title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries

acronym: DESSOLVE III

summary: The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

ReferenceCitation: Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Oct 20:CIRCOUTCOMES121008055. doi: 10.1161/CIRCOUTCOMES.121.008055. [Epub ahead of print]

name: Department of Cardiology, Xijing hospital, Xi’an, China (R.W., C.G., L.T.).

name: Department of Cardiology, National University of Ireland, Galway (NUIG), Ireland (R.W., H.K., H.H., C.G., M.O., O.S., W.W., Y.O., P.W.S.).

name: Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (R.W., C.G., R.J.v.G.).

family: Wang

full_name: Rutao Wang

given: Rutao

name: Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands (H.K., H.H., M.O., K.T.).

family: Kawashima

full_name: Hideyuki Kawashima

given: Hideyuki

family: Hara

full_name: Hironori Hara

given: Hironori

family: Gao

full_name: Chao Gao

given: Chao

family: Ono

full_name: Masafumi Ono

given: Masafumi

family: Takahashi

full_name: Kuniaki Takahashi

given: Kuniaki

name: Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, China (S.T.).

family: Tu

full_name: Shengxian Tu

given: Shengxian

family: Soliman

full_name: Osama Soliman

given: Osama

name: East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom (S.G.).

full_name: Scot Garg

given: Scot

family: van Geuns

full_name: Robert Jan van Geuns

given: Robert Jan

family: Tao

full_name: Ling Tao

given: Ling

name: The Lambe Institute for Translational Medicine, The Smart Sensors Laboratory and Curam, National University of Ireland, Galway (NUIG), Ireland (W.W.).

family: Wijns

full_name: William Wijns

given: William

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

name: NHLI, Imperial College London, United Kingdom (P.W.S.).

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

journal_name: Circulation: Cardiovascular Quality and Outcomes

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172.

name: Department of Clinical and Experimental Cardiology, Amsterdam UMC, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands

family: Katagiri

full_name: Yuki Katagiri

given: Yuki

name: Centro Cardiologico Monzino, University of Milano, Via Carlo Parea, 4, 20138 Milano, Italy

name: Department of Clinical Sciences and Community Health, Cardiovascular Section, University of Milan, Via della Commenda 19, 20122 Milano, Italy

family: Andreini

full_name: Daniele Andreini

given: Daniele

name: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands

family: Miyazaki

full_name: Yosuke Miyazaki

given: Yosuke

family: Komiyama

full_name: Hidenori Komiyama

given: Hidenori

family: Mushtaq

full_name: Saima Mushtaq

given: Saima

name: Department of Cardiology, Cardiovascular Center Aalst, OLV Hospital, Moorselbaan 164, 9300 Aalst, Belgium

name: Department of Advanced Biomedical Sciences, Federico II University of Naples, Corso Umberto I 40 - 80138 Napoli, Italy

family: Sonck

full_name: Jeroen Sonck

given: Jeroen

name: Department of Cardiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Jette, Brussel, Belgium

name: Department of Cardiovascular Surgery, University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland

name: Department of Nuclear Medicine, University Hospital Zurich, Rämistrasse 100, 8091 Zurich, Switzerland

name: Cardialysis BV, Westblaak 98, 3012 KM Rotterdam, The Netherlands

name: Department of Biomedical and Clinical Sciences “Luigi Sacco”, University of Milan, Via Festa del Perdono, 7, 20122 Milano MI, Italy

name: Department of Cardiology, National University of Ireland, Galway (NUIG), University Road, Galway, Ireland H91 TK33

name: Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College of London, Kensington, London SW7 2AZ, UK

journal_name: European Heart Journal - Cardiovascular Imaging

ReferenceCitation: Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29.

name: Department of Cardiology, Amsterdam Universities Medical Centers, Location Academic Medical Center, University of Amsterdam, the Netherlands. (K.T., N.K., K.T.K., J.J.W., R.J.d.W.).

name: Department of Cardiology, National University of Ireland, Galway (NUIG) (P.W.S., Y.O.).

name: Department of Epidemiology and Statistics, Medical University of Silesia, Katowice, Poland (P.B.).

name: Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron (P.B., K.P.M.).

name: Department of Internal Medicine/Cardiology, Heart Center Leipzig at University Leipzig, Germany (P.L.).

name: Department of Cardiology, Treant Zorggroep, Emmen, the Netherlands (G.A.J.J.).

name: Department of Cardiology, VieCuri Medical Centre for Northern Limburg, Venlo, the Netherlands (R.P.T.T.).

name: Department of Cardiology, Meander Medisch Centrum, Amersfoort, the Netherlands (B.J.B.H.).

name: Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.).

name: Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (S.H.H.).

name: The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway (W.W.).

ReferenceCitation: de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wöhrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Żurakowski A, Fischer D, Kośmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5.

location_facility:
Research Center Belchatow
Research Center Leipzig
Research Center Munster
Research Center Nimes
Research Center Ulm
Research Center Amersfoort
Tergooi
Research Center Leeuwarden
Research Center Nijmegen
Research center Chrzanow
Research Center Amsterdam
Research Center Bielsko-Biala
Research Center Emmen
Research Center Jena
Research Center Zgierz
Research Center Wiesbaden
Research Center Poitiers
Research Center Venlo
Research Center Tychy
Research Center Corbeil


title: Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC

acronym: NEO-VC

summary: Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital Tuebingen

location_country: Germany France

location_facility: Department of Dermatology, University Hospital of Nantes

location_facility: Hopital Saint-Louis Hopitaux Universitaires Saint-Louis Laboisiere Fernand-Widal

location_facility: Department of Dermatology, Elbe Hospital

location_facility: Department of Dermatology & Skin Cancer University Hospital La Timone, Aix-Marseille University

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Study 110933: Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

summary: This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production.. Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week 6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive placebo once weekly added-on to insulin therapy. The total duration of a subject's participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of treatment and 12 weeks of Post-treatment Follow-up)

status: Completed

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Pozzilli P, Bosi E, Cirkel D, Harris J, Leech N, Tinahones FJ, Vantyghem MC, Vlasakakis G, Ziegler AG, Janmohamed S. Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jun 1;105(6). pii: dgaa149. doi: 10.1210/clinem/dgaa149.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
France
Spain
Germany
United Kingdom

