title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy

lead_sponsor: Millennium Pharmaceuticals, Inc.

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

location_facility: The Center for Cancer and Blood Disorders

location_facility: Institut de Cancerologie de l'Ouest Paul Papin

location_facility: The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hackensack University Medical Center PARTNER

location_facility: ICL-Alexis Vautrin, Departement dOncologie Medicale

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Beskidzkie Centrum Onkologii im.Jana Pawla II

location_facility: Instytut MSF, Ulica Pilota Stanislawa Wigury 19

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Groupe Hospitalier Saint Andre - Hopital Saint Andre

summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy.


type: EudraCT Number

title: An Open-label, Multicentre, Dose-escalating Phase I/II Trial of 3-weekly Ocrelizumab in Patients With Follicular Non-Hodgkin's Lymphoma (NHL)

summary: This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

location_country: Italy Australia Canada Switzerland France Sweden

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

lead_sponsor: Bristol-Myers Squibb

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2022 Aug 12:JCO2102815. doi: 10.1200/JCO.21.02815. [Epub ahead of print]

ReferenceCitation: Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona

location_facility: Oddzial Hematologii i Transplantacji Szpiku

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Klinikum Der Johannes Gutenberg Universitaet Mainz

location_facility: A. O. U. Di Bologna, Policlinico S. Orsola Malpighi

location_facility: Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych

location_facility: Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino

summary: The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.


title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

acronym: RADIANCE-HTN

summary: RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Azizi M, Mahfoud F, Weber MA, Sharp ASP, Schmieder RE, Lurz P, Lobo MD, Fisher NDL, Daemen J, Bloch MJ, Basile J, Sanghvi K, Saxena M, Gosse P, Jenkins JS, Levy T, Persu A, Kably B, Claude L, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation: Prespecified Analysis at 6 Months of the RADIANCE-HTN TRIO Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 9. doi: 10.1001/jamacardio.2022.3904. [Epub ahead of print]

ReferenceCitation: Sanghvi K, Wang Y, Daemen J, Mathur A, Jain A, Dohad S, Sapoval M, Azizi M, Mahfoud F, Lurz P, Sayer J, Levy T, Zagoria R, Loening AM, Coleman L, Craig D, Horesh-Bar M, Kirtane AJ. Renal Artery Variations in Patients With Mild-to-Moderate Hypertension From the RADIANCE-HTN SOLO Trial. Cardiovasc Revasc Med. 2022 Jun;39:58-65. doi: 10.1016/j.carrev.2021.09.008. Epub 2021 Sep 30.

ReferenceCitation: Fisher NDL, Kirtane AJ, Daemen J, Rader F, Lobo MD, Saxena M, Abraham J, Schmieder RE, Sharp ASP, Gosse P, Claude L, Song Y, Azizi M; RADIANCE-HTN Investigators. Plasma renin and aldosterone concentrations related to endovascular ultrasound renal denervation in the RADIANCE-HTN SOLO trial. J Hypertens. 2022 Feb 1;40(2):221-228. doi: 10.1097/HJH.0000000000002994.

ReferenceCitation: Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

ReferenceCitation: Gosse P, Cremer A, Kirtane AJ, Lobo MD, Saxena M, Daemen J, Wang Y, Stegbauer J, Weber MA, Abraham J, Kario K, Bangalore S, Claude L, Liu Y, Azizi M. Ambulatory Blood Pressure Monitoring to Predict Response to Renal Denervation: A Post Hoc Analysis of the RADIANCE-HTN SOLO Study. Hypertension. 2021 Feb;77(2):529-536. doi: 10.1161/HYPERTENSIONAHA.120.16292. Epub 2020 Dec 28.

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 Mar 17. doi: 10.1161/CIRCULATIONAHA.119.040451. [Epub ahead of print]

ReferenceCitation: Calhoun DA, Schiffrin EL, Flack JM. Resistant Hypertension: An Update. Am J Hypertens. 2019 Jan 1;32(1):1-3. doi: 10.1093/ajh/hpy156.

