title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

acronym: PERSISTExt

summary: This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

lead_sponsor: Sunovion

location_country:
Poland
Serbia
Russian Federation
Argentina
Czech Republic
Hungary
United States
Chile
France
Japan
Bulgaria
Slovakia

location_facility: Instituto Nacional de Psicopatología (INAPSI)

location_facility: State Healthcare and Forensic Psychiatric Expertise Institution

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: Centre Hospitalier Régional Universitaire

location_facility: Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"

location_facility: Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique

location_facility: Saint Anne, s.r.o., Psychiatricke oddeleni

location_facility: Clinical Centre Kragujevac, Psychiatric Hospital

location_facility: St Petersburg State Government Healthcare Institution

location_facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: NZOZ Prywatna Klinika Psychiatryczna Inventiva

location_facility: Clinical Hospital Centre Dragisa Misovic

location_facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.

location_facility: Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)

location_facility: St. Petersburg State Healthcare Institution "City Clinical Hospital #4"

location_facility: Clinic for Mental Health Protection, Clinical Centre Nis

location_facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

location_facility: Mental Health Research Institute of Siberian Branch of RAMS

location_facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"

location_facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika


type: EudraCT Number

type: Other Identifier

title: A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

summary:
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

Evaluate the safety and tolerability of sevelamer carbonate
Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Poland
Lithuania
United States
France
Germany

location_facility:
Investigational Site Number 8201
Investigational Site Number 8012
Investigational Site Number 8026
Investigational Site Number 8027
Investigational Site Number 8006
Investigational Site Number 8102
Investigational Site Number 8101
Investigational Site Number 8019
Investigational Site Number 8013
Investigational Site Number 8202
Investigational Site Number 8018
Investigational Site Number 8007
Investigational Site Number 8001
Investigational Site Number 8005
Investigational Site Number 8301
Investigational Site Number 8103
Investigational Site Number 8003
Investigational Site Number 8002
Investigational Site Number 8302
Investigational Site Number 8401
Investigational Site Number 8010
Investigational Site Number 8014
Investigational Site Number 8017
Investigational Site Number 8023
Investigational Site Number 8025
Investigational Site Number 8020
Investigational Site Number 8402
Investigational Site Number 8016
Investigational Site Number 8009
Investigational Site Number 8022
Investigational Site Number 8011
Investigational Site Number 8008

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

summary: This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

ReferenceType: result

ReferenceCitation: Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44.

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
United Kingdom
Finland
Thailand
Switzerland
Sweden
United States
France
Israel
Singapore
Germany

intervention_type: Procedure


title: A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung Disease

summary: The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.

study_start_date_type: Actual

status: Terminated

ReferenceType: background

ReferenceCitation: Hsu VM, Denton CP, Domsic RT, Furst DE, Rischmueller M, Stanislav M, Steen VD, Distler JHW, Korish S, Cooper A, Choi S, Schafer PH, Horan G, Hough DR. Pomalidomide in Patients with Interstitial Lung Disease due to Systemic Sclerosis: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study. J Rheumatol. 2018 Mar;45(3):405-410. doi: 10.3899/jrheum.161040. Epub 2017 Nov 1.

ReferenceCitation: Hsu V, et al. A Phase 2 Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness in Subjects with Systemic Sclerosis with Interstitial Lung Disease. Presented at the 2016 ACR/ARHP Annual Meeting, November 11-16, 2016, Washington, DC. Abstract No. 823.

lead_sponsor: Celgene

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Switzerland
United States
France
Germany

location_facility: University of Texas Health Science Center at Houston

location_facility: Instytut Reumatologii, Klinika i Poliklinika Ukladowych Chorób Tkanki Lacznej

