title: RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days

summary: A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Finland
Czech Republic
Sweden
Hungary
France
South Africa
Belgium
Germany

location_facility: 1160.25.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35803 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35804 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03304 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06101 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03402 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03306 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03102 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04609 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04301 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06102 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06111 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42009 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04806 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03604 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06106 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06107 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03106 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04605 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03602 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04608 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06110 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03301 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03605 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06105 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04610 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04804 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03408 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03906 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04570 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04574 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04575 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04603 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03104 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02701 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03302 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06109 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03105 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06103 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02703 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03903 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03607 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03403 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04803 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06108 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06104 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03309 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.06113 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03905 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.25.03305 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03601 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03307 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35802 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.35801 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04573 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.42006 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04607 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04601 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03401 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.04604 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03407 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03409 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.03101 Boehringer Ingelheim Investigational Site

location_facility: 1160.25.02702 Boehringer Ingelheim Investigational Site


title: Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.

acronym: FLEX

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 advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

ReferenceType: derived

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Eberhardt WE, de Marinis F, Heeger S, Goddemeier T, O'Byrne KJ, Gatzemeier U. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer. 2012 Aug;77(2):376-82. doi: 10.1016/j.lungcan.2012.03.010. Epub 2012 Apr 11.

ReferenceCitation: Pirker R, Pereira JR, von Pawel J, Krzakowski M, Ramlau R, Park K, de Marinis F, Eberhardt WE, Paz-Ares L, Störkel S, Schumacher KM, von Heydebreck A, Celik I, O'Byrne KJ. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. doi: 10.1016/S1470-2045(11)70318-7. Epub 2011 Nov 4.

ReferenceCitation: O'Byrne KJ, Gatzemeier U, Bondarenko I, Barrios C, Eschbach C, Martens UM, Hotko Y, Kortsik C, Paz-Ares L, Pereira JR, von Pawel J, Ramlau R, Roh JK, Yu CT, Stroh C, Celik I, Schueler A, Pirker R. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795-805. doi: 10.1016/S1470-2045(11)70189-9. Epub 2011 Jul 22.

ReferenceCitation: Gatzemeier U, von Pawel J, Vynnychenko I, Zatloukal P, de Marinis F, Eberhardt WE, Paz-Ares L, Schumacher KM, Goddemeier T, O'Byrne KJ, Pirker R. First-cycle rash and survival in patients with advanced non-small-cell lung cancer receiving cetuximab in combination with first-line chemotherapy: a subgroup analysis of data from the FLEX phase 3 study. Lancet Oncol. 2011 Jan;12(1):30-7. doi: 10.1016/S1470-2045(10)70278-3. Epub 2010 Dec 17.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Spain
Italy
United Kingdom
Ukraine
Belgium
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Sweden
Slovakia
Brazil
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Ireland
Czech Republic
Korea, Republic of
France
Chile
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

summary: The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Lithuania
France
Germany


title: A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

summary: To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

ReferenceCitation: Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany


title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

acronym: BENEFIT-EXT

summary: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

ReferenceCitation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.

ReferenceCitation: Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Argentina
Canada
Sweden
Hungary
United States
Chile
France
South Africa
Belgium
Norway
Germany
Czechia

location_facility: University Of Colorado Health Sciences Center

location_facility: Washington University School Of Medicine

location_facility: University Of California San Francisco Medical Center

location_facility: Henry Ford Hospital, Transplant Institute

location_facility: Columbia University College Of Physicians & Surgeons

location_facility: University Of North Carolina At Chapel Hill

location_facility: Western New England Renal & Transplant Associates, Pc

location_facility: Drexel University College Of Medicine, Department Of Surgery

location_facility: Ucla Kidney & Kidney-Pancreas Transplant Research Office

location_facility: Northwestern University-Feinberg School Of Medicine


title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

acronym: SMART Registry

summary:
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Boston Scientific Corporation

location_country:
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Ospedale Santa Maria della Misericordia di Rovigo

location_facility: Azienda Ospedaliero - Universitaria di Ferrara

location_facility: IKEM - Institut klinicke a experimentalni mediciny

location_facility: Basildon and Thurrock University Hospitals NHS Foundation Trust

location_facility: Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf

location_facility: LHCH (Liverpool Heart and Chest Hospital)

location_facility: Barwon Health Myers House Ground Floor Geelong Hospital

location_facility: Columbia. University Medical Center/ NY Presbyterian Hospital

location_facility: Landeskrankenhaus Salzburg Universitätsklinikum der PMU

location_facility: Voc Cardiologia Ospedaliera Polocino di Bari

location_facility: Magna Graecia University AUO Mater Domini di Catanzaro

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Riverside Medical Center / Midwest Arrhythmia Consultants

location_facility: Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)

location_facility: Azienda Socio-Sanitaria Territoriale dei Sette Laghi

location_facility: North Florida/South Georgia Veterans Health System

location_facility: Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre

location_facility: Western Connecticut Health Network/ Danbury Hospital

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust'

location_facility: The University of Illinois Medical Center

location_facility: Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Klinikum Links der Weser-Elektrophysiologie Bremen

location_facility: Universität Mainz zentrum fur kardiologie

intervention_type: Device


title: A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

summary: The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

ReferenceType: background

ReferenceCitation: Pappas PG, Rotstein CM, Betts RF, Nucci M, Talwar D, De Waele JJ, Vazquez JA, Dupont BF, Horn DL, Ostrosky-Zeichner L, Reboli AC, Suh B, Digumarti R, Wu C, Kovanda LL, Arnold LJ, Buell DN. Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2007 Oct 1;45(7):883-93. Epub 2007 Aug 29. Erratum in: Clin Infect Dis. 2008 Jul 15;47(2):302.

