type: Other Identifier

title: Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)

acronym: ISLAY

summary:
Primary Objective:

To evaluate the efficacy of isatuximab.

Secondary Objectives:

To evaluate the safety profile of isatuximab.
To evaluate the duration of response (DOR).
To evaluate progression free survival (PFS) and overall survival (OS).
To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
To assess minimal residual disease (MRD) and correlate it with clinical outcome.

ReferenceCitation: Wang A, Song Z, Zheng G, Nicolazzi C, Fromm JR, Shehu E, Srinivasan S, Chen X, Zhu C, Blondel MC, Adrian FJ. Evaluation of Preclinical Activity of Isatuximab in Patients with Acute Lymphoblastic Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1916-1925. doi: 10.1158/1535-7163.MCT-21-0058. Epub 2021 Aug 10.

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Sanofi

location_country:
Finland
Italy
Lithuania
Hungary
United States
Russian Federation
France

location_facility:
Investigational Site Number 6430001
Investigational Site Number 3800004
Investigational Site Number 3800001
Investigational Site Number 4400001
Investigational Site Number 8400003
Investigational Site Number 2500002
Investigational Site Number 3480002
Investigational Site Number 3480003
Investigational Site Number 2460001
Investigational Site Number 6430004
Investigational Site Number 2500004
Investigational Site Number 3480001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 6430003
Investigational Site Number 2500001
Investigational Site Number 2500005


type: EudraCT Number

title: A Phase 1/2, MultiCenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability and Preliminary Efficacy of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellullar Carcinoma (HCC) Following First Line Treatment Failure

summary: CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Celgene

location_country:
United States
Italy
Spain
France

location_facility: Institut Universitaire du Cancer IUCT - Oncopole

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

summary: This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Poland
Singapore
Japan
Austria
Mexico
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Organización para Cuidado Integral en Oncología S.A de C.V

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: Grzegorz Czyzewicz Specialised Medical Practice, Cracow

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz


title: Phase IIa, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects With Acromegaly Previously Treated and Controlled With Either Octreotide LAR or Lanreotide Autogel

summary: The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

ReferenceCitation: Neggers S, Badiu C, Biagetti B, Durand-Gasselin L, Petit A, Petrossians P, Regnault B, Rich D, Shafigullina Z, Shustov S, Vydrych A. Pharmacological and safety profile of a prolonged-release lanreotide formulation in acromegaly. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1551-1560. doi: 10.1080/17512433.2021.1986004. Epub 2021 Nov 8.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

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

host_type: repository

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

publisher_dissemination: Informa

lead_sponsor: Ipsen

location_country:
Germany
Italy
Lithuania
Poland
United Kingdom
Romania
Netherlands
Belgium
Spain
Czechia
Russian Federation
France

location_facility: Endocrinological Research Center Ministry of Health Russian Federation

location_facility: Szpital Kliniczny im. H. Święcickiego UM w Poznaniu

location_facility: Vilnius University hospital Santariskiu Klinikos

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: IRCCS AOU San Martino-IST, University of Genova

location_facility: AO Città della Salute e della Scienza di Torino

location_facility: Lithuanian University of Health Sciences (LUHS) Kauno klinikos

location_facility: Szpital Bielanski im. ks. Jerzego Popieluszki SPZOZ

location_facility: Erasmus University Medical Centre Rotterdam

location_facility: Fakultní nemocnice Hradec Králové (University Hospital Hradec)

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Azienda Ospedaliera Universitaria Senese


title: A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

acronym: SAPHIR

summary: The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

design_allocation: Randomized

ReferenceCitation: Scheltens P, Hallikainen M, Grimmer T, Duning T, Gouw AA, Teunissen CE, Wink AM, Maruff P, Harrison J, van Baal CM, Bruins S, Lues I, Prins ND. Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer's disease: results of a randomized, double-blind, placebo-controlled phase 2a study. Alzheimers Res Ther. 2018 Oct 12;10(1):107. doi: 10.1186/s13195-018-0431-6.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Vivoryon Therapeutics N.V.

