title: Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial

acronym: TAVAREC

summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide is more effective when given with or without bevacizumab in treating patients with recurrent glioma.

PURPOSE: This randomized clinical trial is studying how well temozolomide works with or without bevacizumab in treating patients with recurrent glioma.

ReferenceCitation: Draaisma K, Tesileanu CMS, de Heer I, Klein M, Smits M, Reijneveld JC, Clement PM, de Vos FYF, Wick A, Mulholland PJ, Taphoorn MJB, Weller M, Chinot OL, Kros JM, Verschuere T, Coens C, Golfinopoulos V, Gorlia T, Idbaih A, Robe PA, van den Bent MJ, French PJ. Prognostic Significance of DNA Methylation Profiles at MRI Enhancing Tumor Recurrence: a Report from the EORTC 26091 TAVAREC Trial. Clin Cancer Res. 2022 Jun 1;28(11):2440-2448. doi: 10.1158/1078-0432.CCR-21-3725.

evidence: oa repository (via page says license)

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: van den Bent MJ, Klein M, Smits M, Reijneveld JC, French PJ, Clement P, de Vos FYF, Wick A, Mulholland PJ, Taphoorn MJB, Lewis J, Weller M, Chinot OL, Kros JM, de Heer I, Verschuere T, Coens C, Golfinopoulos V, Gorlia T, Idbaih A. Bevacizumab and temozolomide in patients with first recurrence of WHO grade II and III glioma, without 1p/19q co-deletion (TAVAREC): a randomised controlled phase 2 EORTC trial. Lancet Oncol. 2018 Sep;19(9):1170-1179. doi: 10.1016/S1470-2045(18)30362-0. Epub 2018 Aug 13.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Ediebah DE, Reijneveld JC, Taphoorn MJ, Coens C, Zikos E, Aaronson NK, Heimans JJ, Bottomley A, Klein M; EORTC Quality of Life Department and Patient Reported Outcome and Behavioral Evidence (PROBE). Impact of neurocognitive deficits on patient-proxy agreement regarding health-related quality of life in low-grade glioma patients. Qual Life Res. 2017 Apr;26(4):869-880. doi: 10.1007/s11136-016-1426-z. Epub 2016 Oct 15.

repository_institution: PubMed Central - Europe PMC

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

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

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois

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

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

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

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

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Medical University Vienna - General Hospital AKH

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

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Freeman Hospital, Northern Centre For Cancer Care

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: University Of Dundee - Ninewells Hospital

location_facility: Radboud University Nijmegen Medical Centre


title: A Multi-Center Relative Bioavailability Study of Azacitidine 75 mg/m2 Subcutaneous Injection In Myelodysplastic Syndrome Patients Under Fasting Conditions

summary: The purpose of the study is to determine the bioavailability of Azacitidine for Injection relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated statistically to determine if the products meet bioequivalence criteria.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Bioniche Pharma USA LLC

location_country:
United States
France

location_facility: Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire

location_facility: Service d'hématologie et de médecine interne CHU de Nancy Hôpital de Brabois

location_facility: Service d'hématologie clinique Hôpital Avicenne

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Clinical effecT of Heart Failure Management Via Home Monitoring With a Focus on Atrial Fibrillation (effecT)

acronym: effecT

summary: EffecT is a prospective, randomized multicenter study to assess whether management of atrial fibrillation (AF) as well as the early optimization of cardiac resynchronization therapy (CRT) via Home Monitoring decreases mortality and morbidity compared to conventional treatment in subjects with a standard indication for CRT with Implantable Cardioverter Defibrillator (ICD) backup and AF.

study_start_date_type: Actual

status: Terminated

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Biotronik SE & Co. KG

location_country:
Germany
United Kingdom
Sweden
Netherlands
Belgium
Czech Republic
France

location_facility: Karolinska University Hospital Stockholm

intervention_type: Device

status_simplified: Unknown


acronym: PRIMARYS

lead_sponsor: Ipsen

summary:
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.

ReferenceType: result

ReferenceCitation: Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prevost G, Maisonobe P, Clermont A; PRIMARYS Investigators. Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial. J Clin Endocrinol Metab. 2014 Apr;99(4):1282-90. doi: 10.1210/jc.2013-3318. Epub 2013 Jan 1.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: The Endocrine Society

ReferenceType: derived

ReferenceCitation: Caron PJ, Bevan JS, Petersenn S, Houchard A, Sert C, Webb SM; PRIMARYS Investigators Group. Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study. Pituitary. 2016 Apr;19(2):149-57. doi: 10.1007/s11102-015-0693-y.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

publisher_dissemination: Springer-Nature

location_facility: Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Všeobecná fakultní nemocnice, Karlova Univerzita

location_facility: Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia

location_facility: ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie

title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

type: EudraCT Number

source: euctr

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
Finland
Italy
United Kingdom
Netherlands
Belgium
Turkey
Czechia
France

ipd_sharing: Yes


title: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial

acronym: ENERGY

summary: To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: SAGE Publications

ReferenceCitation: Erbel R, Eggebrecht H, Roguin A, Schroeder E, Philipp S, Heitzer T, Schwacke H, Ayzenberg O, Serra A, Delarche N, Luchner A, Slagboom T; ENERGY Investigators. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry. Cardiovasc Revasc Med. 2014 Nov-Dec;15(8):381-7. doi: 10.1016/j.carrev.2014.10.002. Epub 2014 Oct 15.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Elsevier

lead_sponsor: Biotronik AG

location_country: Germany Ireland Israel Netherlands Austria Belgium Switzerland Latvia Spain France

location_facility: Hospital Clinic I Provinvial de Barcelona

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Charité-Universitätsm. Berlin Campus Charité-Mitte

location_facility: Pauls Stradins Clinical University Hospital


title: A Single Arm, Pivotal, Open Label, Multi-centre Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat EverPatch, A Synthetic Tissue Substitute for Concealment of Artificial Ocular Implants

acronym: EverPatch

summary: This clinical trial will assess the clinical safety and performance of the CorNeat EverPatch device used as a tissue substitute for concealment of artificial ocular implants.

