Lady Davis Carmel Medical Center /ID# 236757

location_facility: Midwest Vision Research Foundation at Pepose Vision Institute /ID# 235879

location_facility: Wolstan & Goldberg Eye Associates /ID# 235166

location_facility: Arizona Glaucoma Specialists /ID# 235066

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 237129

location_facility: Scott and Christie and Associates /ID# 234594

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 238315

location_facility: CHU Strasbourg - Hopital Civil /ID# 237837

location_facility: Speciality Eye Care Medical Group /ID# 236001

location_facility: Arizona Advanced Eye Research Institute /ID# 234947

location_facility: Clayton Eye Clinical Research, LLC /ID# 236678

location_facility: California Eye Specialists Medical Group Inc. /ID# 235999

location_facility: Moorfields Eye Hospital NHS Foundation Trust /ID# 237708

location_facility: Peregrine Eye and Laser Institute /ID# 236220

location_facility: Advanced Glaucoma Specialists /ID# 234799

location_facility: Cardinal Santos Medical Center /ID# 235325

location_facility: University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875

location_facility: Albemarle Clinical Trials LLC /ID# 235144

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 237148

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 236902

location_facility: Universitaetsklinikum Magdeburg /ID# 237284

location_facility: Ophthalmology Clinic Bellevue /ID# 234631

location_facility: Tel Aviv Sourasky Medical Center /ID# 237211

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 236806

location_facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 236041

location_facility: CHU de Nice - Hospital Pasteur 2 /ID# 235844

location_facility: Eye Associates of New Mexico /ID# 235115

location_facility: Chu Toulouse Purpan - Hopital Pierre Paul Riquet /ID# 235841

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 237705

location_facility: Dr. Andrew Gardner Logan, FL /ID# 236946

location_facility: Internationale Innovative Ophthalmochirurgie /ID# 235263

location_facility: Samara State Medical University /ID# 236997

location_facility: Eye Associates of South West Florida /ID# 235424

intervention_type: Procedure


acronym: LUPUZOR

title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

lead_sponsor: ImmuPharma

location_country:
Poland
Hungary
Puerto Rico
United States
France
Mauritius
Germany
Czechia

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Clinic for Rheumatology and Internal Medicine

location_facility: Egyesitett Szt.István és Szt. László Kórház

summary: This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.


title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

summary: This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

ReferenceCitation: Johnson CN, Ahn JS, Buck IM, Chiarparin E, Day JEH, Hopkins A, Howard S, Lewis EJ, Martins V, Millemaggi A, Munck JM, Page LW, Peakman T, Reader M, Rich SJ, Saxty G, Smyth T, Thompson NT, Ward GA, Williams PA, Wilsher NE, Chessari G. A Fragment-Derived Clinical Candidate for Antagonism of X-Linked and Cellular Inhibitor of Apoptosis Proteins: 1-(6-[(4-Fluorophenyl)methyl]-5-(hydroxymethyl)-3,3-dimethyl-1 H,2 H,3 H-pyrrolo[3,2- b]pyridin-1-yl)-2-[(2 R,5 R)-5-methyl-2-([(3R)-3-methylmorpholin-4-yl]methyl)piperazin-1-yl]ethan-1-one (ASTX660). J Med Chem. 2018 Aug 23;61(16):7314-7329. doi: 10.1021/acs.jmedchem.8b00900. Epub 2018 Aug 9.

lead_sponsor: Astex Pharmaceuticals, Inc.

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

location_facility: Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

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

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

location_facility: The Ohio State University and Wexner Medical Center, James Cancer Hospital

location_facility: Beatson Cancer Center and University of Glasgow

location_facility: Hospital Universitario Fundacion Jimenez Diaz Preview

location_facility: Summit Medical Group - Florham Park Campus/Atlantic Health

location_facility: The Christie NHS Foundation Trust, Christie Hospital

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Churchill Hospital, Oxford University Hospital NHS Trust

location_facility: University of Oklahoma Stephenson Cancer Center

location_facility: University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research

location_facility: START- South Texas Accelerated Research Therapeutics

location_facility: New York University Langone Medical Center

location_facility: Emory University winship Cancer Institute

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: New York Presbyterian Hospital Columbia University Medical Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