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: SPSK Nr 7 Slaskiego Uniwersytetu Medycznego, Oddzial Chorob Wewnetrznych i Reumatologii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego Pomorskiego UM w Szczec

location_facility: St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital # 25"

location_facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych

location_facility: University of Toledo College of Medicine

location_facility: Klinikum der J.W. Gothe-Universitat Frankfurt

location_facility: Georgetown University School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria S. Martino di Genova

location_facility: LaPorte County Institute for Clinical Research, Inc

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: UMDNJ-Robert Wood Johnson Medical School Clinical Research Center

location_facility: Groupe Hospitalier Saint Vincent de Paul

location_facility: Centrum Miriada Prywatny Gabinet Specjalistyczny Profesora Dra Stanislawa Sierakowskiego

location_facility: Royal Brompton Hospital - Interstitial Lung Disease Unit

status_simplified: Unknown


ipd_sharing: No

title: An Open-Label Study for Previously Treated Ataluren (PTC124®) Patients With Nonsense Mutation Dystrophinopathy

lead_sponsor: PTC Therapeutics

source: euctr

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44.

ReferenceType: derived

ReferenceCitation: McDonald CM, Muntoni F, Penematsa V, Jiang J, Kristensen A, Bibbiani F, Goodwin E, Gordish-Dressman H, Morgenroth L, Werner C, Li J, Able R, Trifillis P, Tulinius M; Study 019 investigators. Ataluren delays loss of ambulation and respiratory decline in nonsense mutation Duchenne muscular dystrophy patients. J Comp Eff Res. 2022 Feb;11(3):139-155. doi: 10.2217/cer-2021-0196. Epub 2021 Nov 18.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Sweden
France
Israel
Belgium
Germany

location_facility: Hadassah Medical Center, Hebrew University Hospital

location_facility: University of Essen - Clinic for Children

location_facility: Institute For Neuromuscular Research, The Children's Hospital at Westmead

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: University of Newcastle Institute of Human Genetics

summary: Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in approximately 10-15% of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study comprises a Phase 3, open-label study of ataluren in participants with nmDBMD who previously received ataluren at an Investigator site in a prior PTC-sponsored clinical study. A separate open-label study (PTC124-GD-016-DMD; NCT01247207) is being conducted for nmDBMD participants who previously received ataluren at an Investigator site in the United States (US).


ipd_sharing: Yes

title: A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)

lead_sponsor: Pfizer

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

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Philippines
Japan
South Africa
Poland
Russian Federation
India
Turkey
Sweden
Malaysia
Slovakia
Canada
Switzerland
Germany
Taiwan
Greece
Estonia
Finland
Korea, Republic of
France

location_facility: Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

location_facility: Dokkyo Medical University Hospital / Urology

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Urological Associates of Southern Arizona

location_facility: University General Hospital of Larisa/ Urology Department

location_facility: Severance Hospital, Yonsei University Health System

location_facility: I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche

location_facility: FGBNU Scientific center of children health

location_facility: Specjalistyczny Gabinet Lekarski Paweł Kroll

location_facility: Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitair Ziekenhuis Antwerpen, Urologie

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

location_facility: Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Hyogo prefectural Kobe Children's Hospital

location_facility: Department of Pediatrics, Christian Medical College and Hospital

location_facility: Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

location_facility: Children's Republican Clinical Hospital, Department of Pediatric Surgery

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO

location_facility: Aichi Children's Health and Medical Center

location_facility: Groupement Hospitalier Est - Hopital Femme Mere Enfant

location_facility: The University of Tokyo Hospital / Urology

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas klinikos

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical

location_facility: Osaka Medical Center and Research Institute for Maternal and Child Health

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: Centre hospitalier universitaire (CHU) Sainte-Justine

summary: The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.


title: Aneurysm Study of Pipeline in an Observational Registry

acronym: ASPIRE

summary: The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Italy
Argentina
Canada
Switzerland
United States
France
Belgium
Germany

location_facility: Radiology Imaging Associates / Colorado Neurological Institute

location_facility: University of Buffalo Neurosurgery, Buffalo General Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Abbott Northwestern Hospital/Consulting Radiologists

location_facility: Ospedale San Giovanni Bosco ASL Napoli 1 Centro

location_facility: The State University of New York, Stony Brook

location_facility: University of Wisconsin Hospital and Clinics

location_facility: The Ohio State University Wexner Medical Center

location_facility: Neurosurgical Associates at Central Baptist

location_facility: Medical College Of Wisconsin/Froedtert Hospital

intervention_type: Device


title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

summary: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

ReferenceCitation: Maltais F, O'Donnell D, Gáldiz Iturri JB, Kirsten AM, Singh D, Hamilton A, Tetzlaff K, Zhao Y, Casaburi R. Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753465818755091. doi: 10.1177/1753465818755091.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
Finland
Argentina
Canada
Hungary
United States
France
Germany

location_facility: 1237.15.11505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01513 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34009 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44151 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44155 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01516 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34001 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01514 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44152 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44154 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44153 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44158 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01510 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35853 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33501 Boehringer Ingelheim Investigational Site


title: A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

summary: This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Canada
United States
France


title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

summary: This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

lead_sponsor: Debiopharm International SA

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

location_facility:
Novartis Investigative Site
Novartis Investigational site
Novartis Investigational Site


title: A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

summary: For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

ReferenceCitation: Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.

lead_sponsor: Shire

location_country:
Poland
Romania
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Ukraine
Sweden
France
Belgium
Germany

location_facility: Poltava Regional Clinical Psychiatric Hospital

location_facility: Institut fur Ganzheitliche Medizin und Wissenschaft GmbH

location_facility: Medizinische Universitat Graz Univ fur Kinder

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Institute of Health Care for Children and Teenagers

location_facility: Klinik und Poliklinik fur Kinder-und Jugendpsychiatrie un psychotherapie

location_facility: Institute of Neurology, Psychiatry and Narcology

location_facility: Centenary House Child and Adolescent Mental Health Services

location_facility: Friedrich Schiller Universitat Jena Klinik fur Kinder und Jugendpsychiatrie

location_facility: Centrum Badari Klinicznych House Sp. z.o.o.

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Somni bene GmbH Institut fur Medizinische Forschung und Schlatmedizin

location_facility: Centre de Reference Neuropediatrique Multidisciplinaire

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy

location_facility: Instituto Valenciano de Neurologia Pediatrica

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Azienda Ospedallera G Salvini - Ospedale Di Circolo de RHO

location_facility: Hospital Infanta Leonor, Servicio de Psiquiatria

location_facility: Indywidualna Specjalisyczna Praktyka Lekarska

location_facility: Zlekenhuis Inkendaal Koninklijke Instelling v.z.w.

location_facility: Vinnitsya regional psychoneurological hospital


title: A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy

summary: The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

ReferenceCitation: Chen LT, Macarulla T, Blanc JF, Mirakhur B, de Jong FA, Belanger B, Bekaii-Saab T, Siveke JT. Early dose reduction/delay and the efficacy of liposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic ductal adenocarcinoma (mPDAC): A post hoc analysis of NAPOLI-1. Pancreatology. 2021 Jan;21(1):192-199. doi: 10.1016/j.pan.2020.10.029. Epub 2020 Oct 10.

ReferenceCitation: Macarulla Mercadé T, Chen LT, Li CP, Siveke JT, Cunningham D, Bodoky G, Blanc JF, Lee KH, Dean A, Belanger B, Wang-Gillam A. Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial. Pancreas. 2020 Jan;49(1):62-75. doi: 10.1097/MPA.0000000000001455. Erratum in: Pancreas. 2020 Mar;49(3):e27.

ReferenceCitation: Bang YJ, Li CP, Lee KH, Chiu CF, Park JO, Shan YS, Kim JS, Chen JS, Shim HJ, Rau KM, Choi HJ, Oh DY, Belanger B, Chen LT. Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study. Cancer Sci. 2020 Feb;111(2):513-527. doi: 10.1111/cas.14264. Epub 2019 Dec 20.