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy

acronym: VIBES

summary: This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Rudà R, Houillier C, Maschio M, Reijneveld JC, Hellot S, De Backer M, Chan J, Joeres L, Leunikava I, Glas M, Grant R. Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES). Epilepsia. 2020 Apr;61(4):647-656. doi: 10.1111/epi.16486.

lead_sponsor: UCB BIOSCIENCES GmbH

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom


title: An Open-label, Multi-center Rollover Protocol for Continued Characterization of Safety and Tolerability for Subjects Who Have Participated in a Novartis-sponsored Spartalizumab Study as Single Agent or in Combination With Other Study Treatments

summary: The purpose of this study is to continue to assess safety and tolerability, and to allow continued access to study treatment for subjects already receiving spartalizumab as single agent or in combination with other study treatments.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Hong Kong
Spain
Switzerland
Germany
France
Czechia
Poland
Thailand
Hungary
Belgium
China
Canada
Korea, Republic of
Taiwan

location_facility: Columbia University Medical Center- New York Presbyterian

location_facility: MD Anderson Cancer Center/University of Texas MDACC

status_simplified: Ongoing


type: EudraCT Number

title: An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

summary:
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.

Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between doses.

Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients.

status: Active, not recruiting

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Vishwanathan K, Dickinson PA, Bui K, Cassier PA, Greystoke A, Lisbon E, Moreno V, So K, Thomas K, Weilert D, Yap TA, Plummer R. The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers. J Clin Pharmacol. 2018 Apr;58(4):474-484. doi: 10.1002/jcph.1035. Epub 2017 Nov 26.

name: QCP, Early Clinical Development; IMED Biotech Unit; AstraZeneca; Waltham MA USA

family: Vishwanathan

full_name: Karthick Vishwanathan

given: Karthick

sequence: first

name: Seda Pharmaceutical Development Services; The BioHub at Alderley Park; Alderley Edge Cheshire UK

family: Dickinson

full_name: Paul A. Dickinson

given: Paul A.

sequence: additional

family: Bui

full_name: Khanh Bui

given: Khanh

name: Department of Medicine, Centre Léon Bérard; 28 Promenade Léa et Napoléon Bullukian; Lyon France

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

name: Northern Centre for Cancer Care, Freeman Hospital, Freeman Road; High Heaton; Newcastle upon Tyne UK

family: Greystoke

full_name: Alastair Greystoke

given: Alastair

family: Lisbon

full_name: Eleanor Lisbon

given: Eleanor

name: START Madrid-FJD, Hospital Fundación Jimenez Díaz; Avenida Reyes Católicos 2; Madrid Spain

family: Moreno

full_name: Victor Moreno

given: Victor

name: Oncology TMU, Early Clinical Development; AstraZeneca, Charter Way; Macclesfield UK

family: So

full_name: Karen So

given: Karen

name: Karen Thomas Statistics Limited; 54 Pullman Lane; Godalming Surrey UK

family: Thomas

full_name: Karen Thomas

family: Weilert

full_name: Doris Weilert

given: Doris

name: Drug Development Unit; Royal Marsden NHS Foundation Trust; London UK

name: The Institute of Cancer Research; London UK

family: Yap

full_name: Timothy A. Yap

given: Timothy A.

family: Plummer

full_name: Ruth Plummer

given: Ruth

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Korea, Republic of
France
Spain

intervention_type: Other


title: Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

acronym: PREVENT

summary:
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.

It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.

lead_sponsor: 4Tech Cardio Ltd.

location_country: Italy Germany France Netherlands

location_facility: Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci

intervention_type: Device


title: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation

acronym: TAVI

summary: A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.

lead_sponsor: Keystone Heart

location_country:
Italy
Netherlands
France
Israel
Germany
United Kingdom

location_facility:
Hôpital de la Cavale Blanche
Universitäts-Herzzentrum Freiburg
Städtische Kliniken Neuss
Leeds General Infirmary
Praxisklinik Herz Und Gefässe
Shaarey Tzedek
Clinique chez APHM
UMC Utrecht
Ferrarotto hospital
Rambam Medical Center
Bristol Heart Institute
Royal Sussex County Hospital
Chru-Lille
Medical Care Center


type: Other Identifier

title: A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

summary: This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
Germany
France
Czechia
Greece
Spain
Denmark
United States
Canada

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Wake Forest University Baptist Medical Center

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Winship Cancer Institute of Emory University

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

location_facility: University of Alberta - Faculty of Medicine and Dentistry

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin


title: Atlas of Human Milk Nutrients

summary:
The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:

To assess whether there is a correlation between human milk composition and mothers' diet
To assess whether there is a correlation between human milk composition and maternal clinical parameters
To assess whether there is a correlation between human milk composition and mother and infant clinical parameters

ReferenceCitation: Raymond F, Lefebvre G, Texari L, Pruvost S, Metairon S, Cottenet G, Zollinger A, Mateescu B, Billeaud C, Picaud JC, Silva-Zolezzi I, Descombes P, Bosco N. Longitudinal Human Milk miRNA Composition over the First 3 mo of Lactation in a Cohort of Healthy Mothers Delivering Term Infants. J Nutr. 2021 Sep 11. pii: nxab282. doi: 10.1093/jn/nxab282. [Epub ahead of print]

bso_classification: Biology (fond.)

journal_name: The Journal of Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: OUP accepted manuscript

lead_sponsor: Nestlé

location_country: Italy Sweden Spain France Norway Romania Portugal

location_facility: Department of Woman and Child Health, Karolinska University Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centro Hospitalar do Alto Ave Guimarães Hospital


title: A Phase 2, Multicenter, Randomized, Double-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination With IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients With Immune Therapy-Naïve, Advanced Urothelial Carcinoma

summary: The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

ipd_sharing: No

lead_sponsor: Infinity Pharmaceuticals, Inc.

location_country:
Italy
Serbia
France
Czechia
Poland
Spain
United States

location_facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)

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

location_facility: Oddzial Chorob Rozrostowych Wojewodzki Szpital

location_facility: University of MD - Greenebaum Comprehensive Cancer Center

location_facility: Hospital Universitario Central de Asturias


title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites

summary: The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

ReferenceCitation: Barret JP, Podmelle F, Lipový B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.

lead_sponsor: Birken AG

location_country: Spain Latvia France Greece

location_facility: Riga East University Hospital, Microsurgery Center

location_facility: Riga East University Hospital, State Burn Center

location_facility: National University, "Andreas Syggros" Skin & Venereal Diseases Hospital


title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)

acronym: FIZZ

summary: 90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.

