acronym: Clover

lead_sponsor: Pfizer

summary:
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: CHU de Liège - Domaine universitaire du Sart Tilman

location_facility: J. Lewis Research, Inc./Foothill Family Clinic

location_facility: Advanced Clinical Research/Gut Whisperer

location_facility: "Acibadem City Clinic University Hospital" EOOD

location_facility: KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Long Beach Clinical Trials Services, Inc.

location_facility: VA Loma Linda Healthcare System Research Pharmacy

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

location_facility: University of Colorado Clinical & Translational Research Center Outpatient Clinic

location_facility: Orszagos Koranyi Pulmonologiai Intezet, VI. Osztaly

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

location_facility: J. Lewis Research, Inc. - Jordan River Family Medicine

location_facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, I. Belgyogyaszati Osztaly

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Kaiser Permanente Center For Health Research

location_facility: Centro de Investigaciones Biomédicas - CIBIOM/Clinica Peruano Americana S.A

location_facility: South Texas Veterans Healthcare System, Audie L Murphy Hospital

location_facility: Gemeinschaftspraxis Dr. med. Heidrun Taeschner und Dr. med. Susanne Bonigut

location_facility: Coastal Clinical Research, LLC, An AMR Company

location_facility: Semmelweis Egyetem III. Sz. Belgyogyaszati Klinika

location_facility: MultiCare Institute for Research & Innovation

location_facility: Universitaetsklinikum Essen, Klinik fuer Infektiologie

location_facility: Veterans Affairs Palo Alto Health Care System

location_facility: Medak s.r.o., Gastroenterologicka ambulancia

location_facility: VA Loma Linda Healthcare System Ambulatory Care System

location_facility: Alliance for Multispecialty Reseach, LLC

location_facility: University of Colorado Department of AIP 2. Pharmacy Bulk Storage

location_facility: Lehigh Valley Health Network/Network Office of Research and Innovation

location_facility: Bajai Szent Rokus Korhaz, II Belgyogyaszat

location_facility: Diabetologische Gemeinschaftspraxis Dr. Schaper & Dr. Faulmann

location_facility: Fleming Island Center for Clinical Research

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Ocean Blue Medical Research Center, Inc.

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Synexus Polska Sp. z o.o Oddzial w Gdansku

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.

location_facility: Waterway Primary Care LLC DBA Tabor City Family Medicine

location_facility: Louis Stokes Cleveland VA Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: Baptist Health Center for Clinical Research

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Luminis Health Research Institute: Research Office

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Infektologiai Osztaly

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Newcastle upon Tyne Hospitals NHS Foundation trust

location_facility: University of North Texas Health Science Center at Fort Worth

location_facility: MHAT "Sveta Anna - Sofia" AD, Clinic of Internal Diseases

location_facility: Nemocnice Kyjov, prispevkova organizace, Infekcni oddeleni

location_facility: Internal Medicine and Pediatric Associates of Bristol, PC

location_facility: MHAT ''Sv.Ivan Rilski-Kozloduy'' EOOD; Internal Department

location_facility: Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: Mater Misericordiae Ltd & Mater Medical Research Institute Ltd

location_facility: PULMO-MEDIK s.r.o., Pneumologicko-ftizeologicka ambulancia

location_facility: Centre Integre de Sante et de Services Sociaux de la Monteregie- Center- Hopital Charles LeMoyne

location_facility: Luminis Health Anne Arundel Medical Center Infusion Center

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: University Hospitals of Leicester NHS Trust

location_facility: St. Vincent Hospital & Health Care Center

location_facility: VA Northern California Health Care System

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

location_facility: Frandsen Family Medicine DBA Sound Medical Research

location_facility: Gothia Forum CTC/Sahlgrenska Universitetssjukhuset

location_facility: Karolinska Trial Alliance, KTA Prim Sabbatsbergs sjukhus

location_facility: Centro de Investigaciones - MedPlus Centro de Recuperación Integral S.A.S.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Social Medical Care Corporation Hose-kai Marunouchi Hospital

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Luminis Health Anne Arundel Medical Center

location_facility: University Of Cincinnati-Internal Medicine Division of Digestive Diseases

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Centre de recherche du CHU de Quebec-Universite Laval

location_facility: SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD

location_facility: Centre Integre Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec

location_facility: St. Vincent Hospital and Health Care Center

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

location_facility: Central Kentucky Research Associates, LLC

location_facility: Asociación IPS Médicos Internistas de Caldas

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: CHU DIJON BOURGOGNE- Hopital Francois Mitterrand

location_facility: The Alverton Practise, St Clare Medical Centre

location_facility: University of Colorado Denver, School of Medicine

location_facility: J. Lewis Research Inc. / Foothill Family Clinic Draper

location_facility: Vancouver Coastal Health Research Institution-clinical research unit-Diamond Health Care Centre

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Sahlgrenska Universitetssjukhuset - Ostra Sjukhuset

location_facility: PMG Research,Inc. d/b/a PMG Research of Knoxville

location_facility: SYNEXUS Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: Florida Sleep Disorder Center of Brandon

location_facility: Multi-Specialty Research Associates, Inc.

location_facility: PMG Research, Inc. d/b/a PMG Research of Knoxville

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: UMHAT "Dr. Georgi Stranski" EAD, Second Psychiatric Clinic of general psychiatry and dependence

location_facility: SPAOLO s.r.o., Ambulancia vnutorneho lekarstva

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC

location_facility: Fundacion Centro de Investigacion Clinica - CIC

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Lawrence J. Ellison Ambulatory Care Center

location_facility: Medical Corporation Tokushukai Koga General Hospital

location_facility: Hospital Senhora de Oliveira - Guimaraes, E.P.E.

location_facility: Slezska Nemocnice v Opave, prispevkova organizace

location_facility: Clinical Research Institute of Arizona, LLC

location_facility: Medical Affiliated Research Center, Inc.

