title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control

ReferenceCitation: Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c ≤ 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

location_country:
Croatia
Romania
Russian Federation
Estonia
Netherlands
Canada
Lithuania
Tunisia
Ukraine
Sweden
France
India
Mexico
Germany

location_facility: 1218.46.91017 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304H Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38506 Boehringer Ingelheim Investigational Site

summary: The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks


ipd_sharing: Yes

status: Terminated

primary_purpose: Treatment

intervention_type: Drug

acronym: MAGE3-AS15-MEL-005 (ADJ)

title: GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

study_completion_date_type: Actual

lead_sponsor: GlaxoSmithKline

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: background

ReferenceCitation: Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.

ReferenceCitation: Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNγ Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

enrollment_type: Actual

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Germany
Bulgaria
Taiwan
Greece
Ireland
Estonia
New Zealand
Korea, Republic of
France
Netherlands

summary:
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

summary: Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

status: Completed

ReferenceType: derived

ReferenceCitation: Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, von Eynatten M. Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial. Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Taiwan
Spain
Finland
Canada
Vietnam
Philippines
Korea, Republic of
United States
France
Japan
Germany

location_facility: Boehringer Ingelheim Investigational Site

status_simplified: Completed


type: Other Identifier

title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Bushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Ureña-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039. Erratum in: Nephrol Dial Transplant. 2019 May 15;:1642.

lead_sponsor: Amgen

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
Russian Federation
United Kingdom
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Czechia


title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

summary: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

primary_purpose: Prevention

ReferenceCitation: Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster JM, Esen M, Launay O, McElhaney JE, van Essen GA, Benoit A, Claeys C, Dewé W, Durand C, Duval X, Falsey AR, Feldman G, Galtier F, Gervais P, Hwang SJ, McNeil S, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. Hum Vaccin Immunother. 2016 Dec;12(12):3043-3055. doi: 10.1080/21645515.2016.1219809.

ReferenceCitation: van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.

ReferenceCitation: McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Poland
Taiwan
Romania
United Kingdom
Russian Federation
Estonia
Mexico
Canada
Netherlands
United States
France
Belgium
Norway
Germany
Czechia

intervention_type: Biological


title: International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.

summary: This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

design_allocation: Non-Randomized

lead_sponsor: Hoffmann-La Roche

location_country:
Luxembourg
Saudi Arabia
Italy
Spain
United Kingdom
Romania
Belgium
Poland
Portugal
Austria
Australia
India
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Ireland
Finland
Czech Republic
France
Netherlands


title: A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

summary: The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

location_country:
Spain
Latvia
Austria
Estonia
Russian Federation
Argentina
Czech Republic
Finland
Ukraine
Hungary
United States
France
Romania
Norway
Germany
Slovakia

location_facility: 1245.10.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37102 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37101 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10028 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37107 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37103 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37104 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37106 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3307A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37105 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37202 Boehringer Ingelheim Investigational Site


title: Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.

summary:
The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.

Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

ReferenceCitation: Flourié B, Hagège H, Tucat G, Maetz D, Hébuterne X, Kuyvenhoven JP, Tan TG, Pierik MJ, Masclee AA, Dewit O, Probert CS, Aoucheta D; MOTUS study investigators. Randomised clinical trial: once- vs. twice-daily prolonged-release mesalazine for active ulcerative colitis. Aliment Pharmacol Ther. 2013 Apr;37(8):767-75. doi: 10.1111/apt.12266. Epub 2013 Mar 4.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Netherlands
France
United Kingdom
Belgium

location_facility: Clinique Saint Martin - 18 rue Rocquemonts

location_facility: Investigational site - 91 rue Caulaincourt

location_facility: Investigational site - 186 avenue de la Rose

location_facility: Investigational site - 127 boulevard St Germain

location_facility: Investigational site - 23 bis, place Sébastol

location_facility: Centre Hospitalier Universitaire Albert MICHALON

location_facility: Clinique Saint Jean Languedoc - 20 route de Revel

location_facility: IJsselmeer Ziekenhuis Loc. Lelystad, Poli MDL


title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

ReferenceCitation: Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.