ReferenceCitation: Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23. Erratum in: Lancet. 2018 Sep 8;392(10150):820.

ipd_sharing: Undecided

ipd_sharing_description: to be determined

lead_sponsor: ReCor Medical, Inc.

location_country:
Poland
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility: University of North Carolina at Chapel Hill School of Medicine

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Renown Institute for Heart& Vascular Health

location_facility: University Hospitals Cleveland Medical Center

location_facility: The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals

location_facility: Imperial College London, Hammersmith Hospital

location_facility: Columbia University / NewYork Presbyterian Hospital

location_facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH

intervention_type: Device

status_simplified: Ongoing


title: An Open-Label, Multicenter, Dose-Escalation, Phase Ia/Ib Study to Evaluate Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281, an Immunocytokine Consisting of Interleukin 2 Variant (IL-2v) Targeting Fibroblast Activation Protein-α (FAP), as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

summary: This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

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

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Ospedale Policlinico S. Matteo; Phase I Clinical Trial Unit and Experimental Therapy

location_facility: Washington University; Division of Oncology

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital


title: A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)

summary:
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

ReferenceCitation: Young MH, Pietz G, Whalen E, Copeland W, Thompson E, Fox BA, Newhall KJ. Immunomodulation by durvalumab and pomalidomide in patients with relapsed/refractory multiple myeloma. Sci Rep. 2021 Aug 12;11(1):16460. doi: 10.1038/s41598-021-95902-x.

lead_sponsor: Celgene

location_country:
Spain
Italy
Netherlands
Canada
United States
France
Germany

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Institut universitaire du cancer de Toulouse (IUCT) - Oncopole

location_facility: Weill Medical College of Cornell University

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

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

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"


title: Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)

summary:
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates.

The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding.

In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand).

In case a participant develops antibodies, treatment will be provided as part of the study.

ipd_sharing: Yes

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

lead_sponsor: Baxalta now part of Shire

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Hong Kong
Austria
Turkey
Norway
Malaysia
Singapore
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Finland
Thailand
Korea, Republic of
France
Netherlands

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Evelina Children's Hospital - St Thomas' Hospital

location_facility: Novant Health Presbyterian Medical Center

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: The University of Hong Kong Queen Mary Hospital

location_facility: Oslo Universitetssykehus - Rikshospitalet

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: Texas Tech University Health Sciences Center

intervention_type: Biological


title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

summary:
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID (twice daily) and 1600 mg QD (once daily). Subjects will be screened for eligibility within 21 days of the planned date of the first dose of tazemetostat and enrolled into one of 8 cohorts:

Cohort using tazemetostat 800 mg BID

Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, and selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO]
Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
Cohort 3 (Closed for enrollment): Other INI1 negative tumors or any solid tumor with an EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma
Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)
Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)
Cohort 6 (Opened for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy
Cohort 7 (Closed for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)

Cohort using tazemetostat 1600 mg QD

• Cohort 8 (Closed for enrollment): Epitheliod sarcoma

Subjects will be dosed in continuous 28-day cycles. (Note: if treatment with study drug is discontinued prior to completing 2 years, subjects will be followed for a maximum duration of 2 years from start of study drug dosing.) Response assessment will be performed every 8 weeks while on study.

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study.

ReferenceCitation: Gounder M, Schöffski P, Jones RL, Agulnik M, Cote GM, Villalobos VM, Attia S, Chugh R, Chen TW, Jahan T, Loggers ET, Gupta A, Italiano A, Demetri GD, Ratan R, Davis LE, Mir O, Dileo P, Van Tine BA, Pressey JG, Lingaraj T, Rajarethinam A, Sierra L, Agarwal S, Stacchiotti S. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study. Lancet Oncol. 2020 Nov;21(11):1423-1432. doi: 10.1016/S1470-2045(20)30451-4. Epub 2020 Oct 6.

lead_sponsor: Epizyme, Inc.

location_country:
Taiwan
United Kingdom
Italy
Australia
Canada
United States
France
Belgium
Germany

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital

location_facility: Institut Jules Bordet Medical Oncology Clinic

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Massachusetts General Hospital - Cancer Center

