title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period

summary: This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

ReferenceCitation: Wijsenbeek MS, Bendstrup E, Valenzuela C, Henry MT, Moor CC, Jouneau S, Fois AG, Moran-Mendoza O, Anees S, Mirt M, Bengus M, Gilberg F, Kirchgaessler KU, Vancheri C. Disease Behaviour During the Peri-Diagnostic Period in Patients with Suspected Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2021 Jul;38(7):4040-4056. doi: 10.1007/s12325-021-01790-y. Epub 2021 Jun 11.

ReferenceCitation: Wijsenbeek M, Bendstrup E, Valenzuela C, Henry MT, Moor C, Bengus M, Perjesi A, Gilberg F, Kirchgaessler KU, Vancheri C. Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2019 Jan;36(1):232-243. doi: 10.1007/s12325-018-0845-3. Epub 2018 Nov 30.

lead_sponsor: Hoffmann-La Roche

location_country:
Ireland
Italy
Russian Federation
Canada
France
Netherlands

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia

location_facility: SBIH at Vladimir Region "Regional Clinical Hospital"

location_facility: Kingston Health Sciences Centre; research Kingston General Health Research Institute

location_facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Clinique de pneumologie et du sommeil de Lanaudiere

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare

location_facility: Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

location_facility: Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia

location_facility: Ospedale Policlinico S. Matteo; S.C. Pneumologia

location_facility: Hopital Arnaud De Villeneuve; Pneumologie A

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

location_facility: P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia

location_facility: SBIH "Chelyabinsk Regional Clinical Hospital"

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: SBI at Rostov Region "Regional Clinical Hospital #2"

location_facility: Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome

study_completion_date_type: Actual

lead_sponsor: GlaxoSmithKline

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Raymond K, Maher S, Saucier CD, O'Connor M, Yarlas A, Kosinski M, Chen WH, Gairy K. Validation of the PROFAD-SSI-SF in Patients with Primary Sjögren's Syndrome with Organ Involvement: Results of Qualitative Interviews and Psychometric Analyses. Rheumatol Ther. 2022 Oct 13. doi: 10.1007/s40744-022-00493-2. [Epub ahead of print]

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

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Netherlands
Argentina
Canada
Sweden
France
Norway
Germany

summary:
This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of belimumab/ rituximab co-administration and of belimumab monotherapy; and to evaluate whether either co-administration therapy or belimumab monotherapy has a substantive effect on disease activity.

This study will consist screening period, double blind treatment period, a general follow-up period and individualized follow-up period. Approximately 70 subjects will be recruited into the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24, interim analyses and sample size re-estimation will be conducted. The total number of subjects randomized may increase following sample size re-estimation up to a maximum of 120 recruited into the study.

Subjects in all arms will receive investigational product (IP) until Week 52 (completion of the treatment phase). All subjects will enter a 16-week general follow-up period after the Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the treatment phase visits prior to Week 52.

After completing the general follow-up period, subjects with cluster of differentiation (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of baseline, if baseline value was below lower limit of normal [LLN]) will enter an individualized safety follow-up phase and return to the clinic for visits every 12 weeks with monthly calls between visits to evaluate subjects for any serious adverse events (SAEs) related to IP or study participation, fatal SAEs, and designated adverse event of special interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and to check concomitant medications.

The total duration of participation of a subject in this study will be approximately up to a maximum of 2 years (i.e., up to Week 104).

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter Randomized, Open-Label Phase II/III Study, To Compare The Efficacy Of NBTXR3, Implanted As Intratumor Injection And Activated By Radiotherapy, Versus Radiotherapy Alone In Patients With Locally Advanced Soft Tissue Sarcoma Of The Extremity And Trunk Wall

summary:
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This phase II/III is a prospective randomized, multi-center, open-label and active controlled two arms study in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. Patients will be randomized to receive either NBTXR3 as intratumor injection, activated by external beam radiation therapy or external beam radiation therapy alone, as preoperative treatment. Once the radiotherapy treatment is completed, tumor surgery will be performed in all patients.

