title: A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

summary:
Primary Objective:

The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin.

Secondary Objectives:

To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on:

Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test;
Percentage of participants reaching HbA1c <7% or ≤6.5%;
7-point Self-Monitored Plasma Glucose (SMPG) profile;
Body weight;
Insulin glargine dose
Fasting Plasma Glucose (FPG);
Percentage of participants requiring rescue therapy during the 24-week open label treatment period;
To assess safety and tolerability of insulin glargine/lixisenatide FRC.

ReferenceCitation: Rosenstock J, Diamant M, Aroda VR, Silvestre L, Souhami E, Zhou T, Perfetti R, Fonseca V; LixiLan PoC Study Group. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. Diabetes Care. 2016 Sep;39(9):1579-86. doi: 10.2337/dc16-0046. Epub 2016 Jun 9.

publisher_dissemination: American Diabetes Association

lead_sponsor: Sanofi

location_country:
Germany
Lithuania
Poland
Slovakia
Hungary
Denmark
Romania
Sweden
Mexico
United States
Chile
Czech Republic
France

location_facility:
Investigational Site Number 348405
Investigational Site Number 840402
Investigational Site Number 250402
Investigational Site Number 152405
Investigational Site Number 840405
Investigational Site Number 642404
Investigational Site Number 840414
Investigational Site Number 484405
Investigational Site Number 703402
Investigational Site Number 752402
Investigational Site Number 440402
Investigational Site Number 348401
Investigational Site Number 840401
Investigational Site Number 840404
Investigational Site Number 840410
Investigational Site Number 152403
Investigational Site Number 752403
Investigational Site Number 616402
Investigational Site Number 440404
Investigational Site Number 203401
Investigational Site Number 840413
Investigational Site Number 250401
Investigational Site Number 203402
Investigational Site Number 840417
Investigational Site Number 840415
Investigational Site Number 642406
Investigational Site Number 208404
Investigational Site Number 840412
Investigational Site Number 152404
Investigational Site Number 208401
Investigational Site Number 152402
Investigational Site Number 703404
Investigational Site Number 348406
Investigational Site Number 203403
Investigational Site Number 616404
Investigational Site Number 276402
Investigational Site Number 642402
Investigational Site Number 703403
Investigational Site Number 840411
Investigational Site Number 484403
Investigational Site Number 276401
Investigational Site Number 250404
Investigational Site Number 616405
Investigational Site Number 203405
Investigational Site Number 208402
Investigational Site Number 616403
Investigational Site Number 484401
Investigational Site Number 616401
Investigational Site Number 348403
Investigational Site Number 484402
Investigational Site Number 703405
Investigational Site Number 484404
Investigational Site Number 348402
Investigational Site Number 348404
Investigational Site Number 152401
Investigational Site Number 840408
Investigational Site Number 616407
Investigational Site Number 642405
Investigational Site Number 752401
Investigational Site Number 642403
Investigational Site Number 642401
Investigational Site Number 840407
Investigational Site Number 703406
Investigational Site Number 440401
Investigational Site Number 703401
Investigational Site Number 440403
Investigational Site Number 840403
Investigational Site Number 208403
Investigational Site Number 276403
Investigational Site Number 616406


type: EudraCT Number

title: A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

summary: The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: von Stackelberg A, Locatelli F, Zugmaier G, Handgretinger R, Trippett TM, Rizzari C, Bader P, O'Brien MM, Brethon B, Bhojwani D, Schlegel PG, Borkhardt A, Rheingold SR, Cooper TM, Zwaan CM, Barnette P, Messina C, Michel G, DuBois SG, Hu K, Zhu M, Whitlock JA, Gore L. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2016 Dec 20;34(36):4381-4389. doi: 10.1200/JCO.2016.67.3301. Epub 2016 Oct 31.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Amgen Research (Munich) GmbH

location_country:
Germany
Italy
Netherlands
Austria
United States
Canada
France

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinikum der Universität München, Dr. von Haunersches Kinderspital

location_facility: University of Milano-Bicocca, Hospital San Gerardo

location_facility: Children's Healthcare of Atlanta at Egleston

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

location_facility: Charité Campus Virchow Klinikum, Otto-Heubner-Centrum (OHC) für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

title: Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Safety, efficacy and pharmacokinetics of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously treated pediatric hemophilia B patients. Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu M-Y, Persson P, Rangarajan S, Santagostino E. Presented 06-Dec-2014 at the American Society of Hematology - 56th Annual Meeting - held in San Francisco, CA, US (poster #1513)

ReferenceType: result

ReferenceCitation: Carcao M, Zak M, Abdul Karim F, Hanabusa H, Kearney S, Lu MY, Persson P, Rangarajan S, Santagostino E. Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial. J Thromb Haemost. 2016 Aug;14(8):1521-9. doi: 10.1111/jth.13360. Epub 2016 Jun 22.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Carcao M, Kearney S, Lu MY, Taki M, Rubens D, Shen C, Santagostino E. Long-Term Safety and Efficacy of Nonacog Beta Pegol (N9-GP) Administered for at Least 5 Years in Previously Treated Children with Hemophilia B. Thromb Haemost. 2020 May;120(5):737-746. doi: 10.1055/s-0040-1709521. Epub 2020 May 5.