location_facility: Accel Research Sites - DeLand Clinical Research Unit

location_facility: Malcom Randall VA Medical Center Investigational Drug Services

location_facility: Clinical Trial Center University of Colorado Denver, School of Medicine

location_facility: Budapesti Szent Ferenc Korhaz, Kardiologiai Rehabilitacios Osztaly

location_facility: Ochsner Center for Primary Care and Wellness

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Duke University Hospital Investigational Drug Services (IDS) Pharmacy

location_facility: Synexus Polska Sp. z o.o. Oddział w Poznaniu

title: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

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:
Finland
Germany
Poland
Argentina
Australia
Japan
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
United States
Belgium
Peru
United Kingdom
Korea, Republic of
Spain
Taiwan
Bulgaria
Sweden


study_start_date_type: Actual

acronym: RESILIENT

intervention_type: Drug

lead_sponsor: Ipsen

summary:
A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy

The study was conducted in two parts:

Dose determination of irinotecan liposome injection
A randomized, efficacy study of irinotecan liposome injection versus topotecan

ReferenceType: derived

ReferenceCitation: Paz-Ares L, Spigel DR, Chen Y, Jove M, Juan-Vidal O, Rich P, Hayes T, Calderon VG, Caro RB, Navarro A, Dowlati A, Zhang B, Moore Y, Yao X, Kokhreidze J, Ponce S, Bunn PA. RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer. Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital de Cancer de Barretos, Fundacoa Pio X II

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

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

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: University of Oklahoma Health Sciences Center

location_facility: SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Baskent University Adana Application and Research Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cancer Treatment Centers of America-Georgia

location_facility: CI Kryvyi Rih Oncological Dispensary of DRC

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Hospital General Universitario de Alicante

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Greenville Hospital System University Medical Center

location_facility: Florida Cancer Specialists (South Region)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Tri County Hematology & Oncology Associates, Inc

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L

location_facility: SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary"

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

status: Completed

title: RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Hungary
Romania
Australia
Brazil
Belgium
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
Ukraine
Serbia
Russian Federation
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title:
Effect of two injections of synchronized methotrexate with the first injection of Adalimumab to prevent anti-adalimumab immunization in spondyloarthritis

 Effet de deux injections de MEthotrexate SYNchronisées avec la première injection d'ADalimumab pour prévenir l'immunisation anti-adalimumab dans les spondyloarthrites

acronym:
MESYNAD

 MESYNAD

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)

lead_sponsor_type: academique


title:
Effet de l’administration intramyocardique de cellules mésenchymateuses dans le traitement de l’ischémie myocardique avec dysfonction ventriculaire gauche
 guidée par le système NOGA :
 Etude multicentrique, randomisée, contrôlée versus placebo

acronym: MESAMI 2

lead_sponsor: CHU Toulouse


title:
PETALS study : PEgylated interferon-alpha2a and TAsigna® for first Line therapy of Philadelphia chromosome-positive chronic phase CML patientS

 Etude randomisée de phase III, comparant le taux de réponse moléculaire 4.5 à 12 mois chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC PC), de novo, chromosome Philadelphie positive, traités par nilotinib 600mg par jour versus nilotinib 600mg par jour plus Interféron-alpha 2a pégylé (PEG-IFN) Protocole PETALS  PEgylated interferon-alpha2a and TAsigna® for first Line therapy of chronic phase CML patientS

acronym:
PETALS

 PETALS

lead_sponsor: Hospices Civils de Lyon


title:
Efficacy and safety of Passiflora Compose in patients newly diagnosed with adjustment disorder with anxiety, as first-line treatment, compared to alprazolam

 Efficacité et tolérance de Passiflora composé dans l’anxiété réactionnelle récente, en première intention, en comparaison de l’alprazolam.

acronym:
PASSIANCE

 PASSIANCE

lead_sponsor: BOIRON


title: Evaluation de l'intérêt d'associer un traitement homéopathique  à la prise en charge anti-émétique conventionnelle dans la prévention des nausées retardées lors des deux premières cures de chimiothérapie dans les cancers thoraciques.

acronym: HONAURE

lead_sponsor: Boiron

status: Ongoing

status_simplified: Ongoing


title:
Evaluation de la reperfusion myocardique et de la masse thrombotique endocoronaire après angioplastie primaire pour infarctus du myocarde sous cangrelor en intraveineux en plus du ticagrelor per os comparé au ticagrelor per os seul en cas de réactivité plaquettaire élevée.

 Evaluation de la reperfusion myocardique et de la masse thrombotique endocoronaire après angioplastie primaire pour infarctus du myocarde sous cangrelor en intraveineux en plus du ticagrelor per os comparé au ticagrelor per os seul en cas de réactivité plaquettaire élevée.

acronym:
ERMIT

 ERMIT

lead_sponsor: CHU CAEN Normandie


title: ESSAI RANDOMISE MULTICENTRIQUE DE PHASE III COMPARANT L’IMMUNOGENICITE ET LA TOLERANCE DE TROIS SCHEMAS DE VACCINATION CONTRE LE VIRUS DE L’HEPATITE B CHEZ DES PATIENTS INFECTES PAR LE VIH AYANT DES LYMPHOCYTES T CD4 SUPERIEURS A 200/mm3

acronym: VIHVAC-B

lead_sponsor: ANRS


title:
An Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB monotherapy in patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based therapy and harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6

 AB-ORL - Etude de Phase II visant à évaluer l’intérêt clinique d’une monothérapie par abemaciclib chez des patients atteints d’un cancer de la tête et du cou localement avancé ou métastatique après échec d’une thérapie à base de platine et de cetuximab ou anti-EGFR, et présentant une délétion homozygote du gène CDKN2A, et/ou une amplification du gène CCND1 et/ou du gène CDK6.