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: CorNeat Vision Ltd.

location_country: Canada Georgia France

location_facility:
Prism Eye Institute
University Health Network
DaVinci Eye Care
EyeCare Miramichi Eye NB
Hôpital Fondation Rothschild

status_simplified: Ongoing


title: DIAMOND AF Post-Approval Study

acronym: DAF PAS

summary: The DIAMOND AF Post Approval study is a prospective, global, multi-center, non-randomized, single-arm observational trial

status: Recruiting

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United States
Italy
France

location_facility: University of Tennessee Methodist Physicians

location_facility: Reunion University Hospital - Saint Pierre


title: A Phase Ia/Ib, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Combination With Chemotherapy Followed by Expansion Cohorts in Patients With Advanced Gastrointestinal Cancers

summary: This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with chemotherapy and bevacizumab. The purpose of the first part is to find the highest BI 905711 dose participants can tolerate. In the second part, participants with colorectal cancer or pancreatic cancer get BI 905711 combined with chemotherapy. Some participants also get bevacizumab. The second part tests whether BI 905711 makes tumours shrink. Participants get BI 905711, chemotherapy and bevacizumab about every 2 weeks as an infusion into a vein. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check the health of the participants and note any health problems that could have been caused by the study treatment. The doctors also monitor the size of the tumour.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Japan
Belgium
United States
China
France

location_facility: The University of Texas MD Anderson Cancer Center


title: A Prospective, Multi-center Clinical Study to Evaluate the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal Allograft Transplantations (MAT)

acronym: FAST-FIX FLEX

summary: This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.

lead_sponsor: Smith & Nephew, Inc.

location_country:
United States
United Kingdom
Australia
France

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust


type: Other Identifier

title: A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors

summary: The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.

lead_sponsor: Eli Lilly and Company

location_country:
Australia
Belgium
United States
Korea, Republic of
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Claudius Regaud - IUCT Oncopole


type: Registry Identifier

title: A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial)

summary: This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma.

lead_sponsor: M.D. Anderson Cancer Center

sponsor_collaborators:
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Assistance Publique - Hôpitaux de Paris

location_country:
United States
Poland
France

location_facility: Siteman Cancer Center at Washington University

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: University of Michigan Comprehensive Cancer Center

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

titre: Participation française à l'étude internationale prospective randomisée comparant le traitement adjuvant par mitotane vs mitotane associé à etoposide et cisplatine après chirurgie du primitif dans les corticosurrénalomes localisés avec risque élevé de rechute (ClinicalTrials.gov Identifier: NCT03583710).

discipline_principale: cancer

nom_porteur: LIBE

prenom_porteur: Rossella


title: CardioMEMS HF System OUS Post Market Study

summary: The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

ReferenceCitation: Cowie MR, Flett A, Cowburn P, Foley P, Chandrasekaran B, Loke I, Critoph C, Gardner RS, Guha K, Betts TR, Carr-White G, Zaidi A, Lim HS, Hayward C, Patwala A, Rogers D, Pettit S, Gazzola C, Henderson J, Adamson PB. Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. ESC Heart Fail. 2022 Feb;9(1):48-56. doi: 10.1002/ehf2.13748. Epub 2021 Dec 9.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: Wiley

ReferenceCitation: Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST. ESC Heart Fail. 2020 Jun;7(3):865-872. doi: 10.1002/ehf2.12646. Epub 2020 Feb 7.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

lead_sponsor: Abbott Medical Devices

location_country:
United Kingdom
Denmark
Australia
Belgium
France

location_facility:
CHR Citadelle
CHRU de Lille
The Prince Charles Hospital
Royal Bromptom Hospital
Rigshospitalet


acronym: Highdes

lead_sponsor: Hansa Biopharma AB

summary: The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.

ReferenceCitation: Kjellman C, Maldonado AQ, Sjoholm K, Lonze BE, Montgomery RA, Runstrom A, Lorant T, Desai NM, Legendre C, Lundgren T, von Zur Muhlen B, Vo AA, Olsson H, Jordan SC. Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2021 Dec;21(12):3907-3918. doi: 10.1111/ajt.16754. Epub 2021 Jul 19.

repository_institution: Uppsala University - Uppsala University Publications

repositories_concat: DiVA.org;PubMed Central

ReferenceCitation: Jordan SC, Legendre C, Desai NM, Lorant T, Bengtsson M, Lonze BE, Vo AA, Runstrom A, Laxmyr L, Sjoholm K, Schiott A, Sonesson E, Wood K, Winstedt L, Kjellman C, Montgomery RA. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.

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

publisher_dissemination: Wolters Kluwer Health

location_facility:
Cedars-Sinai Medical Center
Uppsala University Hospital
New York University School of Medicine
Necker Hospital
The Johns Hopkins Hospital

title: A Phase II Study to Evaluate the Efficacy of IdeS (IgG Endopeptidase) to Desensitize Transplant Patients With a Positive Crossmatch Test

location_country:
United States
Sweden
France


title: A Clinical Investigation Determining the Discriminative Ability of the NIOX VERO NASAL to Differentiate Subjects With Primary Ciliary Dyskinesia From Healthy Controls

summary:
This is a multi-centre, single visit clinical investigation involving patients with known PCD vs. age matched healthy volunteers. This study involves 1 visit which will last one (1) to two (2) hours. Participants (and parent as applicable) will be asked for their consent to participate in the study. A brief medical history will be recorded, including information such as age, gender, height, weight, race, current medications and living environment. If the participant is a PCD patient, they will also be asked about their disease history. Prior to performing the nasal measurements, participants will receive instructions from study personnel and have the opportunity to practice. All participants will have a brief nasal exam and will also have to blow their nose before starting the measurements. Participants will be asked to perform nasal nitric oxide measurements using the tidal breathing method followed by the velum closed with expiration against resistance method.