ReferenceCitation: Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. doi: 10.1093/jac/dkq446. Epub 2010 Dec 8.

lead_sponsor: Astellas Pharma Inc

location_country:
Croatia
Poland
Brazil
Spain
United Kingdom
Austria
Netherlands
Canada
Czech Republic
Switzerland
United States
France
India
Belgium
Germany


type: Other Identifier

type: EudraCT Number

title: A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma

summary: The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

ReferenceCitation: Sonneveld P, Hajek R, Nagler A, Spencer A, Bladé J, Robak T, Zhuang SH, Harousseau JL, Orlowski RZ; DOXIL-MMY-3001 Study Investigators. Combined pegylated liposomal doxorubicin and bortezomib is highly effective in patients with recurrent or refractory multiple myeloma who received prior thalidomide/lenalidomide therapy. Cancer. 2008 Apr 1;112(7):1529-37. doi: 10.1002/cncr.23326.

ReferenceCitation: Orlowski RZ, Nagler A, Sonneveld P, Bladé J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. Epub 2007 Aug 6.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Portugal
Spain
United Kingdom
Austria
Australia
Russian Federation
Argentina
Canada
Czech Republic
United States
France
Israel
Singapore
Belgium
South Africa
Netherlands


title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

summary: This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.

ReferenceCitation: Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
United States
France
Norway
Sweden


title: A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

summary: This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

ReferenceCitation: Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martín A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Portugal
Spain
Greece
Italy
United Kingdom
Canada
Switzerland
Sweden
France
United States
Turkey
Belgium
Germany


title: See Detailed Description

summary: This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

ReferenceCitation: Eron J Jr, Yeni P, Gathe J Jr, Estrada V, DeJesus E, Staszewski S, Lackey P, Katlama C, Young B, Yau L, Sutherland-Phillips D, Wannamaker P, Vavro C, Patel L, Yeo J, Shaefer M; KLEAN study team. The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial. Lancet. 2006 Aug 5;368(9534):476-82. Erratum in: Lancet. 2006 Oct 7;368(9543):1238.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Portugal
Luxembourg
Romania
Italy
Austria
Latvia
Spain
Canada
Switzerland
United States
France
Belgium
Germany


title: Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

summary: The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

ReferenceCitation: Laterre PF, Opal SM, Abraham E, LaRosa SP, Creasey AA, Xie F, Poole L, Wunderink RG. A clinical evaluation committee assessment of recombinant human tissue factor pathway inhibitor (tifacogin) in patients with severe community-acquired pneumonia. Crit Care. 2009;13(2):R36. doi: 10.1186/cc7747. Epub 2009 Mar 15.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Spain
United Kingdom
Australia
Netherlands
Argentina
Canada
New Zealand
Korea, Republic of
United States
Chile
France
Malaysia
Belgium
Peru
Germany
Singapore
South Africa


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

acronym: COMBI-i

summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Tawbi HA, Robert C, Brase JC, Gusenleitner D, Gasal E, Garrett J, Savchenko A, Görgün G, Flaherty KT, Ribas A, Dummer R, Schadendorf D, Long GV, Nathan PD, Ascierto PA. Spartalizumab or placebo in combination with dabrafenib and trametinib in patients with BRAF V600-mutant melanoma: exploratory biomarker analyses from a randomized phase 3 trial (COMBI-i). J Immunother Cancer. 2022 Jun;10(6). pii: e004226. doi: 10.1136/jitc-2021-004226.

ReferenceCitation: Dummer R, Long GV, Robert C, Tawbi HA, Flaherty KT, Ascierto PA, Nathan PD, Rutkowski P, Leonov O, Dutriaux C, Mandalà M, Lorigan P, Ferrucci PF, Grob JJ, Meyer N, Gogas H, Stroyakovskiy D, Arance A, Brase JC, Green S, Haas T, Masood A, Gasal E, Ribas A, Schadendorf D. Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 May 1;40(13):1428-1438. doi: 10.1200/JCO.21.01601. Epub 2022 Jan 14.