acronym:
ABORL

 ABORL

lead_sponsor: Centre Léon Bérard


title: ONCOMEO : Etude pilote évaluant la réponse tumorale chez des patients en échappement thérapeutique et traités par Ruta graveolens 9 CH ou Phenacetinum 4 CH

acronym: ONCOMEO


title:
Treatment of COVID-19 by Nebulization of Inteferon Beta 1b added to lopinavir/ritonavir: Feasibility, Efficiency and Safety Study

 Traitement du COVID-19 : Etude de faisabilité, d’efficacité et de sécurité de l’ajout de Nébubilisation d’Interferon Beta 1b au lopinavir/ritonavir

acronym:
COV-NI

 COV-NI

lead_sponsor: CHU Amiens-Picardie


title: ETUDE MULTICENTRIQUE RANDOMISEE, DE PHASE III, COMPARANT L’IMMUNOGENICITE D’UN SCHEMA VACCINAL RENFORCE CONTRE LE VHB (40 µg à S0, S4, et S24), A UN SCHEMA CLASSIQUE (20 µg à S0, S4, et S24), CHEZ DES PATIENTS INFECTES PAR LE VIH N’AYANT PAS REPONDU A UNE PREMIERE VACCINATION ET A UNE INJECTION DE RAPPEL

acronym: B-BOOST


title: An open-label adaptive-design study of intracisternal administration of adeno-associated viral vector serotype rh.10 carrying the human β-galactosidase cDNA for the treatment of GM1 gangliosidosis

lead_sponsor: Lysogene

status: Prematurely Ended

status_simplified: Unknown


title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

 Étude de phase IIa de preuve de concept, randomisée, en double aveugle, contrôlée par placebo, multicentrique, à dose progressive, évaluant la sécurité d’emploi, la tolérance, l’efficacité et la pharmacocinétique de l’INT-787 chez des patients atteints d’hépatite alcoolique sévère

acronym: FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study

lead_sponsor: Intercept Pharmaceuticals, Inc.


title:
A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels ≤ 1 IU/dL and Pre-existing Antibodies Against AAV5

 Etude de Phase 1/2 destinée à évaluer la sécurité, tolérance, et l’efficacité du BMN 270, un vecteur viral adéno-associé pour le transfert de gène du facteur VIII Humain chez des patients atteints d’hémophilie A ayant des taux de base de FVIII ≤ 1 IU/dL et des anticorps préexistants contre AAV5

lead_sponsor: BioMarin Pharmaceutical Inc.


title: A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T cells (WU-CART-007) in Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

lead_sponsor: Wugen, Inc.


title:
A Phase 2, Open-Label, Efficacy and Safety Study of an RARγ-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)

 Étude  en ouvert, de Phase 2, évaluant l’efficacité et la tolérance d’un agoniste RARγ spécifique (palovarotène) dans la prévention des ossifications hétérotopiques chez des sujets atteints de fibrodysplasie ossifiante progressive (FOP).

lead_sponsor: Clementia Pharmaceuticals Inc.


title:
Randomized double-blind study on the benefit of spironolactone for treating acne of adult woman

 Etude randomisée en double-aveugle sur l'intérêt de la spironolactone dans le traitement de l'acné de la femme adulte

acronym: FASCE

lead_sponsor: CHU de Nantes


title:
Phase II study in patient in first line for HER - metastasis breast cancer treated with eribulin and bevacizumab

 ESSAI DE PHASE II EVALUANT L’ASSOCIATION ÉRIBULINE (HALAVEN®) + BEVACIZUMAB (AVASTIN®) CHEZ LES PATIENTES AYANT UN CANCER DU SEIN METASTATIQUE HER -

lead_sponsor: ARCAGY-GINECO


title:
SEQUENTIAL AND PERSONALIZED BUSULFAN ADMINISTRATION BY PHARMACOKINETICS IN ALLOGENIC GRAFT CONDITIONING FOR PATIENTS WITH MALIGNANT HEMOPATHIA NOT ELIGIBLE FOR STANDARD MYELOABLATIVE PACKAGIN

 ADMINISTRATION DU BUSULFAN SEQUENTIELLE ET PERSONNALISEE PAR LA PHARMACOCINETIQUE DANS LE CONDITIONNEMENT DE GREFFE ALLOGENIQUE CHEZ LES PATIENTS ATTEINTS D’HEMOPATHIES MALIGNES NON ELIGIBLES AU CONDITIONNEMENT MYELOABLATIF STANDARD

acronym:
BUSEQ

 BUSEQ

lead_sponsor: Institut Paoli-Calmettes


title: Apport de l'optimisation posologique individualisée d'amikacine guidée par un logiciel de modélisation pharmacocinétique chez les patients en choc septique  : Essai clinique randomisé, contrôlé, en ouvert

acronym:
AMINO BESTDOSE

 AMINO BESTDOSE

lead_sponsor: CHU de NIMES


title: A Randomized Controlled, Open label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine versus Gemcitabine alone in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

lead_sponsor: SynCore Biotechnology Co., Ltd.


title: A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II.

acronym: ACCELA

lead_sponsor: sanofi-aventis recherche & développement


title: A phase IV, 2x2 factorial, double blind study of 24 versus 48 weeks and 90 versus 180 mcg doses of pegylated interferon alfa 2a 40KD (PEG IFN, Ro 25-8310) in adult patients with HBeAg positive chronic hepatitis B.

acronym: NEPTUNE

lead_sponsor: F.Hoffmann-La Roche Ltd


title: Activity of twice daily per os administration of CD06713 at 8mg versus its placebo during 4 weeks treatment, in patients with erythemato-telangiectatic rosacea.

lead_sponsor: Galderma Research and Development SNC


title: A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis.

acronym: Transition to RNF

lead_sponsor: Merck Serono International SA


title: Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder. A randomised, double-blind, flexible-dose international multicentre study with parallel groups versus escitalopram (10 to 20mg/day). Twelve-week treatment plus double-blind extension for 12 weeks.