The primary objective is to determine the feasibility and capability of the NIOX VERO to discriminate participants with PCD from those that are healthy. Information collected in this study will help researchers understand more about the diagnosis of and identification of patients with PCD.

lead_sponsor: Aerocrine AB

location_country:
United States
Denmark
Germany
France

location_facility:
Germany
Denmark
Paris
St Louis
Chapel Hill


title: A Phase 1 Study of LY3127804 as Monotherapy and in Combination With Ramucirumab in Patients With Advanced Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel

design_allocation: Non-Randomized

ReferenceCitation: Martin-Liberal J, Hollebecque A, Aftimos P, Jungels C, Martin-Romano P, Rodon J, Kremer JD, Zhang W, Bendell J. First-in-human, dose-escalation, phase 1 study of anti-angiopoietin-2 LY3127804 as monotherapy and in combination with ramucirumab in patients with advanced solid tumours. Br J Cancer. 2020 Oct;123(8):1235-1243. doi: 10.1038/s41416-020-1011-7. Epub 2020 Aug 3.

location_country:
United States
Spain
Belgium
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.


title: GNE-Myopathy Disease Monitoring Program (GNEM-DMP): A Registry and Prospective Observational Natural History Study to Assess GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM)

summary: HIBM is a severe progressive myopathy that typically presents in early adulthood as weakness in the distal muscles of the lower extremities and progresses proximally, leading to a loss of muscle strength and function, and ultimately a wheelchair-bound state. The rate of progression is gradual and variable over the course of 10-20 years or longer. There is a need to better understand the disease-specific features of HIBM to heighten disease awareness; facilitate early diagnosis; identify patients; expand knowledge of the clinical presentation, progression and variation of the disease; identify and validate biomarkers and other efficacy measures; inform on the design and interpretation of clinical studies of investigational products; and eventually to optimize patient management.

lead_sponsor: Ultragenyx Pharmaceutical Inc

sponsor_collaborators:
Ultragenyx Pharmaceutical Inc
Newcastle University

location_country:
United Kingdom
United States
Bulgaria
Canada
France

location_facility: Bulgarian Neuromuscular Disease Association


title: A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer

summary: Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

primary_purpose: Diagnostic

lead_sponsor: GE Healthcare

location_country:
Germany
Belgium
United States
Canada
France

location_facility:
Institut Goustave Roussy
AZ St-Jan Brugge AV
Seattle Cancer Care Alliance
Sunnybrook Health Science Centre
Institut fur Radiologie, Charite


title: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

acronym: DONTBIOPCE

summary: This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

ReferenceCitation: Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.

lead_sponsor: Mauna Kea Technologies

sponsor_collaborators:
Mauna Kea Technologies
Cellvizio Inc.
Emissary International LLC

location_country:
United States
Germany
France

location_facility: New York Presbyterian Hospital/Columbia University Medical Center


title: Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

summary: This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

lead_sponsor: Pfizer

location_country:
United States
Spain
France


title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

summary:
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

lead_sponsor: LEO Pharma

location_country: France Denmark Belgium Canada Sweden

location_facility: Department of Dermatology, Marselisborg Centres

location_facility: Hôpital de L'Archet, Service de Dermatologie

location_facility: Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie


title: A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia

summary:
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia.

ReferenceCitation: Gerson SL, Karp J, Rizzieri D, et al.: Low levels of pre-treatment O6-alkylguanine transferase (AGT) in patients with AML correlate with response to Cloretazine® (VNP40101M) induction therapy. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-2640, 2007.

ReferenceCitation: Giles F, Rizzieri D, Karp J, Vey N, Ravandi F, Faderl S, Khan KD, Verhoef G, Wijermans P, Advani A, Roboz G, Kantarjian H, Bilgrami SF, Ferrant A, Daenen SM, Karsten V, Cahill A, Albitar M, Mufti G, O'Brien S. Cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients age 60 years or older with previously untreated acute myeloid leukemia. J Clin Oncol. 2007 Jan 1;25(1):25-31. doi: 10.1200/JCO.2006.07.0961. Epub 2006 Dec 4.

lead_sponsor: Vion Pharmaceuticals

location_country:
United States
United Kingdom
France

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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


title: A Prospective, Observational Study in Patients With Late-Onset Pompe Disease

summary:
Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function.

This study is being conducted to collect prospective, observational data on patients with late-onset Pompe disease. Approximately 60 subjects with late-onset Pompe disease will be enrolled.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
Netherlands
France

location_facility: Children's Hospital & Regional Medical Center

location_facility: Institut de Myologie, Groupe Hospitalier Pitie-Salpetriere, Batimant Babinski


title: TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial

acronym: TRICURE

summary: The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

lead_sponsor: TRiCares GmbH

location_country: Belgium France

location_facility: Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel

location_facility: University Hospital Lille, Institut Cœur Poumon

location_facility: Centre hospitalier universitaire CHU de Liège


title: A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC)

summary:
This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy.

After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients who achieve a CR by Investigator assessment at the end of the induction phase will enter the maintenance phase and receive monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression to MIBC or extravesical disease.

lead_sponsor: Fidia Farmaceutici s.p.a.

location_country:
Italy
Poland
United States
Spain
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej

location_facility: Centre Hospitalier Universitaire Poitiers

location_facility: Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

location_facility: Banner Health- MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette

location_facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

location_facility: CHU de Clermont-Ferrand - Hopital Gabriel Montpied


title: Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures

acronym: IVUS-CHIP

summary:
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or angiographic guided PCI .

The IVUS-guided PCI approach is indicated to reduce the frequency of target-lesion failure (cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization) in patients with complex coronary lesions undergoing PCI.