location_facility: CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire

location_facility: Centre Antoine Lacassagne, Oncologie Médicale

location_facility: Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of Washington, Seattle Cancer Care Alliance

location_facility: Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado


title: A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

acronym: VITALITY-ALS

summary: This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

ReferenceCitation: Andrews JA, Cudkowicz ME, Hardiman O, Meng L, Bian A, Lee J, Wolff AA, Malik FI, Shefner JM. VITALITY-ALS, a phase III trial of tirasemtiv, a selective fast skeletal muscle troponin activator, as a potential treatment for patients with amyotrophic lateral sclerosis: study design and baseline characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):259-266. doi: 10.1080/21678421.2018.1426770. Epub 2018 Feb 6. Erratum in: Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):321.

lead_sponsor: Cytokinetics

location_country:
Portugal
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurology Clinics

location_facility: University of Michigan Hospital and Health System

location_facility: The Penn Comprehensive Neuroscience Center

location_facility: West Virginia University Department of Neurology

location_facility: George Washington University Medical Center

location_facility: Dartmouth Hitchcock Medical Center Dept of Neurology

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda

location_facility: Neurosciences Institute: Neurology - Charlotte

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Froedtert Memorial Lutheran Hospital, Department of Neurology

location_facility: Neurological Institute Columbia University Medical Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Clinical Research Centre, Beaumont Hospital

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: University of Ulm, Department of Neurology

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: University of California Davis Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Carol and Frank Morsini Center for Advanced Health Care - University of South Florida

location_facility: Clinical Research Centre, Royal London Hospital

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: Hospital Santa Maria-Centro Hospitalar Lisboa Norte

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: University of Texas Health Science Center

location_facility: CHU de Quebec - Universite Laval Hopital de l'Enfant-Jesus

location_facility: Hannover Medical School, Department of Neurology

location_facility: Charite Campus Virchow-Klinikum, Neurology Department

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Providence Brain and Spine Institute ALS Center


title: A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

summary: The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

ReferenceCitation: Williamson DJ, Gogate JP, Kern Sliwa JK, Manera LS, Preskorn SH, Winokur A, Starr HL, Daly EJ. Longitudinal Course of Adverse Events With Esketamine Nasal Spray: A Post Hoc Analysis of Pooled Data From Phase 3 Trials in Patients With Treatment-Resistant Depression. J Clin Psychiatry. 2022 Sep 19;83(6). pii: 21m14318. doi: 10.4088/JCP.21m14318.

ReferenceCitation: Chen G, Chen L, Zhang Y, Li X, Lane R, Lim P, Daly EJ, Furey ML, Fedgchin M, Popova V, Singh JB, Drevets WC. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

ReferenceCitation: Daly EJ, Trivedi MH, Janik A, Li H, Zhang Y, Li X, Lane R, Lim P, Duca AR, Hough D, Thase ME, Zajecka J, Winokur A, Divacka I, Fagiolini A, Cubala WJ, Bitter I, Blier P, Shelton RC, Molero P, Manji H, Drevets WC, Singh JB. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Sep 1;76(9):893-903. doi: 10.1001/jamapsychiatry.2019.1189.

location_country:
Poland
Brazil
Spain
Estonia
Mexico
Canada
Sweden
Hungary
United States
France
Turkey
Belgium
Germany
Slovakia
Czechia


title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

acronym: TITAN

summary: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Özgüroğlu M, Juárez Soto Á, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.

ReferenceCitation: Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juárez A, Merseburger AS, Özgüroğlu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.

ReferenceCitation: Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum in: BMC Urol. 2020 Oct 22;20(1):166.

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Özgüroğlu M, Juárez Soto Á, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.