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Instituto Nazionale Tumori - National Cancer Institute Via Giacomo Venezian


title: A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

lead_sponsor: Gilead Sciences

ReferenceType: background

ReferenceCitation: Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13. pii: S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. [Epub ahead of print]

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.

location_country:
Austria
Germany
United States
France

location_facility: North Texas Infectious Diseases Consultants

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Wake Forest University Baptist Medical Center

location_facility: Midway Immunology & Research Center, LLC

location_facility: University of North Carolina at Chapel Hill / UNC School of Medicine

location_facility: Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center

location_facility: Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center

summary: The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).


title: The Medtronic CoreValve™ Evolut R™ FORWARD Study

acronym: FORWARD

summary: Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochellière R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.

ReferenceCitation: Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.

ReferenceCitation: Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schächinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.

ReferenceCitation: Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

ReferenceCitation: Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

ReferenceCitation: Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

ReferenceCitation: Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.

ReferenceCitation: Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27. Review.

ReferenceCitation: Généreux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis JM, Spaziano M, Kappetein AP, Webb JG, Cribier A, Leon MB. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications. Eur Heart J. 2012 Oct;33(19):2388-98. doi: 10.1093/eurheartj/ehs220. Epub 2012 Jul 31. Review.

ReferenceCitation: Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kovac J, Serruys PW, Labinaz M, den Heijer P, Mullen M, Tymchak W, Windecker S, Mueller R, Grube E. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011 Apr 19;57(16):1650-7. doi: 10.1016/j.jacc.2010.11.044.

ReferenceCitation: Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012 Apr;33(8):969-76. doi: 10.1093/eurheartj/ehr491. Epub 2012 Jan 12.

ReferenceCitation: Walther T, Dewey T, Borger MA, Kempfert J, Linke A, Becht R, Falk V, Schuler G, Mohr FW, Mack M. Transapical aortic valve implantation: step by step. Ann Thorac Surg. 2009 Jan;87(1):276-83. doi: 10.1016/j.athoracsur.2008.08.017.

ReferenceCitation: Walther T, Möllmann H, van Linden A, Kempfert J. Transcatheter aortic valve implantation transapical: step by step. Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61. doi: 10.1053/j.semtcvs.2011.05.006.

ReferenceCitation: Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hutter A, Tassani-Prell P, Laborde JC, Bauernschmitt R. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. Eur J Cardiothorac Surg. 2011 Nov;40(5):1105-13. doi: 10.1016/j.ejcts.2011.03.022. Epub 2011 Apr 22.

ReferenceCitation: Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.

ReferenceCitation: Eggebrecht H, Schmermund A, Voigtländer T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012 May 15;8(1):129-38. doi: 10.4244/EIJV8I1A20. Review.

ReferenceCitation: Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodés-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1637-43. doi: 10.1016/j.amjcard.2012.01.389. Epub 2012 Mar 15.

ReferenceCitation: Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Müller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. doi: 10.1016/j.jacc.2011.11.048.

ReferenceCitation: Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.

ReferenceCitation: Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B, Carrie D, Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010 Jan;5(6):659-65.

ReferenceCitation: Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010 Jan;5(6):673-9.

ReferenceCitation: Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, García-García H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.

ReferenceCitation: Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leoni L, Razzolini R, Corrado D, Bonato R, Basso C, Thiene G, Gerosa G, Isabella G, Iliceto S, Napodano M. Incidence, predictors, and outcome of conduction disorders after transcatheter self-expandable aortic valve implantation. Am J Cardiol. 2011 Mar 1;107(5):747-54. doi: 10.1016/j.amjcard.2010.10.054. Epub 2011 Jan 19.

ReferenceCitation: van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodés-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58. Review.

ReferenceCitation: Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011 Jan 15;107(2):285-9. doi: 10.1016/j.amjcard.2010.09.015. Epub 2010 Dec 2.

ReferenceCitation: Sherif MA, Abdel-Wahab M, Stöcker B, Geist V, Richardt D, Tölg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.

ReferenceCitation: Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. doi: 10.1002/ccd.23003. Epub 2011 Jul 25.