ReferenceCitation: Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat® in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.

location_country:
Portugal
United Kingdom
Italy
Russian Federation
Australia
Netherlands
New Zealand
United States
France
Belgium
Germany

location_facility: 205.339.170 Boehringer Ingelheim Investigational Site

location_facility: 205.339.001 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3312C Boehringer Ingelheim Investigational Site

location_facility: 205.339.3304A Boehringer Ingelheim Investigational Site

location_facility: 205.339.3304B Boehringer Ingelheim Investigational Site

location_facility: 205.339.009 Boehringer Ingelheim Investigational Site

location_facility: 205.339.020 Boehringer Ingelheim Investigational Site

location_facility: 205.339.100 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49130 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3313A Boehringer Ingelheim Investigational Site

location_facility: 205.339.223 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07005 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49133 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44181 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3308C Boehringer Ingelheim Investigational Site

location_facility: 205.339.032 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3308A Boehringer Ingelheim Investigational Site

location_facility: 205.339.025 Boehringer Ingelheim Investigational Site

location_facility: 205.339.103 Boehringer Ingelheim Investigational Site

location_facility: 205.339.004 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49135 Boehringer Ingelheim Investigational Site

location_facility: 205.339.221 Boehringer Ingelheim Investigational Site

location_facility: 205.339.101 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3318G Boehringer Ingelheim Investigational Site

location_facility: 205.339.49134 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3301B Boehringer Ingelheim Investigational Site

location_facility: 205.339.029 Boehringer Ingelheim Investigational Site

location_facility: 205.339.231 Boehringer Ingelheim Investigational Site

location_facility: 205.339.023 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07008 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3302A Boehringer Ingelheim Investigational Site

location_facility: 205.339.3309A Boehringer Ingelheim Investigational Site

location_facility: 205.339.07007 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3307A Boehringer Ingelheim Investigational Site

location_facility: 205.339.3318C Boehringer Ingelheim Investigational Site

location_facility: 205.339.3306A Boehringer Ingelheim Investigational Site

location_facility: 205.339.44184 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44194 Boehringer Ingelheim Investigational Site

location_facility: 205.339.234 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3302B Boehringer Ingelheim Investigational Site

location_facility: 205.339.002 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44180 Boehringer Ingelheim Investigational Site

location_facility: 205.339.111 Boehringer Ingelheim Investigational Site

location_facility: 205.339.016 Boehringer Ingelheim Investigational Site

location_facility: 205.339.106 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44190 Boehringer Ingelheim Investigational Site

location_facility: 205.339.105 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49131 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44182 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44191 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49145 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49132 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44183 Boehringer Ingelheim Investigational Site

location_facility: 205.339.224 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49137 Boehringer Ingelheim Investigational Site

location_facility: 205.339.011 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07001 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07002 Boehringer Ingelheim Investigational Site

location_facility: 205.339.003 Boehringer Ingelheim Investigational Site

location_facility: 205.339.010 Boehringer Ingelheim Investigational Site

location_facility: 205.339.019 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07003 Boehringer Ingelheim Investigational Site

location_facility: 205.339.030 Boehringer Ingelheim Investigational Site

location_facility: 205.339.07006 Boehringer Ingelheim Investigational Site

location_facility: 205.339.006 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3318A Boehringer Ingelheim Investigational Site

location_facility: 205.339.171 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44186 Boehringer Ingelheim Investigational Site

location_facility: 205.339.013 Boehringer Ingelheim Investigational Site

location_facility: 205.339.49142 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3314C Boehringer Ingelheim Investigational Site

location_facility: 205.339.104 Boehringer Ingelheim Investigational Site

location_facility: 205.339.014 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3310A Boehringer Ingelheim Investigational Site

location_facility: 205.339.022 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3317E Boehringer Ingelheim Investigational Site

location_facility: 205.339.3314A Boehringer Ingelheim Investigational Site

location_facility: 205.339.021 Boehringer Ingelheim Investigational Site

location_facility: 205.339.017 Boehringer Ingelheim Investigational Site

location_facility: 205.339.031 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3315C Boehringer Ingelheim Investigational Site

location_facility: 205.339.44192 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3313B Boehringer Ingelheim Investigational Site

location_facility: 205.339.3317C Boehringer Ingelheim Investigational Site

location_facility: 205.339.3308B Boehringer Ingelheim Investigational Site

location_facility: 205.339.233 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3312A Boehringer Ingelheim Investigational Site

location_facility: 205.339.225 Boehringer Ingelheim Investigational Site

location_facility: 205.339.44193 Boehringer Ingelheim Investigational Site

location_facility: 205.339.024 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3317D Boehringer Ingelheim Investigational Site

location_facility: 205.339.018 Boehringer Ingelheim Investigational Site

location_facility: 205.339.026 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3317A Boehringer Ingelheim Investigational Site

location_facility: 205.339.3306B Boehringer Ingelheim Investigational Site

location_facility: 205.339.07004 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3303A Boehringer Ingelheim Investigational Site

location_facility: 205.339.44185 Boehringer Ingelheim Investigational Site

location_facility: 205.339.112 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3316A Boehringer Ingelheim Investigational Site

location_facility: 205.339.49140 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3302C Boehringer Ingelheim Investigational Site

location_facility: 205.339.49141 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3314B Boehringer Ingelheim Investigational Site

location_facility: 205.339.110 Boehringer Ingelheim Investigational Site

location_facility: 205.339.005 Boehringer Ingelheim Investigational Site

location_facility: 205.339.3315D Boehringer Ingelheim Investigational Site

summary: This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations


title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

summary: The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.