ReferenceCitation: Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juárez Soto Á, Merseburger AS, Özgüroğlu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.

lead_sponsor: Aragon Pharmaceuticals, Inc.

location_country:
Spain
United Kingdom
Ukraine
United States
Romania
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
China
Germany
Korea, Republic of
France


acronym: ENGAGE

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

lead_sponsor: Biogen

ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

location_country:
Denmark
Taiwan
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Japan
Germany

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National Clinical Research Inc.-Richmond

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Central Coast Neurosciences Research, Gosford

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: Medical University of South Carolina (MUSC)

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Groupe hospitalier Broca - La Rochefoucauld - La Collégiale

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Seconda Università degli Studi di Napoli

location_facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

location_facility: Institute for Neurodegenerative Disorders

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: Christian-Doppler-Klinik - Universitätsklinikum Salzburg

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Jacksonville Center for Clinical Research

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: California Neuroscience Research Medical Group Inc.

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Seoul National University Bundang Hospital

location_facility: University of Tennessee Medical Center. Knoxville

location_facility: KARA Institute for Neurological Diseases

location_facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: New York University Medical Center PRIME

location_facility: St. Joseph's Hospital and Medical Center

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

location_facility: Alexian Brothers Neurosciences Institute

location_facility: Azienda Ospedaliera Ospedali Riuniti di Bergamo

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].


title: A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy

ReferenceCitation: Peipert JD, Efficace F, Pierson R, Loefgren C, Cella D, He J. Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. J Geriatr Oncol. 2022 Sep;13(7):935-939. doi: 10.1016/j.jgo.2021.09.007. Epub 2021 Sep 11.

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
Australia
Sweden
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Germany

summary: The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kühbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panés J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.

location_facility:
Arena 1403
Arena 1440
Arena 1458
Arena 1210
Arena 1432
Arena 1116
Arena 1601
Arena 1607
Arena 1106
Arena 1477
Arena 1478
Arena 1107
Arena 1455
Arena 1489
Arena 1703
Arena 1608
Arena 1505
Arena 1472
Arena 1206
Arena 1484
Arena 1459
Arena 1128
Arena 1467
Arena 1612
Arena 1490
Arena 1497
Arena 1414
Arena 1506
Arena 1410
Arena 1474
Arena 1493
Arena 1610
Arena 1209
Arena 1605
Arena 1101
Arena 1611
Arena 1416
Arena 1462
Arena 1443
Arena 1457
Arena 1454
Arena 1444
Arena 1441
Arena 1469
Arena 1465
Arena 1702
Arena 1208
Arena 1491
Arena 1706
Arena 1452
Arena 1109
Arena 1303
Arena 1127
Arena 1121
Arena 1445
Arena 1420
Arena 1479
Arena 1123
Arena 1451
Arena 1475
Arena 1466
Arena 1119
Arena 1614
Arena 1424
Arena 1433
Arena 1460
Arena 1409
Arena 1115
Arena 1111
Arena 1438
Arena 1143
Arena 1613
Arena 1112
Arena 1302
Arena 1428
Arena 1407
Arena 1408
Arena 1501
Arena 1473
Arena 1615
Arena 1430
Arena 1498
Arena 1494
Arena 1504
Arena 1448
Arena 1204
Arena 1138
Arena 1456
Arena 1103
Arena 1500
Arena 1202
Arena 1437
Arena 1118
Arena 1102
Arena 1705
Arena 1139
Arena 1464
Arena 1419
Arena 1114
Arena 1105
Arena 1141
Arena 1131
Arena 1470
Arena 1476
Arena 1108
Arena 1418
Arena 1421
Arena 1130
Arena 1436
Arena 1480
Arena 1405
Arena 1502
Arena 1704
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Arena 1604
Arena 1142
Arena 1117
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Arena 1136
Arena 1133
Arena 1471
Arena 1486
Arena 1481
Arena 1431
Arena 1425
Arena 1406
Arena 1304
Arena 1137

summary: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.


title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

ReferenceCitation: Bruce IN, van Vollenhoven RF, Morand EF, Furie RA, Manzi S, White WB, Abreu G, Tummala R. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post-hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2022 Aug 26. pii: keac491. doi: 10.1093/rheumatology/keac491. [Epub ahead of print]

ReferenceCitation: Bruce IN, Furie RA, Morand EF, Manzi S, Tanaka Y, Kalunian KC, Merrill JT, Puzio P, Maho E, Kleoudis C, Albulescu M, Hultquist M, Tummala R. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials. Ann Rheum Dis. 2022 Jul;81(7):962-969. doi: 10.1136/annrheumdis-2021-221847. Epub 2022 May 17.