ReferenceCitation: Illidge TM, Mayes S, Pettengell R, Bates AT, Bayne M, Radford JA, Ryder WD, Le Gouill S, Jardin F, Tipping J, Zivanovic M, Kraeber-Bodere F, Bardies M, Bodet-Milin C, Malek E, Huglo D, Morschhauser F. Fractionated ⁹⁰Y-ibritumomab tiuxetan radioimmunotherapy as an initial therapy of follicular lymphoma: an international phase II study in patients requiring treatment according to GELF/BNLI criteria. J Clin Oncol. 2014 Jan 20;32(3):212-8. doi: 10.1200/JCO.2013.50.3110. Epub 2013 Dec 2.

name: Tim M. Illidge, Sam Mayes, John A. Radford, W. David J. Ryder, Manchester Academic Health Science Centre, University of Manchester; Jill Tipping, Maureen Zivanovic, Christie Hospital NHS Foundation Trust, Manchester; Ruth Pettengell, St. George's, University of London, London; Andrew T. Bates, Southampton University Hospitals NHS Foundation Trust, Southampton; Mike Bayne, Poole Hospital NHS Foundation Trust, Dorset, United Kingdom; Steven Le Gouill, Centre Hospitalier Universitaire Nantes; Françoise...

family: Illidge

full_name: Tim M. Illidge

given: Tim M.

family: Mayes

full_name: Sam Mayes

given: Sam

family: Pettengell

full_name: Ruth Pettengell

family: Bates

full_name: Andrew T. Bates

given: Andrew T.

family: Bayne

full_name: Mike Bayne

given: Mike

family: Radford

full_name: John A. Radford

given: John A.

family: Ryder

full_name: W. David J. Ryder

given: W. David J.

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Tipping

full_name: Jill Tipping

given: Jill

family: Zivanovic

full_name: Maureen Zivanovic

given: Maureen

family: Kraeber-Bodere

full_name: Françoise Kraeber-Bodere

given: Françoise

family: Bardies

full_name: Manuel Bardies

given: Manuel

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Malek

full_name: Emmanuel Malek

given: Emmanuel

family: Huglo

full_name: Damien Huglo

given: Damien

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Fractionated 90Y-Ibritumomab Tiuxetan Radioimmunotherapy As an Initial Therapy of Follicular Lymphoma: An International Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria

lead_sponsor: The Christie NHS Foundation Trust

location_country:
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Lille


title: A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma

summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.

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: Switzerland France Japan Spain

location_facility: Hospital Universitario HM Sanchinarro_CIOCC

location_facility: Hospital Universitario Vall d'Hebron - PPDS


title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

summary: This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

ReferenceCitation: Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.

name: Department of Pulmonary Diseases University of Groningen, University Medical Center Groningen  Groningen The Netherlands

name: Groningen Research Institute for Asthma and COPD University of Groningen, University Medical Center Groningen  Groningen The Netherlands

family: Hartman

full_name: Jorine E. Hartman

given: Jorine E.

family: Klooster

full_name: Karin Klooster

given: Karin

family: Gortzak

full_name: Kiki Gortzak

given: Kiki

family: Hacken

full_name: Nick H.T. Hacken

given: Nick H.T.

family: Slebos

full_name: Dirk‐Jan Slebos

given: Dirk‐Jan

journal_name: Respirology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license_normalized: no license

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

evidence: oa repository (via pmcid lookup)

title: Long‐term follow‐up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema

ReferenceCitation: Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.

family: Deslee

full_name: Gaëtan Deslee

given: Gaëtan

family: Hetzel

full_name: Martin Hetzel

given: Martin

family: Stanzel

full_name: Franz Stanzel

given: Franz

family: Kessler

full_name: Romain Kessler

given: Romain

family: Marquette

full_name: Charles-Hugo Marquette

given: Charles-Hugo

family: Witt

full_name: Christian Witt

given: Christian

family: Blaas

full_name: Stefan Blaas

given: Stefan

family: Gesierich

full_name: Wolfgang Gesierich

given: Wolfgang

family: Herth

full_name: Felix J F Herth

given: Felix J F

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_facility:
Krankenhaus von Roten Kreuz
Klinikum Donaustauf
UKT University Hospital
CHRU de Strasbourg-NHC
Gaetan Deslee
University Medical Center Groningen
CHU de Nice - Hospital Pasteur
Campus Charite Mitte
Thoraxklinik
Asklepios
Lungenklinik


title: Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice

summary: The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

lead_sponsor: UCB Pharma

location_country:
Italy
Poland
France
Greece
Spain
Germany
United Kingdom


title: A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease

acronym: FALCON

summary: This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 300 patients will be enrolled.

lead_sponsor: Reata Pharmaceuticals, Inc.

