title: Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy

summary:
Objectives

Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.
Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.

ReferenceCitation: Bachy E, Seymour JF, Feugier P, Offner F, López-Guillermo A, Belada D, Xerri L, Catalano JV, Brice P, Lemonnier F, Martin A, Casasnovas O, Pedersen LM, Dorvaux V, Simpson D, Leppa S, Gabarre J, da Silva MG, Glaisner S, Ysebaert L, Vekhoff A, Intragumtornchai T, Le Gouill S, Lister A, Estell JA, Milone G, Sonet A, Farhi J, Zeuner H, Tilly H, Salles G. Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study. J Clin Oncol. 2019 Nov 1;37(31):2815-2824. doi: 10.1200/JCO.19.01073. Epub 2019 Jul 24.

name: Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France

family: Bachy

full_name: Emmanuel Bachy

given: Emmanuel

name: Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia

family: Seymour

full_name: John F. Seymour

given: John F.

name: Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Offner

full_name: Fritz Offner

given: Fritz

family: López-Guillermo

full_name: Armando López-Guillermo

given: Armando

name: Charles University, Hradec Králové, Czech Republic

family: Belada

full_name: David Belada

given: David

name: Institut Paoli-Calmettes, Aix-Marseille Université, Marseille, France

family: Xerri

full_name: Luc Xerri

given: Luc

name: Frankston Hospital and Monash University, Frankston, Victoria, Australia

family: Catalano

full_name: John V. Catalano

given: John V.

name: Hôpital Saint-Louis, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Brice

full_name: Pauline Brice

given: Pauline

name: Hôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France

family: Lemonnier

full_name: François Lemonnier

given: François

name: Hospital Universitario de Salamanca–Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain

family: Martin

full_name: Alejandro Martin

given: Alejandro

name: Department of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France

family: Casasnovas

full_name: Olivier Casasnovas

name: Herlev University Hospital, Copenhagen, Denmark

family: Pedersen

full_name: Lars M. Pedersen

given: Lars M.

name: Hôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France

family: Dorvaux

full_name: Véronique Dorvaux

given: Véronique

name: North Shore Hospital, Auckland, New Zealand

family: Simpson

full_name: David Simpson

name: Helsinki University Hospital, University of Helsinki, Helsinki, Finland

family: Leppa

full_name: Sirpa Leppa

given: Sirpa

name: Hôpital Pitié-Salpêtrière, Paris, France

family: Gabarre

full_name: Jean Gabarre

given: Jean

name: Portuguese Institute of Oncology, Lisbon, Portugal

family: da Silva

full_name: Maria G. da Silva

given: Maria G.

name: Institut Curie–Hôpital Rene Huguenin, Saint-Cloud, France

family: Glaisner

full_name: Sylvie Glaisner

given: Sylvie

name: Institut Universitaire du Cancer de Toulouse–Oncopole, Toulouse, France

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

name: Saint Antoine Hospital, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Vekhoff

full_name: Anne Vekhoff

given: Anne

name: Chulalongkorn University, Bangkok, Thailand

family: Intragumtornchai

full_name: Tanin Intragumtornchai

given: Tanin

name: Centre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: Queen Mary University of London, London, United Kingdom

name: Concord Hospital, Concord, University of Sydney, New South Wales, Australia

name: Centre Hospitalier Universitaire d’Angers, Angers, France

repository_institution: University of Melbourne - Minerva Access

repository_normalized: HELDA - Digital Repository of the University of Helsinki

publisher_group: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Zhou X, Wang J, Zhang J, Copley-Merriman C, Torigoe Y, Reyes C, Seymour JF, Offner FC, Trneny M, Salles GA. Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma. Hematology. 2015 Apr;20(3):129-36. doi: 10.1179/1607845414Y.0000000179. Epub 2014 Jul 16.

name: RTI Health SolutionsResearch Triangle Park, NC, USA

name: Genentech Inc., South San Francisco, CA, USA

name: Department of HaematologyPeter MacCallum Cancer Centre, University of Melbourne, Victoria, Australia

name: Dienst HematologieUZ Gent, Gent, Belgium

name: 1st Dept MedicineCharles University General Hospital, Prague, Czech Republic

name: HématologieHospices Civils de Lyon—Université de Lyon, Pierre-Bénite, France

ReferenceCitation: Ghesquières H, Cartron G, Seymour JF, Delfau-Larue MH, Offner F, Soubeyran P, Perrot A, Brice P, Bouabdallah R, Sonet A, Dupuis J, Casasnovas O, Catalano JV, Delmer A, Jardin F, Verney A, Dartigues P, Salles G. Clinical outcome of patients with follicular lymphoma receiving chemoimmunotherapy in the PRIMA study is not affected by FCGR3A and FCGR2A polymorphisms. Blood. 2012 Sep 27;120(13):2650-7. Epub 2012 Aug 10.

ReferenceCitation: Salles G, Seymour JF, Offner F, López-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Fermé C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum in: Lancet. 2011 Apr 2;377(9772):1154.

location_country:
Brazil
Peru
Netherlands
Spain
France
Thailand
Belgium
Argentina
Australia
New Zealand
Denmark
Colombia

location_facility: Australia New Zealand Leukemia Lymphoma Group

location_facility: Instituo Nacional de Enfermedades Neoplasicas

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder

summary: This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Perlis RH, Fijal B, Dharia S, Houston JP. Pharmacogenetic investigation of response to duloxetine treatment in generalized anxiety disorder. Pharmacogenomics J. 2013 Jun;13(3):280-5. doi: 10.1038/tpj.2011.62. Epub 2012 Jan 17.

family: Perlis

full_name: R H Perlis

given: R H

sequence: first

family: Fijal

full_name: B Fijal

given: B

sequence: additional

family: Dharia

full_name: S Dharia

given: S

family: Houston

full_name: J P Houston

given: J P

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Pharmacogenomics Journal

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Eli Lilly and Company

location_country:
Austria
Netherlands
Germany
France
Puerto Rico
Portugal
United States

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

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. Overall survival will be taken as the primary measure of efficacy.