ReferenceCitation: Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T, Linke A, Scholtz W, Chevalier B, Gooley R, Zeng C, Oh JK, Grube E. 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2326-2334. doi: 10.1016/j.jcin.2018.07.032.

ReferenceCitation: Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchétché D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. J Am Coll Cardiol. 2017 Aug 15;70(7):845-853. doi: 10.1016/j.jacc.2017.06.045.

lead_sponsor: Medtronic Cardiovascular

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Belgium
South Africa
Czechia
Poland
Portugal
Australia
Israel
Panama
Norway
Sweden
Canada
Hungary
Germany
Greece
France
Colombia
Netherlands

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universitaet Bochum

location_facility: London Health Sciences Centre - University Campus

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

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Centre Hospitalier Universitaire - Hopital Henri Mondor

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

location_facility: Complejo Hospitalario Dr Arnulfo Arias Madrid

location_facility: Herzzentrum Dresden GmbH Universitaetsklinik

location_facility: Hospital Universitario Central de Asturias

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: Deutsches Herzzentrum Muenchen - Klinik an der TU Muenchen


type: Other Identifier

title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18.

ReferenceCitation: Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.

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
Romania
United Kingdom
Georgia
Australia
Canada
Lithuania
Hungary
United States
France
Belgium
Japan
Netherlands
Moldova, Republic of
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.


title: Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A

acronym: PROPEL

summary:
To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

primary_purpose: Prevention

ReferenceCitation: Klamroth R, Windyga J, Radulescu V, Collins PW, Stasyshyn O, Ibrahim HM, Engl W, Tangada SD, Savage W, Ewenstein B. Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study. Blood. 2021 Apr 1;137(13):1818-1827. doi: 10.1182/blood.2020005673.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Poland
Hong Kong
Austria
Australia
Israel
Turkey
Norway
Sweden
Malaysia
Singapore
Switzerland
Hungary
Germany
Bulgaria
Taiwan
France

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital Regional Universitario de Malaga

location_facility: NChSH Okhmatdyt of MoHU Center of Children Oncohematology and Bone Marrow Transplantation

location_facility: M.V. Sklifosovskyi Poltava RCH Dept of Gematology HSEIU Ukrainian Medical Stomatological Academy

location_facility: Inst. f. Experimentelle Hamatologie u. Transfusionsmedizin

location_facility: University of Florida College of Medicine

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: MHAT 'Sv. Marina', EAD, Clinic of Clinical Hematology

location_facility: Kyiv CCH #9 Dept of Surgery City SPC of Diagnostics & Treatment of Patients with HP

location_facility: Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Klinika Hematologii

location_facility: Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: UOC Ematologia, Azienda ULSS 8 Asolo, Regione Veneto

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: AOU Citta della Salute e della Scienza - Presidio Molinette


title: An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

summary: The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.

status: Recruiting

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Malaysia
Singapore
Brazil
Lebanon
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Colombia

location_facility: Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem


title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis

acronym: IXORA-S

summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

ReferenceCitation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

ReferenceCitation: Wasel N, Thaçi D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
Sweden
Hungary
France
Belgium
Germany

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.


title: A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Moore WC, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, Smith SG, Martin N, Gilson MJ, Price RG, Bradford ES, Liu MC. Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study). Eur Respir J. 2022 Jan 6;59(1). pii: 2100396. doi: 10.1183/13993003.00396-2021. Print 2022 Jan.

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

location_country:
Poland
Spain
Russian Federation
Australia
Netherlands
Argentina
Canada
Ukraine
Korea, Republic of
United States
France
Romania
Japan
Germany

summary:
Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.

Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).


title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

lead_sponsor: AstraZeneca

ReferenceCitation: Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.

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

location_country:
Poland
Taiwan
Serbia
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
United Kingdom
Hungary
Korea, Republic of
United States
France
Peru
Belgium
Germany

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).


title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension

summary: This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

lead_sponsor: Maruho Co., Ltd.

location_country:
United Kingdom
Australia
Netherlands
Canada
New Zealand
Sweden
United States
France
Germany


title: A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

ReferenceCitation: Borthakur G, Martinelli G, Raffoux E, Chevallier P, Chromik J, Lithio A, Smith CL, Yuen E, Oakley GJ 3rd, Benhadji KA, DeAngelo DJ. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T-cell acute lymphoblastic leukemia and lymphoma. Cancer. 2021 Feb 1;127(3):372-380. doi: 10.1002/cncr.33188. Epub 2020 Oct 27.

location_country:
Italy
United States
Israel
France
Germany

location_facility: Johann Wolfgang Goethe-Universität Frankfurt

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.