ReferenceCitation: Bonvalot S, Rutkowski PL, Thariat J, Carrère S, Ducassou A, Sunyach MP, Agoston P, Hong A, Mervoyer A, Rastrelli M, Moreno V, Li RK, Tiangco B, Herraez AC, Gronchi A, Mangel L, Sy-Ortin T, Hohenberger P, de Baère T, Le Cesne A, Helfre S, Saada-Bouzid E, Borkowska A, Anghel R, Co A, Gebhart M, Kantor G, Montero A, Loong HH, Vergés R, Lapeire L, Dema S, Kacso G, Austen L, Moureau-Zabotto L, Servois V, Wardelmann E, Terrier P, Lazar AJ, Bovée JVMG, Le Péchoux C, Papai Z. NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial. Lancet Oncol. 2019 Aug;20(8):1148-1159. doi: 10.1016/S1470-2045(19)30326-2. Epub 2019 Jul 8. Erratum in: Lancet Oncol. 2019 Sep;20(9):e468.

lead_sponsor: Nanobiotix

location_country:
Poland
Hong Kong
Romania
Spain
Italy
Australia
Hungary
Philippines
France
South Africa
Belgium
Norway
Germany

location_facility: Hospital Clinico Universitario San Carlos

location_facility: START MADRID, Hospital Fundacion Jimenez Diaz

location_facility: Spitalului Universitar de Urgenta Militar Central

location_facility: Medical Centre, Hungarian Defence Forces

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: START MADRID, Hospital Universitario Madrid Norte Sanchinarro

location_facility: Capital Region Cancer Service, Canberra Hospital

location_facility: Centre Regional de Lutte Contre Le Cancer Paul Lamarque

intervention_type: Device


title: Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

summary: The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be investigated.

status: Terminated

ipd_sharing: No

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Poland Spain Latvia Austria Lithuania Hungary France Germany

location_facility: Hôpital Nord - Dept. of Gastroenterology

location_facility: Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

location_facility: Corporació Sanitaria Parc Taulí Servicio de Digestivo

location_facility: Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

location_facility: Hospital Universitario Marques de Valdecilla Servicio de Digestivo

location_facility: Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

location_facility: Hôpital Brabois Service de gastro-enterologie

location_facility: Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

location_facility: Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

location_facility: Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

location_facility: Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

location_facility: Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

location_facility: Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

location_facility: Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

location_facility: Gastroenterologische Fachpraxis am Germania Campus

location_facility: Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

location_facility: Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

location_facility: Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

location_facility: Centro Medico Teknon Servicio de Aparato Disgestivo

location_facility: Paula Stradina Clinical University Hospital Gastroenterology Centre

location_facility: Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

location_facility: Fundación Hospital de Alcorcón Servicio de Gastroenterología

location_facility: Hôpital Rangueil Service de gastro-enterologie

location_facility: Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

location_facility: Semmelweis Egyetem II. sz. Belgyógyászati Klinika

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

location_facility: Hospital Universitario La Paz Servico de Gastroenterologia

location_facility: Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

location_facility: Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

location_facility: Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

location_facility: Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

location_facility: Universitätsmedizin Mannheim II. Medizinische Klinik

location_facility: ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

location_facility: Klaipedos jurininku ligonine Diagnostikos skyrius

location_facility: Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

location_facility: Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

location_facility: Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

status_simplified: Unknown


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.

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.

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.

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

location_country:
United Kingdom
Italy
Austria
Netherlands
Switzerland
France
Belgium
Germany

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

location_facility: University Of Dundee - Ninewells Hospital

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

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

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: Universitair Medisch Centrum - Academisch Ziekenhuis

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

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

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Radboud University Nijmegen Medical Centre

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

location_facility: Freeman Hospital, Northern Centre For Cancer Care

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

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

intervention_type: Biological


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.

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


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.

lead_sponsor: Biotronik SE & Co. KG

location_country:
United Kingdom
Netherlands
Czech Republic
Sweden
France
Belgium
Germany

location_facility: Karolinska University Hospital Stockholm


acronym: PRIMARYS

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

lead_sponsor: Ipsen

ReferenceType: result

ReferenceCitation: Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prévost 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.