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Renal Division, ASST Santi Paolo e Carlo

location_facility: Brookview Hills Research Associates, LLC

location_facility: University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation

location_facility: Nephrology Dept., General Teaching Hospital

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Nephrology Associates of Northern Virginia, Inc.

location_facility: Manchester University NHS Foundation Trust

location_facility: KidneyCare and Tranplant Services of New England

location_facility: Japan Community Healthcare Organization Sendai Hospital

location_facility: University of Maryland School of Medicine

location_facility: North Carolina Nephrology, P.A. 2nd Floor

location_facility: Kansas Nephrology Research Institute, LLC

location_facility: Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: Division of Kidney Diseases and Hypertension

location_facility: University of Cincinnati College of Medicine

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: University of Colorado Anschutz Medical Center

location_facility: Paragon Health PC d/b/a Nephrology Center PC

location_facility: Mountain Kidney & Hypertension Associates

location_facility: Tokyo Women's Medical University Hospital

location_facility: Hopital Necker, Universite Paris Descartes


title: A Phase I, Multicenter, Open-Label Preoperative, Short-Term Window Study of GDC-9545 in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer

summary: This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.

primary_purpose: Basic Science

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Genentech, Inc.

location_country:
France
Belgium
Australia
Spain
United States
United Kingdom

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: University of Colorado Health Lone Tree Medical Center

location_facility: Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry

location_facility: Fiona Stanley Hospital; Investigational Drugs, Pharmacy Department

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

location_facility: Onkologikoa - Instituto Oncológico de Donostia

location_facility: Hospital Clinico Universitario de Valencia

intervention_type: Procedure


title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 2

summary:
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

ipd_sharing: Undecided

lead_sponsor: Zealand Pharma

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

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Division of Gastroenterology and Hepatology

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: University of Chicago Children's Hospital

location_facility: Azienda Ospedaliero Universitaria Federico II

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Health Network - Toronto General Hospital

location_facility: Universitätsklinikum Tübingen - Innere Medizin I

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka


title: A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)

acronym: TWINSS

summary: This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Greece
Romania
Australia
Russian Federation
France
Japan
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Turkey


title: A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

summary: The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.

ipd_sharing_description: Not an applicable trial, product manufactured outside of US and all study sites outside US.

lead_sponsor: Ethicon, Inc.

location_country:
Israel
Germany
United Kingdom
France

location_facility:
Chirurgie Praxisklinik Kaiserplatz
Rotes Kreuz Krankenhous Kassel
Rabin Medical Center
Martin-Luther-Krankenhaus
Benjamin Ascher
Rambam Medical Center
Catherine Bergeret-Galley
Bernard Mole
Springfield Hospital


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

lead_sponsor: Novo Nordisk A/S

location_country:
Russian Federation
Denmark
Ukraine
India
France
Japan
Poland
Thailand
Norway
Canada
Switzerland
Hungary
Ireland
Algeria
United States
United Kingdom
Italy
Austria
Serbia
Israel
Spain
Estonia
Latvia

source: euctr

title: A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

summary:
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).

Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.


title: A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

acronym: StAR

summary: The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

ReferenceCitation: Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.

ReferenceCitation: van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.

ReferenceCitation: Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25

ReferenceCitation: Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61.

ReferenceCitation: Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7.

lead_sponsor: LifeCell

location_country:
Italy
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Krankenhaus Salem der Evang. Stadtmission Heidelberg

location_facility: Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat

location_facility: Technischen Universität München - Klinikum rechts der Isar

location_facility: Universitätsklinikum Giessen und Marburg GmbH


title: Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)

acronym: MOSAR-ICU

summary:
Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).

In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.

Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.

primary_purpose: Screening

ReferenceCitation: Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragão I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Martí AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23. Erratum in: Lancet Infect Dis. 2014 Jan;14(1):11.

family: Derde

full_name: Lennie P G Derde

given: Lennie P G

family: Cooper

full_name: Ben S Cooper

given: Ben S

family: Goossens

full_name: Herman Goossens

given: Herman

family: Malhotra-Kumar

full_name: Surbhi Malhotra-Kumar

given: Surbhi

family: Willems

full_name: Rob J L Willems

given: Rob J L

family: Gniadkowski

full_name: Marek Gniadkowski

given: Marek

family: Hryniewicz

full_name: Waleria Hryniewicz

given: Waleria

family: Empel

full_name: Joanna Empel

given: Joanna

family: Dautzenberg

full_name: Mirjam J D Dautzenberg

given: Mirjam J D

family: Annane

full_name: Djillali Annane

given: Djillali

family: Aragão

full_name: Irene Aragão

given: Irene

family: Chalfine

full_name: Annie Chalfine

given: Annie

family: Dumpis

full_name: Uga Dumpis

given: Uga

family: Esteves

full_name: Francisco Esteves

given: Francisco

family: Giamarellou

full_name: Helen Giamarellou

given: Helen

family: Muzlovic

full_name: Igor Muzlovic

given: Igor

family: Nardi

full_name: Giuseppe Nardi

given: Giuseppe

family: Petrikkos

full_name: George L Petrikkos

given: George L

family: Tomic

full_name: Viktorija Tomic

given: Viktorija

family: Martí

full_name: Antonio Torres Martí

given: Antonio Torres

family: Stammet

full_name: Pascal Stammet

given: Pascal

family: Brun-Buisson

full_name: Christian Brun-Buisson

family: Bonten

full_name: Marc J M Bonten

given: Marc J M

location_country: Italy Luxembourg Spain France Greece Slovenia Portugal Latvia

location_facility: University Clinic of Respiratory and Allergic Diseases


title: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

summary: Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

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

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

location_country:
Greece
Romania
Belgium
Australia
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Bulgaria
Hungary
Portugal
China
Germany
United States
United Kingdom
Serbia
Mexico
Czechia
Spain

location_facility: Klinicko Bolnicki Centar "Bezanijska Kosa"

location_facility: UAB Department of Medicine Clinical Research Enterprise

location_facility: University Health Network-Toronto Western Hospital

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

location_facility: Klinicki Centar Srbije, Klinika za alergologiju i imunologiju

location_facility: Hospital of the university of occupational and environmental health

location_facility: Laiko General Hospital, University of Athens

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: The First Affiliated Hospital of Baotou Medical College

location_facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Centro Peninsular de Investigación Clínica S.C.P.