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Georg Thieme

ipd_sharing: Yes

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

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
United Kingdom
Japan
Brazil
United States
Malaysia
Croatia
Taiwan
Canada
France

intervention_type: Drug

status_simplified: Ongoing


title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

acronym: OCTAVE

summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

design_allocation: Randomized

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

publisher_dissemination: Wiley

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

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

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panes J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum In: Intest Res. 2018 Jul;16(3):499-501.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_country:
Germany
Poland
New Zealand
Australia
Japan
Croatia
Canada
Serbia
France
Czech Republic
Colombia
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Spain
South Africa
Russian Federation
Israel

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly

location_facility: Huron Gastroenterology Associates / Center for Digestive Care

location_facility: Baylor College of Medicine (Baylor Medical Center)

location_facility: North Florida Gastroenterology Research, LLC

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems

location_facility: Michigan Clinical Research Unit - Univeristy of Michigan Health System

location_facility: Federal State Budgetary Military Educational Institution of High Professional Education

location_facility: Gastroenterology Associates of Central Georgia

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III,

location_facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)

location_facility: State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko

location_facility: Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital

location_facility: General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology

location_facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2

location_facility: X-Ray Department of West Tallinn Central Hospital

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Medical Science Research Building 1 - University of Michigan Health Systems

location_facility: State Institution "National L.T. Malaya Therapy Institute of National Academy

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki

location_facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Javorszky Odon Korhaz/Gasztroenterologiai Osztaly

location_facility: National Hospital Organization Mito Medical Center

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Georgia Endoscopy Center (Colonoscopy only)

location_facility: Washington University School of Medicine - Division of Gastroenterology

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock

location_facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)

location_facility: SOC Gastroenterologia Centro di Riferimento Oncologico

location_facility: Houston Hospital for Specialized Surgery

location_facility: Cedars Sinai Medical Center - Thalians Bldg

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center

location_facility: Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"

location_facility: Hamilton Health Sciences Corporation - McMaster University Medical Centre

location_facility: West Tallinn Central Hospital Internal Diseases Clinic

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: The Private Practice of Simon Lichtiger, MD

location_facility: Shiga University of Medical Science Hospital

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Hertiage Medical Research Clinic- University Of Calgary

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Hospital Clínic i provincial de Barcelona

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: London Health Sciences Centre - University Hospital

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Michigan Heart SJMH (Blood draws and ECGs only)

location_facility: Johns Creek Diagnostic Center (X-Ray only)

location_facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI

location_facility: Bop Clinical School Clinical Trials Unit

location_facility: State Budget Educational Institution of Higher Professional Education

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


lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

summary: Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: KU "Odeska oblasna dytiacha klinichna likarnia"

location_facility: Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv

location_facility: Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"

location_facility: Phramongkutklao Hospital, Neurology Unit,

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Katedra i Klinika Neurologii Wieku Rozwojowego

location_facility: Saint George Hospital - University Medical Center

location_facility: DCC Sveta Anna - Sofia\ Neurological room

location_facility: Neurologicka ambulancia MUDr. Eva Gasparova

location_facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2

location_facility: A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia

location_facility: Perm State Medical University n. a. acad. E.A. Vagner

location_facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia

location_facility: Dokuz Eylül University medical Faculty Internal Medicine Disease

location_facility: Dr. Kenessey Albert Kórház és Rendelőintézet

location_facility: Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia

location_facility: Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"

location_facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li

location_facility: UMHAT "Sveti Georgi" Ltd., Pediatric Clinic

location_facility: State Budgetary Healthcare Institution of Stavropol region

location_facility: The Barberry National Centre for Mental Health

location_facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly

location_facility: GBOU VPO "Smolensk State Medical University"

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.

location_facility: Eskisehir Osmangazi University Medical Faculty

location_facility: SPHI Leningrad Regional Psychoneurological Dispensary

location_facility: UZ Vitebsk Regional Childrens Clinical Centre

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Public Health Institution Hospital "Dr. Mladen Stojanovic"

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: GU Republican Scientific and Practical Center Mother and Child

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

location_facility: Spitalul clinic de copii Dr. Victor Gomoiu

location_facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

location_facility: MAI Children's City Clinical Hospital No 9

location_facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia

location_facility: "Multiprofile Hospital for Active Treatment Puls" AD

location_facility: FSBI V.M. Bekhterev National Research Medical Center

location_facility: Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

location_facility: American University of Beirut Medical Center

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"

location_facility: The First Bethune Hospital of Jilin University

location_facility: Izmir Tepecik Training and Research Hospital

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

location_facility: Ege University Medical Faculty Department of Pediatrics Health and Diseases,

location_facility: Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly

location_facility: Pediatric Epilepsy Center Of Central Florida

location_facility: Pharmacy of Tel Aviv Sourasky Medical Center

location_facility: Siriraj Hospital, Mahidol University, Faculty of Medicine

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/

location_facility: UZ Brussel - Campus Jette - Pediatric Neurology

location_facility: Behcet Uz Children Disease and Surgery Training and Research Hospital

location_facility: NZOZ "IGNIS" Dr. n. med. Alicja Lobinska

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: General Children's Hospital of Athens "P&A Kyriakou"

location_facility: Fakultni nemocnice Brno - Detska nemocnice

location_facility: A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi

location_facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam

location_facility: RSBHI Smolensk Regional Clinical Hospital

location_facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5

location_facility: Regional State Budgetary Institution of Ministry of Health

location_facility: Pediatric Epilepsy and Neurology Specialists, PA

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

location_facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"

location_facility: Gabinet lekarski Neurologii I Leczenia padaczki

title: A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

source: euctr

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Poland
Bosnia and Herzegovina
Thailand
Turkey
Czechia
Serbia
France
Belarus
Montenegro
Hungary
Slovakia
United States
Ukraine
India
Romania
Lebanon
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

acronym: JOSHUA

summary: This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Netherlands
Belgium
Korea, Republic of
Spain
Czechia
France