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

family: Vermorken

full_name: Jan B. Vermorken

given: Jan B.

family: Mesia

full_name: Ricard Mesia

given: Ricard

family: Rivera

full_name: Fernando Rivera

given: Fernando

family: Remenar

full_name: Eva Remenar

given: Eva

family: Kawecki

full_name: Andrzej Kawecki

given: Andrzej

family: Rottey

full_name: Sylvie Rottey

family: Erfan

full_name: Jozsef Erfan

given: Jozsef

family: Zabolotnyy

full_name: Dmytro Zabolotnyy

given: Dmytro

family: Kienzer

full_name: Heinz-Roland Kienzer

given: Heinz-Roland

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Peyrade

full_name: Frederic Peyrade

given: Frederic

family: Benasso

full_name: Marco Benasso

given: Marco

family: Vynnychenko

full_name: Ihor Vynnychenko

given: Ihor

family: De Raucourt

full_name: Dominique De Raucourt

given: Dominique

family: Bokemeyer

full_name: Carsten Bokemeyer

given: Carsten

family: Schueler

full_name: Armin Schueler

given: Armin

family: Amellal

full_name: Nadia Amellal

given: Nadia

family: Hitt

full_name: Ricardo Hitt

given: Ricardo

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer

ReferenceCitation: Mesía R, Rivera F, Kawecki A, Rottey S, Hitt R, Kienzer H, Cupissol D, De Raucourt D, Benasso M, Koralewski P, Delord JP, Bokemeyer C, Curran D, Gross A, Vermorken JB. Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol. 2010 Oct;21(10):1967-1973. doi: 10.1093/annonc/mdq077. Epub 2010 Mar 24.

family: Mesía

full_name: R. Mesía

given: R.

full_name: F. Rivera

given: F.

full_name: A. Kawecki

given: A.

ReferenceCitation: Hecht M, Hahn D, Wolber P, Hautmann MG, Reichert D, Weniger S, Belka C, Bergmann T, Göhler T, Welslau M, Große-Thie C, Guntinas-Lichius O, von der Grün J, Balermpas P, Orlowski K, Messinger D, Stenzel KG, Fietkau R. Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer. BMC Cancer. 2020 Sep 29;20(1):933. doi: 10.1186/s12885-020-07440-w.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repository_institution: University of Zurich - Zurich Open Repository and Archive

evidence: oa repository (via OAI-PMH title and first author match)

ReferenceCitation: Licitra L, Störkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.

title: Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: Analysis of data from the EXTREME and CRYSTAL studies

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
United Kingdom
France
Poland
Slovakia
Hungary
Belgium
Russian Federation
Portugal
Germany
Czech Republic
Ukraine


title: A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

summary: This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.

family: Welsh

full_name: Paul Welsh

given: Paul

family: Tuckwell

full_name: Katie Tuckwell

given: Katie

family: McInnes

full_name: Iain B. McInnes

given: Iain B.

family: Sattar

full_name: Naveed Sattar

given: Naveed

journal_name: Atherosclerosis

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.

family: Keystone

full_name: Edward C. Keystone

given: Edward C.

family: Anisfeld

full_name: Andrew Anisfeld

given: Andrew

family: Ogale

full_name: Sarika Ogale

given: Sarika

family: Devenport

full_name: Jenny N. Devenport

given: Jenny N.

family: Curtis

full_name: Jeffrey R. Curtis

given: Jeffrey R.

journal_name: The Journal of Rheumatology

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

title: Continued Benefit of Tocilizumab Plus Disease-modifying Antirheumatic Drug Therapy in Patients with Rheumatoid Arthritis and Inadequate Clinical Responses by Week 8 of Treatment

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

family: Wang

full_name: J Wang

given: J

family: Bansal

full_name: A T Bansal

given: A T

ReferenceCitation: Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.

title: Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: The tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study

location_country:
Brazil
United States
South Africa
Sweden
Costa Rica
Hong Kong
Mexico
Spain
Germany
Finland
France
Panama
Thailand
Argentina
Australia
Russian Federation
China
Canada
Czech Republic


title: A Phase IIb, 96 Week, Randomized, Open-label Multicenter, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of Different Doses and Regimens of GW873140 in Combination With Kaletra (Lopinavir and Ritonavir) in HIV-1 Infected Antiretroviral Therapy naïve Subjects

summary: This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

status: Terminated

lead_sponsor: ViiV Healthcare

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

status_simplified: Unknown


title: International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

summary:
The purpose of this study is to determine

whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

ReferenceCitation: O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group, O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Hartung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. doi: 10.1016/S1474-4422(09)70226-1. Epub 2009 Sep 2. Erratum in: Lancet Neurol. 2009 Nov;8(11):981. Lancet Neurol. 2011 Feb;10(2):115. Lancet Neurol. 2012 Jan;11(1):27. Cree, B [added]; Harung, H-P [corrected to Hartung, H-P].