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.

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:
United Kingdom
Italy
Netherlands
Finland
France
Turkey
Belgium
Germany
Czechia

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

location_facility: Všeobecná fakultní nemocnice, Karlova Univerzita

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

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

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

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.


title: A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

summary: This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

location_country:
Spain
Georgia
United States
France
Belgium
Bulgaria

location_facility: Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Lee Moffitt Cancer Center and Research Institute

location_facility: Centre de Lutte contre le Cancer - Centre Oscar Lambret

location_facility: Multi-profile Hospital for Active Treatment Uni Hospital

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: University Specialized Hospital for Active Treatment in Oncology EAD

intervention_type: Radiation

status_simplified: Ongoing


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.

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.

lead_sponsor: Biotronik AG

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

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Clinic I Provinvial de Barcelona

location_facility: Charité-Universitätsm. Berlin Campus Charité-Mitte

location_facility: Cliniques Universitaires UCL de Mont-Godinne


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.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention

lead_sponsor: CorNeat Vision Ltd.

location_country: Georgia Canada France

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


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
Korea, Republic of
United States
France
Belgium

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Claudius Regaud - IUCT Oncopole


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.

status: Active, not recruiting

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.

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.

lead_sponsor: Abbott Medical Devices

location_country:
Denmark
United Kingdom
Australia
France
Belgium

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


acronym: Highdes

intervention_type: Procedure

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

lead_sponsor: Hansa Biopharma AB

ReferenceCitation: Kjellman C, Maldonado AQ, Sjöholm K, Lonze BE, Montgomery RA, Runström A, Lorant T, Desai NM, Legendre C, Lundgren T, von Zur Mühlen 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.

ReferenceCitation: Jordan SC, Legendre C, Desai NM, Lorant T, Bengtsson M, Lonze BE, Vo AA, Runström A, Laxmyr L, Sjöholm K, Schiött Å, 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.

location_country:
Sweden
United States
France

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

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.


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:
Denmark
United States
Germany
France

location_facility:
Denmark
Paris
Chapel Hill
St Louis
Germany


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
France
Spain
Belgium

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

location_country:
United Kingdom
Canada
United States
France
Bulgaria

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:
Canada
United States
France
Belgium
Germany

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


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

location_country:
Germany
United States
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: Denmark Canada France Belgium Sweden

location_facility: Department of Dermatology, Marselisborg Centres

location_facility: Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie

location_facility: Hôpital de L'Archet, Service de Dermatologie


type: Registry Identifier

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. Epub 2006 Dec 4.

lead_sponsor: Vion Pharmaceuticals

location_country:
United States
United Kingdom
France

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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:
Netherlands
United States
France

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

location_facility: Children's Hospital & Regional Medical Center


title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

acronym: ReSPECT

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217. Review.

lead_sponsor: Cidara Therapeutics Inc.

location_country:
Spain
Italy
United Kingdom
Canada
France
Belgium
Germany

location_facility: La Fe University and Polytechnic Hospital

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Grenoble Alpes University Hospital Center

location_facility: Puerta de Hierro Majadahonda University Hospital

location_facility: University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven

location_facility: Hamilton Health Sciences' Juravinski Hospital

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Johannes Gutenberg University Medical Center


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.

status: Unknown status

lead_sponsor: BioMérieux

location_country:
United States
Monaco
France

location_facility: University of Colorado School of Medicine


title: Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial

acronym: FAVOR III EJ

summary: Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

ReferenceType: background

ReferenceCitation: Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

ReferenceCitation: Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Bøtker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14). pii: e009603. doi: 10.1161/JAHA.118.009603.

ReferenceCitation: Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bøttcher M, Bøtker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.