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: University Hospital Na Bulovce; Institut of Radiation Oncology

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Masaryk Memorial Cancer Institute; Oncological Clinic

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

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

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.


title: A Non-Interventional Retrospective Correlation Of Tumor Mutation Status To Clinical Benefit From The SU011248, A6181036 Treatment Protocol Titled: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate

summary: Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Reichardt P, Demetri GD, Gelderblom H, Rutkowski P, Im SA, Gupta S, Kang YK, Schoffski P, Schuette J, Soulieres D, Blay JY, Goldstein D, Fly K, Huang X, Corsaro M, Lechuga MJ, Martini JF, Heinrich MC. Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial. BMC Cancer. 2016 Jan 15;16:22. doi: 10.1186/s12885-016-2051-5.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dash.harvard.edu;s-space.snu.ac.kr

unpaywall_oa_status: gold

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
India
Slovakia
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Shands Hospital at the University of Florida

location_facility: Hopital Notre-dame du Centre Hospitalier Universitaire de Montreal

location_facility: Leids Universitair Medisch Centrum/ Klinische Oncologie

location_facility: Helsingin yliopistollinen keskussairaala/Syopatautien klinikka

location_facility: Asan Medical Center, Department of Internal Medicine

location_facility: Prince of Wales Hospital, Oncology Day Center

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: Masonic Cancer Center - Clinical Trials Office

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Schwerpunktpraxis fuer ambulante Tumortherapie

location_facility: HELIOS Klinikum Berlin-Buch, Klinik fuer Interdisziplinaere Onkologie

location_facility: Klinika Nowotworow Tkanek Miekkich i Kosci

location_facility: Seoul National University Hospital/Department of Internal Medicine

location_facility: Peter MacCallum Cancer Institute, Department of Medical Oncology

location_facility: CHU La Timone, Service d'Oncologie Medicale

intervention_type: Other


title: An Observational Study to Assess Respiratory Syncytial Virus (RSV)-Associated Illness in Adults With Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)

summary: The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.

time_perspective: Prospective

lead_sponsor: MedImmune LLC

sponsor_collaborators:
MedImmune LLC
AstraZeneca

location_country:
Germany
Italy
Sweden
United States
Bulgaria
Canada
Czech Republic
Russian Federation
France


title: Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

acronym: ASPIRE

summary: The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

status: Terminated

enrollment_type: Anticipated

ReferenceCitation: Come CE, Kramer MR, Dransfield MT, Abu-Hijleh M, Berkowitz D, Bezzi M, Bhatt SP, Boyd MB, Cases E, Chen AC, Cooper CB, Flandes J, Gildea T, Gotfried M, Hogarth DK, Kolandaivelu K, Leeds W, Liesching T, Marchetti N, Marquette C, Mularski RA, Pinto-Plata VM, Pritchett MA, Rafeq S, Rubio ER, Slebos DJ, Stratakos G, Sy A, Tsai LW, Wahidi M, Walsh J, Wells JM, Whitten PE, Yusen R, Zulueta JJ, Criner GJ, Washko GR. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015 Sep;46(3):651-62. doi: 10.1183/09031936.00205614. Epub 2015 Apr 2.

oa_colors: green other

evidence: open (via free pdf)

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

lead_sponsor: Aeris Therapeutics

location_country:
France
Italy
Netherlands
United States
Spain
Greece
Israel

location_facility: University of Iowa Hospitals and Clinics

location_facility: Azienda Ospedaliera Spedali Civili de Brescia

location_facility: University of South Carolina School of Medicine

location_facility: Kaiser Foundation Hospitals (accepting Kaiser patients only)

location_facility: University of Athens - Sotiria General Hospital

location_facility: Miami VA Healthcare System (accepting Miami VA patients only)

location_facility: Hospital Universitario y Politécnico La Fe

intervention_type: Device

status_simplified: Unknown


title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma

summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

ReferenceCitation: Peters SP, Bleecker ER, Canonica GW, Park YB, Ramirez R, Hollis S, Fjallbrant H, Jorup C, Martin UJ. Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. N Engl J Med. 2016 Sep 1;375(9):850-60. doi: 10.1056/NEJMoa1511190.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Vietnam
Chile
France
Czech Republic
Colombia
Slovakia
United States
Ukraine
India
Romania
Peru
Puerto Rico
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Panama
South Africa
Bulgaria
Russian Federation


lead_sponsor: Helsinn Healthcare SA

summary: The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

ReferenceCitation: Kovacs G, Wachtel AE, Basharova EV, Spinelli T, Nicolas P, Kabickova E. Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. Lancet Oncol. 2016 Mar;17(3):332-344. doi: 10.1016/S1470-2045(15)00520-3. Epub 2016 Jan 19.