The objective of this study is to assess the superiority of an IVUS-guided approach versus an angio-guided approach in patients with complex coronary lesions undergoing PCI.

lead_sponsor: ECRI bv

sponsor_collaborators:
ECRI bv
Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: University Clinical Hospital of Valladolid

location_facility: Cardiovascular Institute of Grenoble, GHM

location_facility: Centre Cardiologique du Nord Saint-Denis

location_facility: Marques de Valdecilla University Hospital


title: Early Identification of SEPsis SIGNs in Emergency Department

acronym: SepSIGN

summary: Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.

lead_sponsor: BioMérieux

collaborators: Centre d'Investigation Clinique - Limoges

location_country:
United States
Monaco
France

location_facility: University of Colorado School of Medicine


lead_sponsor: Hoffmann-La Roche

summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).

ReferenceCitation: Novello S, Mazieres J, Oh IJ, de Castro J, Migliorino MR, Helland A, Dziadziuszko R, Griesinger F, Kotb A, Zeaiter A, Cardona A, Balas B, Johannsdottir HK, Das-Gupta A, Wolf J. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study. Ann Oncol. 2018 Jun 1;29(6):1409-1416. doi: 10.1093/annonc/mdy121.

repository_institution: University of Turin - Institutional Research Information System University of Turin

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
dnet
iris.unito.it

repositories_concat: PubMed Central;dnet;iris.unito.it

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Korea University Guro Hospital; Oncology

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare

location_facility: Hopital Du Haut Leveque; Service Des Maladies Respiratoires

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: POLICLINICO RODOLICO, U.O. di Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib

location_country:
Germany
Italy
Poland
Portugal
Slovakia
Hungary
Hong Kong
Norway
Belgium
Korea, Republic of
Spain
Turkey
Bulgaria
Russian Federation
France


lead_sponsor: Novartis Pharmaceuticals

summary: This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.

ReferenceCitation: Passamonti F, Palandri F, Saydam G, Callum J, Devos T, Guglielmelli P, Vannucchi AM, Zor E, Zuurman M, Gilotti G, Zhang Y, Griesshammer M. Ruxolitinib versus best available therapy in inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): 5-year follow up of a randomised, phase 3b study. Lancet Haematol. 2022 Jul;9(7):e480-e492. doi: 10.1016/S2352-3026(22)00102-8. Epub 2022 May 18.

ReferenceCitation: Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.

ReferenceCitation: Passamonti F, Griesshammer M, Palandri F, Egyed M, Benevolo G, Devos T, Callum J, Vannucchi AM, Sivgin S, Bensasson C, Khan M, Mounedji N, Saydam G. Ruxolitinib for the treatment of inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): a randomised, open-label, phase 3b study. Lancet Oncol. 2017 Jan;18(1):88-99. doi: 10.1016/S1470-2045(16)30558-7. Epub 2016 Dec 2.

title: Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)

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
Italy
India
Hungary
Israel
Australia
Belgium
Korea, Republic of
Spain
Turkey
Canada
France


title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

summary: This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

ReferenceCitation: Mathiesen ER, Andersen H, Kring SI, Damm P. Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins. BMC Pregnancy Childbirth. 2017 Jan 18;17(1):38. doi: 10.1186/s12884-016-1177-4.

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

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, Cypryk K, de Valk H, Dores J, Dunne F, Gall MA, Garcia SD, Hanaire HP, Husemoen LLN, Ivanisevic M, Kempe HP, McCance DR, Damm P. Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study. Diabetes Care. 2021 Sep;44(9):2069-2077. doi: 10.2337/dc21-0472. Epub 2021 Jul 30.

oa_colors: green other

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Israel
Norway
Romania
United Kingdom
Netherlands
Spain
Greece
Croatia
Malaysia
France


title: A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma

summary: This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
France
Poland
Denmark
Netherlands
Spain
Russian Federation
Israel


title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis

acronym: ASPIRE

summary: Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

location_country: Germany Italy Portugal Hungary Sweden Austria Spain Greece France

location_facility: Servicio de nefrología Fundacion Puigvert

location_facility: Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini

location_facility: Kaposi Mór County Hospital Department of Nephrology

location_facility: Department of Nephrology Sahlgrenska University Hospital

location_facility: Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.

location_facility: Servicio de Nefrología, Hospital Universitario Dr Peset,

location_facility: Service de Néphrologie Hémodialyse Clinique de l'Orangerie

location_facility: Klinikum rechts der Isar der TU München, Nephrologie

location_facility: Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi

location_facility: Hôpital Pellegrin Service de Néphrologie

location_facility: Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna

location_facility: Servicio de nefrología Hospital de Galdakao

location_facility: Centro Hospitalar de Coimbra - Serviço de Nefrologia

location_facility: Servicio de nefrología Fundación Hospital Alcorcón

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse

location_facility: Hospital de São João EPE - Serviço de Nefrologia

location_facility: Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes

location_facility: Servicio de nefrología H. Arquitecto Marcide

location_facility: Szekszárd EuroCare Dialysis Centre Number 7

location_facility: Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck

location_facility: Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension

location_facility: Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie

location_facility: Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse


title: Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma

summary: This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of markers potentially predictive of clinical response to specific anticancer therapies.

primary_purpose: Screening

location_country:
Germany
Italy
France
United States
Sweden

intervention_type: Procedure


summary: This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

ReferenceCitation: Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Munoz-Torres M, Donnet JP, Endahl L, Skjoth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1. Erratum In: Eur J Endocrinol. 2012 Sep;167(3):453.