ReferenceCitation: Dummer R, Lebbé C, Atkinson V, Mandalà M, Nathan PD, Arance A, Richtig E, Yamazaki N, Robert C, Schadendorf D, Tawbi HA, Ascierto PA, Ribas A, Flaherty KT, Pakhle N, Campbell CD, Gusenleitner D, Masood A, Brase JC, Gasal E, Long GV. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i. Nat Med. 2020 Oct;26(10):1557-1563. doi: 10.1038/s41591-020-1082-2. Epub 2020 Oct 5.

ipd_sharing: Yes

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

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Thailand
France
Chile
Netherlands

location_facility: University of TX MD Anderson Cancer Center SC-2

location_facility: University of Pittsburgh Medical Center SC

location_facility: NYU Laura and Isaac Perlmutter Cancer Center SC

location_facility: University of Tennessee Medical Center SC

location_facility: California Cancer Associates for Research and Excellence SC-2

intervention_type: Biological

status_simplified: Ongoing


status: Terminated

intervention_type: Other

acronym: JAVELIN HEAD AND NECK 100

title: A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

source: euctr

ReferenceCitation: Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, Harrington K, Chang PM, Lin JC, Razaq MA, Teixeira MM, Lovey J, Chamois J, Rueda A, Hu C, Dunn LA, Dvorkin MV, De Beukelaer S, Pavlov D, Thurm H, Cohen E. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):450-462. doi: 10.1016/S1470-2045(20)30737-3.

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.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Ireland
Korea, Republic of
France

location_facility: Texas Oncology El Paso Cancer Treatment Center

location_facility: Memorial Sloan Kettering Cancer Center: Breast and Imaging Center

location_facility: Hadassah University Hospital, Department of Oncology

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Lehigh Valley Health Network-Cedar Crest

location_facility: Department of Radiation Oncology, CHA Bundang Medical Center, CHA University

location_facility: Hopital Franco-Britannique, Institut d'Oncologie Hauts-de-Seine Nord

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kansas City VA Radiation Oncology Clinic

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: Helios Klinikum Berlin-Buch, Institut fur Rontgendiagnostik

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Department of Radiation Oncology, Ulsan University Hospital

location_facility: Department of Radiation Oncology Methodist Hospital

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

location_facility: NYU Langone Radiology - Ambulatory Care Center East 41st Street

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth

location_facility: Orszagos Onkologiai Intezet, Sugarterapias Osztaly

location_facility: Medical University of South Carolina- Hollings Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS - Fondazione Pascale

location_facility: University of Oklahoma Health Sciences Center- Stephenson Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center- Bergen

location_facility: Helios Klinikum Berlin-Buch, Klinik fur Strahlentherapie

location_facility: UOC Oncologia Medica, AUSL della Romagna - RAVENNA

location_facility: Harbin Medical University Cancer Hospital

location_facility: Petz Aladar Megyei Oktato Koraz, Onkoradiologiai osztaly

location_facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.

location_facility: The West Clinic PC dba West Cancer Center

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Site Paul Papin

location_facility: Budgetary Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

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

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Montefiore-Einstein Center for Cancer Care

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Kantonsspital Winterthur, Medizinische Onkologie

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

location_facility: Cancer Center of Guangzhou Medical University/Oncology Department

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Site Rene Gauducheau

location_facility: Barwon Health, University Hospital Geelong

location_facility: Memorial Sloan Kettering Cancer Center- Nassau

location_facility: Klinik fur Strahlentherapie und Radioonkologie

location_facility: St Luke's Radiation Oncology Network, St Luke's Hospital

location_facility: Lehigh Valley Health Network Cancer Center Pharmacy

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: UC San Diego Medical Center- La Jolla (Thornton Hospital)

location_facility: Centrum Onkologii im. prof. F. Lukaszczyka

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Illawarra Shoalhaven Local Health District

location_facility: University of Maryland School of Medicine

location_facility: Chris O'Brien Lifehouse Radiation Oncology Department

location_facility: Affiliated Tumor Hospital of Guangxi Medical University

location_facility: Shanghai East Hospital/Oncology Department

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: SPZOZ Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

location_facility: Grand Hopital de Charleroi - Site Notre-Dame

location_facility: Cabinet de radiologie Privé - Dr Joseph Mocaer

location_facility: SBIH "Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine"

location_facility: MUSC SCTR Research Nexus Clinical Science Building

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Hospital Bristol NHS Foundation Trust

location_facility: University of Missouri- Ellis Fischel Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej - Curie, Klinika Radioterapii i Chemioterapii

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Colorado Hospital - Anschutz Inpatient Pavilion

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion

location_facility: University Of Colorado Hospital Cancer Center

location_facility: Precision Cancer Research / Gettysburg Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center Westchester

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: UOC Oncologia Medica, AUSL della Romagna -RAVENNA

location_facility: The Oncology Institute of Hope and Innovation

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

location_facility: Pecsi Tudomanyegyetem, Klinikai Kozpont, Onkoterapias Intezet

location_facility: Memorial Sloan Kettering Cancer Center-Basking Ridge

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: Division of Radiation Oncology, Seoul National University Hospital

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: West China Hospital of Sichuan University

location_facility: SBIH "SPb Clinical Research Centre of Specialized Kinds of Medical Care (Oncology)"

location_facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.

location_facility: Center for Specific Organ Cancer, National Cancer Center

location_facility: Istituto Oncologico della Svizzera Italiana IOSI, Ospedale San Giovanni

location_facility: ICANS - Institut de cancerologie Strasbourg Europe

location_facility: Seoul National University Bundang Hospital

location_facility: Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Centro Hospitalar do Porto, E.P.E.- Hospital de Santo Antonio

location_facility: Klinik fur Radiologie und Nuklearmedizin

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Petrov"

location_facility: Herbert-Herman Cancer Center, Sparrow Hospital

location_facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: AULSS 9 - Scaligera Ospedale Mater Salutis

location_facility: Hopital Pellegrin - Service de radiologie et d'imagerie

location_facility: Orszagos Onkologiai Intezet, B Belgyogyaszati Osztaly

location_facility: SBHI YaR "Regional Clinical Oncology Hospital"

location_facility: Xiangya Hospital Central South University/Oncology Department

location_facility: Institut de cancerologie de la Loire Lucien Neuwirth

location_facility: Helios Klinikum Berlin-Buch, Klinik fur Nuklearmedizin

location_facility: Cancer Institute Hospital, Japanese Foundation for Cancer Research

location_facility: Center for Proton Therapy, National Cancer Center

location_facility: Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (I.R.S.T)

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Institut Regional du Cancer Montpellier - Val d'Aurelle

location_facility: The West Clinic, PC dba West Cancer Center

location_facility: UCSD Radiation Oncology South Bay, Cancer Treatment Centers

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

location_facility: Centre Paul Strauss - Radiologie et medecine nucleaire

location_facility: Instituto Portugues de Oncologia de Coimbra Francisco Gentil, E.P.E.

location_facility: Division of Radiation Oncology, Asan Medical Center

summary: This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

status_simplified: Unknown


title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

acronym: PATINA

summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

enrollment_type: Anticipated

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

ReferenceCitation: Welch HG, Gorski DH, Albertsen PC. Trends in Metastatic Breast and Prostate Cancer--Lessons in Cancer Dynamics. N Engl J Med. 2015 Oct 29;373(18):1685-7. doi: 10.1056/NEJMp1510443.

ReferenceCitation: Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

ReferenceCitation: Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortés J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.

ReferenceCitation: Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

ReferenceCitation: Sherr CJ, Roberts JM. CDK inhibitors: positive and negative regulators of G1-phase progression. Genes Dev. 1999 Jun 15;13(12):1501-12. Review.

ReferenceCitation: van den Heuvel S, Harlow E. Distinct roles for cyclin-dependent kinases in cell cycle control. Science. 1993 Dec 24;262(5142):2050-4.

ReferenceCitation: Weinberg RA. The retinoblastoma protein and cell cycle control. Cell. 1995 May 5;81(3):323-30. Review.

ReferenceCitation: Harper JW, Adami GR, Wei N, Keyomarsi K, Elledge SJ. The p21 Cdk-interacting protein Cip1 is a potent inhibitor of G1 cyclin-dependent kinases. Cell. 1993 Nov 19;75(4):805-16.

ReferenceCitation: Koff A, Ohtsuki M, Polyak K, Roberts JM, Massagué J. Negative regulation of G1 in mammalian cells: inhibition of cyclin E-dependent kinase by TGF-beta. Science. 1993 Apr 23;260(5107):536-9.

ReferenceCitation: Polyak K, Kato JY, Solomon MJ, Sherr CJ, Massague J, Roberts JM, Koff A. p27Kip1, a cyclin-Cdk inhibitor, links transforming growth factor-beta and contact inhibition to cell cycle arrest. Genes Dev. 1994 Jan;8(1):9-22.

ReferenceCitation: Sherr CJ. D-type cyclins. Trends Biochem Sci. 1995 May;20(5):187-90. Review.

ReferenceCitation: Toyoshima H, Hunter T. p27, a novel inhibitor of G1 cyclin-Cdk protein kinase activity, is related to p21. Cell. 1994 Jul 15;78(1):67-74.

ReferenceCitation: Lukas J, Parry D, Aagaard L, Mann DJ, Bartkova J, Strauss M, Peters G, Bartek J. Retinoblastoma-protein-dependent cell-cycle inhibition by the tumour suppressor p16. Nature. 1995 Jun 8;375(6531):503-6.

ReferenceCitation: Medema RH, Herrera RE, Lam F, Weinberg RA. Growth suppression by p16ink4 requires functional retinoblastoma protein. Proc Natl Acad Sci U S A. 1995 Jul 3;92(14):6289-93.

ReferenceCitation: Lee RJ, Albanese C, Fu M, D'Amico M, Lin B, Watanabe G, Haines GK 3rd, Siegel PM, Hung MC, Yarden Y, Horowitz JM, Muller WJ, Pestell RG. Cyclin D1 is required for transformation by activated Neu and is induced through an E2F-dependent signaling pathway. Mol Cell Biol. 2000 Jan;20(2):672-83.

ReferenceCitation: Lane HA, Beuvink I, Motoyama AB, Daly JM, Neve RM, Hynes NE. ErbB2 potentiates breast tumor proliferation through modulation of p27(Kip1)-Cdk2 complex formation: receptor overexpression does not determine growth dependency. Mol Cell Biol. 2000 May;20(9):3210-23.

ReferenceCitation: Yu Q, Sicinska E, Geng Y, Ahnström M, Zagozdzon A, Kong Y, Gardner H, Kiyokawa H, Harris LN, Stål O, Sicinski P. Requirement for CDK4 kinase function in breast cancer. Cancer Cell. 2006 Jan;9(1):23-32.

ReferenceCitation: Nahta R, Iglehart JD, Kempkes B, Schmidt EV. Rate-limiting effects of Cyclin D1 in transformation by ErbB2 predicts synergy between herceptin and flavopiridol. Cancer Res. 2002 Apr 15;62(8):2267-71.

ReferenceCitation: Reddy HK, Mettus RV, Rane SG, Graña X, Litvin J, Reddy EP. Cyclin-dependent kinase 4 expression is essential for neu-induced breast tumorigenesis. Cancer Res. 2005 Nov 15;65(22):10174-8.

ReferenceCitation: Yang C, Ionescu-Tiba V, Burns K, Gadd M, Zukerberg L, Louis DN, Sgroi D, Schmidt EV. The role of the cyclin D1-dependent kinases in ErbB2-mediated breast cancer. Am J Pathol. 2004 Mar;164(3):1031-8.

ReferenceCitation: Landis MW, Pawlyk BS, Li T, Sicinski P, Hinds PW. Cyclin D1-dependent kinase activity in murine development and mammary tumorigenesis. Cancer Cell. 2006 Jan;9(1):13-22.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Witkiewicz AK, Cox DW, Rivadeneira D, Ertel AE, Fortina P, Schwartz GF, Knudsen ES. The retinoblastoma tumor suppressor pathway modulates the invasiveness of ErbB2-positive breast cancer. Oncogene. 2014 Jul 24;33(30):3980-91. doi: 10.1038/onc.2013.367. Epub 2013 Oct 14.

ReferenceCitation: Roberts PJ, Bisi JE, Strum JC, Combest AJ, Darr DB, Usary JE, Zamboni WC, Wong KK, Perou CM, Sharpless NE. Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy. J Natl Cancer Inst. 2012 Mar 21;104(6):476-87. doi: 10.1093/jnci/djs002. Epub 2012 Feb 1.

ReferenceCitation: Goel S, Wang Q, Watt AC, Tolaney SM, Dillon DA, Li W, Ramm S, Palmer AC, Yuzugullu H, Varadan V, Tuck D, Harris LN, Wong KK, Liu XS, Sicinski P, Winer EP, Krop IE, Zhao JJ. Overcoming Therapeutic Resistance in HER2-Positive Breast Cancers with CDK4/6 Inhibitors. Cancer Cell. 2016 Mar 14;29(3):255-269. doi: 10.1016/j.ccell.2016.02.006.

ReferenceCitation: Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum in: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jul 1;32(19):2100-8. doi: 10.1200/JCO.2013.54.0955. Epub 2014 May 5. Review.

ReferenceCitation: Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, Barrios CH, Bergh J, Biganzoli L, Blackwell KL, Cardoso MJ, Cufer T, El Saghir N, Fallowfield L, Fenech D, Francis P, Gelmon K, Giordano SH, Gligorov J, Goldhirsch A, Harbeck N, Houssami N, Hudis C, Kaufman B, Krop I, Kyriakides S, Lin UN, Mayer M, Merjaver SD, Nordström EB, Pagani O, Partridge A, Penault-Llorca F, Piccart MJ, Rugo H, Sledge G, Thomssen C, Van't Veer L, Vorobiof D, Vrieling C, West N, Xu B, Winer E. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)†. Ann Oncol. 2014 Oct;25(10):1871-1888. doi: 10.1093/annonc/mdu385. Epub 2014 Sep 18.

ReferenceCitation: Lipton A, Ali SM, Leitzel K, Demers L, Harvey HA, Chaudri-Ross HA, Brady C, Wyld P, Carney W. Serum HER-2/neu and response to the aromatase inhibitor letrozole versus tamoxifen. J Clin Oncol. 2003 May 15;21(10):1967-72.

ReferenceCitation: Burstein HJ, Harris LN, Marcom PK, Lambert-Falls R, Havlin K, Overmoyer B, Friedlander RJ Jr, Gargiulo J, Strenger R, Vogel CL, Ryan PD, Ellis MJ, Nunes RA, Bunnell CA, Campos SM, Hallor M, Gelman R, Winer EP. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol. 2003 Aug 1;21(15):2889-95.

ReferenceCitation: Chan A, Martin M, Untch M, Gil MG, Guillem-Porta V, Wojtukiewicz M, Kellokumpu-Lehtinen P, Sommer HL, Georgoulias V, Battelli N, Pawlicki M, Aubert D, Bourlard T, Gasmi J, Villanova G, Petruzelka L; Navelbine Herceptin Project. Vinorelbine plus trastuzumab combination as first-line therapy for HER 2-positive metastatic breast cancer patients: an international phase II trial. Br J Cancer. 2006 Oct 9;95(7):788-93. Epub 2006 Sep 12.

ReferenceCitation: Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86.

ReferenceCitation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208.

ReferenceCitation: Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.

ReferenceCitation: Finn, R.S., et al., PALOMA-2: Primary results from a phase III trial of palbociclib (P) with letrozole (L) compared with letrozole alone in postmenopausal women with ER+/HER2- advanced breast cancer (ABC). ASCO Meeting Abstracts, 2016. 34(15_suppl): p. 507.

ReferenceCitation: Paridaens R, Dirix L, Lohrisch C, Beex L, Nooij M, Cameron D, Biganzoli L, Cufer T, Duchateau L, Hamilton A, Lobelle JP, Piccart M; European Organization for the Research and Treatment of Cancer (EORTC)- Investigational Drug Branch for Breast Cancer (IDBBC). Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer. Ann Oncol. 2003 Sep;14(9):1391-8.

ReferenceCitation: Pfizer, Inc. Palbociclib (PD-0332991): Investigator's Brochure. N.p.: Pfizer, 2015. Print.

ReferenceCitation: Peddi PF, Slamon DJ. Frontiers in HER2-positive breast cancer in 2020. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):48-52. doi: 10.1097/GCO.0000000000000677. Review.

lead_sponsor: Alliance Foundation Trials, LLC.

location_country:
Spain
Italy
Australia
New Zealand
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: The University of Chicago Medical Center

location_facility: St. Vincent's Hospital, Sydney Kinghorn Cancer Centre

location_facility: Hospital Clínico Universitario de Valencia

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: Vidia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAG Frauenklinik

location_facility: Metro-Minnesota NCI Community Oncology Research Program

location_facility: Praxis Prof. Nitz im Brustzentrum Niederrhein

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Auckland City Hospital Cancer and Blood Research

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut de Cancérologie de l'Ouest, site Paul Papin

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: First Health of the Carolinas Cancer Center

location_facility: Hospital Regional Universitario de Málaga

location_facility: UKSH, Klinik für Gynäkologie und Geburtshilfe

location_facility: Peter MacCallum Cancer Centre, Royal Melbourne Hospital

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: Univ. Klinikum Oldenburg AÖR Hämatologie/Onkologie

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: The Valley Hospital, Okonite Research Center

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Michigan Cancer Research Consortium (St. Joseph Mercy Hospital


title: COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

summary: The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

ReferenceCitation: Caputo R, Fabi A, Romagnoli E, Baldini E, Grasso D, Fenderico N, Michelotti A. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial. Breast Cancer (Dove Med Press). 2022 Oct 18;14:351-362. doi: 10.2147/BCTT.S376902. eCollection 2022.

ReferenceCitation: Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, Vidal M, Jiménez-Rodriguez B, De la Cruz Merino L, Martínez Jañez N, Villanueva Vazquez R, de Toro Salas R, Anton Torres A, Alvarez Lopez IM, Gavila Gregori J, Quiroga Garcia V, Vicente Rubio E, De la Haba-Rodriguez J, Gonzalez-Santiago S, Diaz Fernandez N, Barnadas Molins A, Cantos Sanchez de Ibargüen B, Delgado Mingorance JI, Bellet Ezquerra M, de Casa S, Gimeno A, Martin M. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast. 2022 Sep 28;66:77-84. doi: 10.1016/j.breast.2022.09.006. [Epub ahead of print]

ReferenceCitation: De Laurentiis M, Caputo R, Mazza M, Mansutti M, Masetti R, Ballatore Z, Torrisi R, Michelotti A, Zambelli A, Ferro A, Generali D, Vici P, Coltelli L, Fabi A, Marchetti P, Ballestrero A, Spazzapan S, Frassoldati A, Sarobba MG, Grasso D, Zamagni C. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. Target Oncol. 2022 Sep 24. doi: 10.1007/s11523-022-00913-x. [Epub ahead of print]

ReferenceCitation: Campone M, De Laurentiis M, Zamagni C, Kudryavcev I, Agterof M, Brown-Glaberman U, Palácová M, Chatterjee S, Menon-Singh L, Wu J, Martín M. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.

ReferenceCitation: De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19. Erratum in: Breast Cancer Res Treat. 2021 Oct 8;:.