lead_sponsor: Institut de Recherches Internationales Servier


title:
Effect of Liraglutide on fatty liver content evaluated by 1H-spectroscopy and lipoprotein kinetic, in patients with type 2 diabetes

 Effet du Liraglutide sur le contenu en graisse hépatique (évalué par spectroscopie protonique) et sur la cinétique des lipoprotéines chez des patients diabétiques de type 2

lead_sponsor: CHU Dijon


title: Phase II open-label randomized multicenter trial to compare the efficacy and safety of two different doses of raltegravir and efavirenz, all in combination with tenofovir and lamivudine, in naive HIV-1-infected patients receiving rifampin for active tuberculosis.

acronym: REFLATE TB

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales. ANRS.


title: A randomized, open-label, controlled, multi-center Phase II study to evaluate the efficacy and safety of adecatumumab alone or sequentially to FOLFOX relative to FOLFOX after R0 resection of colorectal liver metastases

lead_sponsor: Micromet AG


title:
Evaluation of perioperative eltrombopag for the management of elective surgery and invasive acts in patients with inherited thrombocytopenia

 Evaluation de l’ELtrombopag en Peri-Opératoire lors de chirurgies et actes invasifs programmés chez les patients ayant une Thrombopénie constitutionnelle

acronym:
ELPOT

 ELPOT

lead_sponsor: CHU Toulouse


title: A phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Infants Aged 1 to 11 months, Inclusive

lead_sponsor: AstraZeneca AB


title:
A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function Score

 Essai de phase II, national, multicentrique évaluant le tislelizumab en monothérapie pour des patients atteints d’un carcinome Hépatocellulaire Child-Pugh B et un score de la fonction hépatique ALBI grade 1 ou 2

acronym: HESTIA

lead_sponsor: UNICANCER


title: ANRS HB 06 PEGAN Essai de phase III, randomisé, multicentrique, sans insu, évaluant à S96 la perte de l’Ag HBs suite à un traitement de 48 semaines par l’interféron pégylé alpha 2a chez des patients ayant une hépatite B chronique (AgHBe négatif), sous traitement et répondeurs (charge virale indétectable) à un traitement par analogue(s) nucléosidique(s) et/ou nucléotidique(s) depuis au moins 12 mois.

acronym: ANRS HB 06 PEGAN

lead_sponsor: ANRS


title: A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas after CAR T-cells therapy

acronym: BiCAR Therapy

lead_sponsor: LYSARC

status: Trial now transitioned


title:
A GINECO phase II trial assessing the safety and efficacy of the Bevacizumab (FKB238), Olaparib (MEDI 4736) and Durvalumab combination in patients with advanced epithelial ovarian cancer in relapse: BOLD

 Etude de phase II évaluant la tolérance et l'efficacité de l'association Bevacizumab (FKB238), Olaparib et Durvalumab (MEDI 4736) chez des patients atteints d'un cancer de l'ovaire épithélial avancé en rechute : BOLD

acronym: BOLD

lead_sponsor: ARCAGY-GINCO


title:
A Phase III trial of acetylsalicylic acid  and atorvastatin in patients with castrate-resistant prostate cancer

 Etude de phase III évaluant l’impact sur la survie de l’acide acétylsalicylique et l’atorvastatine chez les patients atteints de cancer de la prostate  résistant à la castration

lead_sponsor: Gustave Roussy


title: REduced dose versus full-dose of direct oral anticoagulant after uNprOvoked Venous thromboEmbolism. The RENOVE open-label, randomized, controlled trial

acronym: RENOVE

lead_sponsor: CHRU de BREST


title:
Randomized phase III study of gemcitabine and cisplatin (GC) versus high dose intensity methotrexate, vinblastine, doxorubicin and cisplatin (HD-MVAC) in the perioperative setting for patients with locally advanced transitional cell cancer of the bladder.

 ETUDE DE PHASE III RANDOMISEE COMPARANT L’EFFICACITE DE GEMCITABINE ET CISPLATINE (GC) VERSUS METHOTREXATE, VINBLASTINE, DOXO-RUBICINE ET CISPLATINE A HAUTE DOSE (HD-MVAC) DANS LE TRAITEMENT PERI-OPERATOIRE DE PATIENTS PRESENTANT UN CARCINOME A CELLULES TRANSITIONNELLES (CCT) DE VESSIE INFILTRANT LE MUSCLE

acronym:
VESPER

 VESPER

lead_sponsor: CHU-Hôpitaux de Rouen


title: A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen

acronym: DORAL

lead_sponsor: Centre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida  (CREPATS)


title: Phase II Study of Dasatinib (BMS-354825) for Androgen-Deprived Progressive Prostate Cancer + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 15-Aug-06)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A multi-center, double-blind, randomized, placebo-controlled, titration study to investigate the safety, the tolerability and the pharmacodynamic profiles of different doses of RO5073031 in patients with type 2 diabetes mellitus treated with a stable dose of metformin.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Calcipotriol Plus Hydrocortisone Ointment Compared with Tacalcitol Ointment in Patients with Psoriasis Vulgaris on the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas

lead_sponsor: LEO Pharma A/S


title: A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients with Advanced Solid Tumours, Lymphomas and Endometrial Carcinoma

lead_sponsor: Astrazeneca AB


title:
Procollagen-3 driven corticosteroids for persistent Acute Respiratory Distress Syndrome

 Corticothérapie guidée par le Procollagène-3 dans le Syndrome de Détresse Respiratoire Aiguë persistant.

acronym: ProCoCo

lead_sponsor: Assistance Pubique Hôpitaux de Marseille


title: A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C

lead_sponsor: Idenix Pharmaceuticals, Inc.


title: A randomized phase 2 double-blind, placebo-controlled study of GK-001 in hepatocellular carcinoma (HCC) in chronic hepatitis C patients after prior curative HCC treatment

lead_sponsor: GeneCare Research Institute Co., Ltd.