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, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

summary: Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive [NR]).

ReferenceCitation: Munck A, Kerem E, Ellemunter H, Campbell D, Wang LT, Ahluwalia N, Owen CA, Wainwright C. Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations. J Cyst Fibros. 2020 Nov;19(6):962-968. doi: 10.1016/j.jcf.2020.04.015. Epub 2020 Jun 13.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Spain
Austria
Australia
Canada
United States
France
Israel


title: A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

acronym: ADAURA

summary: To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

ReferenceCitation: Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951.

ReferenceCitation: Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clin Cancer Res. 2022 Jun 1;28(11):2286-2296. doi: 10.1158/1078-0432.CCR-21-3530.

ReferenceCitation: Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. J Thorac Oncol. 2022 Mar;17(3):423-433. doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.

ReferenceCitation: Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.

ReferenceCitation: Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

ReferenceCitation: Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Spain
Italy
Ukraine
United States
Romania
Belgium
Japan
Poland
Hong Kong
Russian Federation
Australia
Israel
Turkey
Sweden
Brazil
Canada
Hungary
China
Germany
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Netherlands


title: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis

acronym: Compare Absorb

summary:
The primary objectives of this trial are:

In patients at high-risk for restenosis,

To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
To assess superiority of the BRS to the EES in TLF between 3 and 7 years

ReferenceCitation: Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kočka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.

lead_sponsor: European Cardiovascular Research Center

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany
Czechia

location_facility: Università degli Studi di Napoli Federico II

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Cardiocentre, University Hospital Kralovske

location_facility: Hospital Universitario Marques de Valdecilla


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

acronym: ARISE

summary: To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

ReferenceCitation: Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

ReferenceCitation: Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.

ReferenceCitation: Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.

ReferenceCitation: Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.

ReferenceCitation: Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.

ReferenceCitation: Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. Erratum in: Neurology. 2020 Jun 9;94(23):1052.

ReferenceCitation: Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.

ReferenceCitation: Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.

lead_sponsor: Amgen

location_country:
Denmark
Portugal
Spain
Greece
Russian Federation
Switzerland
United States
France


title: A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

ReferenceCitation: Winston A, Post FA, DeJesus E, Podzamczer D, Di Perri G, Estrada V, Raffi F, Ruane P, Peyrani P, Crofoot G, Mallon PWG, Castelli F, Yan M, Cox S, Das M, Cheng A, Rhee MS. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial. Lancet HIV. 2018 Apr;5(4):e162-e171. doi: 10.1016/S2352-3018(18)30010-9. Epub 2018 Feb 20.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Denmark
Spain
Ireland
Italy
United Kingdom
Canada
Sweden
Puerto Rico
United States
France
Belgium
Germany

location_facility: Ospedale Amedeo di Savoia - Specializzato Malattie infettive

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Highland Hospital - Alameda Health System

location_facility: Hospital Clínico Universitario San Carlos

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: ifi-Studien und Projekte GmbH an der Asklepiosklinik St. Georg

location_facility: La Playa Medical Group and Clinical Research

location_facility: Fondazione IRCCS San Raffaele del Monte Tabor

location_facility: Centre Hospitalier Universitaire CHU Sart Tilman Liege

location_facility: Tarrant County Infectious Disease Associates

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Johann Wolfgang Goethe-University Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: University of California San Diego (UCSD)


ipd_sharing: No

status: Terminated

acronym: Study of INC280 alone and in combination with erlotinib vs. chemotherapy in EGFR+/cMET amp NSCLC

title: A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)

location_country:
Spain
Italy
Netherlands
Korea, Republic of
United States
France
Singapore
Belgium
Japan
Germany

location_facility: University of California Irvine Medical Center Chao Family SC

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: NKI-AVL, Department of Thoracic-Oncology

summary: The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

status_simplified: Unknown


title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

summary: This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

ReferenceCitation: Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

ReferenceCitation: Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.