family: O'Connor

full_name: Paul O'Connor

family: Filippi

full_name: Massimo Filippi

given: Massimo

family: Arnason

full_name: Barry Arnason

given: Barry

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Cook

full_name: Stuart Cook

given: Stuart

family: Goodin

full_name: Douglas Goodin

given: Douglas

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Jeffery

full_name: Douglas Jeffery

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Boateng

full_name: Francis Boateng

given: Francis

family: Filippov

full_name: Vitali Filippov

given: Vitali

family: Groth

full_name: Maria Groth

given: Maria

family: Knappertz

full_name: Volker Knappertz

given: Volker

family: Kraus

full_name: Christian Kraus

given: Christian

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Pohl

full_name: Christoph Pohl

given: Christoph

family: Bogumil

full_name: Timon Bogumil

given: Timon

journal_name: The Lancet Neurology

oa_host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

title: 250 μg or 500 μg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study

lead_sponsor: Bayer

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Poland
Norway
Argentina
Canada
Slovenia
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United States
Italy
Austria
Brazil
Israel
Spain
Latvia


title: A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis

summary: This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Belgium
Denmark
Czech Republic
Taiwan
France
Panama
Poland
Thailand
South Africa
Sweden
Hungary
Puerto Rico
Germany
United Kingdom
United States
Italy
Brazil
Mexico
New Zealand
Spain


title: Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

summary: The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

ReferenceCitation: Ter Maaten JM, Valente MA, Damman K, Cleland JG, Givertz MM, Metra M, O'Connor CM, Teerlink JR, Ponikowski P, Bloomfield DM, Cotter G, Davison B, Subacius H, van Veldhuisen DJ, van der Meer P, Hillege HL, Gheorghiade M, Voors AA. Combining Diuretic Response and Hemoconcentration to Predict Rehospitalization After Admission for Acute Heart Failure. Circ Heart Fail. 2016 Jun;9(6). pii: e002845. doi: 10.1161/CIRCHEARTFAILURE.115.002845.

name: From the Departments of Cardiology (J.M.t.M., M.A.E.V., K.D., D.J.v.V., P.v.d.M., H.L.H., A.A.V.) and Epidemiology (H.L.H.), University of Groningen, University Medical Center Groningen, The Netherlands; University of Hull, Kingston Upon Hull, United Kingdom (J.G.C.); Brigham and Women’s Hospital, Boston, MA (M.M.G.); University of Brescia, Italy (M.M.); Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.C.); University of California at San Francisco, San Francisco Veterans Affairs Medical...

family: ter Maaten

full_name: Jozine M. ter Maaten

given: Jozine M.

family: Valente

full_name: Mattia A.E. Valente

given: Mattia A.E.

family: Damman

full_name: Kevin Damman

given: Kevin

family: Cleland

full_name: John G. Cleland

given: John G.

family: Givertz

full_name: Michael M. Givertz

given: Michael M.

family: Metra

full_name: Marco Metra

given: Marco

family: O’Connor

full_name: Christopher M. O’Connor

given: Christopher M.

family: Teerlink

full_name: John R. Teerlink

given: John R.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Bloomfield

full_name: Daniel M. Bloomfield

given: Daniel M.

family: Cotter

full_name: Gadi Cotter

given: Gadi

family: Davison

full_name: Beth Davison

given: Beth

family: Subacius

full_name: Haris Subacius

given: Haris

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: van der Meer

full_name: Peter van der Meer

given: Peter

family: Hillege

full_name: Hans L. Hillege

given: Hans L.

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

journal_name: Circulation: Heart Failure

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Ambrosy AP, Khan H, Udelson JE, Mentz RJ, Chioncel O, Greene SJ, Vaduganathan M, Subacuis HP, Konstam MA, Swedberg K, Zannad F, Maggioni AP, Gheorghiade M, Butler J. Changes in Dyspnea Status During Hospitalization and Postdischarge Health-Related Quality of Life in Patients Hospitalized for Heart Failure: Findings From the EVEREST Trial. Circ Heart Fail. 2016 May;9(5). pii: e002458. doi: 10.1161/CIRCHEARTFAILURE.115.002458.

name: From the Duke University Medical Center, Durham, NC (A.P.A., R.J.M., S.J.G.); Department of Medicine, Emory University School of Medicine, Atlanta, GA (H.K.); Division of Cardiology, Tufts Medical Center and Tufts University School of Medicine, Boston, MA (J.E.U., M.A.K.); Duke Clinical Research Institute, Durham, NC (R.J.M.); Institute of Emergency for Cardiovascular Diseases ‘Prof. C.C. Iliescu’, University of Medicine and Pharmacy Carol Davila, Bucuresti, Romania (O.C.); Division of Cardiology,...

family: Ambrosy

full_name: Andrew P. Ambrosy

given: Andrew P.

family: Khan

full_name: Hassan Khan

given: Hassan

ReferenceCitation: Mentz RJ, Greene SJ, Ambrosy AP, Vaduganathan M, Subacius HP, Swedberg K, Maggioni AP, Nodari S, Ponikowski P, Anker SD, Butler J, Gheorghiade M. Clinical profile and prognostic value of anemia at the time of admission and discharge among patients hospitalized for heart failure with reduced ejection fraction: findings from the EVEREST trial. Circ Heart Fail. 2014 May;7(3):401-8. doi: 10.1161/CIRCHEARTFAILURE.113.000840. Epub 2014 Apr 15.

name: From the Duke University Medical Center, Durham, NC (R.J.M.); Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.G.); Stanford University School of Medicine, CA (A.P.A.); Massachusetts General Hospital, Boston (M.V.); Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL (H.P.S., M.G.); Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden (K.S.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center,...