ReferenceCitation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.

title: A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

location_country: Finland Germany Poland Spain France


title: A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances

summary: The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment

ReferenceCitation: Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Ireland
Italy
Germany
United Kingdom
Sweden
Korea, Republic of
Spain
France

location_facility: 248.604.3909 IRCCS Fondazione "Salvatore Maugeri"

location_facility: 248.604.4605 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35302 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4905 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4908 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44006 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44009 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4907 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82003 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35802 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4604 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3301A HOP Le Vinatier,Psychiat,Bron

location_facility: 248.604.4903 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4601 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44007 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3908 Azienda Sanitaria San Giovanni Battista

location_facility: 248.604.4909 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82002 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4606 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4910 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3901 Università degli Studi di Bologna

location_facility: 248.604.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4603 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4904 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35805 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4906 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4902 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4901 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4911 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4602 Boehringer Ingelheim Investigational Site


title: An Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib

summary: The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Italy
Germany
Portugal
Norway
United Kingdom
Sweden
Belgium
Spain
Russian Federation
France


title: A Multicenter, Open-label Phase I/II Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2/Neu

summary: Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.

ReferenceType: background

ReferenceCitation: Curigliano G, Romieu G, Campone M, Dorval T, Duck L, Canon JL, Roemer-Becuwe C, Roselli M, Neciosup S, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A phase I/II trial of the safety and clinical activity of a HER2-protein based immunotherapeutic for treating women with HER2-positive metastatic breast cancer. Breast Cancer Res Treat. 2016 Apr;156(2):301-10. doi: 10.1007/s10549-016-3750-y. Epub 2016 Mar 14.

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

location_country: Italy Colombia Belgium Peru France

intervention_type: Biological


title: Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.

PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.

ReferenceCitation: Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

ReferenceCitation: Mekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available.

ReferenceCitation: Churilla TM, Chowdhury IH, Handorf E, Collette L, Collette S, Dong Y, Alexander BM, Kocher M, Soffietti R, Claus EB, Weiss SE. Comparison of Local Control of Brain Metastases With Stereotactic Radiosurgery vs Surgical Resection: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):243-247. doi: 10.1001/jamaoncol.2018.4610.

publisher_dissemination: American Medical Association

ReferenceCitation: Churilla TM, Handorf E, Collette S, Collette L, Dong Y, Aizer AA, Kocher M, Soffietti R, Alexander BM, Weiss SE. Whole brain radiotherapy after stereotactic radiosurgery or surgical resection among patients with one to three brain metastases and favorable prognoses: a secondary analysis of EORTC 22952-26001. Ann Oncol. 2017 Oct 1;28(10):2588-2594. doi: 10.1093/annonc/mdx332.

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: PubMed Central;iris.unito.it

repositories_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Soffietti R, Kocher M, Abacioglu UM, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Mueller RP, Tridello G, Collette L, Bottomley A. A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results. J Clin Oncol. 2013 Jan 1;31(1):65-72. doi: 10.1200/JCO.2011.41.0639. Epub 2012 Dec 3.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

location_country:
Finland
Germany
France
Italy
Portugal
United Kingdom
Netherlands
Switzerland
Belgium
Latvia
Spain
Turkey
Israel

location_facility: Oncology Institute of Southern Switzerland

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Paula Stradina Kliniskas Universitates Slimnica

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Istituto Nazionale Neurologico Carlo Besta

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig


title: A Prospective, Observational Study to Assess the Real-World Usage and Outcomes of HyQvia in Patients With Multiple Myeloma (MM) Diagnosed With Secondary Immunodeficiency (SID)

summary: In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.

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

lead_sponsor: Takeda

location_country: Germany Italy Poland Argentina Romania Sweden Spain Greece Turkey Czechia France

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Centro de investigaciones Clinicas Cordoba

intervention_type: Other


title: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

acronym: HYDRA

summary: The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

collaborators: Insel Gruppe AG, University Hospital Bern

location_country: Italy Netherlands Switzerland Belgium Spain France

location_facility: Cliniques Universitaires Saint-Luc (CUSL)

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

location_facility: Centre Hospitalier Universitaire de Liège (CHU Liège)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

lead_sponsor_type: academique


title: A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

summary: The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Germany
Hungary
United Kingdom
Australia
United States
Spain
France

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

location_facility: Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie

location_facility: Hospital Infanta Luisa Quirón Salud Servicio de Reumatología

location_facility: Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie

location_facility: CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos

location_facility: Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő

location_facility: Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia

location_facility: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: The Queen Elizabeth Hospital Rheumatology Unit

location_facility: Southampton General Hospital, University Hospital Southampton NHS Trust

location_facility: CLINICAL GAIAS SANTIAGO Servicio de Reumatología

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék


acronym: DUART

lead_sponsor: AstraZeneca

summary: This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED])

ReferenceCitation: Filippi AR, Dziadziuszko R, Garcia Campelo MR, Paoli JB, Sawyer W, Diaz Perez IE. DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. Future Oncol. 2021 Dec;17(34):4657-4663. doi: 10.2217/fon-2021-0952. Epub 2021 Nov 15.

publisher_dissemination: Future Science Ltd

title: A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy

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

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

location_country:
Italy
Poland
United States
Spain
Russian Federation
France


title: An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

summary: This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal regulatory protein alpha (SIRPα) receptor, a myeloid checkpoint inhibitor administered as single agent, and in combination with BI 754091, a mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor.

ipd_sharing: Undecided

lead_sponsor: OSE Immunotherapeutics

sponsor_collaborators:
OSE Immunotherapeutics
Boehringer Ingelheim

location_country: Belgium France

location_facility:
Universitair Ziekenhuis Gent
Institut Jules Bordet
Centre Léon Berard
Institut Bergonie
Institut Claudius Regaud
Hospital St Pierre
Universitair Ziekenhuis Brussel
Institut Gustave Roussy


title: Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes

summary: The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

lead_sponsor: Zimmer Biomet

location_country:
Denmark
United Kingdom
Belgium
France

location_facility: South West London Elective Orthopaedic centre - EPSOM General Hospital


lead_sponsor: Mårten Segelmark

summary: This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).

ReferenceCitation: Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, Neumann I, Noel LH, Pusey CD, Waldherr R, Bruijn JA, Bajema IM. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010 Oct;21(10):1628-36. doi: 10.1681/ASN.2010050477. Epub 2010 Jul 8.

ReferenceCitation: van Daalen EE, Jennette JC, McAdoo SP, Pusey CD, Alba MA, Poulton CJ, Wolterbeek R, Nguyen TQ, Goldschmeding R, Alchi B, Griffiths M, de Zoysa JR, Vincent B, Bruijn JA, Bajema IM. Predicting Outcome in Patients with Anti-GBM Glomerulonephritis. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):63-72. doi: 10.2215/CJN.04290417. Epub 2017 Nov 21.

sponsor_collaborators:
Mårten Segelmark
Hansa Biopharma AB

location_facility: Department of Internal Medicine IV (Nephrology and Hypertension)

location_facility: Centre Hospitalier Régional Universitaire de Lille, Nephrology Service

location_facility: Department of Nephrology and Organ Transplant, CHU Rangueil

location_facility: PH USI UNTR, service du Pr Rondeau, Hôpital Tenon

location_facility: Department of Nephrology, Uppsala University Hospital

location_facility: Department of Department of nephrology, First Faculty of Medicine and General Teaching Hospital and Charles University in Prague, Czech Republic,

location_facility: Department of Department of Nephrology, Rigshospitalet, Copenhagen

location_facility: Department of Nephrology, Hemodialysis, Apheresis, and Transplantation, CHUGA (centre hospitalier universitaire Grenoble-Alpes)

title: Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS - GOOD-IDES

location_country: France Denmark Austria Czechia Sweden


title: A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

summary: The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

ReferenceCitation: Pungor K, Bozikas VP, Emsley R, Llorca PM, Gopal S, Mathews M, Wooller A, Bergmans P. Stable patients with schizophrenia switched to paliperidone palmitate 3-monthly formulation in a naturalistic setting: impact of patient age and disease duration on outcomes. Ther Adv Psychopharmacol. 2020 Dec 23;10:2045125320981500. doi: 10.1177/2045125320981500. eCollection 2020.

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Germany
Israel
United Kingdom
Denmark
Netherlands
Korea, Republic of
Saudi Arabia
Spain
Greece
Croatia
Malaysia
Taiwan
Turkey
Russian Federation
France


title: A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

acronym: PARSIFAL

summary: This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

ReferenceCitation: Di Cosimo S, Perez-Garcia JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-De Duenas E, Caranana V, Amillano K, Mina L, Malfettone A, Cortes J, Llombart-Cussac A. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Oncologist. 2023 Jan 18;28(1):23-32. doi: 10.1093/oncolo/oyac205.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

publisher_dissemination: Oxford University Press

ReferenceCitation: Llombart-Cussac A, Perez-Garcia JM, Bellet M, Dalenc F, Gil-Gil M, Ruiz-Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-de Duenas E, Amillano K, Malfettone A, Cortes J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):1791-1799. doi: 10.1001/jamaoncol.2021.4301. Erratum In: JAMA Oncol. 2021 Nov 1;7(11):1729.

lead_sponsor: MedSIR

location_country:
Germany
Italy
United Kingdom
Spain
Czechia
Russian Federation
France

location_facility:
MedSIR investigative site
MedSIR investigative site B


title: A Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib (ONO/GS-4059) in Combination With Other Targeted Anti-cancer Therapies in Subjects With B-cell Malignancies

summary:
The primary objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib (ONO/GS-4059) in combination with other targeted anti-cancer therapies and to evaluate the long-term safety of tirabrutinib as a monotherapy and in combination with other targeted anti-cancer therapies in adults with relapsed or refractory B-cell lymphoproliferative malignancies.

This study consists of three parts: Dose Escalation, Dose Expansion, and Long-term Safety Monitoring. During the Dose Escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety, tolerability, PK, and pharmacodynamics. The Long-term Safety Monitoring phase will evaluate the long-term safety of tirabrutinib both as a monotherapy and in combination with other anti-cancer therapies. As of Amendment 9, all participants currently on the study who have no clinical evidence of disease progression will transition into long-term safety monitoring. Participants from the ongoing Study GS-US-401-1787 and participants who came off Study GS-US-401-1757 and Study GS-US-401-1787 but continued to receive treatment via named patient use (or individual expanded use) will be enrolled into the long-term safety monitoring group (Group VI). Participants enrolled in Group VI will continue the same treatment regimen in Study GS-US-401-1787 or named patient use (or individual expanded use). As of Protocol Amendment 8, the maximum treatment duration for any participant is an additional 6 years from the date of this amendment (ie. until November 2025). As of Amendment 9, entospletinib will be provided until 31 December 2020 to participants who are currently receiving entospletinib. Participants treated with entospletinib as part of a combination regimen with tirabrutinib will stop receiving entospletinib by 31 December 2020 but may continue to be treated with tirabrutinib monotherapy. Idelalisib will be provided as 50 mg tablets until 31 December 2020 and 100 mg tablets until study completion. Participants assigned to the 50 mg tablet will be given the option, at the investigator's discretion, to switch to 100 mg once daily idelalisib dose.

ReferenceCitation: Danilov AV, Herbaux C, Walter HS, Hillmen P, Rule SA, Kio EA, Karlin L, Dyer MJS, Mitra SS, Yi PC, Humeniuk R, Huang X, Zhou Z, Bhargava P, Jurgensmeier JM, Fegan CD. Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia. Clin Cancer Res. 2020 Jun 15;26(12):2810-2818. doi: 10.1158/1078-0432.CCR-19-3504. Epub 2020 Mar 10.