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 https://www.clinicalstudydatarequest.com/.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Philippines
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Russian Federation
Argentina
India
Israel
Panama
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Lebanon
Canada
Hungary
Bulgaria
Denmark
Taiwan
Jordan
Greece
Oman
Finland
Thailand
France
Chile
Netherlands

location_facility: Joliet Oncology-Hematology Associates Presence Cancer Center

location_facility: Arizona Oncology Associates Arizona Oncology Assoc. (2)

location_facility: Sarah Cannon at Overland Park Regional Medical Center

location_facility: The Christ Hospital Cancer Center Research Program Linder Research Center

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Cancer Therapy and Research Center UT Health Science Center

location_facility: Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee

location_facility: University of Kansas Cancer Center University of Kansas Med Ctr 9

location_facility: Millennium Research Clin Develop Millennium Oncology - FL

location_facility: Indiana University Health Goshen Center for Cancer SC

location_facility: McLeod Center for Cancer Treatment and Research

location_facility: Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)

location_facility: University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center

location_facility: John Ochsner Heart and Vascular Institute Clinical Trials

location_facility: Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr

location_facility: Watson Clinic Center for Research 1730 Location

location_facility: Carolina Blood and Cancer Care of South Carolina

location_facility: Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI

location_facility: California Pacific Medical Center Onc Dept

location_facility: University of California Irvine UC Irvine (11)

location_facility: Poudre Valley Hospital Poudre Valley Health System

location_facility: Oregon Health and Science University SC-5

location_facility: Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)

location_facility: Stroger Cook County Hospital Division of Hematology & Onc

location_facility: Oklahoma Cancer Specialists and Research Institute SC-2

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2

location_facility: Maryland Oncology Hematology, P.A. Columbia

location_facility: Summit Cancer Care Summit Cancer Care (SC)

location_facility: Northwest Medical Specialties Dept.ofNW Med. Specialties

location_facility: Alaska Cancer Research and Education Center

location_facility: Providence Regional Medical Centre of Everett

location_facility: Centura Health Research Center Centura Health Research Center

location_facility: Florida Cancer Research Institute Dept of Oncology

location_facility: Foundation for Sickle Cell Disease Research

location_facility: Valley Medical Center Research Valley Medical Center

location_facility: Virginia Mason Medical Center-Oncology SC

location_facility: John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)


title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

lead_sponsor: Shire

ReferenceCitation: Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, Cordonnier C, Duarte RF, Florescu DF, Kamar N, Kumar D, Maertens J, Marty FM, Papanicolaou GA, Silveira FP, Witzke O, Wu J, Sundberg AK, Fournier M; SOLSTICE Trial Investigators. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results From a Phase 3 Randomized Clinical Trial. Clin Infect Dis. 2022 Sep 10;75(4):690-701. doi: 10.1093/cid/ciab988.

ReferenceCitation: Del Pozo Martín Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31.

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

location_country:
Denmark
Croatia
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
United States
France
Singapore
Belgium
Germany

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Medical University of South Carolina - PPDS

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: University of Utah Health Sciences Center - PPDS

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: University Hospitals Cleveland Medical Center

location_facility: Royal Liverpool and Broadgreen University Hospitals NHS Trust

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

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

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

summary: The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.


title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

summary: To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis

status: Recruiting

location_country:
Croatia
Spain
Italy
United States
Japan
Poland
Portugal
Slovenia
Argentina
Puerto Rico
India
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
China
Bulgaria
Greece
France


title: A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

summary: The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

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

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Russian Federation
Argentina
India
Mexico
Brazil
Canada
Hungary
China
Germany
Taiwan
Korea, Republic of
France
Netherlands


title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

acronym: DIVERSITYLTE

summary: The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in Crohn's disease (CD).

status: Enrolling by invitation

lead_sponsor: Galapagos NV

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Iceland
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Malaysia
Singapore
Sweden
Slovakia
Sri Lanka
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Georgia
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Washington University School of Medicine

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: S.L. Raheja Hospital (A Fortis Associate)

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Gastroenterology Associates of Tidewater

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: University of Louisville, Clinical Trials Unit

location_facility: Southern California Research Center, Inc.

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: The University of Chicago Medical Center (Clinic)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zancty

location_facility: UOC Medicina Interna a Gastroenterologia

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego

location_facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Gastroenterology Research of San Antonio

location_facility: Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: UOC Gastroenterologia ed Endoscopia Digestiva

location_facility: Saitama Medical Center, Saitama Medical University

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: The University of Texas Health Science Center at Houston

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

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

location_facility: Center for Interventional Endoscopy - Florida Hospital

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: New York University School of Medicine / NYU Gastroenterology Associates

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN

location_facility: Digestive Health Specialists Of The Southeast

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

location_facility: GZA Ziekenhuizen, campus Sint-Vincentius

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: Lakeshore Hospital and Research Centre Ltd

location_facility: Hyogo College of Medicine College Hospital

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: Shiga University of Medical Science Hospital

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: University of Miami Crohn's and Colitis Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Baylor College of Medicine - McNair Campus

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: University of Mississippi Medical Center

location_facility: University of Colorado Denver and Hospital

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Charlottesville Medical Research Center, LLC

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

location_facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

location_facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

location_facility: CHA Bundang Medical Center, CHA University

location_facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

location_facility: SR Kalla Memorial Gastro and General Hospital

location_facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

location_facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: Clinical Research Center Sp. z o.o. Medic-R Sp.k.

location_facility: Seth G.S. Medical College & KEM Hospital


title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease

summary:
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Iceland
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Norway
Malaysia
Singapore
Sweden
Slovakia
Sri Lanka
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Georgia
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Indiana University Health University Hospital

location_facility: Washington University School of Medicine

location_facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

location_facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

location_facility: M S Ramaiah Medical College and Hospital

location_facility: Great Lakes Gastroenterology Research, LLC,

location_facility: Medical Center - Complete Medical Solutions OOD

location_facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

location_facility: Municipal Institution "Uzhgorod District Hospital", Therapy Department

location_facility: Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

location_facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

location_facility: Gastroenterology Associates of Tidewater

location_facility: Unidade Local de Saude do Alto Minho, EPE

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

location_facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.

location_facility: Southern California Research Center, Inc.