ReferenceCitation: Vital EM, Merrill JT, Morand EF, Furie RA, Bruce IN, Tanaka Y, Manzi S, Kalunian KC, Kalyani RN, Streicher K, Abreu G, Tummala R. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials. Ann Rheum Dis. 2022 Jul;81(7):951-961. doi: 10.1136/annrheumdis-2021-221425. Epub 2022 Mar 25.

ReferenceCitation: Loncharich MF, Anderson CW. Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. ACR Open Rheumatol. 2022 Jun;4(6):486-491. doi: 10.1002/acr2.11414. Epub 2022 Feb 14.

ReferenceCitation: Chia YL, Zhang J, Tummala R, Rouse T, Furie RA, Morand EF. Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 May 5;61(5):1900-1910. doi: 10.1093/rheumatology/keab704.

ReferenceCitation: Furie R, Morand EF, Askanase AD, Vital EM, Merrill JT, Kalyani RN, Abreu G, Pineda L, Tummala R. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12.

ReferenceCitation: Furie R, Morand EF, Bruce IN, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials. Arthritis Rheumatol. 2021 Nov;73(11):2059-2068. doi: 10.1002/art.41778. Epub 2021 Sep 22.

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

ReferenceCitation: Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

lead_sponsor: AstraZeneca

location_country:
Brazil
Spain
Russian Federation
Mexico
Argentina
Canada
Lithuania
Korea, Republic of
United States
France
South Africa
Belgium
Japan
Germany
Bulgaria


title: A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

summary: The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

ReferenceCitation: Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

lead_sponsor: ViiV Healthcare

location_country:
Poland
Spain
Italy
United Kingdom
Argentina
Canada
United States
Chile
France
South Africa
Mexico
Germany


title: An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

summary: The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

ReferenceCitation: Salles G, Gopal AK, Minnema MC, Wakamiya K, Feng H, Schecter JM, Wang M. Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 May;19(5):275-284. doi: 10.1016/j.clml.2018.12.013. Epub 2019 Jan 2.

location_country:
Australia
Korea, Republic of
United States
France
Turkey
Belgium
Netherlands


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

ReferenceCitation: Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

lead_sponsor: Alliance for Clinical Trials in Oncology

location_country:
Denmark
Spain
Ireland
Italy
Australia
Netherlands
United Kingdom
Switzerland
United States
France
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Radboud University Nijmegen Medical Centre

location_facility: BI-LO Charities Children's Cancer Center

location_facility: The Children's Hospital at TriStar Centennial

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: Marshfield Medical Center-River Region at Stevens Point

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: University of Berlin Charite Campus Benjamin Franklin

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: Children's Hospitals and Clinics of Minnesota - Minneapolis

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Marshfield Medical Center-EC Cancer Center

location_facility: Duran i Reynals Hospital-Catalan Institute of Oncology

location_facility: University of Pennsylvania/Abramson Cancer Center

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: The Royal Marsden NHS Foundation Trust - Sutton

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hopital Tenon/Assistance Publique - Hopitaux de Paris

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa


title: T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry

acronym: T-STAR

summary: The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).

status: Withdrawn

study_type: Observational

time_perspective: Prospective

location_country:
Taiwan
Spain
Italy
Russian Federation
Netherlands
United States
France
China
Germany


title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3

lead_sponsor: Bayer

ReferenceCitation: Matasar MJ, Capra M, Özcan M, Lv F, Li W, Yañez E, Sapunarova K, Lin T, Jin J, Jurczak W, Hamed A, Wang MC, Baker R, Bondarenko I, Zhang Q, Feng J, Geissler K, Lazaroiu M, Saydam G, Szomor Á, Bouabdallah K, Galiulin R, Uchida T, Soler LM, Cao A, Hiemeyer F, Mehra A, Childs BH, Shi Y, Zinzani PL. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. doi: 10.1016/S1470-2045(21)00145-5. Epub 2021 Apr 10. Erratum in: Lancet Oncol. 2021 Jun;22(6):e239.