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Yahiaoui A, Meadows SA, Sorensen RA, Cui ZH, Keegan KS, Brockett R, Chen G, Queva C, Li L, Tannheimer SL. PI3Kdelta inhibitor idelalisib in combination with BTK inhibitor ONO/GS-4059 in diffuse large B cell lymphoma with acquired resistance to PI3Kdelta and BTK inhibitors. PLoS One. 2017 Feb 8;12(2):e0171221. doi: 10.1371/journal.pone.0171221. eCollection 2017.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: Gilead Sciences

location_country:
United States
United Kingdom
France

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Institut Universitaire du Cancer-Oncopole I.U.C.T-O

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Leeds Teaching Hosptials NHS Trust, Dept of Haematology

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Cardiff and Vale Health Board, Clinical Research Facility

location_facility: University Hospitals of Leicester NHS Trust


title: A Phase I/IB Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Evaluate Safety, Tolerability of TG1050 Single/Multiple Doses, and Evaluation of TG1050 Immunologic/Antiviral Activity in Patients With Chronic Hep B Infection

summary:
Methodology:

This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled

lead_sponsor: Transgene

location_country: Germany Canada France


title: A Multicentre, Multinational, Randomised, Open-labelled, Parallel-group, Active-controlled Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

acronym: REAL 2

summary: This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

ReferenceCitation: Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

location_country:
Germany
France
United Kingdom
Denmark
Japan
Sweden


title: An Open Label Study Examining the Efficacy and Cardiovascular Risk of Immediate Versus Deferred Switch From a Boosted PI to Dolutegravir (DTG) in HIV Infected Patients With Stable Virological Suppression

summary:
The purpose of the study is to investigate the benefits of switching away from a kind of drug called a boosted protease inhibitor (PI) to a new drug called dolutegravir on patients' cardiovascular health (the health of their hearts). Patients are currently taking two other anti-HIV drugs, called nucleoside reverse transcriptase inhibitors (NRTIs), with their boosted PIs; these NRTIs will not be changed throughout the study. In order to compare the boosted PI and dolutegravir more accurately, half of study participants will be switched to dolutegravir immediately, and the other half will be switched after 48 weeks of continuing on the boosted PI.

Boosted PIs are associated with increased heart and circulation risk so it is hoped that switching from a boosted PI to dolutegravir will improve the health of the patients' hearts. Dolutegravir is a drug for HIV treatment which has been approved for use in HIV patients in the US and Europe. Clinical trials using dolutegravir have found that it is effective at suppressing the HIV virus, and it is at least as effective as the other drugs.

This study will also investigate the safety (in terms of other side effects and the routine blood tests which the investigators ordinarily use to monitor patients' treatment) and monitor effectiveness, patients' viral load and CD4 counts, when patients switch treatment from a boosted PI to dolutegravir. Viral load is the amount of the HIV virus they have in their blood, and CD4 count is a measure of a type of cell that is in their immune system. We also aim to improve patients' cardiovascular health in general by providing them with information on how to live a healthy lifestyle (eg improving their diet, stopping smoking etc).

ReferenceCitation: Saumoy M, Sanchez-Quesada JL, Assoumou L, Gatell JM, Gonzalez-Cordon A, Guaraldi G, Domingo P, Giacomelli A, Connault J, Katlama C, Masia M, Ordonez-Llanos J, Pozniak A, Martinez E, Podzamczer D. Atherogenicity of low-density lipoproteins after switching from a protease inhibitor to dolutegravir: a substudy of the NEAT022 study. J Antimicrob Chemother. 2022 Jun 29;77(7):1980-1988. doi: 10.1093/jac/dkac117.

ReferenceCitation: Gatell JM, Assoumou L, Moyle G, Waters L, Johnson M, Domingo P, Fox J, Martinez E, Stellbrink HJ, Guaraldi G, Masia M, Gompels M, De Wit S, Florence E, Esser S, Raffi F, Stephan C, Rockstroh J, Giacomelli A, Vera J, Bernardino JI, Winston A, Saumoy M, Gras J, Katlama C, Pozniak AL; European Network for AIDS Treatment 022 (NEAT022) Study Group. Immediate Versus Deferred Switching From a Boosted Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age >/=50 Years: Final 96-Week Results of the NEAT022 Study. Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.

evidence: open (via free article)

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of Sussex - Sussex Research Online

version: acceptedVersion

lead_sponsor: St Stephens Aids Trust

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
France

location_facility: Service des Maladies Infectieuses et Tropicales du CHU de NANTES

location_facility: Azienda Ospedaliera - Polo Universitario 'Luigi Sacco'

location_facility: Klinikum der Goethe-Universität Frankfurt


title: An Open Label, Non-randomized, Phase I Dose Escalation Study to Characterize Safety, Tolerability, Pharmacokinetics and Maximum Tolerated Dose of BAY1163877 in Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors

summary:
This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined.
After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification).
The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877.
BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.

ReferenceCitation: Schuler M, Cho BC, Sayehli CM, Navarro A, Soo RA, Richly H, Cassier PA, Tai D, Penel N, Nogova L, Park SH, Schostak M, Gajate P, Cathomas R, Rajagopalan P, Grevel J, Bender S, Boix O, Nogai H, Ocker M, Ellinghaus P, Joerger M. Rogaratinib in patients with advanced cancers selected by FGFR mRNA expression: a phase 1 dose-escalation and dose-expansion study. Lancet Oncol. 2019 Oct;20(10):1454-1466. doi: 10.1016/S1470-2045(19)30412-7. Epub 2019 Aug 9.

ReferenceCitation: Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

lead_sponsor: Bayer

location_country:
Germany
Singapore
Switzerland
United States
Korea, Republic of
Spain
France


title: Renvela® Post-Marketing Observational Study to Monitor the Clinical Use in Adult Hyperphosphataemic Chronic Kidney Disease Patients Not On Dialysis With Serum Phosphorus ≥1.78 mmol/L

summary: The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

lead_sponsor: Genzyme, a Sanofi Company

location_country: Germany Italy Denmark Netherlands Austria Spain France


title: A Phase I/II Study of ARGX-110 in Patients With Advanced Malignancies Expressing CD70.

summary: The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).