ReferenceCitation: Macarulla T, Blanc JF, Wang-Gillam A, Chen LT, Siveke JT, Mirakhur B, Chen J, de Jong FA. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial. J Geriatr Oncol. 2019 May;10(3):427-435. doi: 10.1016/j.jgo.2019.02.011. Epub 2019 Mar 4.

ReferenceCitation: Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, Mirakhur B, Chen LT. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019 Feb;108:78-87. doi: 10.1016/j.ejca.2018.12.007. Epub 2019 Jan 14.

ReferenceCitation: Chen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP, Shan YS, Jameson GS, Macarulla T, Lee KH, Cunningham D, Blanc JF, Chiu CF, Schwartsmann G, Braiteh FS, Mamlouk K, Belanger B, de Jong FA, Hubner RA. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial. Eur J Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010. Epub 2018 Nov 8.

ReferenceCitation: Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. Erratum in: Lancet. 2016 Feb 6;387(10018):536.

lead_sponsor: Merrimack Pharmaceuticals

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Czech Republic
Hungary
Korea, Republic of
United States
France
South Africa
Germany


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

summary: The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027

lead_sponsor: Bristol-Myers Squibb

location_country:
Canada
Sweden
United States
France
Germany

location_facility: Palm Beach Neurological Center Advanced Research Consultants

location_facility: Associated Neurologists Of Southern Connecticut, P.C.

location_facility: Alexian Brothers Neurosciences Institute Clinical Research

location_facility: Hospital Of The University Of Pennsylvania


title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

summary: This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Austria
Canada
Switzerland
Hungary
United States
France
Germany
Slovakia


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bendamustine and Rituximab (BR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously treated patients with chronic lymphocytic leukemia (CLL).

ReferenceCitation: Steurer M, Montillo M, Scarfò L, Mauro FR, Andel J, Wildner S, Trentin L, Janssens A, Burgstaller S, Frömming A, Dümmler T, Riecke K, Baumann M, Beyer D, Vauléon S, Ghia P, Foà R, Caligaris-Cappio F, Gobbi M. Olaptesed pegol (NOX-A12) with bendamustine and rituximab: a phase IIa study in patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2019 Oct;104(10):2053-2060. doi: 10.3324/haematol.2018.205930. Epub 2019 May 16.

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

lead_sponsor: TME Pharma AG

location_country: Austria France Italy Belgium

location_facility: Azienda Sanitaria Locale 8, Department of Oncology

location_facility: University La Sapienza, Department of Cellular Biotechnologies and Hematology

location_facility: Medical University Innsbruck, Division of Hematology and Oncology

location_facility: Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology)

location_facility: University School of Medicine, Department of Hematology

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: University Hospital, Institute of Hematology and Oncology

location_facility: Centre Hospitalier Universitaire de la Milétrie, Department of Hematology

location_facility: University Scientific Research Institute San Raffaele

location_facility: Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology)

location_facility: Centre Hospitalier Universitaire Clémenceau, Department of Hematology

location_facility: Institute Jules Bordet, Department of Hematology

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: Hospices Civils, Department of Hematology

location_facility: University Hospital Gasthuisberg, Department of Hematology


title: Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures

acronym: VERVE

summary: The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

ReferenceCitation: Baulac M, Byrnes W, Williams P, Borghs S, Webster E, De Backer M, Dedeken P. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017 Apr;135(4):434-441. doi: 10.1111/ane.12691. Epub 2016 Oct 6.

lead_sponsor: UCB Pharma

location_country:
Denmark
Spain
Australia
Sweden
United States
France
Romania
Germany
Bulgaria


title: A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension

summary: The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Spain
United Kingdom
Canada
United States
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

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.

location_facility: Children's Heathcare of Atlanta, Inc. at Egleston


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

ReferenceCitation: Wedemeyer H, Forns X, Hézode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Nájera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.

location_country:
Spain
Italy
Canada
Puerto Rico
United States
France
Germany


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: McGill University, Montreal Chest Institute; Viral and other Infectious

location_facility: Winnipeg Regional Health Authority; Section of Hepatology

location_facility: Hospital Clinic I Provincial; Servicio de Digestivo

location_facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

location_facility: Royal Bournemouth Hospital, Gastroenterology

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology

location_facility: Uniklinik Freiburg; Abteilung Innere Medizin II

location_facility: Hospital Carlos III; Laboratorio de Biologia Molecular

location_facility: University Health Network - Toronto Western Hospital; Hepatology

location_facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Universitäts Klinikum; Schleswig-Holstein Kiel

location_facility: Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

location_facility: King'S College Hospital; Institute of Liver Studies

location_facility: Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility

location_facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Hospital Universitario de Canarias; Servicio de Digestivo

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: GI Research Institute; Gastroenterology & Hepatology

location_facility: Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons

location_facility: Uni of Cincinnati College of Medicine; Div. of Digestive Diseases

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive


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

summary:
Primary Objective:

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

Secondary Objectives:

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

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

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

lead_sponsor: Sanofi

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

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


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

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

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

lead_sponsor: Amgen Research (Munich) GmbH

location_country:
Italy
Austria
Netherlands
Canada
United States
France
Germany

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

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

location_facility: Children's Healthcare of Atlanta at Egleston

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

location_facility: University of Milano-Bicocca, Hospital San Gerardo

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

intervention_type: Biological


type: Registry Identifier

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

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

status: Active, not recruiting

study_completion_date_type: Anticipated

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

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

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

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

lead_sponsor: Novo Nordisk A/S

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

status_simplified: Ongoing


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

acronym: OCTAVE

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

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Nov 7. pii: izac084. doi: 10.1093/ibd/izac084. [Epub ahead of print]

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

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panés J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2022 Jun 1. pii: izac063. doi: 10.1093/ibd/izac063. [Epub ahead of print]

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

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Apr 5. pii: izac061. doi: 10.1093/ibd/izac061. [Epub ahead of print]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: Institut klinicke a experimentalni mediciny

location_facility: North Florida Gastroenterology Research, LLC

location_facility: West Tallinn Central Hospital Internal Diseases Clinic

location_facility: Bop Clinical School Clinical Trials Unit

location_facility: Samara Diagnostic center, X-ray Department

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III,

location_facility: Hospital Clínic i provincial de Barcelona

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

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

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia

location_facility: Cabinet Particular Policlinic Algomed SRL

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

location_facility: Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly

location_facility: National Hospital Organization Sendai Medical Center

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

location_facility: National Hospital Organization Mito Medical Center

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

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

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

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

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

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

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

location_facility: X-Ray Department of West Tallinn Central Hospital

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

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

location_facility: Cambridge University Hospitals Nhs Foundation Trust

location_facility: Javorszky Odon Korhaz/Gasztroenterologiai Osztaly

location_facility: The Private Practice of Simon Lichtiger, MD

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

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

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

location_facility: Gastroenterology Associates of Central Georgia

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

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: National Hospital Organization Hirosaki National Hospital

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

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Atlanta Gastroenterology Specialists, PC

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

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki

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

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

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

location_facility: Baylor College of Medicine (Baylor Medical Center)

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Hertiage Medical Research Clinic- University Of Calgary

location_facility: Shiga University of Medical Science Hospital

location_facility: SOC Gastroenterologia Centro di Riferimento Oncologico

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

location_facility: Houston Hospital for Specialized Surgery

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Cedars Sinai Medical Center - Thalians Bldg

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

location_facility: Chris Hani Baragwanath Academic Hospital

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

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

location_facility: NYU Langone Nassau Gastroenterology Associates

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

location_facility: Hamilton Health Sciences Corporation - McMaster University Medical Centre

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

location_facility: Georgia Endoscopy Center (Colonoscopy only)

location_facility: London Health Sciences Centre - University Hospital

location_facility: Washington University School of Medicine - Division of Gastroenterology

location_facility: Gastroenterology Center of Connecticut, PC

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

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

location_facility: Huron Gastroenterology Associates / Center for Digestive Care

location_facility: Medical Research Center of Connecticut, LLC


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

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

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

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

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

location_facility: Pharmacy of Tel Aviv Sourasky Medical Center

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

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

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

location_facility: DCC Sveta Anna - Sofia\ Neurological room

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

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

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski

location_facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital

location_facility: Izmir Tepecik Training and Research Hospital

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

location_facility: Katedra i Klinika Neurologii Wieku Rozwojowego

location_facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5

location_facility: GU Republican Scientific and Practical Center Mother and Child

location_facility: KU "Odeska oblasna dytiacha klinichna likarnia"

location_facility: Dokuz Eylül University medical Faculty Internal Medicine Disease

location_facility: SPHI Leningrad Regional Psychoneurological Dispensary

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

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

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

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

location_facility: Pediatric Epilepsy Center Of Central Florida

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS

location_facility: MAI Children's City Clinical Hospital No 9

location_facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia

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

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

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

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

location_facility: Pediatric Epilepsy and Neurology Specialists, PA

location_facility: American University of Beirut Medical Center

location_facility: Regional State Budgetary Institution of Ministry of Health

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: "Multiprofile Hospital for Active Treatment Puls" AD

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

location_facility: The Barberry National Centre for Mental Health

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

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

location_facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly

location_facility: Siriraj Hospital, Mahidol University, Faculty of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Mother and Child Healthcare Institute Dr Vukan Cupic

location_facility: RSBHI Smolensk Regional Clinical Hospital

location_facility: Neurologicka ambulancia MUDr. Eva Gasparova

location_facility: Fakultni nemocnice Brno - Detska nemocnice

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

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Dr. Kenessey Albert Kórház és Rendelőintézet

location_facility: Spitalul clinic de copii Dr. Victor Gomoiu

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

location_facility: Eskisehir Osmangazi University Medical Faculty

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: UZ Brussel - Campus Jette - Pediatric Neurology

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

location_facility: GBOU VPO "Smolensk State Medical University"

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

location_facility: Gabinet lekarski Neurologii I Leczenia padaczki

location_facility: UZ Vitebsk Regional Childrens Clinical Centre

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

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: The First Bethune Hospital of Jilin University

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

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

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

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

location_facility: Saint George Hospital - University Medical Center

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

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly

location_facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: State Budgetary Healthcare Institution of Stavropol region

location_facility: Phramongkutklao Hospital, Neurology Unit,

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


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

acronym: JOSHUA

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

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

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

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

location_facility: University Hospital Na Bulovce; Institut of Radiation Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

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

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

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

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

location_facility: Klinikum Mannheim III. Medizinische Klinik

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

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Masaryk Memorial Cancer Institute; Oncological Clinic

location_facility: Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde

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

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

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


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

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

time_perspective: Retrospective

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

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

location_facility: Shands Hospital at the University of Florida

location_facility: Masonic Cancer Center - Clinical Trials Office

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

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: Schwerpunktpraxis fuer ambulante Tumortherapie

location_facility: Helsingin yliopistollinen keskussairaala/Syopatautien klinikka

location_facility: Leids Universitair Medisch Centrum/ Klinische Oncologie

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Peter MacCallum Cancer Institute, Department of Medical Oncology

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Seoul National University Hospital/Department of Internal Medicine

location_facility: CHU La Timone, Service d'Oncologie Medicale

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

location_facility: Asan Medical Center, Department of Internal Medicine

location_facility: Prince of Wales Hospital, Oncology Day Center

location_facility: Klinika Nowotworow Tkanek Miekkich i Kosci

intervention_type: Other


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

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

lead_sponsor: MedImmune LLC

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


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

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

enrollment_type: Anticipated

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

lead_sponsor: Aeris Therapeutics

location_country:
Spain
Italy
Greece
United States
Israel
France
Netherlands

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

location_facility: University of South Carolina School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Kaiser Foundation Hospitals (accepting Kaiser patients only)

location_facility: University of Athens - Sotiria General Hospital

location_facility: Azienda Ospedaliera Spedali Civili de Brescia


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

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

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

lead_sponsor: AstraZeneca

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


primary_purpose: Prevention

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

lead_sponsor: Helsinn Healthcare SA

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

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

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

location_facility: University of Kentucky - Chandler Medical Center

location_facility: CHRU de Lille - Hopital d'Hematologie Pediatrique

location_facility: Moscow State Institution: Morozovskaya Pediatric City Clinical Hospital

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

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

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

location_facility: Backus Children's Hospital at University Pediatrics

location_facility: Semmelweis University, 2nd Department of Pediatrics

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

location_facility: Hospital Privado Centro Medico de Cordoba

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

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

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

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

location_facility: Chelyabinsk Pediatric Regional Clinical Hospital, Oncohematology Department

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

location_facility: Instituto Nacional de Enfermedades Neoplásicas

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

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

location_facility: Tartu University Hospital, Hematology - Oncology Clinic

location_facility: Fundeni Clinical Institute, Pediatrics Clinic

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

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

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologica CAA

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

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

location_facility: University Hospital in Ostrava, Clinic of Pediatric

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital

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


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

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

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

lead_sponsor: Genentech, Inc.

location_country:
United Kingdom
Spain
United States
France
Germany


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

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

lead_sponsor: Bial - Portela C S.A.

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

location_facility: Universitätsklinik für Neurologie; Christian-Doppler-Klinik

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

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie

location_facility: Polyclinic for neurology and psychiatry 'Interneuron

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

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

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Klinik für Epileptologie Universität Bonn

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

location_facility: AIBILI - Centro de Estudos de Biodisponibildade

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

location_facility: Neurologische Gemeinschaftspraxis am Seelberg

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

location_facility: General County Hospital Požega, Neurology department

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

location_facility: Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika

location_facility: Diagnostic & Consultative Center "Sveta Anna" EOOD

location_facility: Medizinische Universitat Wien Klinik fur Neurologie

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


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

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

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

summary:
Primary Objective:

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

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

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

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

Secondary Objectives:

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


ipd_sharing: Undecided

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

lead_sponsor: Sandoz

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

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

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

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


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

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

lead_sponsor: Merck KGaA, Darmstadt, Germany

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

location_facility: University of Cologne Children's Hospital

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Centro di Endocrinologia e Diabetologia Pediatrica

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: University of Calgary - Alberta Children's Hospital

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Hospital de Niños de la Santisima Trinidad

location_facility: Istituto Giannina Gaslini - Clinica Pediatrica

location_facility: Faculty of Health Sciences, Linkping University

location_facility: CHU Bordeaux - Hopital pédiatrique Pellegrin

location_facility: Karolinska University Hospital Campus Solna


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

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

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

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Latvia
Netherlands
United States
France
Belgium
Germany

location_facility: Southern Illinois University-Memorial Medical Center

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

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

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

location_facility: Presbyterian University of Pennsylvania Medical Center


acronym: PALS

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

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Italy
United States
France
Germany

location_facility: Nemours Children's Clinic - Jacksonville

location_facility: Azienda Ospedaliera Instituti Ospitalieri di Verona

location_facility: Kinder und Jugendklinik, Abteilung Lungen Bronchialheikunde

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Catania

location_facility: Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem

location_facility: Hospital Infantil Universitario Nino Jesus

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


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

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

lead_sponsor: Janssen Research & Development, LLC

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


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

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

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

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

location_country:
United States
Spain
France

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: University of California Los Angeles (UCLA)

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Rhode Island Mood & Memory Research Institute

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