title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy (Study #2)

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: Randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy (bronchodilation) and safety of 4 weeks of once daily treatment of orally inhaled BI 1744 CL (2 µg, 5 µg, 10 µg, 20 µg) delivered by the Respimat® inhaler in patients with asthma

acronym: BI 1744 CL in Asthma

lead_sponsor: Boehringer Ingelheim France


title: An Open-Label, Sequential, Ascending dose study, to Evaluate the safety, Pharmacokinetics, and Dose Response, of fixed, Repeated Doses of NE-180 (GlycoPEGylated™rHuEPO) in Anemic Cancer Patients Receiving Chemotherapy.

lead_sponsor: Neose Technologies, Inc.


title: A 12 week double-blind, randomised, placebo-controlled, modified dose-escalation trial to investigate safety, efficacy, and pharmacokinetics of BIRT 2584XX tablets at doses of 100, 300 and 500 mg administered once daily in patients with moderate to severe psoriasis with a 12 week treatment extension for PASI 50 responders.


title: A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer

lead_sponsor: Amgen Inc.


title: A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris

lead_sponsor: Incyte Corporation


title: Long-term, open-label, multicenter extension study of bosentan in patients with pulmonary hypertension associated with sickle cell disease completing a double-blind ASSET study (AC-052-368 or AC-052-369)

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: Randomised, double-blind, placebo-controlled, Phase II study to assess the safety and efficacy of different doses of intravenous APD405 (buspirone for IV injection) for the prevention of post-operative nausea and vomiting

lead_sponsor: Acacia Pharma Ltd.


title: Etude de phase III du SU011248 chez les patients atteints d'un cancer épidermoïde de la tête et du cou en situation de rechute locorégionale et/ou métastatique

lead_sponsor: UCL Saint Luc 1200 Bruxelles


title: Diagnostic value of 18F-choline PET/CT for the detection of systemic prostate cancer disease.

lead_sponsor: CIS bio international, member of IBA group


title: Recherche de l’excrétion du virus vaccinal de la rougeole dans le lait de femmes vaccinées en postpartum par un vaccin trivalent Rougeole-Rubéole-Oreillons(RRO)

acronym: BREMEAVAC

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY

acronym: CURE

lead_sponsor: GETAID


title: Incidence of inhibitors in previously untreated patient with severe haemophilia A treated with Octanate (Phase III)

acronym: Etude AVI 4-03

lead_sponsor: OCTAPHARMA AG

status: Not Authorised


title: An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the Treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients.

lead_sponsor: EUSA Pharma


title: ALdosterone antagonist Chronic HEModialysis Interventional Survival Trial

acronym: ALCHEMIST

lead_sponsor: CHRU de Brest


title:
"Adaptation Bayésienne de posologie des immunosuppresseurs chez les patients transplantés pulmonaires, atteints ou non de mucoviscidose"
 “Bayesian dose Adjustment of immunoSuppressants After Lung Transplantation"

acronym: BASALT

lead_sponsor: CHU de Limoges


title: ESSAI RANDOMISE - SORAFENIB-PRAVASTATINE VERSUS SORAFENIB SEUL POUR LE TRAITEMENT PALLIATIF DU CARCINOME HEPATOCELLULAIRE CHILD-PUGH A

acronym: PRODIGE 11

lead_sponsor: CHU de DIJON - Délégation à la recherche clinique et à l’innovation


title:
A multicenter study to evaluate a risk-adapted strategy for treatment of extra cranial non seminomateous malignant germ cell tumour in children, adolescent and young adult

 Etude multicentrique évaluant une stratégie thérapeutique adaptée au pronostic dans les tumeurs germinales malignes non séminomateuses extra-crâniennes de l’enfant et de l’adolescent et du jeune adulte

acronym: TGM 2013 - NS

lead_sponsor: CENTRE LEON BERARD


title: A PHASE III STUDY OF VELCADE (BORTEZOMIB) DEXAMETHASONE (VD) VERSUS VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA.

acronym: VD vesus VTD

lead_sponsor: Intergroupe Francophone du Myélome


title:
Open label, multicentre study, evaluating the safety, tolerability, efficacy, compliance and the acceptability of alkalising treatments at long-term in patients with cystinuria

 Etude multi-centrique, en ouvert, évaluant la sécurité d’emploi, la tolérabilité, l’efficacité, l’observance et l’acceptabilité de traitements alcalinisants à long terme chez des patients présentant une cystinurie.

lead_sponsor: Advicenne


title:
A Phase 1/2, Open-Label, Multicenter Study of INCB000928
 Administered as a Monotherapy in Participants With Anemia Due to
 Myelodysplastic Syndromes or Multiple Myeloma


title: A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Chemotherapy and Anti-PD-[L]1 Immunotherapy

acronym: CheckMate 79X: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 79X

lead_sponsor: Bristol-Myers Squibb International Corporation


title: "Etude en simple aveugle évaluant l'efficacité et la tolérance du BF 2.649 dans le trouble de l'attention/hyperactivité de l'adulte"

lead_sponsor: BIOPROJET


title: A Phase II Clinical Trial of PXD101 in Patients with Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

lead_sponsor: CuraGen Corporation


title: Multicentre, controlled, randomised, open-label, cross-over clinical study of the efficacy and tolerability of L-thyroxine (T4) soft capsules, in comparison to L-thyroxine tablets, in thyroidectomised patients.

lead_sponsor: IBSA, Institut Biochimique SA


title:
An open-label, multi-center rollover protocol for patients
 who have participated in a Novartis-sponsored ribociclib
 (LEE011) study and are continuing to benefit from
 ribociclib as single agent or in combination with other
 investigational treatments