title: Clinical Profile and Prognostic Value of Anemia at the Time of Admission and Discharge Among Patients Hospitalized for Heart Failure With Reduced Ejection Fraction

ReferenceCitation: Hauptman PJ, Burnett J, Gheorghiade M, Grinfeld L, Konstam MA, Kostic D, Krasa HB, Maggioni A, Ouyang J, Swedberg K, Zannad F, Zimmer C, Udelson JE; Everest Investigators. Clinical course of patients with hyponatremia and decompensated systolic heart failure and the effect of vasopressin receptor antagonism with tolvaptan. J Card Fail. 2013 Jun;19(6):390-7. doi: 10.1016/j.cardfail.2013.04.001. Epub 2013 May 14.

title: Clinical Course of Patients With Hyponatremia and Decompensated Systolic Heart Failure and the Effect of Vasopressin Receptor Antagonism With Tolvaptan

ReferenceCitation: Ambrosy AP, Vaduganathan M, Mentz RJ, Greene SJ, Subačius H, Konstam MA, Maggioni AP, Swedberg K, Gheorghiade M. Clinical profile and prognostic value of low systolic blood pressure in patients hospitalized for heart failure with reduced ejection fraction: insights from the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial. Am Heart J. 2013 Feb;165(2):216-25. doi: 10.1016/j.ahj.2012.11.004. Epub 2012 Dec 29.

title: Clinical profile and prognostic value of low systolic blood pressure in patients hospitalized for heart failure with reduced ejection fraction: Insights from the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial

ReferenceCitation: Allen LA, Gheorghiade M, Reid KJ, Dunlay SM, Chan PS, Hauptman PJ, Zannad F, Konstam MA, Spertus JA. Identifying patients hospitalized with heart failure at risk for unfavorable future quality of life. Circ Cardiovasc Qual Outcomes. 2011 Jul;4(4):389-98. doi: 10.1161/CIRCOUTCOMES.110.958009. Epub 2011 Jun 21.

name: From the Colorado Cardiovascular Outcomes Research Group, University of Colorado Denver, Aurora, CO (L.A.A.); Northwestern University Feinberg School of Medicine, Chicago, IL (M.G.); St. Luke's Mid America Heart Institute, Kansas City, MO (K.J.R., P.S.C., J.A.S.); Mayo Clinic, Rochester, MN (S.M.D.); St. Louis University School of Medicine, St. Louis, MO (P.J.H.); Institut National de la Santé et de la Recherche Médicale, Nancy, France (F.Z.); and Tufts–New England Medical Center, Boston, MA (M.A.K.).

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Identifying Patients Hospitalized With Heart Failure at Risk for Unfavorable Future Quality of Life

ReferenceCitation: O'Connor CM, Miller AB, Blair JE, Konstam MA, Wedge P, Bahit MC, Carson P, Haass M, Hauptman PJ, Metra M, Oren RM, Patten R, Piña I, Roth S, Sackner-Bernstein JD, Traver B, Cook T, Gheorghiade M; Efficacy of Vasopressin Antagonism in heart Failure Outcome Study with Tolvaptan (EVEREST) investigators. Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: results from Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) program. Am Heart J. 2010 May;159(5):841-849.e1. doi: 10.1016/j.ahj.2010.02.023. Erratum in: Am Heart J. 2012 May;163(5):900.

title: Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: Results from efficacy of vasopressin antagonism in heart failure outcome study with tolvaptan (EVEREST) program

ReferenceCitation: Blair JE, Zannad F, Konstam MA, Cook T, Traver B, Burnett JC Jr, Grinfeld L, Krasa H, Maggioni AP, Orlandi C, Swedberg K, Udelson JE, Zimmer C, Gheorghiade M; EVEREST Investigators. Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure results from the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) program. J Am Coll Cardiol. 2008 Nov 11;52(20):1640-8. doi: 10.1016/j.jacc.2008.07.056.

journal_name: Journal of the American College of Cardiology

title: Continental Differences in Clinical Characteristics, Management, and Outcomes in Patients Hospitalized With Worsening Heart Failure

ReferenceCitation: Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials. JAMA. 2007 Mar 28;297(12):1332-43. Epub 2007 Mar 25.

ReferenceCitation: Konstam MA, Gheorghiade M, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007 Mar 28;297(12):1319-31. Epub 2007 Mar 25.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
United States
Brazil
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Poland
Norway
Romania
Belgium
Argentina
Russian Federation
Spain
Canada
Czech Republic

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: The Heart and Vascular Institute of Florida

location_facility: Heart and Vascular Clinic of North Colorado

location_facility: Hospital Santa Isabel da Santa Casa de Misericordia da Bahia

location_facility: University of Miami/ Jackson Memorial Hospital

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Moscow State University of Medicine and Dentistry - City Hospital #40

location_facility: St. Vincents Hospital and Medical Center

location_facility: Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)

location_facility: Poliambulatorio Valdichiana Ospedale di Cortona

location_facility: Hjerte med. Avd. Haukeland Universitets Sykehus

location_facility: Interni klinika, Oddeleni Interna I, Kardiologie

location_facility: Moscow Regional Research Clinical Institute n.a. Vishnevsky

location_facility: Centre Hospitalier Universitaire de Nancy-Brabois

location_facility: University of Arkansas for Medical Sciences

location_facility: Akademisches Lehrkrankenhaus d. HGS Essen

location_facility: Cardiology Associates of North Mississippi

location_facility: St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care

location_facility: Hospital de Base da Faculdade de Medicina de Sao Jose do Rio Preto