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

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

location_country:
Spain
Italy
Lithuania
Ukraine
United States
Belgium
Japan
Philippines
Romania
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Malaysia
Singapore
Slovakia
Brazil
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia

location_facility:
MSK Basking Ridge
MSK Bergen
MSK Monmoth
MSK Rockville Centre
MSK Westchester
MSK Commack

summary: The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.


title: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

summary: This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

ReferenceCitation: Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.

lead_sponsor: Acorda Therapeutics

location_country:
Poland
Romania
Serbia
Spain
United Kingdom
Austria
Netherlands
Hungary
France
United States
Israel
Belgium
Germany
Czechia

location_facility:
Acorda Site #7037
Acorda Site #7133
Acorda Site #7150
Acorda Site # 7142
Acorda Site #7130
Acorda Site #7053
Acorda Site #7123
Acorda Site #7045
Acorda Site #7013
Acorda Site #7036
Acorda Site #7051
Acorda Site #7148
Acorda Site #7141
Acorda Site #7111
Acorda Site #7135
Acorda Site #7012
Acorda Site #7083
Acorda Site #7023
Acorda Site #7145
Acorda Site #7138
Acorda Site #7140
Acorda Site #7118
Acorda Site #7034
Acorda Site #7021
Acorda Site #7102
Acorda Site #7122
Acorda Site #7024
Acorda Site #7088
Acorda Site #7093
Acorda Site #7103
Acorda Site #7063
Acorda Site #7031
Acorda Site #7050
Acorda Site #7137
Acorda Site #7120
Acorda Site #7113
Acorda Site #7035
Acorda Site #7032
Acorda Site #7116
Acorda Site #7003
Acorda Site #7002
Acorda Site #7046
Acorda Site #7044
Acorda Site #7047
Acorda Site #7042
Acorda Site #7131
Acorda Site #7094
Acorda Site #7043
Acorda Site #7095
Acorda Site #7115
Acorda Site #7004
Acorda Site #7121
Acorda Site #7022
Acorda Site #7086
Acorda Site #7134
Acorda Site #7082
Acorda Site #7084
Acorda Site #7011
Acorda Site #7085
Acorda Site #7091
Acorda Site #7119
Acorda Site #7081
Acorda Site #7064
Acorda Site #7139
Acorda Site #7025
Acorda Site #7033
Acorda Site #7048
Acorda Site #7062
Acorda Site #7101
Acorda Site #7114
Acorda Site #7112
Acorda Site #7092
Acorda Site #7041
Acorda Site #7087
Acorda Site #7049
Acorda Site #7061


acronym: RE-CIRCUIT

title: Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy (The RE-CIRCUIT Trial)

ReferenceCitation: Kimata A, Nogami A, Yamasaki H, Ohigashi T, Gosho M, Igarashi M, Sekiguchi Y, Ieda M, Calkins H, Aonuma K. Optimal interruption time of dabigatran oral administration to ablation (O-A time) in patients with atrial fibrillation: Integrated analysis of 2 randomized controlled clinical trials. J Cardiol. 2021 Jun;77(6):652-659. doi: 10.1016/j.jjcc.2020.12.010. Epub 2021 Jan 25.

ReferenceCitation: Hohnloser SH, Calkins H, Willems S, Verma A, Schilling R, Okumura K, Nordaby M, Kleine E, Biss B, Gerstenfeld EP; RE-CIRCUIT® investigators. Regional differences in patient characteristics and outcomes during uninterrupted anticoagulation with dabigatran versus warfarin in catheter ablation of atrial fibrillation: the RE-CIRCUIT study. J Interv Card Electrophysiol. 2019 Aug;55(2):145-152. doi: 10.1007/s10840-019-00518-x. Epub 2019 Feb 13.