 Protocole multicentrique en ouvert évaluant la poursuite du traitement par ribociclib (LEE011) chez des patients ayant terminé leur participation à une étude promue par Novartis et qui continuent de bénéficier du ribociclib seul ou associé à d’autres traitements expérimentaux

lead_sponsor: Novartis Pharma Services AG


title:
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients

 Étude de première administration chez l’homme visant à évaluer la sécurité d’emploi, la tolérance, la pharmacocinétique, la pharmacodynamique et l’efficacité préliminaire du PPSGG (PN-1007) chez des patients atteints de neuropathie anti-MAG.

lead_sponsor: Polyneuron Pharmaceuticals AG


title: A phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms

lead_sponsor: Durata Therapeutic International B.V.


title:
A Phase 2, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with Relapsed or Refractory BAP1 deficientMalignant Mesothelioma

 Étude multicentrique de phase II de l’inhibiteur de l'EZH2 Tazemetostat chez des patients adultes atteints d'un mésothéliome malin en rechute ou réfractaire avec perte de fonction BAP1

lead_sponsor: Epizyme, Inc.


title: A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment

lead_sponsor: Allergan


title: EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES

lead_sponsor: LFB BIOTECHNOLOGIES


title: OPTIMAL CONTROL OF LIVER METASTASES WITH INTRAVENOUS CETUXIMAB AND HEPATIC ARTERY INFUSION OF THREE-DRUG CHEMOTHERAPY IN PATIENTS WITH LIVER-ONLY METASTASES FROM COLORECTAL CANCER. A PHASE II TRIAL

lead_sponsor: ARTBC


title: A Randomized, Double-blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing  SCH 420814 5 mg BID

lead_sponsor: Schering Plough Research Institute


title: Open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5083945, a Glycoengineered Antibody against EGFR, in patients with metastatic and/or locally advanced malignant EGFR+ Solid Tumors

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
D2 Resection and HIPEC (Hyperthermic intraperitoneal chemoperfusion) in locally advanced gastric carcinoma. A national randomized and multicentric phase III study

 INTERET DE LA CHIMIOHYPERTHERMIE INTRAPERITONEALE (CHIP) ADJUVANTE A L’OXALIPLATINE DANS LE TRAITEMENT CURATIF DES CANCERS GASTRIQUES AVANCES. ETUDE NATIONALE, RANDOMISEE ET MULTICENTRIQUE DE PHASE III.

acronym:
GASTRICHIP

 GASTRICHIP

lead_sponsor: Hospices Civils de Lyon


title: SCARLET-2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Sepsis and Coagulopathy

lead_sponsor: Asahi Kasei Pharma America Corporation


title: A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)

lead_sponsor: INSERM


title:
A GLP-1 receptor PET imaging substudy within the VER-AT1D trial investigating the effects on beta cell mass.

 Etude de l’imagerie TEP du récepteur GLP-1,  compagnon de l’étude Ver-A-T1D évaluant les effets d’une thérapie sur la masse des cellules bêta pancréatiques.

acronym:
PET imaging of beta cells in Type 1 diabetes, effect of verapamil (Image-Ver-A-T1D)

 Imagerie TEP des cellules bêta dans le diabête de Type 1 , effet du vérapamil (Image-Ver-A-T1D)

lead_sponsor: Radboud University Medical Center


title: A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056


title: A Phase I trial of figitumumab, an IGF-1R antibody, in children aged 1-12 years old with relapsed/refractory Solid Tumours

acronym: FOREST

lead_sponsor: University of Birmingham


title: A multicentre, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children

lead_sponsor: Advicenne


title: A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

lead_sponsor: Seagen Inc.


title: Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE

acronym: PROPEL OLE

lead_sponsor: QED Therapeutics, Inc.


title: A MULTI-CENTRE, SINGLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS OF PITOLISANT (BF2.649) IN CHILDREN FROM 6 TO LESS THAN 18 YEARS WITH NARCOLEPSY

acronym: PITOLISANT PHARMACOKINETICS SINGLE DOSE TRIAL IN CHILDREN  FROM 6 TO LESS THAN 18 YEARS OLD

lead_sponsor: Bioprojet Pharma


title: A Multinational Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer

lead_sponsor: SOLTI


title: An open Phase I/II study of immunization with the recMAGE-A3 + AS15 Antigen Specific Cancer Immunotherapeutic in association with dacarbazine in patients with MAGE-A3 positive unresectable and progressive metastatic cutaneous melanoma

acronym: MAGE3-AS15-MEL-002 (MET-chemo)

lead_sponsor: GlaxoSmithKline Biologicals


title: Etude de phase III randomisée, ouverte, multicentrique comparant chez des sujets âgés de plus de 70 ans atteints de cancer bronchique non à petites cellules de stade IV ou IIIb (T4 plèvre ou péricarde) une stratégie « classique » d’attribution d’un traitement par bithérapie à base de carboplatine ou une monothérapie par Docetaxel seul basée sur le PS et l’âge à une stratégie « optimisée » utilisant les mêmes drogues attribuées selon une échelle gériatrique simplifiée de dépistage plus ou moins complétée d’une évaluation gériatrique approfondie

acronym: esogia

lead_sponsor: CHU de Rennes


title: A Randomized, Placebo-Controlled, Phase 1/2 Study Of ARQ 197 in Combination With Irinotecan and Cetuximab in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Who Have Received Front-Line Systemic Therapy

summary:
ARQ 197 or placebo in combination with irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC), in participants with wild-type KRAS alleles who have failed front-line systemic therapy, to evaluate the safety, tolerability, and efficacy of ARQ 197, define the recommended dose for Phase 2.