ReferenceCitation: Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

ipd_sharing: Undecided

lead_sponsor: Aarhus University Hospital Skejby

location_country: Denmark Poland Spain Italy Latvia Netherlands Lithuania Switzerland Sweden France Japan Germany

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: San Luigi Gonzaga University Hospital, Turin

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier

location_facility: Arcispedale S. Maria Nuova di Reggio Emilia

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg Klinik und Poliklinik für Kardiologie

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Clinico de Santiago de Compostela

intervention_type: Diagnostic Test

lead_sponsor_type: academique


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

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Novello S, Mazières J, Oh IJ, de Castro J, Migliorino MR, Helland Å, 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.

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

location_facility: IPO do Porto; Servico de Oncologia Medica

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Chonnam National University Hwasun Hospital

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

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

location_facility: Hopital Du Haut Leveque; Service Des Maladies Respiratoires

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

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

location_facility: Hospital de Cruces; Servicio de Oncologia

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

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

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

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

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

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Korea University Guro Hospital; Oncology

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

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

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

location_facility: Queen Elizabeth Hospital; Clinical Oncology

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

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

location_facility: Adana Acıbadem Hospital Oncology Department

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

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

location_facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

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).


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)

lead_sponsor: Novartis Pharmaceuticals

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.

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

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

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

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.


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.

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, Ivanišević 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.

lead_sponsor: Novo Nordisk A/S

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


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:
Denmark
Poland
Spain
Italy
Russian Federation
Netherlands
France
Israel
Germany


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: Portugal Spain Greece Austria Italy Sweden Hungary France Germany

location_facility: Hospital de São João EPE - Serviço de Nefrologia

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

location_facility: Klinikum rechts der Isar der TU München, Nephrologie

location_facility: Centro Hospitalar de Coimbra - Serviço de Nefrologia

location_facility: Servicio de nefrología Fundación Hospital Alcorcón

location_facility: Service de Néphrologie Hémodialyse Clinique de l'Orangerie

location_facility: Servicio de Nefrología, Hospital Universitario Dr Peset,

location_facility: Hôpital Pellegrin Service de Néphrologie

location_facility: Department of Nephrology Sahlgrenska University Hospital

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

location_facility: Servicio de nefrología Hospital de Galdakao

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

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

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

location_facility: Servicio de nefrología Fundacion Puigvert

location_facility: Szekszárd EuroCare Dialysis Centre Number 7

location_facility: Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi

location_facility: Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna

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

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

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

location_facility: Servicio de nefrología H. Arquitecto Marcide

location_facility: Kaposi Mór County Hospital Department of Nephrology


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:
Italy
Sweden
United States
France
Germany


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

ReferenceCitation: Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Muñoz-Torres M, Donnet JP, Endahl L, Skjøth 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. Review.

location_country: Poland Spain Finland France Germany

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.


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

location_facility: 248.604.4602 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4909 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4901 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35302 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4902 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44009 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4904 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4601 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4604 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4605 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4907 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44007 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44006 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4903 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3301A HOP Le Vinatier,Psychiat,Bron

location_facility: 248.604.4905 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35802 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3901 Università degli Studi di Bologna

location_facility: 248.604.4606 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82003 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4910 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4911 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4906 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3909 IRCCS Fondazione "Salvatore Maugeri"

location_facility: 248.604.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4908 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4603 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35805 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3908 Azienda Sanitaria San Giovanni Battista

location_facility: 248.604.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82002 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:
Portugal
Spain
Italy
Russian Federation
United Kingdom
Finland
Sweden
France
Belgium
Norway
Germany


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.

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: Belgium Italy Peru France Colombia


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, Villà 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.

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.

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.

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.

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

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

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Paula Stradina Kliniskas Universitates Slimnica

location_facility: Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

location_facility: Oncology Institute of Southern Switzerland

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

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

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Istituto Nazionale Neurologico Carlo Besta

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Phase 1, FIH, Dose Escalation Study of JNJ-74856665 (Dihydroorotate Dehydrogenase [DHODH] Inhibitor) Alone or in Combination in Participants With AML or MDS

acronym: DHODH

summary: The purpose of this study is to determine the safety, tolerability, maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of JNJ-74856665 as monotherapy and/or in combinations.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United Kingdom
Spain
Korea, Republic of
United States
France

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

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: Open-label, Non-randomized Phase 1, Multicenter Study to Assess Radium-223 Biodistribution in Participants With Bone Metastatic Castration Resistant Prostate Cancer (CRPC) Receiving Radium-223 Dichloride Treatment.

summary: In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

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

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

lead_sponsor: Bayer

location_country:
United Kingdom
Italy
Austria
Finland
Lithuania
Israel
France
Germany

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

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital


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

acronym: DUART

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, García Campelo MR, Paoli JB, Sawyer W, Díaz Pérez 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.

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.

lead_sponsor: AstraZeneca

location_country:
Poland
Spain
Italy
Russian Federation
United States
France


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy

summary: The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite standard of care, which includes treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). These patients are at high risk for progression of kidney disease, which can result in end-stage renal failure.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Taiwan
Spain
United Kingdom
Canada
Sweden
Singapore
France
Philippines
Malaysia


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
France
United Kingdom
Belgium

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


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

lead_sponsor: Mårten Segelmark

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.

location_country: Denmark Austria France Sweden Czechia

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

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 Department of Nephrology, Rigshospitalet, Copenhagen

location_facility: Centre Hospitalier Régional Universitaire de Lille, Nephrology Service

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 Nephrology, Hemodialysis, Apheresis, and Transplantation, CHUGA (centre hospitalier universitaire Grenoble-Alpes)

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).


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


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, Pérez-García JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavilá J, Sampayo-Cordero M, Aguirre E, Schmid P, Marmé F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martínez-De Dueñas E, Carañana V, Amillano K, Mina L, Malfettone A, Cortés 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. 2022 Oct 14. pii: oyac205. doi: 10.1093/oncolo/oyac205. [Epub ahead of print]

ReferenceCitation: Llombart-Cussac A, Pérez-García JM, Bellet M, Dalenc F, Gil-Gil M, Ruíz-Borrego M, Gavilá J, Sampayo-Cordero M, Aguirre E, Schmid P, Marmé F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martínez-de Dueñas E, Amillano K, Malfettone A, Cortés 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:
Spain
Italy
Russian Federation
United Kingdom
France
Germany
Czechia

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, Jürgensmeier 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.

ReferenceCitation: Yahiaoui A, Meadows SA, Sorensen RA, Cui ZH, Keegan KS, Brockett R, Chen G, Quéva C, Li L, Tannheimer SL. PI3Kδ inhibitor idelalisib in combination with BTK inhibitor ONO/GS-4059 in diffuse large B cell lymphoma with acquired resistance to PI3Kδ and BTK inhibitors. PLoS One. 2017 Feb 8;12(2):e0171221. doi: 10.1371/journal.pone.0171221. eCollection 2017.

lead_sponsor: Gilead Sciences

location_country:
United States
United Kingdom
France

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Leeds Teaching Hosptials NHS Trust, Dept of Haematology

location_facility: Cardiff and Vale Health Board, Clinical Research Facility

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Cambridge University Hospitals NHS Foundation Trust

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


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, Sværke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2022 Nov 15. doi: 10.1007/s11102-022-01283-3. [Epub ahead of print]

location_country:
Denmark
United Kingdom
Sweden
France
Japan
Germany


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, Sánchez-Quesada JL, Assoumou L, Gatell JM, González-Cordón A, Guaraldi G, Domingo P, Giacomelli A, Connault J, Katlama C, Masiá M, Ordónez-Llanos J, Pozniak A, Martínez 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.

lead_sponsor: St Stephens Aids Trust

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

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

location_facility: Klinikum der Goethe-Universität Frankfurt

location_facility: Azienda Ospedaliera - Polo Universitario 'Luigi Sacco'


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: Grünewald S, Politz O, Bender S, Héroult 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.

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


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: Denmark Spain Italy Austria Netherlands France Germany


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.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country: France Belgium


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 naïve 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

location_country:
Spain
Italy
United Kingdom
Australia
France
Sweden


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

lead_sponsor: Astellas Pharma Europe Ltd.

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:
Poland
United Kingdom
Italy
France
Belgium
Germany
Czechia

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

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.