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

location_facility: Tartu University Hospital, Hematology - Oncology Clinic

location_facility: Clinical Center Nis, Clinic for pediatrics internal diseases, Department for hematology and oncology

location_facility: Public Treatment and Prophylaxis Institution: Regional Children's Clinical Hospital

location_facility: CHRU de Lille - Hopital d'Hematologie Pediatrique

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca Pediatric Department

location_facility: Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department

location_facility: State Institution: V. K. Husak Institute of Urgent and Reconstructive Surgery

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital

location_facility: Public Healthcare Institution: Regional Children's Clinical Hospital #1

location_facility: University Hospital Brno, Children's Medical Centre, Clinic of Pediatric Oncology

location_facility: Institut Pomnik - The Children Memorial Health Institute, Department of Oncology

location_facility: Sf. Maria - Chidren's Emergency Clinical Hospital

location_facility: University Hospital in Ostrava, Clinic of Pediatric

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologica CAA

location_facility: University of Szeged, Szent-Gyorgyl Albert Clinical Center, Department of Pediatrics

location_facility: "Prof. Dr. Alexandru Trestioreanu" Institute of Oncology, Pediatric Oncology Department

location_facility: Specialised Pediatric Clinic of Clinical Hematology and Oncology Mutiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: CHRU de Tours - Centre de Pediatrie Gatien de Clocheville

location_facility: Backus Children's Hospital at University Pediatrics

location_facility: University of Kentucky - Chandler Medical Center

location_facility: Semmelweis University, 2nd Department of Pediatrics

location_facility: Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital

location_facility: Specialised Hospital for Active Treatment of Oncohematological Diseases in Children

location_facility: University Hospital Motol, Department of Paediatric Heamatology and Oncology

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Szpital Uniwersytecki - Department of Pediatrics, Hematology and Oncology

location_facility: Fundeni Clinical Institute, Pediatrics Clinic

location_facility: Hospital Nacional "Prof. Dr. Alejandro Posadas"

title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC

primary_purpose: Prevention

location_country:
France
Germany
Poland
Hungary
Argentina
Romania
Austria
United States
Chile
Peru
Ukraine
Bulgaria
Estonia
Serbia
Russian Federation
Czech Republic


title: A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy

summary: Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.

ReferenceCitation: Powles T, Lackner MR, Oudard S, Escudier B, Ralph C, Brown JE, Hawkins RE, Castellano D, Rini BI, Staehler MD, Ravaud A, Lin W, O'Keeffe B, Wang Y, Lu S, Spoerke JM, Huw LY, Byrtek M, Zhu R, Ware JA, Motzer RJ. Randomized Open-Label Phase II Trial of Apitolisib (GDC-0980), a Novel Inhibitor of the PI3K/Mammalian Target of Rapamycin Pathway, Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol. 2016 May 10;34(14):1660-8. doi: 10.1200/JCO.2015.64.8808. Epub 2016 Mar 7.

lead_sponsor: Genentech, Inc.

location_country:
Germany
United Kingdom
United States
Spain
France


title: Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

summary: This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

lead_sponsor: Bial - Portela C S.A.

location_country: Germany Poland Portugal Romania Austria Spain Croatia Czechia Bulgaria France

location_facility: Medizinische Universitat Wien Klinik fur Neurologie

location_facility: Polyclinic for neurology and psychiatry 'Interneuron

location_facility: Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika

location_facility: Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia

location_facility: Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)

location_facility: Universitätsklinik für Neurologie; Christian-Doppler-Klinik

location_facility: Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: General County Hospital Požega, Neurology department

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz

location_facility: Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie

location_facility: IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

location_facility: Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Neurologische Gemeinschaftspraxis am Seelberg

location_facility: Klinik für Epileptologie Universität Bonn

location_facility: AIBILI - Centro de Estudos de Biodisponibildade

location_facility: Diagnostic & Consultative Center "Sveta Anna" EOOD

location_facility: Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie


summary:
Primary Objective:

Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for :

Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and
Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia.

PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for:

Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and
Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET.

Secondary Objectives:

To evaluate the safety of SAR302503.
To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.
To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts.
To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8.
To evaluate splenic response as measured by spleen volume using MRI or CT.
To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.
To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.
To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life.
To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.

location_facility:
Investigational Site Number 410004
Investigational Site Number 826001
Investigational Site Number 724002
Investigational Site Number 250004
Investigational Site Number 840004
Investigational Site Number 276003
Investigational Site Number 840001
Investigational Site Number 826004
Investigational Site Number 724004
Investigational Site Number 036002
Investigational Site Number 380003
Investigational Site Number 250001
Investigational Site Number 840007
Investigational Site Number 124001
Investigational Site Number 380001
Investigational Site Number 380004
Investigational Site Number 036003
Investigational Site Number 840003
Investigational Site Number 124002
Investigational Site Number 036004
Investigational Site Number 410003
Investigational Site Number 410002
Investigational Site Number 724001
Investigational Site Number 826006
Investigational Site Number 826003
Investigational Site Number 124003
Investigational Site Number 276004
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 036001
Investigational Site Number 840011
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840005
Investigational Site Number 410001

title: A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea

location_country:
Germany
Italy
United Kingdom
Australia
United States
Korea, Republic of
Spain
Canada
France


lead_sponsor: Sandoz

summary: The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

ReferenceCitation: Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017 Aug;4(8):e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.

oa_host_type: closed

sponsor_collaborators:
Sandoz
Novartis Pharmaceuticals

location_facility:
India
Invstigative site
Investigator site
Investigative Site
Investigative site
Investigtive site

title: A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
France
Colombia
Portugal
Hungary
Ukraine
India
Romania
Malaysia
Peru
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

ipd_sharing: Undecided


title: First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study

summary: PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).

design_allocation: Non-Randomized

lead_sponsor: Merck KGaA, Darmstadt, Germany

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A., Geneva

location_country:
Germany
Italy
United Kingdom
Argentina
Sweden
Spain
Canada
Czech Republic
France

location_facility: University of Cologne Children's Hospital

location_facility: Karolinska University Hospital Campus Solna

location_facility: Faculty of Health Sciences, Linkping University

location_facility: Hospital de Niños de la Santisima Trinidad

location_facility: CHU Bordeaux - Hopital pédiatrique Pellegrin

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: Centro di Endocrinologia e Diabetologia Pediatrica

location_facility: Istituto Giannina Gaslini - Clinica Pediatrica

location_facility: University of Calgary - Alberta Children's Hospital

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Infantil Universitario Niño Jesús


title: OMEGA: A Prospective, Multicenter Single-Arm Trial to Assess the OMEGA™ Coronary Stent System for the Treatment of a Single De Novo Coronary Artery Lesion

summary: The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

ReferenceCitation: Wang JC, Carrie D, Masotti M, Erglis A, Mego D, Watkins MW, Underwood P, Allocco DJ, Hamm CW. Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent. Cardiovasc Revasc Med. 2015 Mar;16(2):65-9. doi: 10.1016/j.carrev.2014.12.007. Epub 2014 Dec 23.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Netherlands
Belgium
United States
Latvia
Spain
France

location_facility: Southern Illinois University-Memorial Medical Center

location_facility: St. Mary's Duluth Clinic Regional Heart Center

location_facility: Presbyterian University of Pennsylvania Medical Center

location_facility: The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH


acronym: PALS

lead_sponsor: Gilead Sciences

summary: This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Nemours Children's Clinic - Jacksonville

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem

location_facility: Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Kinder und Jugendklinik, Abteilung Lungen Bronchialheikunde

location_facility: Azienda Ospedaliera Instituti Ospitalieri di Verona

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Catania

title: Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways

location_country:
Germany
Italy
Poland
United States
Spain
France


title: An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease

summary: The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
New Zealand
Israel
Hong Kong
Norway
Singapore
Brazil
United Kingdom
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Canada
Egypt
France


title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

summary: This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.

ReferenceCitation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

ReferenceCitation: Salloway S, Honigberg LA, Cho W, Ward M, Friesenhahn M, Brunstein F, Quartino A, Clayton D, Mortensen D, Bittner T, Ho C, Rabe C, Schauer SP, Wildsmith KR, Fuji RN, Suliman S, Reiman EM, Chen K, Paul R. Amyloid positron emission tomography and cerebrospinal fluid results from a crenezumab anti-amyloid-beta antibody double-blind, placebo-controlled, randomized phase II study in mild-to-moderate Alzheimer's disease (BLAZE). Alzheimers Res Ther. 2018 Sep 19;10(1):96. doi: 10.1186/s13195-018-0424-5.

location_country:
United States
Spain
France

location_facility: Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.

location_facility: Memory Enhancement Center of America, Inc.

location_facility: University of California Los Angeles (UCLA)

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research


summary: Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.

ReferenceCitation: Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.

ReferenceCitation: Verschuur AC, Bajciova V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20.

evidence: open (via page says license)

location_facility: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles

title: A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR

location_country:
United States
Czechia
France


title: A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

lead_sponsor: Jennerex Biotherapeutics

sponsor_collaborators:
Jennerex Biotherapeutics
Transgene

location_country:
United States
Canada
France

location_facility: Ottawa Hospital and Research Institute (OHRI)


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

ReferenceCitation: Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

location_country:
France
Germany
Hungary
Israel
Australia
Japan
Netherlands
Austria
United States
Korea, Republic of
Spain
Greece
Croatia
South Africa
Ukraine
Bulgaria
Canada
Czech Republic

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Shands Hospital at the University of Florida

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)

location_facility: Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly

location_facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

location_facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp

location_facility: Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"

location_facility: University Hospitals Chagrin Highlands Health Center

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Heartland Medical Research, Inc (Administrative Only)

location_facility: Gasteroenterology Consultants of Clearwater

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: The Hospital of Hyogo College of Medicine

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: Advanced Clinical Research Institute - Phase 1, LLC

location_facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I

location_facility: Severance Hospital, Yeonsei University Health System

location_facility: Clinical Research Institute of Michigan LLC

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly

location_facility: University Hospitals Westlake Medical Center

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Suncoast Endoscopy Center (Colonoscopy Only)

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Medical Diagnostic Imaging (MDI) X-ray and MRI only

location_facility: Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre

location_facility: State Institution "Institute of Gastroenterology of AMS of Ukraine"

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Digestive Diseases Institute, Shaare Zedek Medical Center

location_facility: University Hospitals Case Medical Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Charlotte Gastroenterology and Hepatology, PLLC

location_facility: Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Endoscopy Center of the Rockies - Longmont

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

location_facility: Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course

location_facility: University of Kentucky Chandler Medical Center


acronym: FUTURE 4

lead_sponsor: Actelion

summary: The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

ReferenceCitation: Steinhorn RH, Fineman J, Kusic-Pajic A, Cornelisse P, Gehin M, Nowbakht P, Pierce CM, Beghetti M; FUTURE-4 study investigators. Bosentan as Adjunctive Therapy for Persistent Pulmonary Hypertension of the Newborn: Results of the Randomized Multicenter Placebo-Controlled Exploratory Trial. J Pediatr. 2016 Oct;177:90-96.e3. doi: 10.1016/j.jpeds.2016.06.078. Epub 2016 Aug 5.

location_facility: Fakultní nemocnice v Motole Novorozenecké oddělení - Site 2001

location_facility: Charité Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für Neonatologie - Site 1201

location_facility: Instytut Centrum Zdrowia Matki Polki - Site 2106

location_facility: Liverpool Women's NHS Foundation Trust - Site 1702

location_facility: LURIE CHILDREN'S HOSPITAL OF CHICAGO - Site 6021

location_facility: Kantonsspital Luzern, Kinderspital Kinder-Intensivmedizin / Pädiatrie / Neonatologie - Site 1902