After the recommended dose is determined for Phase 2, participants receive study drug or placebo with irinotecan and cetuximab.

ipd_sharing: No

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Italy
United States
Russian Federation
France


lead_sponsor: Cephalon

summary: The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

ReferenceCitation: Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.

oa_host_type: closed

publisher_dissemination: Elsevier

location_facility: Hopital Universitaire Caremeau-Batiment Polyvalent, Service

location_facility: District Department of Psychiatric Disorders With Stationary

location_facility: Donetsk National Medical University n.a. M. Horkyy

location_facility: Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie

location_facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy

location_facility: Centro de Investigación y asistencia en Psiquiatria (CIAP)

location_facility: Northern Area Mental Health Services Northern Psychiatric R

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM

location_facility: Kiev City Psychoneurological Hospital N 1, CNTRP

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc

location_facility: Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"

location_facility: Odessa Regional Psychoneurology Dispensary

location_facility: South Coast Medical Associates/SC Clinical Trials, Inc.

location_facility: Midwest Center for Neurobehavioral Medicine

location_facility: Vinnytsa National Medical University named by M.I. Pirogov

location_facility: Diagnostic Consultative Center "Tchaika"

location_facility: Belmont Center for Comprehensive Treatment

location_facility: Psychiatric clinic, University Hospital "Alexandrovska"

location_facility: Danylo Galitsky Lviv State Medical University

location_facility: Public Institution "Institute of Neurology, Psychiatry and N

location_facility: Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)

location_facility: Behavioral Medical Research of Staten Island

title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

location_country:
Poland
Argentina
Australia
United States
Spain
South Africa
Ukraine
Bulgaria
Canada
France


acronym: COMPOSE 2

lead_sponsor: Bayer

summary: A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

status: Terminated

title: A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

location_country:
Germany
Ireland
Argentina
Austria
Belgium
Mexico
United States
Philippines
France


title: Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks

acronym: CONFIDENT-PD

summary: A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

lead_sponsor: Phytopharm

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
United States
Serbia
Canada
Czech Republic
France

location_facility: Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Southern Illinois University School of Medicine

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Colorado Neurological Institute, Rocky Mountain Movement Disorders Center

location_facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly

location_facility: prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi

location_facility: Fakultni nemocnice Hradec Kralove Neurologicka klinika

location_facility: Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju

location_facility: Spitalul Clinic de Recuperare Cluj-Napoca

location_facility: Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju

location_facility: Vseobecna fakultni nemocnice v Praze Neurologicka klinika

location_facility: The Royal Devon and Exeter NHS Foundation Trust

location_facility: Weil Medical College of Cornell University

location_facility: Clinique Sainte-Anne "Memoire et mouvement"

location_facility: Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly

location_facility: Fakultni nemocnice Olomouc Neurologicka klinika

location_facility: Parkinsons Neurodegenerative Disorder Clinic

location_facility: University of Tennessee Health Science Center

location_facility: Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya

location_facility: Washington University School of Medicine

location_facility: Institute for Neurodegenerative Disorders

location_facility: Klinik für Neurologie Charité, Universitaetsmedizin Berlin

location_facility: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus

location_facility: Semmelweis Egyetem AOK Neurologiai Klinika

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly

location_facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

location_facility: Luton and Dunstable Hospital Foundation Trust

location_facility: Neurological Institute, Cleveland Clinic

location_facility: Rush University Medical Center Neuroscience Inst.

location_facility: Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik

location_facility: Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders


type: Other Identifier

title: AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA

summary: This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

design_allocation: Non-Randomized

ReferenceCitation: Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

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

publisher_dissemination: Informa

ReferenceCitation: Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. doi: 10.1158/1078-0432.CCR-15-2488. Epub 2016 May 6.

oa_host_type: repository

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
UCB Pharma

location_country:
United Kingdom
Hong Kong
Singapore
Japan
Belgium
United States
Korea, Republic of
Canada
France

location_facility: Davis Cancer Pavillion and Shands Medical Plaza

location_facility: Shands Hospital at the University of Florida

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Hopital Saint-Louis -Universite Paris VII

location_facility: Cancer Sciences Division, Somers Cancer Research Building

location_facility: Hospital Saint-Louis - Service d'Hemato-Oncologie

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: Shands Cancer Hospital At The University Of Florida

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie


title: Multi-Center Randomized Placebo-controlled Trial of Nocturnal Oxygen Therapy in Chronic Obstructive Pulmonary Disease. The International Nocturnal Oxygen (INOX) Trial

acronym: INOX

summary: This multicenter randomized placebo controlled trial aims to determine if in patients with COPD not qualifying for LTOT but presenting significant nocturnal arterial oxygen desaturation, whether nocturnal oxygen therapy provided for a period of 4 years decreases mortality or delay the prescription of LTOT.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Lacasse Y, Series F, Martin S, Maltais F. Nocturnal oxygen therapy in patients with chronic obstructive pulmonary disease: a survey of Canadian respirologists. Can Respir J. 2007 Sep;14(6):343-8. doi: 10.1155/2007/487831.

ReferenceCitation: Lacasse Y, Series F, Corbeil F, Baltzan M, Paradis B, Simao P, Abad Fernandez A, Esteban C, Guimaraes M, Bourbeau J, Aaron SD, Bernard S, Maltais F; INOX Trial Group. Randomized Trial of Nocturnal Oxygen in Chronic Obstructive Pulmonary Disease. N Engl J Med. 2020 Sep 17;383(12):1129-1138. doi: 10.1056/NEJMoa2013219.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Lacasse Y, Bernard S, Series F, Nguyen VH, Bourbeau J, Aaron S, Maltais F; International Nocturnal Oxygen (INOX) Research Group. Multi-center, randomized, placebo-controlled trial of nocturnal oxygen therapy in chronic obstructive pulmonary disease: a study protocol for the INOX trial. BMC Pulm Med. 2017 Jan 9;17(1):8. doi: 10.1186/s12890-016-0343-9.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Ottawa - uO Research

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

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

repository_normalized: dnet

repositories:
PubMed Central
dnet
ruor.uottawa.ca

repositories_concat: PubMed Central;dnet;ruor.uottawa.ca

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Laval University

collaborators: Canadian Institutes of Health Research (CIHR)

location_country: Spain Canada Portugal France

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Centro Hospitalara Vila Nova de Gaia-Espinho EPE

location_facility: Hospital Pedro Hispano Unidade Local de Saude de Matosinhos

location_facility: Centre de la santé et des services sociaux de Laval (Cité de la Santé de Laval)

location_facility: Hospital Pulido Valente - Centro Hospitalar Lisboa Norte

location_facility: Centro Hospitalar do Barlavento Algarvio - EPE

intervention_type: Device


acronym: NEuroSIS

lead_sponsor: University Children's Hospital Tuebingen

summary:
HYPOTHESIS:

Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%.