lead_sponsor: Ipsen

location_country:
Serbia
United Kingdom
Italy
United States
Belgium
Philippines
Romania
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Lebanon
Hungary
China
Germany
Taiwan
Jordan
Latvia
Estonia
Thailand
Algeria
France
Korea, Republic of
United Arab Emirates

location_facility: National Rehabilitation center "Vaivari"

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II

location_facility: Instituto de Medicina Física e Reabilitaçao

location_facility: State Federal Budgetary Institution Scientific Center of Neurology RAMS

location_facility: Spitalul Universitar de Urgenta Bucuresti, neurologie

location_facility: Pusan National University Yangsan Hospital

location_facility: CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

location_facility: Department of Neurology 1st LF UK and VFN

location_facility: Istanbul University Cerrahpaşa Medical Faculty

location_facility: Hospital General Dr. Santiago Ramón y Cajal

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro

location_facility: Medical University of Vienna Spitalgasse 23

location_facility: The Parkinson's and Movement Disorders Center

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: State Institution "Interregional clinical diagnostic centre"

location_facility: Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"

location_facility: Policlinico Umberto I, Università La Sapienza

location_facility: Tartu University Hospital, Neurology Clinic

location_facility: P. Stradins Clinical University hospital

location_facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"

location_facility: State Educational Institution of high professional education "Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky of the Ministry of Health and Social Development of Russia"

location_facility: Hospital das Clínicas, Universidade Federal de Minas Gerais

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Rehabilitación Integral de Querétaro

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Parkinson's and Movement Disorders Center of Maryland


title: A Multicentre, Open Label, Early Stopping Design, Proof Of Concept Study With Tasquinimod In Treating Patients With Advanced Or Metastatic Hepatocellular, Ovarian, Renal Cell And Gastric Carcinomas

summary: This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies.

ReferenceCitation: Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget JC, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Target Oncol. 2017 Oct;12(5):655-661. doi: 10.1007/s11523-017-0525-2.

location_country:
United Kingdom
Spain
Canada
France
Belgium

location_facility: Hospital Beaujon, 100 Blvd du Général Leclerc

location_facility: Hospital Gregorio Marañon, Dr. Esquerdo, 44-46

location_facility: Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc

location_facility: Leicester General Hospital, Gwndolen Road

location_facility: Centre Oscar Lambret, 3 rue Frédéric Combemale

location_facility: London Health Sciences Center, 790 Commissoners Road East

location_facility: Juravinski Cancer Centre, 699 Concession St

location_facility: Leuven cancer institute (LKI), Herestraat

location_facility: Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec

location_facility: MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,

location_facility: Centre René Gauducheau, Boulevard Jacques Monod

location_facility: Centre Eugene Marquis, Avenue bataille Flandres Dunkerque

location_facility: The Royal Marsden Hospital, Downs Rd, Sutton

location_facility: Institute Gustave-Roussy, 114 rue Edouard Vaillant

location_facility: Freeman Hospital, Freeman Road, High Heaton

location_facility: Ghent University Hospital, 1K12 IE, De Pintelaan 185

location_facility: Sunnybrook, 2075 Bayview Avenue, Suite T2049

location_facility: Southampton General Hospital, Tremona Road, Shirley

location_facility: Princess Margaret, 610 University Avenue

location_facility: Antwerp University Hospital, Wilrijkstraat 10

location_facility: The Christie Hospital, Wilmslow Road, Withington

location_facility: Beatson West of Scotland Cancer Centre, 1053 Great Western Road

location_facility: Hospital Saint-Antoine, 184 rue du Faubourg St Antoine


title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon

summary: The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. eCollection 2016.

location_country:
Portugal
Spain
Greece
Italy
Australia
New Zealand
Canada
United Kingdom
United States
France
Belgium
Germany

location_facility: 1241.36.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39028 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00030 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39023 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00034 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00032 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39025 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39021 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49014 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00019 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00044 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00039 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00035 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00043 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00033 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00027 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00013 Boehringer Ingelheim Investigational Site


title: Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

acronym: FOXFIREGlobal

summary:
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

ReferenceType: result

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodríguez J, Kröning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum in: J Clin Oncol. 2016 Nov 20;34(33):4059.