ReferenceCitation: Calkins H, Willems S, Gerstenfeld EP, Verma A, Schilling R, Hohnloser SH, Okumura K, Serota H, Nordaby M, Guiver K, Biss B, Brouwer MA, Grimaldi M; RE-CIRCUIT Investigators. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017 Apr 27;376(17):1627-1636. doi: 10.1056/NEJMoa1701005. Epub 2017 Mar 19.

location_country:
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
United States
France
Belgium
Japan
Germany

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Instit.of Surgery na Vishnevskiy,Treatm.of comp.arrhythm.dep

location_facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Tennessee Methodist Physicians

location_facility: Yaroslavl Regional Clin. Hospital, Dept. Endocrinology

location_facility: Antwerpen - HOSP ZNA Middelheim - Pneumo

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: CLI Nouvelles Cliniques Nantaises,Cardio,Nantes Cedex 2

location_facility: University at Buffalo, The State University of New York

location_facility: University of Utah Health Sciences Center

location_facility: Mercy Medical Group, a service of Dignity Health Medical Foundation

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: Mission Cardiovascular Research Institute

location_facility: Golden Jubilee National Hospital, Clydebank

location_facility: St Luke's Health Baylor College of Medicine Med Center

summary:
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

summary: This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

ReferenceCitation: Taylor-Cousar JL, Munck A, McKone EF, van der Ent CK, Moeller A, Simard C, Wang LT, Ingenito EP, McKee C, Lu Y, Lekstrom-Himes J, Elborn JS. Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del. N Engl J Med. 2017 Nov 23;377(21):2013-2023. doi: 10.1056/NEJMoa1709846. Epub 2017 Nov 3.

lead_sponsor: Vertex Pharmaceuticals Incorporated

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


title: A Multi-centre, Double-blind, Parallel-group, Randomised Controlled Study to Investigate Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Cognitive Impairment Due to Alzheimer's Disease

summary: The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

ReferenceCitation: Frölich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

location_country:
Poland
Portugal
United Kingdom
Italy
Austria
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: West Devon (Tavistock) CMHT & Memory Clinic (EDI)

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: Inst. of Rural Health, Spec. Outp. Clin. & Rural Occup. Dis.

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Psychiatry And Alzheimer's Care of Rochester, PLLC

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Private Practice for Psychiatry and Neurology

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Non-Public Outpatient Clinic Neuromed M. i M. Nastaj

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center


title: A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab

acronym: STORM

summary: This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

ReferenceCitation: Tremblay G, Daniele P, Breeze J, Li L, Shah J, Shacham S, Kauffman M, Engelhardt M, Chari A, Nooka A, Vogl D, Gavriatopoulou M, Dimopoulos MA, Richardson P, Biran N, Siegel D, Vlummens P, Doyen C, Facon T, Mohty M, Meuleman N, Levy M, Costa L, Hoffman JE, Delforge M, Kaminetzky D, Weisel K, Raab M, Dingli D, Tuchman S, Laurent F, Vij R, Schiller G, Moreau P, Richter J, Schreder M, Podar K, Parker T, Cornell RF, Lionel K, Choquet S, Sundar J. Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study. BMC Cancer. 2021 Sep 6;21(1):993. doi: 10.1186/s12885-021-08453-9.

ReferenceCitation: Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.

ReferenceCitation: Chari A, Florendo E, Mancia IS, Cho H, Madduri D, Parekh S, Richter J, Dhadwal A, Thomas J, Jiang G, Lagana A, Bhalla S, Jagannath S. Optimal Supportive Care With Selinexor Improves Outcomes in Patients With Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):e975-e984. doi: 10.1016/j.clml.2021.07.014. Epub 2021 Jul 18.

ReferenceCitation: Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019 Aug 22;381(8):727-738. doi: 10.1056/NEJMoa1903455.

ReferenceCitation: Vogl DT, Dingli D, Cornell RF, Huff CA, Jagannath S, Bhutani D, Zonder J, Baz R, Nooka A, Richter J, Cole C, Vij R, Jakubowiak A, Abonour R, Schiller G, Parker TL, Costa LJ, Kaminetzky D, Hoffman JE, Yee AJ, Chari A, Siegel D, Fonseca R, Van Wier S, Ahmann G, Lopez I, Kauffman M, Shacham S, Saint-Martin JR, Picklesimer CD, Choe-Juliak C, Stewart AK. Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 20;36(9):859-866. doi: 10.1200/JCO.2017.75.5207. Epub 2018 Jan 30.