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

location_facility: SUNY Upstate Medical University - Clinical Research Unit

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

location_facility: Tianjin Medical University General Hospital

location_facility: West Broward Rheumatology Associates, Inc

location_facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

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

location_facility: Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska

location_facility: Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"

location_facility: CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Prince of Wales Hospital - The Chinese University of Hong Kong

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Unidade Local de Saude do Alto Minho, E.P.E.

location_facility: State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"

location_facility: The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital

location_facility: Morales Vargas Centro de Investigación S.C.

location_facility: Atlanta Research Center for Rheumatology

location_facility: Investigación y Biomedicina de Chihuahua, Sociedad Civil

location_facility: Vojnomedicinska akademija, Klinika za reumatologiju

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: UAB Hospital-Clinical Research Unit (CRU)

location_facility: East Bay Rheumatology Medical Group, Inc.

location_facility: University of Michigan Brighton Center for Specialty Care

location_facility: Communal non-profitable enterprise "Lviv City Clinical Hospital #4"

location_facility: Investigational Drug Services University of Kansas Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: CINTRE Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Department of Medicine MSG at SUNY HSC at Syracuse, Inc. d/b/a

location_facility: Arthritis and Osteoporosis Medical Center

location_facility: Zespol Klinik Narodowego Instytutu Geriatrii, Reumatologii i Rehabilitacji w Warszawie

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Multifield Medical Center of Odessa National Medical University

location_facility: CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque

location_facility: Rheumatic Disease Clinical Research Center, LLC

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)

location_facility: Kyungpook National University Hospital (KNUH)

location_facility: Feinstein Institute for Medical Research

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: Centre de Recherche Musculo-Squelettique

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

location_facility: Centre intégré de santé et de services sociaux du Bas-Saint-Laurent

location_facility: Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji

location_facility: Universitätsklinikum Schleswig Holstein - Campus Lübeck

location_facility: CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council

location_facility: Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna

location_facility: The Affiliated Nanjing Drum Tower Hospital

location_facility: Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Zakarpattia Regional Clinical Hospital n.a. A. Novak

location_facility: Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS

location_facility: Centro Hospitalar Universitario do Porto, E.P.E

location_facility: The First Affiliated Hospital, Sun Yet-san University

location_facility: Institut Niska Banja, Klinika za Reumatologiju

location_facility: University General Hospital of Heraklion

location_facility: Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI

location_facility: Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2

location_facility: Irving Institute for Clinical and Transitional Research

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V

location_facility: Inland Rheumatology and Osteoporosis Medical Group

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


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

acronym: SLE-BRAVE-X

summary: The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

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:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
India
Croatia
France
Japan
Poland
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Switzerland
Netherlands
Philippines
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Gen. Hosp. of Thessaloniki "Hippokration"

location_facility: Institute for Treatment and Rehabilitation Niska Banja

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: HPTU-El Hospital con alma Pablo Tobon Uribe

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Tianjin Medical University General Hospital

location_facility: The First Affliated Hospital of Soochow University

location_facility: CINVEC- Estudos Clínicos Quinta Región Limitada

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Clinica para el Diagnostico y Tratamiento de la Enfermedades

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Centro Peninsular de Investigacion S.C.P

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Vrije Universiteit Medisch Centrum Amsterdam

location_facility: Angeles University Foundation and Medical Center

location_facility: City Clinical Hospital 1 named after N.I. Pirogov

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: First Affiliated Hospital of the Harbin Medical University

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Moscow State University of Medicine and Dentistry n.a. Evdokimov

location_facility: Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Centro de Estudos em Terapias Inovadoras-CETI

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

location_facility: People's Hospital of Xinjiang Uygur Autonomous Region

location_facility: SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

location_facility: The Feinstein Institute for Medical Research

location_facility: Orenburg State Medical Academy of Roszdrav

location_facility: Regional General University Hospital of Larissa

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: China Medical University (CMU) - First Affiliated Hospital

location_facility: Craiova Emergency Clinical County Hospital

location_facility: Centro de Investigaciones Médicas Tucuman

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

location_facility: Oncovida- Centro de Onco-Hematologia de Mato Grosso

location_facility: Kasturba Medical College Hospital, Mangalore

location_facility: IR Medical Center S.A. Instituto de Reumatologia

location_facility: Immanuel Krankenhaus Rheuma Klinik Berlin Buch

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: ChanRe Rheumatology And Immunology Center And Research

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: University of Occupational and Enviromental Health

location_facility: The First Affiliated Hospital of Zhengzhou Universtiy

location_facility: Box Arthritis & Rheumatology of the Carolinas, PLLC

location_facility: Napoca Emergency Clinical County Hospital

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

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

location_facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Research Institute of Clinical Immunology

location_facility: The Rheumatology Research Unit Sunshine Coast

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: Sushruta Multispecialty Hospital & Research Center Pvt Ltd

location_facility: Morales Vargas Centro de Investigacion, S.C.

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: Sociedad Medica Del Aparato Locomotor SA

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Departmental Hospital at Smolensk Station "rzhd" JSC

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch


lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Italy
Germany
United Kingdom
France

acronym: NT crow's feet

title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

summary: To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).


title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

summary: Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

lead_sponsor: Astellas Pharma Inc

location_country:
France
Poland
Ireland
Spain
Germany
United Kingdom


title: A Randomized, Single Blinded, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.

lead_sponsor: GlaxoSmithKline

location_country: Peru India France Greece Spain


title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

acronym: RAVEN

summary: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Thailand
Netherlands
Spain
Germany
France
Czechia
Greece
Israel
Japan
Malaysia
Hungary
Australia
Puerto Rico
Russian Federation
China
Turkey
Canada
United Kingdom


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Sweden
France
Australia
New Zealand
Spain
Canada

acronym: Pembrolizumab (MK-3475) as First-Line Therapy for Advanced Merkel Cell Carcinoma

location_facility: Hospital General Universitario de Valencia ( Site 0262)

location_facility: C.H.R.U. de Tours. Hopital Trousseau ( Site 0202)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0203)

location_facility: Melanoma Institute Australia ( Site 0400)

location_facility: Hospital Universitari Vall d Hebron ( Site 0264)

location_facility: Princess Margaret Cancer Centre ( Site 0051)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0282)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0200)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0224)

location_facility: Hospital Clinic de Barcelona ( Site 0261)

location_facility: Hospital Universitario La Paz ( Site 0263)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 0281)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0201)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0004)

location_facility: IEO Istituto Europeo di Oncologia ( Site 0223)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0222)

location_facility: Hopital de la Cote de Nacre - Caen ( Site 0204)

title: A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)

summary: This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.


title: An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

summary: The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

ReferenceCitation: Harmon CS, DePrimo SE, Raymond E, Cheng AL, Boucher E, Douillard JY, Lim HY, Kim JS, Lechuga MJ, Lanzalone S, Lin X, Faivre S. Mechanism-related circulating proteins as biomarkers for clinical outcome in patients with unresectable hepatocellular carcinoma receiving sunitinib. J Transl Med. 2011 Jul 25;9:120. doi: 10.1186/1479-5876-9-120.