ReferenceCitation: Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct - Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.

lead_sponsor: Pearl Therapeutics, Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Mexico
Sweden
Canada
Hungary
China
Germany
Taiwan
New Zealand
France
Chile
Netherlands


title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

summary: To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

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

lead_sponsor: Pfizer

location_country:
Spain
United Kingdom
Austria
Australia
Russian Federation
Canada
Ukraine
United States
France
Israel
Turkey
Mexico
Germany

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

location_facility: OU Medical Center Investigational Drug Pharmacy

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"

location_facility: AdventHealth Orlando-Pharmacy Investigational Drug Services

location_facility: Dnipropetrovsk Regional Children's Hospital

location_facility: Connecticut Children's Medical Center Pharmacy

location_facility: Loma Linda University Children's Hospital

location_facility: JDCH Division of Pediatric Hematology and Oncology

location_facility: Ankara City Hospital Pediatric Hematology and Oncology Clinic

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit

location_facility: Lucile Packard Children's Hosptial - Stanford University

location_facility: Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD

location_facility: Nemours/ Alfred I. duPont Hospital for Children

location_facility: Texas Children's Hospital- Wallace Tower

location_facility: Noah's Ark Children's Hospital for Wales

location_facility: Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"

location_facility: Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali

location_facility: University of Oklahoma Health Sciences Center

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

location_facility: Texas Children's Hospital- Main Hospital

location_facility: Bleeding and Clotting Disorders Institute

location_facility: Riley Hospital for Children at IU Health

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt

location_facility: Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital

location_facility: Levine Children's Hospital, Pediatric Research

location_facility: Hamilton Health Science Corporation/McMaster Children's Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: CHRU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Children's Hospital Colorado - Investigational Drug Services

location_facility: Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child

location_facility: University of Mississippi Medical Center

location_facility: Medical University of South Carolina: Investigational Drug Services

location_facility: Children's Healthcare of Atlanta-Egleston

location_facility: Children's Hematology and Oncology a division of Kidz medical Service

location_facility: State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of

location_facility: Investigational Drug Service, Duke University Hospital

location_facility: Instituto Nacional De Cardiologia Ignacio Chavez

location_facility: O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde

location_facility: University of Iowa Hospitals and Clinics

location_facility: AdventHealth Pediatric Oncology Hematology at Orlando

location_facility: Technische Universitat, Deutsches Herzzentrum Munchen

location_facility: Children's Hospital and Research Center Oakland

location_facility: FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia

location_facility: UCSF Mission Bay Pediatric Clinical Research Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: State Autonomous Healthcare Institution of Sverdlovsk Region

location_facility: New York-Presbyterian Morgan Stanley Children's Hospital

location_facility: Service d'Imagerie Medicale du Pr F. Laurent

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)


title: An International, Multicentre, Observational, Prospective, Longitudinal Cohort Study to Assess the Impact of Integrated Upper Limb Spasticity Management Including the Use of BoNT-A- Injections on Patient-centred Goal Attainment in Real Life Practice - ULIS III

acronym: ULIS III

summary: The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.

ReferenceCitation: Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR. [Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation]. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(11):39-48. doi: 10.17116/jnevro202112111139. Russian.

ReferenceCitation: Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770.

ReferenceCitation: Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

lead_sponsor: Ipsen

location_country:
Poland
Taiwan
Brazil
Hong Kong
Portugal
Italy
Austria
Australia
Russian Federation
United States
France
Mexico
Philippines
Germany

location_facility: National Institute of Neurology/Rehabilitation

location_facility: Federal State Hospital for Treatment and Rehabilitation

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico

location_facility: Pavlov First Saint-Petersburg State Medical University

location_facility: Regional State Budgetary Healthcare Institution "City Hospital N°5"

location_facility: Institut Universitaire de Réadaptation de Clémenceau

location_facility: Azienda Ospedaliero Universitaria Policlinico "G Martino"