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: S.C. Centrul Medical Sana S.R.L., Gastroenterologie

location_facility: Vestre Viken Hospital Trust, Baerum Hospital

location_facility: Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

location_facility: Kyiv City Clinical Hospital No. 18, Proctology Department

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Gastroenterology Research of San Antonio

location_facility: Bay of Plenty District Health Board - Tauranga Hospital

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: University of Louisville, School of Medicine

location_facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII

location_facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC

location_facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

location_facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

location_facility: Medstar Georgetown University Hospital (Patient Exams)

location_facility: Saitama Medical Center, Saitama Medical University

location_facility: Ohmori Toshihide gastro-intestinal Clinic

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.

location_facility: The University of Texas Health Science Center at Houston

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki

location_facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

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

location_facility: Victoria Hospital, Bangalore Medical College and Research Institute

location_facility: Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

location_facility: CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main

location_facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

location_facility: St Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

location_facility: Klinikum der Universitat Munchen - Grosshadern

location_facility: Unimed Ajara LLC - Batumi Referral Hospital

location_facility: Hutt Valley District Health Board - Hutt Valley Hospital

location_facility: S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

location_facility: Centre Hospitalier Universitaire de Lyon Sud

location_facility: Centre d'Investigation Clinique - CHU Hotel-Dieu

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: New York University School of Medicine/NYU Gastroenterology Associates

location_facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

location_facility: UOC di Gastroenterologia ed Endoscopia Digestiva

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Szent Margit Korhaz, Gasztroenterológiai Osztály

location_facility: University Medical Center Groningen (UMCG)

location_facility: Spitalul Clinic Colentina, Gastroenterologie

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: "Scientific Research Centre ECO-safety" LLC

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Delta Health Care/ Ponderas Academic Hospital

location_facility: Yokohama Health Medicine Association Kannai Suzuki Clinic

location_facility: Centrul Medical Tuculanu, Gastroenterologie

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

location_facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Centro Hospitalar e Universitario de Coimbra, E.P.E.

location_facility: Illinois Gastroenterology Group - Arlington Heights

location_facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

location_facility: Hospital Universitario de Gran Canaria "Dr. Negrin"

location_facility: Yonsei University Health System, Severance Hospital

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Institute of Gastroenterology & Liver Disease. Sunshine Hospitals

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego

location_facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

location_facility: University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"

location_facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

location_facility: Illinois Gastroenterology Group - Gurnee

location_facility: Hyogo College of Medicine College Hospital

location_facility: University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: Shiga University of Medical Science Hospital

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Asian Institute of Gastroenterology Pvt Ltd

location_facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

location_facility: University of Calgary, Heritage Medical Research Clinic

location_facility: Lakeshore Hospital and Research Centre Ltd.

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

location_facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

location_facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

location_facility: Charlotte Gastroenterology & Hepatology, PLLC

location_facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

location_facility: University of Iowa Hospitals and Clinics

location_facility: S.R.Kalla Memorial Gastro.&General Hospital

location_facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

location_facility: Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

location_facility: Universiti Kebangsaan Malaysia Medical Center

location_facility: University of Wisconsin Hospital & Clinics

location_facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

location_facility: Wellcome Trust HRB Clinical Research Facility

location_facility: Ltd. Unimed Kakheti - Telavi Referral Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Imperial College Healthcare NHS Trust, St Mary's Hospital

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Center for Interventional Endoscopy - AdventHealth Orlando

location_facility: London Health Sciences Centre - University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Lokmanya Tilak Municipal General Hospital

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Coral Sea Clinical Research Institute (Mackay)

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

location_facility: Medical corporation Ryowakai, Hamamatsu South Hospital

location_facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

location_facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

location_facility: Digestive Health Specialists of the Southeast

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Gastroenterologische Praxis Balsiger, Seibold und Partner

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Gastroplus Digestive Disease Centre Pvt Ltd

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Complejo Hospitalario Universitario de Pontevedra

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: CHU de Clermont-Ferrand - Hopital d'Estaing

location_facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

location_facility: VGM Hospital Institute of Gastroenterology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

location_facility: Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

location_facility: Texas Digestive Disease Consultants (IP Shipment)

location_facility: Kitasato University Hospital, THE KITASATO INSTITUTE

location_facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

location_facility: Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)