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust - Site 1703

location_facility: Medical University of South Carolina, Pediatric Cardiology - Site 6019

location_facility: Advocate Hope Children's Hospital - Site 6009

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre - Service de réanimation néonatale - Site 1802

location_facility: Klinikum der Universität zu Köln Klinik und Poliklinik für Kinder-und Jugendmedizin, Dep. Neonatologie u. Pädiatrische Intensivmedizin - Site 1203

location_facility: Szpital Kliniczny im. ks. Anny Mazowieckiej - Site 2101

location_facility: The Royal Children's Hospital, Department of Neonatology - Site 3001

location_facility: KK Women's and Children's Hospital - Site 5401

location_facility: Division of Neonatology, Mater Mothers' Hospital, Mater Health Services, Brisbane Ltd. - Site 3003

location_facility: Federal State Budgetary Institution "Scientific Center for obstetrics, gynecology and perinatology named after V.I. Kulakov" Ministry of Healthcare of the Russian Federation - Site 2501

location_facility: Všeobecná fakultní nemocnice Klinika dětského a dorostového lékařství - Site 2002

location_facility: Advocate Lutheran General Div. of Neonatal & Development Medicine - Site 6010

location_facility: Centre Hospitalier Universitaire Vaudois Départment Médico-Chirurgical de Pédiatrie / Service de Néonatologie - Site 1901

location_facility: Great Ormond Street Hospital, Paediatric and Neonatal Intensive Care Unit - Site 1700

location_facility: Hôpital Trousseau - Service de réanimation néonatale et pédiatrique - Site 1804

location_facility: Uniwersytet Medyczny im. K. Marcinkowskiego w Poznaniu - Site 2103

title: Multicenter, Double-blind, Placebo-controlled, Randomized, Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn (PPHN)

location_country:
Germany
Poland
United Kingdom
Singapore
Australia
Switzerland
Belgium
United States
Korea, Republic of
Czech Republic
Russian Federation
France


title: A Study to Assess the Safety, Tolerability and Preliminary Efficacy of GSK2251052 in the Treatment of Complicated Intra-abdominal Infection in Adults

summary: This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Spain
Czechia
Canada
Russian Federation
France


title: A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

summary:
Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.

Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in.

This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

ReferenceCitation: Jagasia M, Scheid C, Socie G, Ayuk FA, Tischer J, Donato ML, Batai A, Chen H, Chen SC, Chin T, Boodee H, Mitri G, Greinix HT. Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD. Blood Adv. 2019 Jul 23;3(14):2218-2229. doi: 10.1182/bloodadvances.2019000145.

evidence: oa journal (via observed oa rate)

publisher_dissemination: American Society of Hematology

ipd_sharing: No

lead_sponsor: Mallinckrodt

sponsor_collaborators: Mallinckrodt Parexel

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
United States
Spain
France

location_facility: Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551,

location_facility: Egyesített Szent István és Szent László Kórház, Gyáli út 5-7,

location_facility: Medical City Dallas Hospital,Transplant center

location_facility: Universita de Genova - Ospedale S. Martino

location_facility: Indiana Blood and Marrow Transplantation Research

location_facility: University of Birmingham: Queen Elizabeth Hospital

location_facility: General Hospital of Vienna (Medical University of Vienna)

location_facility: Methodist healthcare system of san Antonio


lead_sponsor: Hoffmann-La Roche

summary: This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken

location_facility: Uni of Utah Health Science Center; Pediatric Nephrology

location_facility: KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover

location_facility: University of Florida Pediatric Nephrology

location_facility: Hop Necker Enfants Malades;Nephrologie Pediatrique

location_facility: Children'S Hospital At Westmead; Department of Nephrology

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: Royal Hospital For Sick Children; Dept. of Child Health

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: UCLA Center For Health Sciences; Division of Pediatric Nephrology

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln

title: Tolerability of up to 200 Days of Valganciclovir Oral Solution or Tablets in Pediatric Kidney Transplant Recipients

location_country:
Germany
United Kingdom
Australia
Brazil
Sweden
Mexico
United States
Spain
France


title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

summary: This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

ReferenceCitation: Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE 3rd, Mariathasan S, O'Hear C, Narayanan S, Fasso M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. Clin Cancer Res. 2021 Jun 15;27(12):3360-3369. doi: 10.1158/1078-0432.CCR-20-1981. Epub 2021 Feb 10.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Chiang AC, Sequist LVD, Gilbert J, Conkling P, Thompson D, Marcoux JP, Gettinger S, Kowanetz M, Molinero L, O'Hear C, Fasso M, Lam S, Gordon MS. Clinical Activity and Safety of Atezolizumab in a Phase 1 Study of Patients With Relapsed/Refractory Small-Cell Lung Cancer. Clin Lung Cancer. 2020 Sep;21(5):455-463.e4. doi: 10.1016/j.cllc.2020.05.008. Epub 2020 May 12.

ReferenceCitation: Molinero L, Li Y, Chang CW, Maund S, Berg M, Harrison J, Fasso M, O'Hear C, Hegde P, Emens LA. Tumor immune microenvironment and genomic evolution in a patient with metastatic triple negative breast cancer and a complete response to atezolizumab. J Immunother Cancer. 2019 Oct 23;7(1):274. doi: 10.1186/s40425-019-0740-8.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Hamid O, Molinero L, Bolen CR, Sosman JA, Munoz-Couselo E, Kluger HM, McDermott DF, Powderly JD, Sarkar I, Ballinger M, Fasso M, O'Hear C, Chen DS, Hegde PS, Hodi FS. Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Clin Cancer Res. 2019 Oct 15;25(20):6061-6072. doi: 10.1158/1078-0432.CCR-18-3488. Epub 2019 Jul 29.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fasso M, O'Hear C, Lin YG, Emens LA. Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers. Gynecol Oncol. 2019 Aug;154(2):314-322. doi: 10.1016/j.ygyno.2019.05.021. Epub 2019 Jun 14.