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Greece
Austria
United States
France
Belgium
Germany

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Med. Klinik und Poliklinik II Universitätsklinikum

location_facility: Hackensack University Medical Center / John Therurer Cancer Center

location_facility: Emory University / Winship Cancer Institute

location_facility: Hopital Saint-Antoine, Service d´Hematologie Clinique et Therapie Cellulaire

location_facility: University hospital of Tuebingen, Internal Medicine II

location_facility: Universitätsklinikum des Saarlandes Klinik für Innere Medizin I

location_facility: University of Florida Health Cancer Center- Shands Cancer Center Hospital

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Medical University Vienna, Department of Internal Medicine I

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: Jonnsson Comprehensive Cancer Center / University of Los Angeles

location_facility: La Pitie-Salpetriere University Hospital, Department of Clinical Hematology

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: National & Kapodistrain University of Athens School of Medicine, Alexandra Hospital

location_facility: South Lyon Hospital Center, Department of Clinical Hematology

location_facility: Claude Huriez Hospital, Department of Blood Diseases

location_facility: H. Lee Moffitt Cancer Center Research Institute

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Universitätsklinikum Heidelberg Medizinische Klinik V

location_facility: University Hospital Freiburg, Department of Internal Medicine I


title: The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure

acronym: REDUCE FMR

summary: The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

ReferenceType: background

ReferenceCitation: Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tübler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

ReferenceCitation: Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

ReferenceCitation: Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.

ReferenceCitation: Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.

lead_sponsor: Cardiac Dimensions Pty Ltd

location_country:
Poland
United Kingdom
Australia
Netherlands
New Zealand
France
Germany
Czechia

location_facility: Institut klinické a experimentální medicíny (IKEM)

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid


title: A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard Care

acronym: OPAL

summary: The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

time_perspective: Other

ipd_sharing_description: Discussions ongoing with regards to data sharing/registry.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Denmark
Poland
Portugal
Spain
Ireland
Austria
Italy
Netherlands
Finland
United Kingdom
Sweden
Hungary
France
Belgium
Norway
Germany
Czechia

location_facility: Swedish Oprhan Biovitrum Investigational Site

location_facility: Swedish Orphan Biovitrum Investigational Site


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

acronym: RAINFALL

summary: The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1. Erratum in: Lancet Oncol. 2019 May;20(5):e242.

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

lead_sponsor: Eli Lilly and Company

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Mexico
Netherlands
Argentina
Canada
Finland
United Kingdom
Hungary
Puerto Rico
United States
France
Israel
Belgium
Japan
Germany
Czechia

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Central Coast Medical Oncology Corporation

location_facility: Florida Cancer Specialists and Research Institute

location_facility: University of Colorado School of Medicine


title: A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

acronym: REPAIR

summary: The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

ReferenceCitation: Vonk Noordegraaf A, Channick R, Cottreel E, Kiely DG, Marcus JT, Martin N, Moiseeva O, Peacock A, Swift AJ, Tawakol A, Torbicki A, Rosenkranz S, Galiè N. The REPAIR Study: Effects of Macitentan on RV Structure and Function in Pulmonary Arterial Hypertension. JACC Cardiovasc Imaging. 2022 Feb;15(2):240-253. doi: 10.1016/j.jcmg.2021.07.027. Epub 2021 Nov 17.

lead_sponsor: Actelion

location_country:
Hong Kong
United Kingdom
Italy
Russian Federation
Australia
Netherlands
United States
France
Israel
Malaysia
Singapore
Germany

location_facility: Washington University School of Medicine

location_facility: Pulmonology institute, Soroka Medical Center

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health

location_facility: Fondazione IRCCS Policlinico San Matteo Ambulatorio Scompenso Cardiaco e Trapianti

location_facility: University of Texas Southwestern Medical

location_facility: "CHRU de Lille - Hôpital Albert Calmette "

location_facility: Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin

location_facility: National University Hospital - The Heart Institute - Cardiac Department

location_facility: Medizinische Klinik und Poliklinik II Universitätsklinik Bonn

location_facility: "Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital"

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg