title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms

summary:
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.

However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.

The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.

Also data on the safety of the product in the disease will be collected.

ReferenceCitation: Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.

location_country:
Finland
Italy
Germany
Norway
Romania
Sweden
Netherlands
Austria
Spain
South Africa
Ukraine
Russian Federation
France

location_facility: 248.596.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3302B Centre Hospitalier du Pays d'Aix

location_facility: 248.596.27001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49014 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología

location_facility: 248.596.70005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39003 Università degli studi di Napoli "Federico II"

location_facility: 248.596.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34004 Hospital General de Catalunya. Departamento de Neurología

location_facility: 248.596.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA

location_facility: 248.596.40006 Country Clinical Emergency Hospital

location_facility: 248.596.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.47003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.31004 Amphia ziekenhuis, Locatie Molengracht

location_facility: 248.596.39005 Clinica Neurologica Policlinico G. Martino

location_facility: 248.596.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología

location_facility: 248.596.49008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3302A Centre Hospitalier du Pays d'Aix

location_facility: 248.596.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39009 Istituti Clinici di Perfezionamento

location_facility: 248.596.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34003 Hospital de Alcorcón. Departamento de Neurología

location_facility: 248.596.70002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27007 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología

location_facility: 248.596.39006 Neurologia Ospedale Evangelico Valdese

location_facility: 248.596.40004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.43005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.3301A Hôpital Guillaume et René Laennec

location_facility: 248.596.40002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39004 Neurologia Ospedale della Misericordia

location_facility: 248.596.27006 Boehringer Ingelheim Investigational Site

location_facility: 248.596.40003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.38005 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.596.49013 Boehringer Ingelheim Investigational Site

location_facility: 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología

location_facility: 248.596.47002 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39007 Clinica Neurologica Policlinico Tor Vergata

location_facility: 248.596.47004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.70001 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27008 Boehringer Ingelheim Investigational Site

location_facility: 248.596.39008 Clinica Neurologica I Policlinico di Catania

location_facility: 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio"

location_facility: 248.596.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.596.27004 Boehringer Ingelheim Investigational Site

location_facility: 248.596.46004 Boehringer Ingelheim Investigational Site


type: EudraCT Number

type: Other Identifier

title: Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

summary: The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Bayer

location_country: Finland Spain Austria France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

acronym: CHOICE

summary: This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

study_start_date_type: Actual

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.

ReferenceCitation: Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805.

ReferenceCitation: Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. doi: 10.1080/13697130701298107.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Norway
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
France


title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

summary: This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

ReferenceCitation: Vilsboll T, Brock B, Perrild H, Levin K, Lervang HH, Kolendorf K, Krarup T, Schmitz O, Zdravkovic M, Le-Thi T, Madsbad S. Liraglutide, a once-daily human GLP-1 analogue, improves pancreatic B-cell function and arginine-stimulated insulin secretion during hyperglycaemia in patients with Type 2 diabetes mellitus. Diabet Med. 2008 Feb;25(2):152-6. doi: 10.1111/j.1464-5491.2007.02333.x. Epub 2008 Jan 14.

ReferenceCitation: Courreges JP, Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Verhoeven R, Buganova I, Madsbad S. Beneficial effects of once-daily liraglutide, a human glucagon-like peptide-1 analogue, on cardiovascular risk biomarkers in patients with Type 2 diabetes. Diabet Med. 2008 Sep;25(9):1129-31. doi: 10.1111/j.1464-5491.2008.02484.x. No abstract available.

ReferenceCitation: Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.

ReferenceCitation: Horowitz M, Vilsboll T, Zdravkovic M, Hammer M, Madsbad S. Patient-reported rating of gastrointestinal adverse effects during treatment of type 2 diabetes with the once-daily human GLP-1 analogue, liraglutide. Diabetes Obes Metab. 2008 Jul;10(7):593-6. doi: 10.1111/j.1463-1326.2008.00861.x. Epub 2008 Apr 22. No abstract available.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

location_country: Denmark Netherlands Slovakia France


title: A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

summary: The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Denmark
Netherlands
Belgium
South Africa
Canada
France

location_facility: Med. Einrichtung der Universitat zu Koln

location_facility: Department of Medicine, Health Sciences Centre

location_facility: A. O. Universitaria di Ferrara - Arcispedale S. Anna

location_facility: Pneumologisches Forschungsinstitut GmbH am Krankenhaus

location_facility: A.O. S. Martino e Cliniche Universitarie di Genova

location_facility: Boehringer Ingelheim Investigational Site


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.

ReferenceType: derived

ReferenceCitation: Bachy E, Seymour JF, Feugier P, Offner F, Lopez-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.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

host_type: repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

unpaywall_oa_status: hybrid

publisher_dissemination: 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.

publisher_dissemination: Informa

ReferenceCitation: Ghesquieres 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. doi: 10.1182/blood-2012-05-431825. Epub 2012 Aug 10.

ReferenceCitation: Salles G, Seymour JF, Offner F, Lopez-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, Ferme 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.

ipd_sharing: No

lead_sponsor: Lymphoma Study Association

collaborators: HOVON - Dutch Haemato-Oncology Association

collaborators: Australasian Leukaemia and Lymphoma Group

collaborators: Institute of Cancer Research, United Kingdom

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

location_facility: Australia New Zealand Leukemia Lymphoma Group

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

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

location_facility: Instituo Nacional de Enfermedades Neoplasicas


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.

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.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
Germany
Portugal
Netherlands
Austria
United States
Puerto Rico
France

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.

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.


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.

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.

ReferenceCitation: Mesia 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.

ReferenceCitation: Hecht M, Hahn D, Wolber P, Hautmann MG, Reichert D, Weniger S, Belka C, Bergmann T, Gohler T, Welslau M, Grosse-Thie C, Guntinas-Lichius O, von der Grun 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.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

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)

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Licitra L, Storkel 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.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Merck KGaA, Darmstadt, Germany

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


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.

evidence: open (via crossref license)

repository_institution: PubMed Central - Europe PMC

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

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.

publisher_dissemination: The Journal of Rheumatology

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.

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.

lead_sponsor: Hoffmann-La Roche

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


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

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].

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


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.

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


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: Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.

oa_colors: green other

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

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):e002845. doi: 10.1161/CIRCHEARTFAILURE.115.002845.

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):e002458. doi: 10.1161/CIRCHEARTFAILURE.115.002458.

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.

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.

ReferenceCitation: Ambrosy AP, Vaduganathan M, Mentz RJ, Greene SJ, Subacius 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.

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.

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, Pina 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.

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.

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. doi: 10.1001/jama.297.12.1332. 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. doi: 10.1001/jama.297.12.1319. Epub 2007 Mar 25.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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

location_facility: Sint Lucas Andreas Ziekenhuis (loc. Lucas)

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Katedra i Klinika Chorab Wewnetrznych i Kardiologii

location_facility: Central Arkansas Veterans Healthcare Systems

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Cabinet de Cardiologie et d'Explorations

location_facility: Cardiology Associates Covenant Medical Group

location_facility: Cardiovascular Consultants Medical Group, Inc.

location_facility: St. Vincents Hospital and Medical Center

location_facility: Medisch Centrum Haaglanden (location Westeinde)

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

location_facility: Pitt County Memorial Hospital, The Heart Center

location_facility: Cardiology Associates of North Mississippi

location_facility: Scott & White Clinic Division of Cardiology

location_facility: Herz- und Diabetes Zentrum Nordrhein-Westfalen

location_facility: Santa Casa de Misericordia do Rio de Janeiro

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

location_facility: University Health Network, Toronto Western Hospital

location_facility: IMC- Instituto de Molestias Cardiovasculares

location_facility: University of Arkansas for Medical Sciences

location_facility: Hjerte med. Avd. Haukeland Universitets Sykehus

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

location_facility: Cardiology Associates of Fort Lauderdale

location_facility: University of Miami/ Jackson Memorial Hospital

location_facility: Poliambulatorio Valdichiana Ospedale di Cortona

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: Centre Hospitalier Universitaire de Nancy-Brabois

location_facility: Martini Ziekenhuis (Loc. Martini Paviljoen)

location_facility: Centre Hospitalier de l'Universite de Sherbrooke

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

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

location_facility: Spitalul de Urgenta Floreasca, Clinica de Cardiologie

location_facility: Akademisches Lehrkrankenhaus d. HGS Essen

location_facility: I. interni kardio-angiologicka klinika LF MU

location_facility: Burdenko Main Military Clinical Hospital

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Spitalul Judetean Brasov, Sectia de Cardiologie

location_facility: Heart and Vascular Clinic of North Colorado

location_facility: Spitalul Clinic Universitar ,,Sf. Spiridon"

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

location_facility: Interni klinika, Oddeleni Interna I, Kardiologie

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Spitalul Universitar de Urgenta Bucuresti

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

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

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

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

location_facility: Atlanta Heart and Vascular Research Group

location_facility: St. Petersburg Medical Postgraduate Academy

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Buffalo Cardiology and Pulmonary Associates

location_facility: Jacksonville Center for Clinical Research

location_facility: Cardiopulmonary Research Science and Technology Institute

location_facility: The Heart and Vascular Institute of Florida

location_facility: Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii

location_facility: Hospital General Universitario de Valencia

location_facility: City Alexandrovsky Hospital, ICU Department

location_facility: Lousiana State University Health Sciences Center

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

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Enheten for internmedicin, Karolinska Institutet

location_facility: University of Texas Health Science Center

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


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 3018250 in Patients With Symptomatic Proximal Deep Vein Thrombosis

acronym: SIRIUS

summary:
Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT).

DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.

BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.

The main purposes of this study are to learn:

How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and
How safe is BAY3018250 as a treatment for participants with proximal DVT?

For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.

And researchers will collect the number of bleeding events that require medical attention.

The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.

Researchers will closely monitor participants for 90 days after receiving the study treatment.

During the study, the doctors and their study team will:

take blood samples
do physical examinations
examine heart health using electrocardiogram (ECG)
check vital signs such as blood pressure, heart rate
undergo ultrasound tests to measure the blood clots
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

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

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

location_country: Germany Italy Netherlands Belgium Canada France

location_facility: Gruppo Humanitas - Humanitas Research Hospital - Centro Trombosi

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Europeen Georges-Pompidou (HEGP)

location_facility: Charité Universitaetsmedizin Berlin - Campus Benjamin Franklin | Med. Klinik fuer Kardiologie, Angiologie und Intensivmedizin

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"

location_facility: McGill University Health Centre - Glen Site

location_facility: Ziekenhuis Oost-Limburg | Genk, Sint-Jan campus - Thoracic Vascular Surgery Department

location_facility: Hopitaux Universitaires de Strasbourg - Le Nouvel Hopital Civil (NHC)

location_facility: Katholieke Universiteit Leuven (KU Leuven) - Center for Molecular and Vascular Biology (CMVB)

location_facility: Azienda Unita Locale Socio Sanitaria (ULSS) 2 Marca trevigiana - Ospedale Treviso

location_facility: Universiteit Ziekenhuis Antwerpen | Thoraxheelkunde Afdeling

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova (ASMN)

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

location_facility: ASST dei Sette Laghi | Ospedale Di Circolo e Fondazione Macchi Di Varese - Centro Trombosi ed Emostasi

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) - Hopital Albert Michallon

location_facility: Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

location_facility: Rijnstate | Arnhem - Internal Medicine Department - Vascular Research

location_facility: Universitaetsklinikum Muenster | Klinik fuer Kardiologie I - Sektion Angiologie

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital de Rangueil

location_facility: Azienda Unita Locale Socio Sanitaria 2 Marca Trevigiana | Castelfranco Veneto Hospital - Angiologia Department

location_facility: Radboud Universitair Medisch Centrum (Radboudumc) (Radboud University Medical Center)

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Zentrum fuer Kardiologie - Kardiologie III - Angiologie

location_facility: Franziskus-Krankenhaus Berlin | Klinik für Innere Medizin

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Padova

location_facility: LMU Klinikum Campus Innenstadt | Medizinische Klinik und Poliklinik IV - FB Angiologie

location_facility: Hamilton Health Sciences - Hamilton General Hospital (HGH)

location_facility: Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

location_facility: Universiteit Maastricht (UM) - Maastricht University Medical Centre (Maastricht UMC+)

location_facility: Zuyderland Medisch Centrum Sittard-Geleen

location_facility: Universitaetsklinikum Hamburg-Eppendorf | II. Medizinische Klinik und Poliklinik - Bereich Haemostaseologie

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden | Medizinische Klinik I - FB Haemostaseologie

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

status_simplified: Ongoing


title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA

summary: This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.

status: Recruiting

ipd_sharing: Yes

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: Finland Germany Italy Poland Slovakia Hungary Israel Denmark Norway Sweden Netherlands Austria Belgium Switzerland Spain Greece Czechia France

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy

location_facility: Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

location_facility: Bordeaux University Hospital - Pellegrin

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus

location_facility: Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

location_facility: The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric

location_facility: CHUV (centre hospitalier universitaire vaudois)


title: The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

acronym: REDEFINE 3

summary: This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

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

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
Serbia
France
Colombia
Denmark
United States
India
Malaysia
Italy
United Kingdom
Netherlands
Mexico
Spain
South Africa
Bulgaria


title: Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial

acronym: EPCORE DLBCL-3

summary: The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

lead_sponsor: Genmab

sponsor_collaborators: Genmab AbbVie

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Austria
Belgium
United States
Korea, Republic of
Spain
Czechia
France

location_facility: AUSL Piacenza Ospedale Guglielmo da Saliceto

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: IEO Istituto Europeo di Oncologia Parent

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda sanitaria integrata università di Trieste

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo


title: A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

acronym: TILIA

summary: The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

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

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
India
Romania
Belgium
China
Malaysia
Peru
Puerto Rico
Egypt
Philippines
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel


title: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

summary: The primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on progression-free survival (PFS) and overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

lead_sponsor: Gilead Sciences

sponsor_collaborators:
Gilead Sciences
Arcus Biosciences, Inc.

location_country:
Germany
Argentina
Brazil
Turkey
Chile
Canada
France
Portugal
Hong Kong
United States
Belgium
Italy
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

location_facility: IRCCS Policlinico S. Matteo, Dipartimento Oncologia Ematologia-Oncologia Medica

location_facility: Peachtree Hematology Oncology Consultants

location_facility: Ambroise-Pare Hospital, Assistance Publique - Hopitaux de Paris

location_facility: Ospedale Guglielmo da Saliceto AUSL di Piacenza

location_facility: Hospital Beatriz Angelo. Hospital de Loures.

location_facility: Fundacao Universidade De Caxias Do Sul - FUCS/RS

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc

location_facility: Centre de santé et services sociaux de Rimouski-Neigette

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Institut de Cancer de Montpellier (ICM) - Val d'Aurelle

location_facility: Clinique Victor Hugo, Centre de Cancerologie de la Sarthe

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: Instituto Brasiliero de Controle do Cancer IBCC

location_facility: Regina Elena Institute for Cancer Research

location_facility: Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation

location_facility: Oncosite - Centro de Pesquisa Clinica em Oncologia LTDA

location_facility: James Lind Centro de Investigacion del Cancer

location_facility: Centre Integre de sante et de services sociaux de la Monteregie Centre

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Institut de Cancerologie Strasbourg Europe (ICANS)

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Cenantron Centro Avançado de Tratamento Oncologico Ltda

location_facility: California Cancer Associates for Research and Excellence

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: ASST Bergamo Ovest- ospedale di Treviglio

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Vincentius-Diakonissen-Kliniken gAG, St. Vincentius-Kliniken, Medizinische Klinik 2

location_facility: Centro Médico Privado Centro de Especialidades Médicas Ambulatorias e Investigación Clínica

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universitatsklinikum Essen / Westdeutsches Tumorzentrum, Innere Klinik (Tumorforschung)

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Institut de cancerologie de l'ouest (ICO)

location_facility: CHI de Toulon la Seyne-sur-Mer Hopital Sainte Musse

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: CAIPO - Centro para la Atención Integral del Paciente Oncológico

location_facility: Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

location_facility: Munchen Klinik Bogenhausen, Klinik fur Pneumologie und Pneumologische Onkologie

location_facility: Centro Des Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

location_facility: Centro Hospitalar Universitario Sao Joao, EPE

location_facility: Lungenklinik Hemer, Zentrum fur Pneumologie and Thoraxchirurgie

location_facility: Soroka University Medical Center, Itzchak Rager Blvd.

location_facility: Unidade Local de Saude de Matosinhos EPE - Hospital Pedro Hispano SA

location_facility: Hopital d'Instruction des Armees (HIA) Begin

location_facility: Azienda Sanitaria Territoriale Pesaro e Urbino (AST)

location_facility: Hospital Universitari Dexeus (USP Institut Universitari Dexeus/Hospital Universitari Quiron Dexeus)

location_facility: IRCCS Fondazoine del Piemonte per l'Oncologia

location_facility: Oncology Institute, Galilee Medical Center, Route 89 Nahariya-Cabri

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Acibadem Mehmet Ali Aydinlar Universitesi Atakent Hastanesi

location_facility: Kliniken der Stadt Köln ggmbh, Krankenhaus Koln-Merheim/Lungenklinik


title: An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 6-month Formulation Administered Subcutaneously in Participants With Locally Advanced and/or Metastatic Prostate Cancer Previously Treated and Castrated With a GnRH Analogue

acronym: TriptoSwitch

summary: The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.

status: Active, not recruiting

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country: Germany Lithuania Netherlands Belgium Spain Czechia France

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CHU Brest-Hopital Morvan Institut de Cancerologie et d'Hemat

location_facility: Centre Hospitalier Universitaire D'Angers - Urologie

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Polyclinique de Blois - Service oncologie

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Hospital Universitario 12 de Octubre- Urology

location_facility: The Netherlands Cancer Institute - Oncology

location_facility: Saint Jean Languedoc and La Croix du Sud Hospital

location_facility: Hopital Privé Métropole Lille - Polyclinique Du Bois

location_facility: POLUSA - Policlínico Lucense - Oncología

location_facility: Hospital Universitario Virgen del Rocio- Urología Pediátrica

location_facility: Hopital Foch - Urologie et Transplantation Ré

location_facility: Hospital de La Santa Creu i Sant Pau - Oncología Médica


title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

summary:
Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.

Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

lead_sponsor: H. Lundbeck A/S

location_country:
Germany
Italy
Norway
Denmark
Australia
Sweden
Netherlands
United States
Spain
France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC - ClinEdge - Louisiana - PPDS

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Fondazione Policlinico Universitario A Gemelli-Rome

location_facility: Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

location_facility: Clinvest - National Ave - Headlands - PPDS

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: Clinical Research of Central Florida - ClinEdge - PPDS

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone-Piazza Delle Cliniche 2

location_facility: Montefiore Headache Center - BRANY - PPDS

location_facility: AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-Via Celoria, 11

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Praxis fuer Neurologie, Spezielle Schmerztherapie und Psychotherapie

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand -58 Rue Montalembert

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda


summary: This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

title: A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

source: euctr

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

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

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
Canada
France
Hungary
United States
India
Belgium
China
Philippines
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
South Africa
Taiwan


title: A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

summary: The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

lead_sponsor: Kite, A Gilead Company

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Novant Health Cancer Institute Hematology - Charlotte

location_facility: The University Hospital Southampton NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: TriStar Centennial Medical Center - Cell Processing

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of Arkansas for Medical Sciences

location_facility: Universitatsklinikum Koln Klinik I fur Innere Medizin

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Columbia University Irving Medical Center

location_facility: Oncology_Hematology Care Clinical Trials, LLC

location_facility: Fondazione IRCCS - Istituto Nazionale Tumori


title: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)

summary: Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Poland
Australia
Japan
Canada
France
Portugal
Hong Kong
Switzerland
United States
Belgium
China
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: IRCCS Istituto Oncologico Giovanni Paolo II

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Fujian Medical University - Union Hospital Foochow Christian Union Hospital

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Hospital Univeritario Marques de Valdecilla

location_facility: Harbin Medical University - Tumor Hospital The Third Affiliated Hospital

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Centro Hospitalar de Vila Nova de Gaia - Espinho

location_facility: Oslo University Hospital-The Norwegian Radium Hospital

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou

location_facility: Fudan University - Shanghai Cancer Center FUSCC

location_facility: Kaiser Permanente - Vallejo Medical Center

location_facility: The First Hospital of China Medical University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: University of Texas Southwestern Medical Center

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

location_facility: University Hospital Birmingham NHS Trust

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: The First Affiliated Hospital of College of Medicine Zhejiang University

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital

location_facility: Instituto Portugues de Oncologio de Lisboa

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: The Royal Marsden Hospital NHS Foundation Trust

location_facility: Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio

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

location_facility: University of Hong Kong/Queen Mary Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: The First Affiliate Hospital of Xi'an Jiaotong University

location_facility: Seoul National University Bundang Hospital

location_facility: General Hospital of Eastern Theater Command

location_facility: Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre

location_facility: Sarah Cannon/Florida Cancer Specialists - FCS South

location_facility: National University Cancer Institute National University Hospital

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria

location_facility: The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology

location_facility: National Taiwan University Hospital NTUH

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

location_facility: The First Affiliated Hospital of Guangxi Medical University

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: Hackensack Meridian Health-Southern Ocean Medical Center

location_facility: Kantonsspital Graubuenden - Hauptstandort


title: A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

acronym: EDGE-Gastric

summary: This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).

design_allocation: Non-Randomized

ipd_sharing_description:
Arcus 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.

For more information, please visit our website.

lead_sponsor: Arcus Biosciences, Inc.

sponsor_collaborators:
Arcus Biosciences, Inc.
Gilead Sciences

location_country:
United States
Korea, Republic of
France

location_facility: Virginia Cancer Specialists-Fairfax Office

location_facility: Institut de Recherche en Cancerologie de Montpellier

location_facility: SCRI - Florida Cancer Specialists - South Region Research Office

location_facility: Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers

location_facility: SCRI - Florida Cancer Specialists - North Region Research Office

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

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Greenville Health System Cancer Institute (Prisma)

location_facility: Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie


title: A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease

acronym: AMPLITUDE

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

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:
Colombia
Portugal
United Kingdom
Brazil
Netherlands
Belgium
United States
Spain
Canada
Ghana
Puerto Rico
France

location_facility: CHU Grenoble Alpes - Hôpital Nord Michallon

location_facility: Kaiser Permanente - Los Angeles Medical Center

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Eastern Nephrology Associates - Wilmington Office

location_facility: South Florida Nephrology Group PA, Research Div.

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

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

location_facility: University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic

location_facility: Service de Nephrologie - Hopital Universitaire Necker

location_facility: SUNY Downstate Health Sciences University

location_facility: Morehouse School of Medicine, Grady Memorial Hospital

location_facility: Inova Clinical Trials and Research Center

location_facility: Virginia Commonwealth University - Division of Nephrology

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

location_facility: Albert Einstein Hospital - Montefiore Medical Center

location_facility: Renal Physicians of Montgomery County, PA

location_facility: Clinical Research Development Associates LLC

location_facility: University Hospitals Cleveland Medical Center

location_facility: Unidade De Pesquisa Clinica Do Complexo Hospitalar Da UFC

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

location_facility: Hôpital de la Conception, Centre de néphrologie et transplantation rénale

location_facility: Eastern Nephrology Associates - New Bern Office

location_facility: Zucker School of Medicine at Hofstra/Northwell

location_facility: Barts Health NHS Trust, The Royal London Hospital

location_facility: Hopitaux Universitaires Est Parisien - Hopital Tenon

location_facility: University of Arkansas for Medical Sciences

location_facility: Texas Tech University Health Sciences Center

location_facility: Dallas Nephrology Associates - Dallas Landry Office

location_facility: Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site

location_facility: Louisiana State University Health Sciences Center LSUHSC

location_facility: North Carolina Nephrology P.A. - Cary Office

location_facility: Velocity Clinical Research - Hallandale Beach

location_facility: Javara Inc./Privia Medical Group Georgia, LLC

location_facility: Clinical Research Strategies - Romano North Main Office

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil

location_facility: University of Virginia Health - Nephrology Clinical Research Center

location_facility: Nevada Kidney Disease and Hypertension Centers

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

location_facility: Eastern Nephrology Associates - Greenville Office

location_facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital

location_facility: AKDHC Medical Research Service LLC - Banner Desert Office

location_facility: North Florida/South Georgia Veterans Health System

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Eastern Nephrology Associates - Kinston Office

location_facility: The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension

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

location_facility: Université Paris-Descartes / Hôpital Européen Georges Pompidou

location_facility: Javara Inc./Privia Medical Group Georgia, PLLC

location_facility: Children's Hospital of Pittsburgh of UPMC

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

location_facility: Nephrology & Hypertension Associates, PC

location_facility: Center for Specialized Medicine - SSM Health Saint Louis University Hospital

location_facility: Nephrology and Hypertension Associates, LTD

location_facility: Mid Florida Kidney and Hypertension Care, PL

location_facility: King's College Hospital NHS Foundation Trust - Guthrie Clinic

location_facility: Eastern Nephrology Associates - Jacksonville Office

location_facility: Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD

location_facility: Kidney Care and Transplant Services of New England

location_facility: Columbia University - Division of Nephrology

location_facility: Northwest Louisiana Nephrology, LLC - Shreveport

location_facility: UNC Clinical and Translational Research Center

location_facility: New York University Grossman School of Medicine

location_facility: Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research

location_facility: Vanderbilt University Medical Center, Nephrology Clinical Trials Center

location_facility: Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE


title: A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-3)

summary: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

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

location_country:
Germany
Japan
Brazil
Thailand
Vietnam
Canada
France
Portugal
United States
India
Belgium
China
Malaysia
Puerto Rico
Philippines
Egypt
Italy
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Russian Federation


title: A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants With Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma

summary: The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma and non-Hodgkin lymphoma.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Dell Children's Medical Center of Central Texas (DCMC) - Strictly Pediatrics Subspecialty Center

location_facility: Phoenix Childrens Hospital PCH - Phoenix Childrens Medical Group - Hematology Oncology

location_facility: CHU Grenoble Alpes - Hopital Couple Enfant (HCE)

location_facility: University of Minnesota Medical School - Masonic Childrens Hospital

location_facility: CHRU de Strasbourg-Hopital de Hautepierre

location_facility: Lucile Packard Childrens Hospital - Stanford University

location_facility: Penn State Health Milton S. Hershey Medical Center - Penn State Children's Hospital

location_facility: UW Health - American Family Children's Hospital Pediatric Bone Marrow Transplant Clinic

location_facility: Siteman Cancer Center - Washington University Medical Campus Location

location_facility: Hackensack University Medical Center HUMC - The Joseph M. Sanzari Childrens Hospital - Children's Cancer Institute

location_facility: University of Mississippi Medical Center

location_facility: Golisano Children's Hospital of Southwest Florida


title: A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

collaborators:
AstraZeneca
Merck Sharp & Dohme LLC

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca
Merck Sharp & Dohme LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Canada
France
Portugal
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan

location_facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia - Clinica Lacks

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Tianjin Medical University General Hospital

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: IRCCS Istituto Oncologico Giovanni Paolo II

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

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Centro de Investigacion Clinica de Oaxaca (CICLO)

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Centro Hospitalar e Universitário do Porto

location_facility: Oncosite - Centro de Pesquisa Clinica Oncologia

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: The First Hospital of China Medical University

location_facility: Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst

location_facility: Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Semmelweis University Department of Pulmonology

location_facility: Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO

location_facility: Centro Hospitalar Universitário de São João

location_facility: Jeroen Bosch Ziekenhuis J BZ Hieronymus Bosch Hospital

location_facility: The First Affiliate Hospitalof Xi'An Jiaotong University

location_facility: Xiangyang Central Hospital- 5 Lumen Avenue

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The First Affiliated Hospital of College of Medicine Zhejiang University

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Dana Farber Cancer Institute - Milford Medical Center

location_facility: DFCI - Steward St. Elizabeth's Medical Center

location_facility: CHU de Poitier Pole Regional de Cancerologie

location_facility: Sotiria General Hosptial of Chest Diseases

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Faculty of Medicine Chulalongkorn University

location_facility: Instituto de Ensino e Pesquisas Sao Lucas

location_facility: Inner Mongolia Medical University- the Affiliated Hospital

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Centro de Investigaciones Clinicas Vina Del Mar

location_facility: Prince of Wales Hospital / The Chinese University of Hong Kong 99999

location_facility: Seoul National University Bundang Hospital

location_facility: Fundacion CENIT para la investigación en Neurociencias

location_facility: Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch

location_facility: Harbin Medical University Cancer Hospital

location_facility: Karl-Landsteiner Institute for Lung Research and Pulmonary Oncology c/o Klinik Floridsdorf

location_facility: The Oncology Institute of Hope and Innovation

location_facility: The Second People's Hospital of Neijiang

location_facility: Instituto Portuguas de Oncologia do Porto Francisco Gentil

location_facility: Prince of Songkla University PSU - Faculty of Medicine

location_facility: Dana Farber Cancer Institute - Foxborough

location_facility: A.O. Perugia Santa Maria della Misericordia

location_facility: Bordeaux University Hospital - Hopital Saint Andre

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University

location_facility: MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Sp. Jawna

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: The First Affiliated Hospital Xiamen University

location_facility: Grand Hopital de Charleroi - Hopital Saint Joseph

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Hospital Universitario Arnau de Vilanova - Lleida

location_facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu

location_facility: National Cheng Kung University Hospital Nckuh

location_facility: University of Texas Health Science Center San Antonio

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Az Maria Middelares - Campus Maria Middelares


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

acronym: GRAVITI

summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Taiwan
New Zealand
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
France
Lithuania
Slovakia
Hungary
Denmark
United States
Belgium
China
Malaysia
Italy
Netherlands
Korea, Republic of
Spain
Jordan
Israel

location_facility: Pecsi Tudomanyegyetem Orvostudomanyi Es Egeszsegtudomanyi Centrum, I. Belgyogyaszati Klinika

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Central Arkansas Veterans Healthcare System

location_facility: SER - Servicos Especializados em Reumatologia da Bahia

location_facility: DiGiovanna Institute for Medical Education & Research

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Gastroenterology Associates of the Piedmont, P.A.

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: Bülent Ecevit Üniversitesi Sağlık Uygulama ve Araştırma Hastanesi

location_facility: Niigata University Medical & Dental Hospital

location_facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

location_facility: BR TRIALS-Ensaios Clinicos e Consultoria Ltda

location_facility: Gastroenterology Associates of Tidewater

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Gastroenterology Associates of SW Florida

location_facility: National Hospital Organization Mito Medical Center

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika, SP ZOZ

location_facility: University hospital Clinical centre Banja Luka

location_facility: The First Affiliated Hospital of Fujian Medical University

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

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: The Affiliated Hospital of Bengbu Medical College

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: University of Mississippi Medical Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: The second Xiangya Hospital of Central South University

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Shengjing Hospital of China Medical University

location_facility: National Taiwan University Hospital, Division of Infectious Diseases

location_facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'

location_facility: The First Affiliated Hospital of NanChang University

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

location_facility: Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: The Speciality Hospital (TSH) / Advanced Clinical Center

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Universidade Federal da Bahia - Hospital Professor Edgard Santos

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: Gastroentreology and Nutrition Specialists, P.A.

location_facility: Xiangya Hospital Central South University

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Digestive Health Specialists of the Southeast

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

location_facility: Private Practice - Dr. Krzysztof Cymerman

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Egyesített Szent István és Szent László Kórház

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

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

location_facility: Associacao dos Funcionarios Publicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: The first affiliated hospital of suzhou University

location_facility: CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Institute for Digestive Health and Liver Disease

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Luka-Wendrowska sp.j.

location_facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Harmony Medical Research Institute, Inc.

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

location_facility: USF Asthma, Allergy, Immunology Clinical Research Unit

location_facility: Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Oklahoma University Health Science Center

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Northshore Gastroenterology Research, LLC

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Hospital das Clinicas - Universidade Federal de Pernambuco


title: Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia

acronym: V-DIFFERENCE

summary: Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

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: Germany Poland Latvia Spain Czechia Bulgaria Estonia France