location_facility: University Health Network, Toronto Western Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Lousiana State University Health Sciences Center

location_facility: Moscow State University of Medicine and Dentistry - City Hospital #11

location_facility: Spitalul Clinic Universitar ,,Sf. Spiridon"

location_facility: I. interni kardio-angiologicka klinika LF MU

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: Cardiopulmonary Research Science and Technology Institute

location_facility: Jacksonville Center for Clinical Research

location_facility: Martini Ziekenhuis (Loc. Martini Paviljoen)

location_facility: Sint Lucas Andreas Ziekenhuis (loc. Lucas)

location_facility: St. Petersburg Clinical Hospital of Russian Academy of Sciences

location_facility: Scott & White Clinic Division of Cardiology

location_facility: Cardiovascular Consultants Medical Group, Inc.

location_facility: Spitalul Judetean Brasov, Sectia de Cardiologie

location_facility: Medisch Centrum Haaglanden (location Westeinde)

location_facility: Atlanta Heart and Vascular Research Group

location_facility: Enheten for internmedicin, Karolinska Institutet

location_facility: Buffalo Cardiology and Pulmonary Associates

location_facility: Centre Hospitalier Regional d'Arras-Service de Cardiologie

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: St. Petersburg Medical Postgraduate Academy

location_facility: Cardiology Associates of Fort Lauderdale

location_facility: Cardiology Associates Covenant Medical Group

location_facility: Cabinet de Cardiologie et d'Explorations

location_facility: Cardiology Research Institute of the Ministry of Health of the Russian Federation

location_facility: Pitt County Memorial Hospital, The Heart Center

location_facility: Centre Hospitalier de l'Universite de Sherbrooke

location_facility: Herz- und Diabetes Zentrum Nordrhein-Westfalen

location_facility: University of Texas Health Science Center

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie

location_facility: Central Arkansas Veterans Healthcare Systems

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: IMC- Instituto de Molestias Cardiovasculares

location_facility: Spitalul de Urgenta Floreasca, Clinica de Cardiologie

location_facility: Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo

location_facility: City Alexandrovsky Hospital, ICU Department

location_facility: Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Burdenko Main Military Clinical Hospital

location_facility: Katedra i Klinika Chorab Wewnetrznych i Kardiologii

location_facility: Santa Casa de Misericordia do Rio de Janeiro

location_facility: Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii


type: Registry Identifier

title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent)

summary:
The primary objectives of the study are:

To assess the safety profile of the study vaccines in each study intervention group.
To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.
To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a two-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster.
To demonstrate that two doses of monovalent (B.1.351)-AS03 or bivalent (D614 + B.1.351)-AS03 SARS-CoV-2 vaccine induce an immune response that is non inferior to the response induced by monovalent (D614)-AS03 vaccine.

The secondary objectives of the study are:

To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.
To assess the neutralizing and binding antibody responses of booster vaccination.
To describe the occurrences of laboratory-confirmed symptomatic COVID-19 after primary series and booster vaccination.
To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country:
Honduras
France
Australia
Spain
United States
United Kingdom
Kenya

location_facility:
Investigational Site Number :8400187
Investigational Site Number :2500005
Investigational Site Number :2500013
Investigational Site Number :0360004
Investigational Site Number :8400272
Investigational Site Number :8400045
Investigational Site Number :8260012
Investigational Site Number :8400100
Investigational Site Number :8400057
Investigational Site Number :2500004
Investigational Site Number :8260015
Investigational Site Number :8400239
Investigational Site Number :8400077
Investigational Site Number :7240009
Investigational Site Number :8400097
Investigational Site Number :8400094
Investigational Site Number :8400173
Investigational Site Number :2500015
Investigational Site Number :8400270
Investigational Site Number :8400048
Investigational Site Number :8400230
Investigational Site Number :0360002
Investigational Site Number :2500016
Investigational Site Number :8400030
Investigational Site Number :0360005
Investigational Site Number :4040006
Investigational Site Number :3400002
Investigational Site Number :8400201
Investigational Site Number :8400204
Investigational Site Number :3400001
Investigational Site Number :8400269
Investigational Site Number :8400220
Investigational Site Number :0360001
Investigational Site Number :8400207
Investigational Site Number :2500003
Investigational Site Number :8400199
Investigational Site Number :8260010
Investigational Site Number :8400212
Investigational Site Number :8400271
Investigational Site Number :8400191
Investigational Site Number :8400233
Investigational Site Number :8400179
Investigational Site Number :2500014
Investigational Site Number :8400072
Investigational Site Number :2500008
Investigational Site Number :8400251
Investigational Site Number :0360003
Investigational Site Number :8400267
Investigational Site Number :8400089
Investigational Site Number :2500002
Investigational Site Number :2500006
Investigational Site Number :8400203
Investigational Site Number :2500007

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD)

acronym: FJORD

summary: The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP)

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:
Italy
Spain
Germany
France
Bulgaria
Greece
Israel
Japan
Australia
China
United States


title: Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

summary:
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices.