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Liverpool Brain Injury Rehabilitation Unit

location_facility: Centre Régional de Rééducation et Réadaptation Fonctionnelle

location_facility: Interregional Cinical and Diagnostic Centre

location_facility: Hospital dos Clinicas Universitaria de Sao Paulo

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Azienda Ospedaliero Universitaria di Ferrara


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis

summary: This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

lead_sponsor: Celtaxsys, Inc.

location_country:
United Kingdom
Italy
Canada
United States
France
Belgium
Germany

location_facility: Carl-Gustav-Klinikum Dresden, Mukoviszidose Centrum "Christiane Herzog"

location_facility: Universiy of Tennessee Medical Center UHS

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Banner University of Arizona Medical Center

location_facility: Institut für klinische Forschung Pneumologie

location_facility: University of California Davis Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University

location_facility: University of Oklahoma Health Sciences Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universität


title: Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma.

summary: The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

ReferenceCitation: Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.

lead_sponsor: AbbVie

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

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Washington University School of Medicine

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat

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

location_facility: Hamburger Institut für Therapieforschung GmbH (HIT)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Respiratory and Sleep Disorders Specialists

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed

summary: The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum in: Lancet. 2018 Feb 1;:.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

lead_sponsor: ViiV Healthcare

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
United States
France
Belgium
Germany


acronym: OPTIMUM

title: Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

lead_sponsor: Actelion

ReferenceCitation: Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdová EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Czechia
Poland
Portugal
Russian Federation
Israel
Turkey
Mexico
Sweden
Bosnia and Herzegovina
Canada
Hungary
Germany
Bulgaria
Belarus
Greece
Georgia
Latvia
Finland
France

location_facility:
Investigator Site 3725
Investigator Site 1509
Investigator Site 8102
Investigator Site 4005
Investigator Site 4006
Investigator Site 2110
Investigator Site 3215
Investigator Site 3819
Investigator Site 3403
Investigator Site 8120
Investigator Site 3805
Investigator Site 1703
Investigator Site 3833
Investigator Site 1502
Investigator Site 2811
Investigator Site 1602
Investigator Site 3006
Investigator Site 1113
Investigator Site 8006
Investigator Site 7410
Investigator Site 3003
Investigator Site 1501
Investigator Site 1403
Investigator Site 3802
Investigator Site 3604
Investigator Site 9004
Investigator Site 3715
Investigator Site 1413
Investigator Site 3002
Investigator Site 2905
Investigator Site 2702
Investigator Site 3008
Investigator Site 3216
Investigator Site 2502
Investigator Site 3902
Investigator Site 2103
Investigator Site 3502
Investigator Site 3834
Investigator Site 1603
Investigator Site 3004
Investigator Site 3822
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Investigator Site 9104

summary: International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

summary: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

ReferenceCitation: Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

ReferenceCitation: Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

ReferenceCitation: Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

ReferenceCitation: Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

ReferenceCitation: Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA(1c) and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.

lead_sponsor: Lexicon Pharmaceuticals

location_country:
Poland
Romania
Spain
Italy
Austria
Netherlands
United Kingdom
Lithuania
Switzerland
Sweden
Hungary
France
Israel
Belgium
Germany
Bulgaria
Slovakia


acronym: RELAY

title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

ReferenceCitation: Nakagawa K, Garon EB, Gao L, Callies S, Zimmermann A, Walgren R, Visseren-Grul C, Reck M. RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small cell lung cancer: exposure-response relationship. Cancer Chemother Pharmacol. 2022 Aug;90(2):137-148. doi: 10.1007/s00280-022-04447-x. Epub 2022 Jul 16.

ReferenceCitation: Nishio M, Nishio K, Reck M, Garon EB, Imamura F, Kawaguchi T, Yamaguchi H, Ikeda S, Hirano K, Visseren-Grul C, Ceccarelli M, Wijayawardana SR, Zimmermann A, Matsui T, Enatsu S, Nakagawa K. RELAY+: Exploratory Study of Ramucirumab Plus Gefitinib in Untreated Patients With EGFR-Mutated Metastatic NSCLC. JTO Clin Res Rep. 2022 Feb 26;3(4):100303. doi: 10.1016/j.jtocrr.2022.100303. eCollection 2022 Apr.