family: Harmon

full_name: Charles S Harmon

given: Charles S

family: DePrimo

full_name: Samuel E DePrimo

given: Samuel E

family: Raymond

full_name: Eric Raymond

given: Eric

family: Cheng

full_name: Ann-Lii Cheng

given: Ann-Lii

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

family: Lim

full_name: Ho Y Lim

given: Ho Y

family: Kim

full_name: Jun S Kim

given: Jun S

family: Lechuga

full_name: Maria José Lechuga

given: Maria José

family: Lanzalone

full_name: Silvana Lanzalone

given: Silvana

family: Lin

full_name: Xun Lin

given: Xun

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Faivre S, Zappa M, Vilgrain V, Boucher E, Douillard JY, Lim HY, Kim JS, Im SA, Kang YK, Bouattour M, Dokmak S, Dreyer C, Sablin MP, Serrate C, Cheng AL, Lanzalone S, Lin X, Lechuga MJ, Raymond E. Changes in tumor density in patients with advanced hepatocellular carcinoma treated with sunitinib. Clin Cancer Res. 2011 Jul 1;17(13):4504-12. doi: 10.1158/1078-0432.CCR-10-1708. Epub 2011 Apr 29.

family: Zappa

full_name: Magaly Zappa

given: Magaly

family: Vilgrain

full_name: Valérie Vilgrain

given: Valérie

publisher: American Association for Cancer Research (AACR)

title: Changes in Tumor Density in Patients with Advanced Hepatocellular Carcinoma Treated with Sunitinib

ReferenceCitation: Faivre S, Raymond E, Boucher E, Douillard J, Lim HY, Kim JS, Zappa M, Lanzalone S, Lin X, Deprimo S, Harmon C, Ruiz-Garcia A, Lechuga MJ, Cheng AL. Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study. Lancet Oncol. 2009 Aug;10(8):794-800. doi: 10.1016/S1470-2045(09)70171-8. Epub 2009 Jul 6.


title: A Phase II, Multi-Centre, Randomised, Double-blind, Dose-Ranging Study Comparing the Efficacy and Safety of a Single Treatment With 15, 30 or 45 Units (Per Eye) of Dysport to Placebo in the Symptomatic Treatment of Lateral Canthal Lines (Crow's Feet)

summary: Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.

lead_sponsor: Ipsen

location_country:
Germany
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt


title: IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study

acronym: IWOT

summary: The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Switzerland
Netherlands
France
Australia
Belgium
Spain
Denmark
United Kingdom

location_facility: Princess Alexandra Hospital - University of Queensland

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove

location_facility: IRCCS - Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Aarhus University Hospitals - Aarhus University Hospital-Skejby

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

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone (APHM)

location_facility: Institut de Cancerologie Strasbourg Europe (formar Paul Strauss)

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Westmead Hospital - Crown Princess Mary Cancer Centre

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Illawarra Cancer Care Centre - Wollongong Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust - Clatterbridge NHS -Wirral

location_facility: Maastro Clinic - Maastricht Radiation Oncology

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

location_facility: ETZ Tilburg - St. Elisabethziekenhuis TweeSteden

intervention_type: Radiation


lead_sponsor: LEO Pharma

location_country:
France
Czechia
Poland
Belgium
Spain
Germany
United Kingdom

acronym: ECZTRA 7

title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With Severe Atopic Dermatitis

summary:
Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.


title: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

summary: The purpose of this study is to assess the efficacy and safety of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).

ReferenceCitation: Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.

family: Gong

full_name: Xiaohua Gong

given: Xiaohua

full_name: Xuejun Chen

given: Xuejun

family: Kuligowski

full_name: Michael E. Kuligowski

given: Michael E.

family: Liu

full_name: Xing Liu

given: Xing

full_name: Xiang Liu

given: Xiang

family: Cimino

full_name: Evan Cimino

given: Evan

family: McGee

full_name: Ryan McGee

given: Ryan

family: Yeleswaram

full_name: Swamy Yeleswaram

given: Swamy

journal_name: American Journal of Clinical Dermatology

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, Forman SB, Venturanza ME, Sun K, Kuligowski ME, Simpson EL. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021 Oct;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085. Epub 2021 May 4.

family: Papp

full_name: Kim Papp

given: Kim

family: Szepietowski

full_name: Jacek C. Szepietowski

given: Jacek C.

family: Kircik

full_name: Leon Kircik

given: Leon

family: Toth

full_name: Darryl Toth

given: Darryl

family: Eichenfield

full_name: Lawrence F. Eichenfield

given: Lawrence F.

family: Leung

full_name: Donald Y.M. Leung

given: Donald Y.M.

family: Forman

full_name: Seth B. Forman

given: Seth B.

family: Venturanza

full_name: May E. Venturanza

given: May E.

family: Sun

full_name: Kang Sun

given: Kang

journal_name: Journal of the American Academy of Dermatology

ReferenceCitation: Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Front Immunol. 2021 Feb 15;11:620098. doi: 10.3389/fimmu.2020.620098. eCollection 2020.

location_country:
Italy
United States
France
Poland
Hungary
Germany
Canada

location_facility: Well Pharma Medical Research Corporation

location_facility: Medycyna Kliniczna Marzena Waszczak-Jeka

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Clinical Research Institute Of Southern Oregon - Crisor

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Dawes Fretzin Clinical Research Group LLC

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Budapest

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

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

location_facility: Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

location_facility: Synexus (DRS) - Synexus Magyarország Kft. Gyula


title: A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

acronym: IMAGINE

summary: This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.

lead_sponsor: CSL Behring

location_country:
United States
Netherlands
Germany
France
Czechia
Hungary
Australia
Spain
Canada

location_facility: St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia

location_facility: CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut)

location_facility: Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Debreceni Egyetem, Klinikai Központ, Auguszta

location_facility: Vancouver General Hospital - Gordon & Leslie Diamond Centre

location_facility: Shared Health Inc. operating as the Health Sciences Centre

location_facility: University of Wisconsin School of Medicine and Public Health (UWSMPH)

location_facility: Maine Medical Center/ Maine Medical Center Research Institute

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Central Pennsylvania Transplant Foundation


title: Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)

acronym: ISLAY

summary:
Primary Objective:

To evaluate the efficacy of isatuximab.