The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
Spain
France
Greece
Portugal
United States
United Kingdom

location_facility: The James Cook University Hospital - SouthTees Hospitals NHS

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospita;

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

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

location_facility: Hospital da Senhora da Oliveira -Guimarães

location_facility: Presbyterian Columbia University Irving Medical Center

location_facility: Azienda Ospedaliera ospedale Niguarada ca Granda

location_facility: Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital

location_facility: Central Manchester University Hospitals NHS - mancester Royal Infirmary

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Azienda Ospedaliera Ospedale Niguarda CaGranda

location_facility: Azienda Sanitaria Provinciale di Cosenza"Ospedale di Castrovillari"

location_facility: The University of Vermont Medical Center

location_facility: Centro Hospitalar Universitário de SãoJoão

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Cardiovascular Consultants Medical Group

location_facility: Centre Hospitalier Universitaire Saint Étienne

location_facility: Azienda ospedaleria Santa Maria dellaMisericordia di Udine

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari

location_facility: Presidio Ospedaliero Centrale - SS.Annunziata

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE

location_facility: North Memorial Health Heart & Vascular Center

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera

location_facility: Brigham and Women's Hospital (Boston MA)

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: MedStar Health Research Institute (Baltimore)

intervention_type: Device


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

summary: This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

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

lead_sponsor: GlaxoSmithKline

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
France
Norway
Argentina
Colombia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain


title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

summary: This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

ipd_sharing: No

lead_sponsor: Exelixis

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Georgia
Spain

location_facility: Odensklinikum Linz GmbH Elisabethinen #156


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

location_country:
Italy
United States
India
Mexico
Netherlands
Germany
France
Japan
Romania
Belgium
Puerto Rico
Russian Federation
Spain
Canada
United Kingdom

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: San Jorge Children and Women's Hospital- Shipping Location

location_facility: Rehabilitation & Neurological Services LLC

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel

location_facility: Children Mercy Pediatric Clinical Research Unit

location_facility: New England Institute for Clinical Research

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Houston Neurology Clinical & Diagnostic Consultants

location_facility: Pirogov Russian National Research Medical University

location_facility: Seattle Women's: Health, Research, Gynecology

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Japanese Red Cross Kyoto Daiichi Hospital

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Children's Hospital of New Orleans LCMC Health

location_facility: New England Regional Headache Center, Inc

location_facility: P. D. Hinduja National Hospital & Medical Research Centre

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov

location_facility: Integrated Clinical Trial Services, Inc.

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Colorado Springs Neurological Associates

location_facility: Spitalul clinic de urgenta pentru copii "Sf. Maria", Iasi

location_facility: Centre Hospitalier Intercommunal De Creteil

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Hospital de la Santa Creu I Sant Pau - NEURO

location_facility: University of North Carolina School of Medicine - Children's Hospital - Children's Research Institute

location_facility: Ziekenhuis Oost - Limburg ZOL - Kinderneurologie

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Orange County Research Institute - Ontario

location_facility: University Hospital Cleveland Medical Center

location_facility: University of Kentucky College of Medicine

location_facility: Hospital Clinico Universitario de Valladolid

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

location_facility: Post Graduate Institute of Medical Education & Research

type: Other Identifier

type: EudraCT Number

source: euctr

title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2

summary: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.


location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: San Jorge Children and Women's Hospital- Shipping Location

location_facility: Rehabilitation & Neurological Services LLC

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel

location_facility: Children Mercy Pediatric Clinical Research Unit

location_facility: New England Institute for Clinical Research

location_facility: PMG Research, Inc. d/b/a PMG Research of Piedmont Care

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Houston Neurology Clinical & Diagnostic Consultants

location_facility: Pirogov Russian National Research Medical University

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Japanese Red Cross Kyoto Daiichi Hospital

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Children's Hospital of New Orleans LCMC Health

location_facility: New England Regional Headache Center, Inc

location_facility: P. D. Hinduja National Hospital & Medical Research Centre

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Spitalul Clinic de Urgenta pentru Copii Brasov

location_facility: Integrated Clinical Trial Services, Inc.

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Hospital Universitario Quironsalud Madrid

title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

summary: The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.


title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)

summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).

status: Active, not recruiting

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_country:
Finland
Australia
Belgium
Russian Federation
Ukraine
India
Croatia
France
Poland
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Czechia
Israel
Georgia
Spain
Estonia

location_facility:
Research Site 663
Research Site 506
Research Site 431
Research Site 656
Research Site 162
Research Site 177
Research Site 638
Research Site 218
Research Site 576
Research Site 331
Research Site 381
Research Site 562
Research Site 437
Research Site 473
Research Site 231
Research Site 369
Research Site 102
Research Site 151
Research Site 307
Research Site 332
Research Site 410
Research Site 128
Research site 645
Research Site 406
Research Site 424
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Research Site 612
Research Site 507
Research Site 217
Research Site 286
Research Site 627
Research Site 511
Research Site 643
Research Site 616
Research Site 650
Research Site 639
Research Site 565
Research Site 600
Research Site 224
Research Site 491
Research Site 265
Research Site 301
Research Site 457
Research Site 172
Research Site 403
Research Site 704
Research Site 621
Research Site 675
Research Site 636
Research Site 243
Research Site 625
Research Site 211
Research Site 109
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Research Site 318
Research Site 634
Research Site 404
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Research Site 571
Research Site 212
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Research Site 213
Research Site 308
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Research Site 635
Research Site 363
Research Site 673
Research Site 215
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Research Site 262
Research Site 285
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Research Site 284
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Research Site 104
Research Site 360
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Research Site 219
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Reasearch Site 175
Research Site 664
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Research Site 179
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Research Site 563
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location_country:
Italy
Mexico
France
Japan
Poland
Israel
Belgium
Spain
United States
United Kingdom

acronym: SYNERGY-NASH

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: The National Diabetes & Obesity Research Institute (NDORI)

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: Harborview Medical Center/University of Washington

location_facility: Virginia Commonwealth University Medical Center Gastroenterology Hepatology