ReferenceCitation: Emens LA, Cruz C, Eder JP, Braiteh F, Chung C, Tolaney SM, Kuter I, Nanda R, Cassier PA, Delord JP, Gordon MS, ElGabry E, Chang CW, Sarkar I, Grossman W, O'Hear C, Fasso M, Molinero L, Schmid P. Long-term Clinical Outcomes and Biomarker Analyses of Atezolizumab Therapy for Patients With Metastatic Triple-Negative Breast Cancer: A Phase 1 Study. JAMA Oncol. 2019 Jan 1;5(1):74-82. doi: 10.1001/jamaoncol.2018.4224.

ReferenceCitation: Colevas AD, Bahleda R, Braiteh F, Balmanoukian A, Brana I, Chau NG, Sarkar I, Molinero L, Grossman W, Kabbinavar F, Fasso M, O'Hear C, Powderly J. Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. Ann Oncol. 2018 Nov 1;29(11):2247-2253. doi: 10.1093/annonc/mdy411.

ReferenceCitation: Horn L, Gettinger SN, Gordon MS, Herbst RS, Gandhi L, Felip E, Sequist LV, Spigel DR, Antonia SJ, Balmanoukian A, Cassier PA, Liu B, Kowanetz M, O'Hear C, Fasso M, Grossman W, Sandler A, Soria JC. Safety and clinical activity of atezolizumab monotherapy in metastatic non-small-cell lung cancer: final results from a phase I study. Eur J Cancer. 2018 Sep;101:201-209. doi: 10.1016/j.ejca.2018.06.031. Epub 2018 Aug 1.

ReferenceCitation: Lukas RV, Rodon J, Becker K, Wong ET, Shih K, Touat M, Fasso M, Osborne S, Molinero L, O'Hear C, Grossman W, Baehring J. Clinical activity and safety of atezolizumab in patients with recurrent glioblastoma. J Neurooncol. 2018 Nov;140(2):317-328. doi: 10.1007/s11060-018-2955-9. Epub 2018 Aug 2.

ReferenceCitation: Petrylak DP, Powles T, Bellmunt J, Braiteh F, Loriot Y, Morales-Barrera R, Burris HA, Kim JW, Ding B, Kaiser C, Fasso M, O'Hear C, Vogelzang NJ. Atezolizumab (MPDL3280A) Monotherapy for Patients With Metastatic Urothelial Cancer: Long-term Outcomes From a Phase 1 Study. JAMA Oncol. 2018 Apr 1;4(4):537-544. doi: 10.1001/jamaoncol.2017.5440.

ReferenceCitation: McDermott DF, Sosman JA, Sznol M, Massard C, Gordon MS, Hamid O, Powderly JD, Infante JR, Fasso M, Wang YV, Zou W, Hegde PS, Fine GD, Powles T. Atezolizumab, an Anti-Programmed Death-Ligand 1 Antibody, in Metastatic Renal Cell Carcinoma: Long-Term Safety, Clinical Activity, and Immune Correlates From a Phase Ia Study. J Clin Oncol. 2016 Mar 10;34(8):833-42. doi: 10.1200/JCO.2015.63.7421. Epub 2016 Jan 11.

ReferenceCitation: Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011.

location_country:
United States
Spain
United Kingdom
France

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Stanford Univ Medical Center; Dept Central Pharmacy


title: An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

summary: This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.

lead_sponsor: Pfizer

location_country:
France
Germany
Italy
Norway
Australia
Brazil
Netherlands
Belgium
United States
Spain
Canada
Czech Republic


title: A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

summary: The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

ReferenceCitation: Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

lead_sponsor: CSL Behring

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

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc

location_facility: Centre De Recherche Musculo-Squelettique


title: A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

acronym: SAKURA

summary: The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

lead_sponsor: Santen Inc.

location_country:
Germany
Italy
Poland
Colombia
India
Israel
Argentina
United Kingdom
Japan
Brazil
Austria
United States
Spain
Turkey
Chile
Peru
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

acronym: MEASURE 1

summary: This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

ReferenceCitation: Braun J, Buehring B, Baraliakos X, Gensler LS, Porter B, Quebe-Fehling E, Haemmerle S. Effects of secukinumab on bone mineral density and bone turnover biomarkers in patients with ankylosing spondylitis: 2-year data from a phase 3 study, MEASURE 1. BMC Musculoskelet Disord. 2021 Dec 13;22(1):1037. doi: 10.1186/s12891-021-04930-1.

ReferenceCitation: van der Horst-Bruinsma I, Miceli-Richard C, Braun J, Marzo-Ortega H, Pavelka K, Kivitz AJ, Deodhar A, Bao W, Porter B, Pournara E. A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis. Rheumatol Ther. 2021 Dec;8(4):1775-1787. doi: 10.1007/s40744-021-00380-2. Epub 2021 Oct 7.