ReferenceCitation: Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators, van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

ReferenceCitation: Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

ipd_sharing: No

lead_sponsor: Sirtex Medical

location_country:
Taiwan
Portugal
Spain
Italy
Australia
New Zealand
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centre Hospitalier General de Longjumeau

location_facility: Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie

location_facility: Sheba Medical Center - Governmental Hospital - Oncology Division

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

location_facility: Spartanburg Regional Healthcare / Gibbs Cancer Center

location_facility: Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin

location_facility: Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin

location_facility: Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo

location_facility: U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello

location_facility: Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie

location_facility: CHU de Poitiers, Pole regional de cancerologie

location_facility: Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie

location_facility: Klinikum rechts der Isar der TU Munchen Medizinische Klinik II

location_facility: SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie

location_facility: TA Sourasky Medical Center, Oncology Department 6

location_facility: Dipartimento di Oncologia, Ospendali Riuniti di Bergamo

location_facility: Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie

location_facility: Schwerpunktpraxix fur Hamatologie und Onkologie

intervention_type: Device


title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

ReferenceCitation: Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.

ReferenceCitation: Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Brazil
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Switzerland
United States
France
Israel
Belgium
Germany

location_facility: Sir Mortimer B Davis - Jewish General Hospital

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Washington University School Of Medicine

location_facility: Network Office of Research and Innovation


title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

summary:
This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

ReferenceCitation: Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.

ReferenceCitation: Haluzík M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.

ReferenceCitation: Yang W, Akhtar S, Franek E, Haluzík M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
Algeria
United States
France
Norway


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

lead_sponsor: Gilead Sciences

ReferenceCitation: Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. Epub 2016 Aug 23.

ReferenceCitation: Younossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17.

ReferenceCitation: Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Bräu N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.

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

location_country:
Spain
Italy
United Kingdom
Puerto Rico
United States
France
Germany

summary: The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.


title: A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.

ReferenceCitation: Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.

location_country:
Denmark
Poland
United Kingdom
Greece
Austria
Australia
Estonia
Canada
Italy
Latvia
Netherlands
Russian Federation
Hungary
Switzerland
United States
France
Belgium
Norway
Germany
Czechia


title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

acronym: DUAL™ III

summary:
This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

ReferenceCitation: Linjawi S, Bode BW, Chaykin LB, Courrèges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.

ReferenceCitation: Lingvay I, Handelsman Y, Linjawi S, Vilsbøll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

location_country:
Australia
Hungary
United States
France
Slovakia


title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

ReferenceCitation: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum in: J Clin Oncol. 2021 Apr 1;39(10):1190.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

ReferenceCitation: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Arén Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crinò L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

ReferenceCitation: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

location_country:
Spain
Italy
United States
Peru
Romania
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Mexico
Norway
Singapore
Brazil
Canada
Switzerland
Hungary
Germany
France
Chile

location_facility: Winthrop University Hospital Oncology/Hematology

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University Of Texas Southwestern Medical Center


title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

summary: The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

ReferenceCitation: Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.

ReferenceCitation: Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

lead_sponsor: Boston Scientific Corporation

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Latvia
Canada
Finland
New Zealand
United States
France
Singapore
Belgium
Japan
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Washington University School of Medicine

location_facility: Department of Cardiology, Tokyo Women's Medical University

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: Medisch Spectrum Twente, Haaksbergerstraat

location_facility: University Hospitals Case Medical Center

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: University of California Davis Health System

location_facility: Hospital Universitario Clínico San Carlos

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

location_facility: Centre Hospitalier de Lagny - Marne La Vallée

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

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Clinique Saint-Hilaire - Centre Frédéric Joliot

location_facility: P. Stradins Clinical University Hospital

location_facility: Prairie Cardiovascular Consultants, Ltd.

location_facility: Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

location_facility: National Cerebral and Cardiovascular Center

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Lahey Clinic Medical Center - Burlington

location_facility: University of Miami McKnight Brain Institute


title: An Observational Disease and Clinical Outcomes Registry of Patients With Lysosomal Acid Lipase (LAL) Deficiency

summary: This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency. Participation in the Registry by both physicians and patients is voluntary.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Soll D, Spira D, Hollstein T, Haberbosch L, Demuth I, Steinhagen-Thiessen E, Bobbert T, Spranger J, Kassner U. Clinical outcome of a patient with lysosomal acid lipase deficiency and first results after initiation of treatment with Sebelipase alfa: A case report. Mol Genet Metab Rep. 2019 Jun 18;20:100479. doi: 10.1016/j.ymgmr.2019.100479. eCollection 2019 Sep.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Croatia
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Slovenia
Australia
Israel
Mexico
Brazil
Canada
Germany
Denmark
Greece
Ireland
France
Netherlands

status_simplified: Ongoing


title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

acronym: ARCH

summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

ReferenceCitation: Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

ReferenceCitation: Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.