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Cotton O'Neil Diabetes and Endocrinology Center

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI)

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Synexus North Teesside Clinical Research Centre

location_facility: East Coast Institute for Research at The Jones Center

location_facility: Synexus North East Clinical Research Centre

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia

location_facility: A.O.U. Citta' della Salute e della Scienza di Torino

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

location_facility: Phylasis Clinicas Research S de RL de CV

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

location_facility: Research Centers of America, LLC-Hollywood

location_facility: University at Buffalo-Clinical and Translational Research Center

location_facility: Niigata University Medical & Dental Hospital

location_facility: A.O. Universitaria Policlinico P. Giaccone

location_facility: National Research Institute - Huntington Park

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Synexus Midlands Clinical Research Center

location_facility: Synexus Clinical Research US, Inc - Orlando

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

summary: The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).


ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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).

location_country: Italy Chile Peru Mexico Spain France Czechia Poland Romania Hungary Argentina China Slovenia Portugal

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Cancer Hospital , Chinese Academy of Medical

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

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

location_facility: Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: Presidio Ospedaliero di Summa-Perrino; Oncologia Medica

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY

location_facility: Univerzitetni klinični center Maribor; Oddelek za onkologijo

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: AULSS3 - Presidio di Mirano; Dip. di Oncologia

location_facility: Hospital General de Segovia; Servicio de Oncologia

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Nemocnice na Bulovce; Ustav radiacni onkologie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Nemocnice Horovice, NH Hospital a.s.; Oncology Department

location_facility: Azienda Universitaria Magna Grecia; Dip. di Medicina Sperimentale e Clinica_U.O. Oncologia Medica

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: USL Umbria 1 - Osp. Città di Castello; U.O. di Oncologia

location_facility: Hospital de S. Francisco Xavier; Unidade de Oncologia Medica

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Komarom-Esztergom Megyei Onkormanyzat Szent Borbala Korhaz; Onkologiai Osztaly

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii

location_facility: Hospital Cuf Descobertas; Unidade de Oncologia

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Institut de Cancérologie de Bourgogne; Oncologie Médicale

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Hospital Central Fap Juan Benavides Dorich; Oncology

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

title: An Open-Label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

summary: Study MO39874 is an open-label, phase IIIb, single arm, multicenter study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.


ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

lead_sponsor: Vertex Pharmaceuticals Incorporated

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

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: Charite Paediatric Pulmonology Department

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: University of California Davis Medical Center

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Banner University of Arizona Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: University of Miami Miller School of Medicine

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Utah / Primary Children's Medical Center

title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

summary: This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).


location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

acronym: SURPASS-CVOT

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Illawarra Shoalhaven Local Health District

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: Zentrum für klinische Studien Dr Hanusch Gmbh

location_facility: UMC Utrecht, Dept. of Internal Medicine, MDL

location_facility: Boden Collaboration for Obesity, Nutrition, Exercise & Eating Disorders

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani

location_facility: CIPREC-Centro de Investigacion y Prevencion Cardiovascular-

location_facility: AKP - Avdelningen för Kliniska Prövningar

location_facility: Centro de Pesq. em Diabetes e Doencas Endocrino Metabol.

location_facility: CEIM Hospital Universitario y Politecnico la Fe

location_facility: Clalit Health Services -Diabetes and Endocrinology Clinic Jerusalem

location_facility: Lahoja Asociación para la Investigación y Farmacovigilancia S.C.

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Regional Public Institution "Chernivtsi Regional Endocrinology Center"

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: MVZ Riesa, Medizinisches Versorgungzentrum am Klinikum Döbel

location_facility: NorCal Endocrinology and Internal Medicine - Roseville

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

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

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: Austin Health - Heidelberg Repatriation Hospital

location_facility: East Coast Institute for Research at The Jones Center

location_facility: Northeast Endocrine Metabolic Associates

location_facility: Investigacion en Salud y Metabolismo S.C

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: LEC Communal Inst Hc Kharkiv City Clinical Hosp #8

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Canadian Centre for Research on Diabetes

location_facility: Praxis für Innere Medizin Toralf Schwarz

location_facility: Centro De Estudios Clinicos De Queretaro S.C.

location_facility: Centro Medico Privado San Vicente Diabetes

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet

location_facility: John Muir Physician Network Clinical Research Center

location_facility: The First Hospital of Lanzhou University

location_facility: Ryazan Regional Clinical Cardiology Dispensary

location_facility: Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Atrium Health - Department of Family Medicine Research

location_facility: ClinPhenomics GmbH & Co KG, Studienzentrum

location_facility: Riverside County Regional Medical Center

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesida

location_facility: IPECC - Instituto de Pesquisa Clinica de Campinas

location_facility: Institutul National de Diabet Nutritie si Boli Metabolice

location_facility: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Siberian State Medical University of Roszdrav

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Black Hills Cardiovascular Research Group

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: The First Afflicated Hospital of Xian Jiaotong University

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

location_facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

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

location_facility: Diabet2 s.r.o., Diabetologicka a interni ambulance

location_facility: University of Alabama at Birmingham Medical Center

location_facility: Institute of Diabetes and Endocrinology Kaplan Medical Center

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

location_facility: Cotton O'Neil Diabetes and Endocrinology Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Med

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: The Institute for Adult Disease, Asahi Life Foundation

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Diseno y Planeacion en Investigacion Medica

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedlaliero-Univeristaria Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: Dr. Sadi Konuk Egitim ve Arastirma Hastanesi

location_facility: Interni a diabetologicka ordinace, s.r.o.