sponsor_collaborators:
Vivoryon Therapeutics N.V.
Julius Clinical
Amsterdam UMC, location VUmc

location_country: Finland Germany Sweden Netherlands Belgium Spain France

location_facility: Verksamheten för neuropsykiatri Sahlgrenska universitetssjukhuset

location_facility: CHU François Mitterand (Centre Mémoire Ressources Recherche (CMRR))

location_facility: Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik

location_facility: Ziekenhuis Netwerk Antwerpen / Geheugenkliniek

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS)

location_facility: Universitätsmedizin Göttingen / Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsmedizin Rostock / Zentrum für Nervenheilkunde/ Klinik für Psychosomatik und Psychotherapeutische Medizin

location_facility: Hospital de la Santa Creu i Sant Pau, Neurology Department, Memory Unit

location_facility: Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung

location_facility: Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Münster / Klinik für Allgemeine Neurologie

location_facility: Hôpital La Grave / Centre de Recherche Clinique

location_facility: Fundació ACE. Institut Català de Neurociències Aplicades


title: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.

acronym: FOUNDATION

summary:
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Edwards Lifesciences

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
Austria
Switzerland
Spain
France

location_facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

location_facility: Università Cattolica del Sacro Cuore Policlinico

location_facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie

location_facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt

location_facility: Westdeutsches Herzcentrum Uniklinik Essen

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Universitätsklinik Für Herz und Gefässchirurgie


title: A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment

summary:
This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.

Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.

Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Hong Kong
Australia
Switzerland
United States
Spain
France

location_facility: Massachusetts General Hospital Mass General Hospital

status_simplified: Unknown


title: An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter

acronym: X-TRA

summary: A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.

ReferenceCitation: Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories_concat: Pure (Denmark)

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country:
Germany
Poland
Turkey
Bulgaria
Ukraine
Russian Federation
France


title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1. Erratum In: Cancer. 2020 Jun 15;126(12):2941.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Korea, Republic of
Spain
Czechia
Canada
France


title: A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

summary: This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.

design_allocation: Non-Randomized

lead_sponsor: Genentech, Inc.

sponsor_collaborators:
Genentech, Inc.
AbbVie (prior sponsor, Abbott)

location_country:
United States
Germany
France

location_facility: University of California San Diego Medical Center

location_facility: Apotheke des Universitätsklinikums Freiburg

location_facility: Ingalls Hospital; Cancer Clinical Trials

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III


lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

ReferenceCitation: Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19.

repositories_concat: PubMed Central

publisher_dissemination: Wiley

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.

oa_host_type: closed

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

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

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

ReferenceCitation: Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

ReferenceCitation: le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjoth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. Erratum In: Lancet. 2017 Apr 8;389(10077):1398.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

ReferenceCitation: Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12226. Epub 2017 Oct 16.

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

ReferenceCitation: Williams DM, Staff M, Bain SC, Min T. Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity. touchREV Endocrinol. 2022 Mar;18(1):43-48. doi: 10.17925/EE.2022.18.1.43. Epub 2022 Mar 18.

title: Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Canada
Serbia
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Former Serbia and Montenegro
India
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Russian Federation
Israel


acronym: TIS

lead_sponsor: Horizon Pharma USA, Inc.

summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

ReferenceCitation: Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

sponsor_collaborators:
Horizon Pharma USA, Inc.
Forest Laboratories

location_facility: CRCM adulte Hôpital Larrey-CHU de Toulouse

location_facility: Universitätsklinik für Kinder- und Jugendmedizin

location_facility: CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve

location_facility: Hôpital Pellegrin Enfants - CHU Bordeaux

location_facility: Ludwig-Maximilians Universität Klinikum Innenstadt

location_facility: Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik

location_facility: Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Safra Childrens Hospital, Sheba Medical Center

location_facility: Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz

location_facility: Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro

location_facility: Schneider Childrens Medical Center of Israel

title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients

source: euctr

location_country:
Ireland
Germany
France
United Kingdom
United States
Israel


title: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum In: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

oa_colors: green other

evidence: open (via free article)

repository_institution: Ghent University - Ghent University Academic Bibliography

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: ViiV Healthcare

collaborators: Shionogi GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Shionogi
GlaxoSmithKline