Secondary Objectives:

To evaluate the safety profile of isatuximab.
To evaluate the duration of response (DOR).
To evaluate progression free survival (PFS) and overall survival (OS).
To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
To assess minimal residual disease (MRD) and correlate it with clinical outcome.

ReferenceCitation: Wang A, Song Z, Zheng G, Nicolazzi C, Fromm JR, Shehu E, Srinivasan S, Chen X, Zhu C, Blondel MC, Adrian FJ. Evaluation of Preclinical Activity of Isatuximab in Patients with Acute Lymphoblastic Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1916-1925. doi: 10.1158/1535-7163.MCT-21-0058. Epub 2021 Aug 10.

family: Wang

full_name: Anlai Wang

given: Anlai

family: Song

full_name: Zhili Song

given: Zhili

family: Zheng

full_name: Gang Zheng

given: Gang

family: Nicolazzi

full_name: Celine Nicolazzi

given: Celine

family: Fromm

full_name: Jonathan R. Fromm

given: Jonathan R.

family: Shehu

full_name: Elvis Shehu

given: Elvis

family: Srinivasan

full_name: Srimathi Srinivasan

given: Srimathi

family: Chen

full_name: Xueyan Chen

given: Xueyan

family: Zhu

full_name: Chen Zhu

given: Chen

family: Blondel

full_name: Marielle Chiron Blondel

given: Marielle Chiron

family: Adrian

full_name: Francisco J. Adrian

given: Francisco J.

journal_name: Molecular Cancer Therapeutics

publisher_dissemination: American Association for Cancer Research

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country:
Italy
Finland
France
Lithuania
Hungary
Russian Federation
United States

location_facility:
Investigational Site Number 2500001
Investigational Site Number 3800001
Investigational Site Number 2500004
Investigational Site Number 8400003
Investigational Site Number 3480002
Investigational Site Number 3480003
Investigational Site Number 4400001
Investigational Site Number 3800004
Investigational Site Number 3480001
Investigational Site Number 6430004
Investigational Site Number 2460001
Investigational Site Number 2500002
Investigational Site Number 6430003
Investigational Site Number 6430001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 2500005


title: A Phase 1/2, MultiCenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability and Preliminary Efficacy of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellullar Carcinoma (HCC) Following First Line Treatment Failure

summary: CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

lead_sponsor: Celgene

location_country:
Italy
United States
France
Spain

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: Institut Universitaire du Cancer IUCT - Oncopole


title: A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo

summary: This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

ReferenceCitation: Schoser B, Roberts M, Byrne BJ, Sitaraman S, Jiang H, Laforêt P, Toscano A, Castelli J, Díaz-Manera J, Goldman M, van der Ploeg AT, Bratkovic D, Kuchipudi S, Mozaffar T, Kishnani PS; PROPEL Study Group. Safety and efficacy of cipaglucosidase alfa plus miglustat versus alglucosidase alfa plus placebo in late-onset Pompe disease (PROPEL): an international, randomised, double-blind, parallel-group, phase 3 trial. Lancet Neurol. 2021 Dec;20(12):1027-1037. doi: 10.1016/S1474-4422(21)00331-8.

family: Schoser

full_name: Benedikt Schoser

given: Benedikt

family: Roberts

full_name: Mark Roberts

given: Mark

family: Byrne

full_name: Barry J Byrne

given: Barry J

family: Sitaraman

full_name: Sheela Sitaraman

given: Sheela

family: Jiang

full_name: Hai Jiang

given: Hai

family: Laforêt

full_name: Pascal Laforêt

given: Pascal

family: Toscano

full_name: Antonio Toscano

given: Antonio

family: Castelli

full_name: Jeff Castelli

given: Jeff

family: Díaz-Manera

full_name: Jordi Díaz-Manera

given: Jordi

family: Goldman

full_name: Mitchell Goldman

given: Mitchell

family: van der Ploeg

full_name: Ans T van der Ploeg

given: Ans T

family: Bratkovic

full_name: Drago Bratkovic

given: Drago

family: Kuchipudi

full_name: Srilakshmi Kuchipudi

given: Srilakshmi

family: Mozaffar

full_name: Tahseen Mozaffar

given: Tahseen

family: Kishnani

full_name: Priya S Kishnani

given: Priya S

family: Sebok

full_name: Agnes Sebok

given: Agnes

family: Pestronk

full_name: Alan Pestronk

given: Alan

family: Dominovic-Kovacevic

full_name: Aleksandra Dominovic-Kovacevic

given: Aleksandra

family: Khan

full_name: Aneal Khan

given: Aneal

family: Koritnik

full_name: Blaž Koritnik

given: Blaž

family: Tard

full_name: Celine Tard

family: Lindberg

full_name: Christopher Lindberg

given: Christopher

family: Quinn

full_name: Colin Quinn

given: Colin

location_country:
Greece
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Slovenia
Korea, Republic of
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
New Zealand
Spain

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: UF Helath: University of Florida Clinical Research Center

location_facility: University of Minnesota Clinical Research Unit

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: Heritage Medical Research Clinic, University of Calgary

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: University of Texas Health Science Center San Antonio

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Utah, Center for Clinical and Translational Sciences