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Monterey Endocrine & Diabetes Institute, Inc.

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: Hausarzt-Diabetologische Schwerpunktpraxis Dr. Karsten Milek

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: MUDr. Barbora Diepoltova, Diabetologie Praha 9

location_facility: Clalit Health Services - Sakhnin Community Clinic

location_facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

location_facility: Centro Periférico de Especialidades Bola Azul

location_facility: LLC Medical Consultations and Research center - PRAKTIKA

location_facility: Jacksonville Center for Clinical Research

location_facility: Yonsei University Wonju Severance Christian Hospital

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

location_facility: International Institute of Clinical Trials LLC

location_facility: South Texas Veterans Administration Health Care

location_facility: Arkhangelsk First City Clinical Hospital n.a. E.E. Volosevich

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente

location_facility: Szent Margit Rendelőintézet Nonprofit Kft

location_facility: Groupe Hospitalier Paris Saint Joseph - Site Saint-Michel

location_facility: Cardiology Partners Clinical Research Institute, LLC-Palm Beach Gardens

location_facility: Ukrainian State Research Institute of medical and social problems of disability

location_facility: Pirogov Russian National Research Medical University

location_facility: NS ZOZ Osrodek Diabetologiczny " Popula"

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: Sumy State University/Sumy Regional Clinical hospital

location_facility: FSBI "National Medical Research Center for Preventive Medicine" of MOH of Russian Fed

location_facility: Ospedale san Giovanni di Dio-Diabetologia

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Fundacion Cardiovascular de Aguascalientes A.C.

location_facility: Polyclinic of Communal 4th city clinical hospital

location_facility: Franciscus Gasthuis Rotterdam - Cardiologie

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Consultorio de Medicina especializada del Sector Privado

location_facility: Centro Privado de Cardiologia Investigaciones Clinicas Tucum

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Milan Kvapil s.r.o., Diabetologicka ambulance

location_facility: Cardiovascular Research Institute of Dallas

location_facility: The People's Hospital of Liaoning Province

location_facility: PHREI - Pacific Health Research and Education Institute - VA Pacific Islands Health Care System

location_facility: Praxis Oedeme - Diabetologische Schwerpunktpraxis

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Kyunghee University Hospital at Gangdong

location_facility: The Fourth Affiliated Hospital of Harbin Medical University

location_facility: Diabetologicka a obezitologicka ambulance

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Diabeteszentrum DO, Diabetische Schwerpunktpraxis Dortmund

location_facility: Centro Universitario de Investigaciones en Farmacologia Clinica (CUIFC)

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"

location_facility: Vinnytsia Regional Clinical Highly Specialized Endocrinology Center

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centro de Investigación Médica Integral S.C.

location_facility: Batra Hospital & Medical Research Centre

location_facility: Diabetesinstitut am St. Josefskrankenhaus

location_facility: Southern Adelaide Diabetes & Endocrine Services

location_facility: Baskent Universitesi Adana Uygulama ve Arastirma Merkezi Yuregir Hastanesi

location_facility: Zentrum für Klinische Studien Südbrandenburg GmbH

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Tianjin Medical University General Hospital

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: Diabetes & Endocrinology Consultants of Pennsylvania, LLC

location_facility: Complejo Hospitalario Universitario De Ferrol - Hospital Naval

location_facility: Diabetologische Schwerpunktpraxis Marck Linn Pickel

location_facility: CECIP - Centro de Estudos do Interior Paulista

location_facility: Fatih Sultan Mehmet Training and Research Hospital

location_facility: Institut für klinische Forschung und Entwicklung

location_facility: China-Japan Union Hospital of Jilin University

location_facility: CHU de Bordeaux, Hopital du Haut Leveque

location_facility: Cardiology Partners Clinical Research Institute, LLC

location_facility: Poradnia Diabetologiczna SN ZOZ Lege Artis

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: FSBI "National Medical Research Center of Cardiology" of MOH of Russian Federation

location_facility: Centro Especialidades San Jose Obrero (Barbarela)

location_facility: Hospital Universitario Central de Asturias

location_facility: Diabetes and Thyroid Center of Fort Worth

location_facility: Lviv Regional State Clinical Treatment and Diagnostic Endocrinology Center

location_facility: Inst. de Diabetes, Obesidad y Nutricion S.C

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

location_facility: Hospital Universitario Principe de Asturias

location_facility: Amsterdam AMC - Research Vasculaire Geneeskunde

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: General Hospital of Ningxia Medical University

location_facility: National Endocrinology Research Center of the Ministry of Health

location_facility: UCSD Clinical & Translational Research Institute

location_facility: NZOZ Regionalna Poradnia Diabetologiczna

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical Univers

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

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

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: Topiwala National Medical College & BYL Nair Hospital

location_facility: St Cloud Hospital/Central Minnesota Heart Center

title: The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)

summary: The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.


lead_sponsor: ADC Therapeutics S.A.

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

location_facility: Memorial Sloan-Kettering Cancer Center - New York

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Hospital Clínico Universitario de Valencia

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

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: The University of Texas Health Science Center at San Antonio

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

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

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

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University Hospitals Seidman Cancer Center

location_facility: UCSF Health - Hematology and Blood and Marrow Transplant Clinic

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Norton Cancer Institute - Saint Matthews

location_facility: Washington University School of Medicine in Saint Louis

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).


title: A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country: France Czechia Poland Hungary Belgium

location_facility: CMed Rehabilitációs és Diagnosztikai Központ