ReferenceCitation: Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Romania
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Guatemala
Hungary
Germany
Bulgaria
Denmark
Taiwan
Dominican Republic
Greece
Estonia
Ireland
Finland
Latvia
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

acronym: Hallmark DUAL

summary: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

ReferenceCitation: Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

ReferenceCitation: Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. Erratum in: Lancet. 2014 Nov 1;384(9954):1576.

location_country:
Poland
Taiwan
Spain
Ireland
Austria
Australia
Italy
Argentina
Canada
Netherlands
New Zealand
Russian Federation
Korea, Republic of
United States
France
Israel
United Kingdom
Germany

location_facility: Washington University School Of Medicine

location_facility: University Of Colorado Denver And Hospital

location_facility: The Health Care Authority For Baptist Health

location_facility: North Shore-Long Island Jewish Health System

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: University Of North Carolina At Chapel Hill School Of Med

location_facility: Gastrointestinal Research Institute (G.I.R.I.)

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Toronto General Hospital-University Health Network


status: Unknown status

title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

lead_sponsor: Alaunos Therapeutics

location_country:
Poland
Taiwan
United Kingdom
Italy
Russian Federation
Australia
Canada
Hungary
United States
France
Israel

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum

location_facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie

location_facility: Fairfax Northern Virginia Hematology-Oncology, PC

location_facility: Centre Hospitalier Universitaire, Hopital Bretonneau

location_facility: Southern Medical Day Oncology Care Centre

location_facility: State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"

location_facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Dayton Cancer Center, Medical Oncology Hematology Associates

location_facility: GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary

location_facility: Birmingham Hematology and Oncology Associates, LLC

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center

location_facility: Texas Oncology- Baylor, Charles A. Sammons Cancer Center

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: University of Texas Medical Branch at Galveston

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Cancer Research Center n.a. N.N. Blokhin

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Medical Oncology Associates Of Wyoming Valley, PC

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

location_facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Peachtree Hematology Oncology Consultants

location_facility: Centre Hospitalier Universitaire -Hôpital Morvan

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Wisconsin Institutes for Medical Research

location_facility: Saint-Petersburg State Medical University n. a. I. P. Pavlov

location_facility: State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"

location_facility: Indiana University Health Ball Memorial Hospital

summary:
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.


title: A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.

acronym: ADMIRE-CD

summary: The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.

ReferenceCitation: Garcia-Olmo D, Gilaberte I, Binek M, D Hoore AJL, Lindner D, Selvaggi F, Spinelli A, Panés J. Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial. Dis Colon Rectum. 2022 May 1;65(5):713-720. doi: 10.1097/DCR.0000000000002325.

ReferenceCitation: Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.

ReferenceCitation: Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.

lead_sponsor: Tigenix S.A.U.

location_country: Spain Italy Austria Netherlands France Israel Belgium Germany

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Seconda Università degli Studi di Napoli

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

intervention_type: Other


title: An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

summary: This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

ReferenceCitation: Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAF(V600)-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.

ReferenceCitation: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309. Erratum in: N Engl J Med. 2018 Oct 18;379(16):1585.

location_country:
Spain
United Kingdom
United States
France
China
Germany

location_facility: Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

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

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: The Royal Marsden Hospital; Dept of Medicine


title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

summary: The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Russian Federation
Argentina
Canada
Switzerland
United Kingdom
United States
France
Israel
Germany

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: University Of North Carolina At Chapel Hill School Of Med


title: Phase III in Partial and Null Responders

acronym: ATTAIN

summary: The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

ReferenceCitation: Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5. Erratum in: Lancet Infect Dis. 2016 Apr;16(4):404.

lead_sponsor: Janssen R&D Ireland

location_country:
Spain
United Kingdom
United States
Romania
Belgium
Poland
Portugal
Austria
Australia
Argentina
Puerto Rico
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Czech Republic
France


title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study

acronym: IMAGINE 1

summary:
The purpose of this study is:

To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

ReferenceCitation: Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

ReferenceCitation: Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

ReferenceCitation: Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Italy
Austria
Russian Federation
United States
France
Mexico
Japan
Germany

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