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Semmelweis University, Institute of Genomic Medicine and Rare Disease

location_facility: The Ohio State University Wexner Medical Center

location_facility: Indiana University Health Neuroscience Center

location_facility: National Center of Neurology and Psychiatry

location_facility: University of South Florida Research Center

location_facility: The Feinstein Institute for Medical Research

location_facility: Rigshospitalet Copenhagen Neuromuscular Center


title: Phase IIa, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects With Acromegaly Previously Treated and Controlled With Either Octreotide LAR or Lanreotide Autogel

summary: The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

ReferenceCitation: Neggers S, Badiu C, Biagetti B, Durand-Gasselin L, Petit A, Petrossians P, Regnault B, Rich D, Shafigullina Z, Shustov S, Vydrych A. Pharmacological and safety profile of a prolonged-release lanreotide formulation in acromegaly. Expert Rev Clin Pharmacol. 2021 Nov 8:1-10. doi: 10.1080/17512433.2021.1986004. [Epub ahead of print]

name: Medicine and Endocrinology, Erasmus University Medical Center, Erasmus University Rotterdam, Doctor Molewaterplein 40, 3015 GD Rotterdam, Netherlands

family: Neggers

full_name: Sebastian Neggers

given: Sebastian

name: Endocrinology, Carol Davila University of Medicine and Pharmacy, National Institute of Endocrinology, Aviatorilor 34–38, S1, 11863 Bucharest, Romania

family: Badiu

full_name: Corin Badiu

given: Corin

name: Department of Endocrinology, Hospital Universitari Vall d’Hebron, Passeig de la Vall d’Hebron, 119, 08035, Barcelona, Spain

family: Biagetti

full_name: Betina Biagetti

given: Betina

name: Clinical Pharmacokinetics & Pharmacometrics, Ipsen Innovation, 5 Avenue du Canada, 91140 Les Ulis, France

family: Durand-Gasselin

full_name: Lucie Durand-Gasselin

given: Lucie

name: Drug Product Development & Industrialization, Ipsen, PharmSciences, 17 Rue Ethe Virton, 28108 Dreux, France

family: Petit

full_name: Anne Petit

given: Anne

name: Department of Endocrinology, University Hospital of Liège, Sart Tilman Campus, 4000 Liège, Belgium

family: Petrossians

full_name: Patrick Petrossians

given: Patrick

name: Ipsen, Aixial, 65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France

family: Regnault

full_name: Benjamin Regnault

given: Benjamin

name: Global Development, Rare Diseases, Ipsen BioInnovation, Milton Park, Abingdon, OX14 4RY, UK

family: Rich

full_name: David Rich

given: David

name: Department of Endocrinology, North-Western State Medical University named after I.I Mechnikov, Kirochnaya str.,41, St. Petersburg, Russia

family: Shafigullina

full_name: Zulfiya Shafigullina

given: Zulfiya

family: Shustov

full_name: Sergey Shustov

given: Sergey

family: Vydrych

full_name: Anna Vydrych

given: Anna

journal_name: Expert Review of Clinical Pharmacology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

location_country:
Italy
Netherlands
France
Czechia
Lithuania
Poland
Romania
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Szpital Kliniczny im. H. Święcickiego UM w Poznaniu

location_facility: Fakultní nemocnice Hradec Králové (University Hospital Hradec)

location_facility: Vilnius University hospital Santariskiu Klinikos

location_facility: Lithuanian University of Health Sciences (LUHS) Kauno klinikos

location_facility: Erasmus University Medical Centre Rotterdam

location_facility: AO Città della Salute e della Scienza di Torino

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Szpital Bielanski im. ks. Jerzego Popieluszki SPZOZ

location_facility: Endocrinological Research Center Ministry of Health Russian Federation

location_facility: IRCCS AOU San Martino-IST, University of Genova


title: A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

acronym: SAPHIR

summary: The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

ReferenceCitation: Scheltens P, Hallikainen M, Grimmer T, Duning T, Gouw AA, Teunissen CE, Wink AM, Maruff P, Harrison J, van Baal CM, Bruins S, Lues I, Prins ND. Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer's disease: results of a randomized, double-blind, placebo-controlled phase 2a study. Alzheimers Res Ther. 2018 Oct 12;10(1):107. doi: 10.1186/s13195-018-0431-6.

family: Scheltens

full_name: Philip Scheltens

given: Philip

family: Hallikainen

full_name: Merja Hallikainen

given: Merja

family: Grimmer

full_name: Timo Grimmer

given: Timo

family: Duning

full_name: Thomas Duning

given: Thomas

family: Gouw

full_name: Alida A Gouw

given: Alida A

family: Teunissen

full_name: Charlotte E Teunissen

given: Charlotte E

family: Wink

full_name: Alle Meije Wink

given: Alle Meije

family: Maruff

full_name: Paul Maruff

given: Paul

family: Harrison

full_name: John Harrison

given: John

family: van Baal

full_name: Caroline M van Baal

given: Caroline M

family: Bruins

full_name: Suzanne Bruins

given: Suzanne

family: Lues

full_name: Inge Lues

given: Inge

family: Prins

full_name: Niels D Prins

given: Niels D

journal_name: Alzheimer's Research & Therapy

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of Eastern Finland - UEF eRepo

title: Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer’s disease: results of a randomized, double-blind, placebo-controlled phase 2a study

location_country: Sweden Netherlands Finland France Belgium Spain Germany

location_facility: Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung

location_facility: Ziekenhuis Netwerk Antwerpen / Geheugenkliniek

location_facility: Universitätsmedizin Göttingen / Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsmedizin Rostock / Zentrum für Nervenheilkunde/ Klinik für Psychosomatik und Psychotherapeutische Medizin

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS)

location_facility: Fundació ACE. Institut Català de Neurociències Aplicades

location_facility: CHU François Mitterand (Centre Mémoire Ressources Recherche (CMRR))

location_facility: Universitätsklinikum Münster / Klinik für Allgemeine Neurologie

location_facility: Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie

location_facility: Hôpital La Grave / Centre de Recherche Clinique

location_facility: Verksamheten för neuropsykiatri Sahlgrenska universitetssjukhuset

location_facility: Hospital de la Santa Creu i Sant Pau, Neurology Department, Memory Unit

location_facility: Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik


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

lead_sponsor: Hoffmann-La Roche

location_country:
Austria
France
Poland
Spain
United States
Korea, Republic of

location_facility: Hospital San Pedro de Alcantara; Servicio de Hematología

location_facility: University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica

location_facility: Katedra i Klinika Hematologii; Nowotworów Krwi i Transplantacji Szpiku

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: University of California; Moores Cancer Center

location_facility: University of Miami Miller School of Medicine

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Centre Henri Becquerel- Centre de Lutte Contre le Cancer

title: A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).