ReferenceCitation: Silence K, Dreier T, Moshir M, Ulrichts P, Gabriels SM, Saunders M, Wajant H, Brouckaert P, Huyghe L, Van Hauwermeiren T, Thibault A, De Haard HJ. ARGX-110, a highly potent antibody targeting CD70, eliminates tumors via both enhanced ADCC and immune checkpoint blockade. MAbs. 2014 Mar-Apr;6(2):523-32. doi: 10.4161/mabs.27398. Epub 2013 Dec 6.

publisher_dissemination: Informa

lead_sponsor: OncoVerity, Inc.

sponsor_collaborators:
OncoVerity, Inc.
argenx
Janssen Research & Development, LLC


title: An Open-Label, Single-Arm Phase III Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Subjects

acronym: RESTORE

summary: The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both treatment-naïve and treatment experienced, chronic hepatitis C (HCV) virus, genotype-4 infected patients.

ReferenceCitation: Moreno C, Hezode C, Marcellin P, Bourgeois S, Francque S, Samuel D, Zoulim F, Grange JD, Shukla U, Lenz O, Ouwerkerk-Mahadevan S, Fevery B, Peeters M, Beumont M, Jessner W. Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or experienced patients infected with chronic HCV genotype 4. J Hepatol. 2015 May;62(5):1047-55. doi: 10.1016/j.jhep.2014.12.031. Epub 2015 Jan 14.

lead_sponsor: Janssen R&D Ireland


title: An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.

summary:
Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
France
Italy
United Kingdom
Australia
Spain
Sweden


lead_sponsor: Astellas Pharma Europe Ltd.

summary:
Parts A & B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.

Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.

location_facility:
Site BE21
Site GB62
Site PL51
Site FR33
Site BE22
Site FR34
Site FR32
Site PL52
Site GB64
Site DE41
Site IT75
Site FR31
Site FR35
Site GB61
Site IT74
Site CZ42

title: A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
Czechia
France


acronym: EASSI

lead_sponsor: Shire

summary: This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

ReferenceCitation: Aberer W, Maurer M, Reshef A, Longhurst H, Kivity S, Bygum A, Caballero T, Bloom B, Nair N, Malbran A. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema. Allergy. 2014 Mar;69(3):305-14. doi: 10.1111/all.12303.

repository_institution: CONICET - CONICET Digital

sponsor_collaborators:
Shire
Jerini AG

location_facility: Bnai-Zion M.C. Clinical Immunology and Allergy Division

location_facility: The Chaim Sheba Medical Center, The Allergy and Clinical Immunology Unit

location_facility: Hospital Universitario La Fe, Servicio de Alergia

location_facility: Derriford Combined Laboratory, Department of Clinical Immunology & Allergy

location_facility: Universita degli Studi di Napoli 'Federico II'

location_facility: Universitätsklinik für Dermatologie und Venerologie

location_facility: Barts & The London NHS Trust, Pathology and Pharmacy Building

location_facility: Hospital Universitario La Paz, Servicio de Alergia

location_facility: Klinkum der Johann Wolfgang Goethe-Universitat

location_facility: Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität

location_facility: Universitäts-Hals-Nasen-Ohren-Klinik Essen, Universität Duisburg-Essen

location_facility: Southmead Hospital, Department of Immunology

location_facility: Hopital Europeen Georges Pompidou Immunologie Clinique

location_facility: Tel Aviv Sourasky Medical Center - Allergy Unit

location_facility: Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie, Charité

location_facility: Clinique Universitaire de Medicine/ Centre National de reference

location_facility: Hopital Claude Huriex/ Service de medicine interne

location_facility: Hospital Universitario Vall de Hebrón / Sección de Alergia, Escola Infermeria

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire/ Service de Dermatologie

location_facility: Universitätsspital Zürich / Dermatologische Klinik

title: Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema

location_country:
Germany
Italy
Israel
Argentina
Denmark
United Kingdom
Switzerland
Austria
Spain
France


title: A Multicenter, Open Label, Phase I Trial of the MEK Inhibitor MSC1936369B Given Orally to Subjects With Solid Tumours

summary: This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.

ReferenceCitation: Lebbe C, Italiano A, Houede N, Awada A, Aftimos P, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Raymond E, Faivre S, Pages C, Gomez-Roca C, Schueler A, Goodstal S, Massimini G, Delord JP. Selective Oral MEK1/2 Inhibitor Pimasertib in Metastatic Melanoma: Antitumor Activity in a Phase I, Dose-Escalation Trial. Target Oncol. 2021 Jan;16(1):47-57. doi: 10.1007/s11523-020-00767-1.

ReferenceCitation: Delord JP, Italiano A, Awada A, Aftimos P, Houede N, Lebbe C, Pages C, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Faivre S, Gomez-Roca C, Scheuler A, Massimini G, Raymond E. Selective Oral MEK1/2 Inhibitor Pimasertib: A Phase I Trial in Patients with Advanced Solid Tumors. Target Oncol. 2021 Jan;16(1):37-46. doi: 10.1007/s11523-020-00768-0.

lead_sponsor: Merck KGaA, Darmstadt, Germany

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

location_country: Australia Netherlands Belgium France

location_facility: Netherlands Cancer Institute - Antonie van Leeuwenhoek Hospital


acronym: MAGE3-AS15-MEL-004 (MET)

lead_sponsor: GlaxoSmithKline

summary: The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.

ReferenceCitation: Baurain JF, Robert C, Mortier L, Neyns B, Grange F, Lebbe C, Ulloa-Montoya F, De Sousa Alves PM, Gillet M, Louahed J, Jarnjak S, Lehmann FF. Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic. ESMO Open. 2018 Jul 25;3(5):e000384. doi: 10.1136/esmoopen-2018-000384. eCollection 2018.

title: Clinical Activity, Safety and Immunogenic Properties of Cancer Immunotherapeutic GSK2132231A in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma


title: An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

summary:
Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

Immunogenicity

To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects

Safety

- To describe the safety profile after vaccination in each group

Acceptability

To describe the pain at the injection site
To describe the comfort of the injection

ReferenceCitation: Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.

lead_sponsor: Sanofi Pasteur, a Sanofi Company