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


title: A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia

summary: The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

ReferenceCitation: Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, Potulska-Chromik A, Ferreira JJ, Bihari K, Ehler E, Bares M, Dzyak LA, Belova AN, Pham E, Liu WJ, Picaut P. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

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

location_country:
Germany
Poland
Portugal
Hungary
Australia
Austria
Belgium
Czechia
Ukraine
Russian Federation
France

location_facility: Institute of Neurology, Psychiatry and Narcology AMS of Ukraine

location_facility: Research Medical Complex "Vashe Zdorovie"

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

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: Jósa András Oktató Kórház Nonprofit Kft.

location_facility: Ukrainian State Institute of Medical and Social Problems of Disability

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Nizhniy Novgorod Research Institute for Traumatology and Orthopaedics

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Department of Neurosciences Alfred Hospital

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Smolensk State Medical Academy Smolensk Regional Clinical Hospital

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"


title: A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

ReferenceCitation: Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Denmark
Australia
United States
Canada
France

location_facility:
Alamo Medical Research
Options Health Research, Llc
California Liver Institute
Digestive Disease Associates, P.A.
Local Institution


title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

acronym: TERACLES

summary:
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
Disability progression
Burden of disease and disease progression as measured by brain MRI
Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
Assess associations between variations in genes and clinical outcomes (safety and efficacy)
Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

status: Terminated

location_country:
Finland
Germany
Argentina
Australia
Brazil
Chile
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Tunisia
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Sweden

location_facility:
Investigational Site Number 276005
Investigational Site Number 410004
Investigational Site Number 840028
Investigational Site Number 076012
Investigational Site Number 380010
Investigational Site Number 170007
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Investigational Site Number 246001
Investigational Site Number 380004
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Investigational Site Number 440002
Investigational Site Number 528002
Investigational Site Number 826003
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Investigational Site Number 056001
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acronym: STRIDE

lead_sponsor: Astellas Pharma Inc

summary: In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.

title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

location_country:
Finland
Ireland
Italy
Poland
Slovenia
Slovakia
Hungary
United Kingdom
Romania
Netherlands
Austria
Belgium
Spain
Greece
Czechia
France


title: Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

summary: This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

ReferenceCitation: Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Colombia
India
Hungary
Argentina
Romania
Australia
Sweden
United Kingdom
Mexico
United States
Korea, Republic of
Russian Federation
France


title: A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

acronym: ZORO

summary: The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

ReferenceCitation: Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14.

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

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
United States
India
Belgium
China
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation


title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures

acronym: IR

summary: The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.

location_country:
Germany
Italy
Poland
Denmark
Netherlands
Belgium
Spain
Thailand
Bulgaria
Ukraine
Russian Federation
France


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

lead_sponsor: Gilead Sciences

location_country:
France
Germany
Italy
Poland
United Kingdom
Austria
Belgium
United States
Spain
Canada
Czech Republic

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Emory University, Infectious Disease Clinic

location_facility: Association of Physicians for Infection Diseases

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: University of Miami Center for Liver Diseases

location_facility: Institute of Clinic and Experimental Medicine

location_facility: Epatologia, Azienda Ospedaliero "Spedali Civili"

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Cornell University Gastroenterology & Hepatology

location_facility: Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista

location_facility: Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH

location_facility: U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Ottawa Hospital, Division of Infectious Diseases

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

location_facility: Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Clínico Universitario San Cecilio

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Medicina Generale - Azienda Ospedaliera di Padova

location_facility: SGS - Clinical Pharmacology Unit Antwerpen

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Institute of Cellular Medicine (Hepatology)

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: University of Alberta, Division of Gastroenterology

location_facility: University Hospitals Case Medical Center

location_facility: U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Ntra. Sra. de Valme


title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

acronym: SENTIO

summary: The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

primary_purpose: Diagnostic

lead_sponsor: Guerbet

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Austria
United States
Korea, Republic of
Spain
Chile
France

location_facility: University of Texas - Health Science Center

location_facility: University of Alabama at Birmingham, UABMC

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Complejo Hospitalario Universitario de Vigo - Serviço de radiologia

location_facility: Universidade Federal de São Paulo / UNIFESP

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Gruss Magnetic resonance Research Clinic

location_facility: Fédération d'Imagerie Médicale,Hôpital Pontchaillou


acronym: HOMER

intervention_type: Biological

summary:
This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen.

The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed.

Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.

ReferenceCitation: Maloney DG, Ogura M, Fukuhara N, Davis J, Lasher J, Izquierdo M, Banerjee H, Tobinai K. A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy. Blood Adv. 2020 Aug 25;4(16):3886-3893. doi: 10.1182/bloodadvances.2020001942.

evidence: oa journal (via observed oa rate)

publisher_dissemination: American Society of Hematology

title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

location_country:
Bulgaria
Slovakia
Hungary
Japan
Brazil
Belgium
United States
China
Korea, Republic of
South Africa
Czechia
Ukraine
Canada
Peru
Puerto Rico
France


title: A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

summary: The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.

lead_sponsor: Amgen

location_country:
Poland
Australia
Netherlands
Belgium
United States
Spain
Canada
France


acronym: ARTEMIS AF LT

lead_sponsor: Sanofi

summary:
Primary Objective:

- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

Explore potential PK interaction between Dronedarone and Amiodarone
Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety

ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brule L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: St George's University of London - St George's Online Research Archive

version: acceptedVersion

publisher_dissemination: SAGE Publications

location_facility:
Investigational Site Number 208-003
Investigational Site Number 276-001
Investigational Site Number 170007
Investigational Site Number 170001
Investigational Site Number 208-001
Investigational Site Number 170005
Investigational Site Number 484004
Investigational Site Number 724002
Investigational Site Number 203001
Investigational Site Number 203004
Investigational Site Number 724006
Investigational Site Number 484005
Investigational Site Number 203006
Investigational Site Number 203005
Investigational Site Number 276-003
Investigational Site Number 250-003
Investigational Site Number 724004
Investigational Site Number 203008
Investigational Site Number 250-001
Investigational Site Number 484001
Investigational Site Number 276-005
Investigational Site Number 250-004
Investigational Site Number 484003
Investigational Site Number 250-006
Investigational Site Number 250-002
Investigational Site Number 208-002
Investigational Site Number 276-004
Investigational Site Number 250-005
Investigational Site Number 724001
Investigational Site Number 203002
Investigational Site Number 203003
Investigational Site Number 170006
Investigational Site Number 724003
Investigational Site Number 724005
Investigational Site Number 276-002
Investigational Site Number 484006
Investigational Site Number 484002
Investigational Site Number 203007
Investigational Site Number 170002
Investigational Site Number 170003

title: A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment.

location_country:
Germany
Colombia
Denmark
Mexico
Spain
Czech Republic
France


title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

summary: A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. doi: 10.1200/JCO.20.01894. Epub 2020 Aug 21.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. doi: 10.1200/JCO.2017.74.7824. Epub 2017 Dec 15.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Hungary
Hong Kong
United States
Ukraine
India
Romania
Belgium
China
Peru
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease


title: Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

summary: The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

location_country:
Germany
Ireland
Italy
Colombia
United Kingdom
Argentina
Australia
Brazil
Netherlands
Sweden
Belgium
United States
Spain
Czechia
Russian Federation
France


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: PE-Prove

summary: The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

ReferenceCitation: Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07.

repository_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: Europa Digital & Publishing

ipd_sharing: No

ipd_sharing_description: Data are presented at the 2013 EuroPCR congress.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Pharmaceutical Research Associates
Medidata Solutions

location_country:
Germany
Ireland
Italy
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
France

location_facility: Centre Hôpital Universitaire Sart Tilman

location_facility: Centre Hospitalier Privé Saint Martin gds

location_facility: Dept. of Internal Medicine and Cardiological Center

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

location_facility: Hospital Universitari Germans Trias i Pujol

intervention_type: Device


title: A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

summary: This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

ReferenceCitation: Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.

location_country:
Finland
Germany
Italy
Argentina
Switzerland
Austria
Belgium
United States
Spain
Czechia
Canada
France


acronym: GRIPHON

lead_sponsor: Actelion

summary: The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

ReferenceCitation: Sitbon O, Channick R, Chin KM, Frey A, Gaine S, Galie N, Ghofrani HA, Hoeper MM, Lang IM, Preiss R, Rubin LJ, Di Scala L, Tapson V, Adzerikho I, Liu J, Moiseeva O, Zeng X, Simonneau G, McLaughlin VV; GRIPHON Investigators. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2015 Dec 24;373(26):2522-33. doi: 10.1056/NEJMoa1503184.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repositories_concat: PubMed Central;cris.unibo.it

ReferenceCitation: Gaine S, Sitbon O, Channick RN, Chin KM, Sauter R, Galie N, Hoeper MM, McLaughlin VV, Preiss R, Rubin LJ, Simonneau G, Tapson V, Ghofrani HA, Lang I. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. Chest. 2021 Jul;160(1):277-286. doi: 10.1016/j.chest.2021.01.066. Epub 2021 Feb 3.

ReferenceCitation: Chin KM, Rubin LJ, Channick R, Di Scala L, Gaine S, Galie N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin VV, Preiss R, Simonneau G, Sitbon O, Tapson VF. Association of N-Terminal Pro Brain Natriuretic Peptide and Long-Term Outcome in Patients With Pulmonary Arterial Hypertension. Circulation. 2019 May 21;139(21):2440-2450. doi: 10.1161/CIRCULATIONAHA.118.039360.

ReferenceCitation: McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galie N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
LIRIAS (KU Leuven)
Zenodo

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

ReferenceCitation: Coghlan JG, Channick R, Chin K, Di Scala L, Galie N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Gaine S. Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study. Am J Cardiovasc Drugs. 2018 Feb;18(1):37-47. doi: 10.1007/s40256-017-0262-z.

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

ReferenceCitation: Gaine S, Chin K, Coghlan G, Channick R, Di Scala L, Galie N, Ghofrani HA, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Hoeper MM. Selexipag for the treatment of connective tissue disease-associated pulmonary arterial hypertension. Eur Respir J. 2017 Aug 17;50(2):1602493. doi: 10.1183/13993003.02493-2016. Print 2017 Aug.

ReferenceCitation: Krause A, Machacek M, Lott D, Hurst N, Bruderer S, Dingemanse J. Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):477-485. doi: 10.1002/psp4.12202. Epub 2017 May 27.

ReferenceCitation: Skoro-Sajer N, Lang IM. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2014 Feb;15(3):429-36. doi: 10.1517/14656566.2014.876007. Epub 2014 Jan 7.

location_facility: Kaohsiung Veterans General Hospital (KVGH)

location_facility: University of Alberta Hospital - Children's Centre

location_facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: University of Texas-Houston Health Center Department of Pulmonary & Critical Care

location_facility: John Hunter Hospital Autoimmune Resource and Research Centre

location_facility: Montefiore Medical Center, Weiler Division

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

location_facility: Universitätsklinkum Regensburg / Innere Medizin II

location_facility: ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia

location_facility: Pulmonology Institute, Hadassah University Hospital at Ein Karem

location_facility: "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""

location_facility: VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48

location_facility: Shanghai Pulmonary Hospital, Department of Pulmonary Circulation

location_facility: "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"

location_facility: Massachusetts General Hospital - Pulmonary Critical Care Unit

location_facility: Prince Charles Hospital Lung Transplant, Thoracic Department

location_facility: Medizinische Hochschule Hannover / Klinik für Pneumologie

location_facility: "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"

location_facility: Universitätsspital Bern, Clinic for Pneumology (Inselspital)

location_facility: Samsung Medical Center, Division of Cardiology

location_facility: Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: Peking Union Medical College Hospital, Rheumatology Department

location_facility: Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie

location_facility: Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare

location_facility: Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2

location_facility: Universität Greifswald / Klinik für Innere Medizin B

location_facility: Municipal Medical Institution City Hospital #5

location_facility: Massachusetts General Hospital-Pulmonary Critical Care Unit

location_facility: Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen

location_facility: Instituto de Enfermedades Respiratorias Clinica San Gabriel

location_facility: University of California, Davis, UC Davis Medical Center

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Health Care Municipal Institution, City Clinical Hospital #13

location_facility: Instituto Nacional del Torax Teaching Dept

location_facility: Rigshospitalet, Hjertemedicinsk klinik - Cardiology

location_facility: Boston University School of Medicine / Boston University Medical Center

location_facility: Kantonsspital St. Gallen Klinik für Pneumologie

location_facility: "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13

location_facility: University Hospital Gasthuisberg - Pneumologie

location_facility: University of Wisconsin Hospital-Department of Medicine

location_facility: Medical University of Vienna and AKH Cardiology

location_facility: "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"

location_facility: "Semmelweis Egyetem, Pulmonológiai Klinika"

location_facility: State Institution, "Institute fo Rheumatology of RAMS"

location_facility: Hosp Vall D'Hebron - Barcelona - Pneumology

location_facility: Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

location_facility: The Ohio State University Medical Center

location_facility: Sanjivani Hospitals - Department of Cardiology

location_facility: Erasmus Medisch Centrum Rotterdam afdeling longziekten

location_facility: Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia

location_facility: Umeå University Hospital, Cardiology (Umeå)

location_facility: CARE Hospitals Nampally, Cardiology Dep. Hyderabad

location_facility: University Hospital Basel Division of Pneumology

location_facility: "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Tomsk Regional Clinical Hospital/ Pulmonology Unit

location_facility: Newark Beth Isreal Medical Center-Department of Pulmonary Medicine

location_facility: Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital

location_facility: "Pécsi Tudományegyetem Klinikai Központ,

location_facility: Minsk Regional Clinical Hospital of the Red Banner of Labour

location_facility: University of California San Diego Medical Center (La Jolla)

location_facility: "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"

location_facility: The University of Arizona, Clinical and Translational Science (CATS) Research Center

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: "Klinički Centar Srbije, Klinika za pulmologiju"

location_facility: Washington University School of Medicine

location_facility: "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"

location_facility: The Republican Scientific-Practical Center "Cardiology"

location_facility: "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"

location_facility: Linköping University Hospital, Cardiology

location_facility: St. Antonius Ziekenhuis afdeling Longziekten

location_facility: Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine

location_facility: HUG Hôpitaux Universitaires de Genève; Pneumology, PAH

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"

location_facility: Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine

location_facility: Froedtert Hospital - Medical College of Wisconsin

location_facility: Yonsei University Health System Dept of Cardiology

location_facility: Johns Hopkins University School of Medicine

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez

location_facility: Istanbul Üniversitesi Kardiyoloji Enstitisü

location_facility: Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F

location_facility: St. Vincent's Hospital / Heart and Lung Transplant Unit

location_facility: Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.

location_facility: "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"

location_facility: Hosp A. Beclere - Dept Pulmo & Resp Intensive Care

location_facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

location_facility: Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai

location_facility: Royal Hobart Hospital, Centre for Clinical Research

location_facility: Hopital General Juif (Jewish General Hospital)

location_facility: The Institution of the Clinical Cardiology named after A. L. Myaskinov

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: University Hospitals Case Medical Center

location_facility: Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center

location_facility: Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department

location_facility: National Taiwan University Hospital / Department of Surgery

location_facility: Limited liability company, Consultative diagnostic centre Healthy Joints

location_facility: Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology

location_facility: Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases

location_facility: Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia

location_facility: Lung Health & Sleep Emhancement Center, LLC

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

location_facility: "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"

location_facility: Columbia University Medical Center, Pediatric Cardiology

location_facility: "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"

location_facility: Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares

title: A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

location_country:
Germany
Ireland
Poland
Argentina
Australia
Thailand
Turkey
Chile
Czechia
Canada
Serbia
France
Belarus
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Malaysia
Peru
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


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

summary:
RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

location_facility: Helsinky University Central Hospital - Skin & Allergy Hospital

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

location_facility: Csu de Bellvitge (Institut Catala D'Oncologia)

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Chu de Bordeaux - Hopital Du Haut Leveque

location_facility: Guy'S and St Thomas' Nhs - St Thomas Hospital

location_facility: Medical University Vienna - General Hospital

title: A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma

location_country:
Finland
Germany
United Kingdom
Switzerland
Austria
Belgium
Spain
France


title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)

summary: The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Australia
United States
Greece
Canada
Russian Federation
France

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


intervention_type: Other

lead_sponsor: UCB BIOSCIENCES GmbH

summary: The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).

ReferenceCitation: Landewe R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47. doi: 10.1136/annrheumdis-2013-204231. Epub 2013 Sep 6.

publisher_dissemination: British Medical Journal

ReferenceCitation: Baraliakos X, Kruse S, Auteri SE, de Peyrecave N, Nurminen T, Kumke T, Hoepken B, Braun J. Certolizumab pegol treatment in axial spondyloarthritis mitigates fat lesion development: 4-year post-hoc MRI results from a phase 3 study. Rheumatology (Oxford). 2022 Jul 6;61(7):2875-2885. doi: 10.1093/rheumatology/keab841.

publisher_dissemination: Oxford University Press

ReferenceCitation: Landewe R, Nurminen T, Davies O, Baeten D. A single determination of C-reactive protein does not suffice to declare a patient with a diagnosis of axial spondyloarthritis 'CRP-negative'. Arthritis Res Ther. 2018 Sep 14;20(1):209. doi: 10.1186/s13075-018-1707-8.

ReferenceCitation: van der Heijde D, Braun J, Rudwaleit M, Purcaru O, Kavanaugh AF. Improvements in workplace and household productivity with certolizumab pegol treatment in axial spondyloarthritis: results to week 96 of a phase III study. RMD Open. 2018 Apr 9;4(1):e000659. doi: 10.1136/rmdopen-2018-000659. eCollection 2018.

ReferenceCitation: van der Heijde D, Dougados M, Landewe R, Sieper J, Maksymowych WP, Rudwaleit M, Van den Bosch F, Braun J, Mease PJ, Kivitz AJ, Walsh J, Davies O, Bauer L, Hoepken B, Peterson L, Deodhar A. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509. doi: 10.1093/rheumatology/kex174.

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: van der Heijde D, Deodhar A, Fleischmann R, Mease PJ, Rudwaleit M, Nurminen T, Davies O. Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1030-1039. doi: 10.1002/acr.23092. Epub 2017 Jun 2.

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

ReferenceCitation: Rudwaleit M, Rosenbaum JT, Landewe R, Marzo-Ortega H, Sieper J, van der Heijde D, Davies O, Bartz H, Hoepken B, Nurminen T, Deodhar A. Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2016 Jun;68(6):838-44. doi: 10.1002/acr.22848.

ReferenceCitation: Sieper J, Kivitz A, van Tubergen A, Deodhar A, Coteur G, Woltering F, Landewe R. Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1475-80. doi: 10.1002/acr.22594.

title: Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

location_country:
Germany
Italy
Poland
Hungary
Argentina
United Kingdom
Brazil
Netherlands
Mexico
Belgium
United States
Spain
Czechia
Canada
France


acronym: PROSIPAL

lead_sponsor: Janssen-Cilag International NV

summary: The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.

title: A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia

location_country:
Germany
Poland
Taiwan
Turkey
Croatia
France
Czech Republic
Lithuania
Slovakia
Hungary
Ukraine
Romania
Belgium
Estonia
Egypt
United Kingdom
Austria
Korea, Republic of
Spain
Greece
South Africa
Jordan
Bulgaria
Russian Federation
Israel


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha Agent(s)

summary: The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

ReferenceCitation: Helliwell PS, Gladman DD, Chakravarty SD, Kafka S, Karyekar CS, You Y, Campbell K, Sweet K, Kavanaugh A, Gensler LS. Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naive active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials. RMD Open. 2020 Feb;6(1):e001149. doi: 10.1136/rmdopen-2019-001149.

ReferenceCitation: Siebert S, Sweet K, Dasgupta B, Campbell K, McInnes IB, Loza MJ. Responsiveness of Serum C-Reactive Protein, Interleukin-17A, and Interleukin-17F Levels to Ustekinumab in Psoriatic Arthritis: Lessons From Two Phase III, Multicenter, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2019 Oct;71(10):1660-1669. doi: 10.1002/art.40921. Epub 2019 Sep 3.

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

repositories_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Rahman P, Puig L, Gottlieb AB, Kavanaugh A, McInnes IB, Ritchlin C, Li S, Wang Y, Song M, Mendelsohn A, Han C; PSUMMIT 1 and 2 Study Groups. Ustekinumab Treatment and Improvement of Physical Function and Health-Related Quality of Life in Patients With Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1812-1822. doi: 10.1002/acr.23000. Epub 2016 Oct 21.

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

ReferenceCitation: Kavanaugh A, Puig L, Gottlieb AB, Ritchlin C, You Y, Li S, Song M, Randazzo B, Rahman P, McInnes IB. Efficacy and safety of ustekinumab in psoriatic arthritis patients with peripheral arthritis and physician-reported spondylitis: post-hoc analyses from two phase III, multicentre, double-blind, placebo-controlled studies (PSUMMIT-1/PSUMMIT-2). Ann Rheum Dis. 2016 Nov;75(11):1984-1988. doi: 10.1136/annrheumdis-2015-209068. Epub 2016 Apr 20.

location_country:
Germany
Poland
Hungary
United Kingdom
Sweden
Austria
United States
Canada
Russian Federation
France


acronym: LEPHT

lead_sponsor: Bayer

summary: The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

ReferenceCitation: Ghio S, Bonderman D, Felix SB, Ghofrani HA, Michelakis ED, Mitrovic V, Oudiz RJ, Frey R, Roessig L, Semigran MJ. Left ventricular systolic dysfunction associated with pulmonary hypertension riociguat trial (LEPHT): rationale and design. Eur J Heart Fail. 2012 Aug;14(8):946-53. doi: 10.1093/eurjhf/hfs071. Epub 2012 Jun 20.

ReferenceCitation: Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ; Left Ventricular Systolic Dysfunction Associated With Pulmonary Hypertension Riociguat Trial (LEPHT) Study Group. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: a phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation. 2013 Jul 30;128(5):502-11. doi: 10.1161/CIRCULATIONAHA.113.001458. Epub 2013 Jun 17.

status: Active, not recruiting

title: Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

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

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

location_country:
Germany
Italy
Poland
United Kingdom
Singapore
Denmark
Australia
Japan
Netherlands
Austria
Belgium
Switzerland
United States
China
Spain
Czechia
Canada
France

status_simplified: Ongoing


title: Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer

summary: The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Colombia
Hungary
Denmark
United States
Romania
Puerto Rico
Italy
Norway
United Kingdom
Netherlands
Mexico
Spain
Greece
Sweden

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Providence Regional Medical Center Everett

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Southern California Permanente Medical Group

location_facility: Hematology Oncology Associates Of The Treasure Coast

location_facility: Scott & White Memorial Hospital And Clinic

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Lynn Cancer Institute Center For Hematology-Oncology

location_facility: North Shore Hematology/Oncology Associates, P.C.


lead_sponsor: Boehringer Ingelheim

summary: To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

ReferenceCitation: Maltais F, Kirsten AM, Hamilton A, De Sousa D, Voss F, Decramer M. Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies. Respir Res. 2016 Jul 6;17(1):77. doi: 10.1186/s12931-016-0389-5.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

location_facility: 1222.37.33004 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4371 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33006 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6172 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33002 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4970 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4972 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6174 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1072 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4971 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1073 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.1074 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33003 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33001 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4372 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6173 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.6171 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.33005 Boehringer Ingelheim Investigational Site

location_facility: 1222.37.4973 Boehringer Ingelheim Investigational Site

title: Randomised, Double-blind, Placebo-controlled, 3-way Cross-over Study to Determine the Effect of Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 µg] and 10 µg [2 Actuations of 5 µg]) Delivered by the Respimat® Inhaler on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease

location_country: Germany Australia Austria Canada France


type: Registry Identifier

title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

summary: The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

ReferenceCitation: Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.

location_country:
Ireland
Germany
Italy
United Kingdom
Argentina
United States
Spain
France

location_facility: Hospital Of The University Of Pennsylvania

location_facility: University Of North Carolina, Chapel Hill

location_facility: Alabama Liver & Digestive Specialists (Alds)