ReferenceCitation: Nadal E, Horinouchi H, Shih JY, Nakagawa K, Reck M, Garon EB, Wei YF, Kollmeier J, Frimodt-Moller B, Barrett E, Lipkovich O, Visseren-Grul C, Novello S. RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Drug Saf. 2022 Jan;45(1):45-64. doi: 10.1007/s40264-021-01127-2. Epub 2021 Dec 20.

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: Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4.

ReferenceCitation: Reck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21.

ReferenceCitation: Garon EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8.

location_country:
Taiwan
Hong Kong
Spain
Greece
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
Turkey
Romania
Japan
Germany

location_facility: Policlinico S. Orsola Malpighi - Universita di Bologna

location_facility: Kliniken der Stadt Köln gGmbH Klinikum Köln-Merheim

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Hyogo Prefectual Amagasaki General Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Azienda per l'Assistenza Sanitaria n°5 "Friuli Occidentale"

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Foundation for Biomedical Research and innovation

location_facility: Azienda Ospedaliero - Universitaria S. Luigi Gonzaga

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Gyeong-Sang National University Hospital

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Cent

location_facility: National Hospital Organization Himeji Medical Center

summary:
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.

The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

ReferenceCitation: Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.

ReferenceCitation: Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.

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

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: Klinikum der Universität München Campus Großhadern

location_facility: Michigan Head, Pain, and Neurological Institute

location_facility: New England Institute for Clinical Research

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) 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."


title: A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

summary: A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

lead_sponsor: SecuraBio

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium


intervention_type: Dietary Supplement

title: A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

ReferenceCitation: Curtis JR, Trivedi M, Haraoui B, Emery P, Park GS, Collier DH, Aras GA, Chung J. Defining and characterizing sustained remission in patients with rheumatoid arthritis. Clin Rheumatol. 2018 Apr;37(4):885-893. doi: 10.1007/s10067-017-3923-z. Epub 2017 Dec 9.

ReferenceCitation: Curtis JR, Emery P, Karis E, Haraoui B, Bykerk V, Yen PK, Kricorian G, Chung JB. Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission. Arthritis Rheumatol. 2021 May;73(5):759-768. doi: 10.1002/art.41589. Epub 2021 Mar 24.

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

location_country:
Poland
Portugal
Spain
Greece
Italy
Argentina
Canada
Hungary
United States
France
South Africa
Mexico
Germany
Bulgaria
Czechia

summary:
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.

This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.


acronym: Phase I trial of afatinib in pediatric tumours

title: Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Andrade RC, Boroni M, Amazonas MK, Vargas FR. New drug candidates for osteosarcoma: Drug repurposing based on gene expression signature. Comput Biol Med. 2021 Jul;134:104470. doi: 10.1016/j.compbiomed.2021.104470. Epub 2021 May 7.

location_country:
Denmark
Faroe Islands
Italy
Austria
Australia
Netherlands
Canada
Spain
United Kingdom
United States
France
Germany

location_facility: St. Anna Children-Hospital, Children's Cancer Research, Wien

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: The University of Texas Health Science Center at Houston

summary:
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.

The trial will consist of 2 parts:

Dose finding part to determine the MTD
Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types


title: A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

summary: The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

ReferenceCitation: Malvehy J, Samoylenko I, Schadendorf D, Gutzmer R, Grob JJ, Sacco JJ, Gorski KS, Anderson A, Pickett CA, Liu K, Gogas H. Talimogene laherparepvec upregulates immune-cell populations in non-injected lesions: findings from a phase II, multicenter, open-label study in patients with stage IIIB-IVM1c melanoma. J Immunother Cancer. 2021 Mar;9(3):e001621. doi: 10.1136/jitc-2020-001621.

location_country:
Poland
Spain
Greece
Austria
Italy
Netherlands
Russian Federation
United Kingdom
Hungary
United States
France
Belgium
Germany


acronym: OI

title: To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Canada
Hungary
United States
France
Belgium
Germany
Bulgaria
Czechia

summary: This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.