ReferenceCitation: Schett G, Baraliakos X, Van den Bosch F, Deodhar A, Ostergaard M, Gupta AD, Mpofu S, Fox T, Winseck A, Porter B, Shete A, Gensler LS. Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies. J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
archive.ugent.be

ReferenceCitation: Himmler S, Branner JC, Ostwald DA. The societal impact of a biologic treatment of ankylosing spondylitis: a case study based on secukinumab. J Comp Eff Res. 2021 Feb;10(2):143-155. doi: 10.2217/cer-2020-0077. Epub 2020 Nov 30.

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Kvien TK, Conaghan PG, Gossec L, Strand V, Ostergaard M, Poddubnyy D, Williams N, Porter B, Shete A, Gilloteau I, Deodhar A. Secukinumab and Sustained Reduction in Fatigue in Patients With Ankylosing Spondylitis: Long-Term Results of Two Phase III Randomized Controlled Trials. Arthritis Care Res (Hoboken). 2022 May;74(5):759-767. doi: 10.1002/acr.24517. Epub 2022 Mar 10.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Deodhar AA, Miceli-Richard C, Baraliakos X, Marzo-Ortega H, Gladman DD, Blanco R, Das Gupta A, Martin R, Safi J Jr, Porter B, Shete A, Rosenbaum JT. Incidence of Uveitis in Secukinumab-treated Patients With Ankylosing Spondylitis: Pooled Data Analysis From Three Phase 3 Studies. ACR Open Rheumatol. 2020 May;2(5):294-299. doi: 10.1002/acr2.11139. Epub 2020 Apr 30.

ReferenceCitation: Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Braun J, Deodhar A, Landewe R, Baraliakos X, Miceli-Richard C, Sieper J, Quebe-Fehling E, Martin R, Porter B, Gandhi KK, van der Heijde D; MEASURE 1 and MEASURE 2 study groups. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018 Nov 21;4(2):e000749. doi: 10.1136/rmdopen-2018-000749. eCollection 2018.

repositories_institution:
Leiden University - Leiden Repository
PubMed Central - Europe PMC

ReferenceCitation: Wei JC, Baeten D, Sieper J, Deodhar A, Bhosekar V, Martin R, Porter B. Efficacy and safety of secukinumab in Asian patients with active ankylosing spondylitis: 52-week pooled results from two phase 3 studies. Int J Rheum Dis. 2017 May;20(5):589-596. doi: 10.1111/1756-185X.13094. Epub 2017 May 25. Erratum In: Int J Rheum Dis. 2017 Jul;20(7):911.

ReferenceCitation: Braun J, Baraliakos X, Deodhar A, Baeten D, Sieper J, Emery P, Readie A, Martin R, Mpofu S, Richards HB; MEASURE 1 study group. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077. doi: 10.1136/annrheumdis-2016-209730. Epub 2016 Dec 13.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.

ReferenceCitation: Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, Deodhar A, Porter B, Martin R, Andersson M, Mpofu S, Richards HB; MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med. 2015 Dec 24;373(26):2534-48. doi: 10.1056/NEJMoa1505066.

location_country:
Germany
Italy
United Kingdom
Netherlands
Mexico
Belgium
United States
Turkey
Taiwan
Peru
Bulgaria
Canada
Russian Federation
France


title: Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (ThoraflexTM)in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

summary:
ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy.

Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane.

The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced.

The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.

status: Withdrawn

lead_sponsor: Vascutek Ltd.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Canada
France

location_facility: Cliniques Universitaires Saint-Luc (UCL)

location_facility: Service de Chirurgie Cardaque et Vasculaire

location_facility: Medisch Specturm Twente, Department of Surgery

location_facility: Institute University de Cardiologie et de

location_facility: University of Maastricht, Department of Surgery

location_facility: Academic Medical Centre (AMC), Department of Surgery

location_facility: Erasmus Medical Centre, Department of Surgery


title: A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

acronym: STRASS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.

PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.

ReferenceCitation: Bonvalot S, Gronchi A, Le Pechoux C, Swallow CJ, Strauss D, Meeus P, van Coevorden F, Stoldt S, Stoeckle E, Rutkowski P, Rastrelli M, Raut CP, Hompes D, De Paoli A, Sangalli C, Honore C, Chung P, Miah A, Blay JY, Fiore M, Stelmes JJ, Dei Tos AP, Baldini EH, Litiere S, Marreaud S, Gelderblom H, Haas RL. Preoperative radiotherapy plus surgery versus surgery alone for patients with primary retroperitoneal sarcoma (EORTC-62092: STRASS): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1366-1377. doi: 10.1016/S1470-2045(20)30446-0. Epub 2020 Sep 14.

evidence: open (via crossref license, author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_concat: HAL

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

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Center

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Hopital Notre-Dame

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

location_facility: Dana-Farber Cancer Institute & Harvard Medical School

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet (101)

location_facility: Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital

intervention_type: Procedure


acronym: Safety FU Study of Amb in 8-17yr olds

summary:
An open label, long term extension to Study AMB112529. All subjects may remain in the extension study for a minimum of six months. Beyond the six month period, subjects may continue in the extension study until one of the following conditions is met:

the subject turns 18 years of age (when the subject can receive marketed product) the product is approved and available for use in the subject's age group, development for use in the paediatric population is discontinued. the subject decides he/she no longer wants to participate in the study, the investigator considers it is in the best interest of the subject to discontinue ambrisentan (e.g. for safety reasons).

The primary objective is the long-term safety and tolerability of ambrisentan in the paediatric PAH population. Secondary objectives are all cause mortality and change from baseline in Study AMB112529 on efficacy parameters.

title: An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired

location_country:
Germany
Italy
Hungary
Argentina
Japan
United States
Spain
Russian Federation
France