PRIMARY OBJECTIVE:

To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.

SECONDARY OBJECTIVES:

To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen.

RATIONALE:

Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects.

STUDY DESIGN:

Randomised placebo-controlled, multi-centre clinical trial.

RESEARCH PLAN:

Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.

CLINICAL SIGNIFICANCE:

BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

ReferenceCitation: Bassler D, Halliday HL, Plavka R, Hallman M, Shinwell ES, Jarreau PH, Carnielli V, van den Anker J, Schwab M, Poets CF. The Neonatal European Study of Inhaled Steroids (NEUROSIS): an eu-funded international randomised controlled trial in preterm infants. Neonatology. 2010;97(1):52-5. doi: 10.1159/000227294. Epub 2009 Jul 7. No abstract available.

ReferenceCitation: Bassler D, Shinwell ES, Hallman M, Jarreau PH, Plavka R, Carnielli V, Meisner C, Engel C, Koch A, Kreutzer K, van den Anker JN, Schwab M, Halliday HL, Poets CF; Neonatal European Study of Inhaled Steroids Trial Group. Long-Term Effects of Inhaled Budesonide for Bronchopulmonary Dysplasia. N Engl J Med. 2018 Jan 11;378(2):148-157. doi: 10.1056/NEJMoa1708831.

oa_colors: green other

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Bassler D, Plavka R, Shinwell ES, Hallman M, Jarreau PH, Carnielli V, Van den Anker JN, Meisner C, Engel C, Schwab M, Halliday HL, Poets CF; NEUROSIS Trial Group. Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia. N Engl J Med. 2015 Oct 15;373(16):1497-506. doi: 10.1056/NEJMoa1501917.

location_facility: University Hospital Plzen, Department of Neonatology

location_facility: Hôpital Clocheville, Service de RéanimationNéonatale

location_facility: Hospital Nuernberg Sued, Dept. of Neonatology

location_facility: Charles University, General Faculty Hospital and 1st Faculty of Medicine, Department of Obstetrics and Gynecology

location_facility: Kaplan Medical Center Rehovot, Dept. of Neonatology

location_facility: University Children's Hospital Essen, Dept. of Pediatrics

location_facility: University Hospital Hannover, Dept. of Neonatology

location_facility: CHU de LilleHôpital Jeanne de Flandres, Pôle de Médecine néonataleUnité de Réanimation néonatale

location_facility: Ospedale Sant'Anna, Terapia Intensiva Neonatale Clinica -3°piano

location_facility: University Children's Hospital Aachen, Dept. of Neonatology

location_facility: University Children´s Hospital Tuebingen, Dept. of Neonatology

location_facility: Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology

location_facility: University Hospital of Tomas Bati, Department of Neonatology

location_facility: Ben-Gurion University of NegevSoroka Medical Center, Neonatal Department

location_facility: Children's Hospital Hannover auf der Bult, Dept. of Neonatology

location_facility: AZ Sint-Jan Brugge Oostende AV, Department of Neontalogy

location_facility: Azienda Ospedaliera di Padova, Dipartimento di Pediatria Salus Pueri

location_facility: Bnai Zion Medical Center Haifa, Department of Neonatology

location_facility: Erasmus MC - Sophia, Department of Neonatology

location_facility: University Hospital Ostrava, Department of Neonatology

location_facility: University Hospital Motol Prague 5, Department of Neonatology

location_facility: Hadassah Medical Center, Department of Neonatology

location_facility: University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology

location_facility: Georg-August University Hospital Goettingen, Dept. of Pediatrics

location_facility: Azienda Ospedaliera Universitaria Pisana, U.O. Neonatologia

location_facility: Tartu University Children's Clinic, Paediatric Intensive Care Unit

location_facility: University Children's Hospital Erlangen, Dept. of Neonatology

location_facility: University Children's Hospital Heidelberg, Dept. of Neonatology

location_facility: Meir Medical Center, Premature Baby Unit

location_facility: University Hospital Hamburg-Eppendorf, Dept. of Neonatology

location_facility: Helsinki University Central Hospital,Hospital for Children and Adolescents, NICU

location_facility: ASO S. Croce e Carie, Terapia Intensiva Neonatale-Neonatologia

location_facility: University Hospital Brno, Department of Neonatology

title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

primary_purpose: Prevention

location_country:
Finland
Germany
Italy
Israel
Netherlands
Belgium
Czech Republic
France

ipd_sharing: Undecided


title: A Phase III Randomized, Double Blind, Placebo Controlled Multi-center Study of Panobinostat for Maintenance of Response in Patients With Hodgkin's Lymphoma Who Are at Risk for Relapse After High Dose Chemotherapy and Autologous Stem Cell Transplant (ASCT)

acronym: PATH

summary: The primary objective was to provide drug to ongoing patients who were receiving panobinostat and to characterize the safety and tolerability of panobinostat in patients with HL after achieving a complete response following autologous hematopoietic stem cell transplant (AHSCT) with high dose chemotherapy (HDT). Primary objective as stated above reflects a change from the original protocol as of an amendment. The original objective was no longer feasible with only 41 of 367 patients randomized after the study was halted due to poor recruitment. An amendment was written to allow patients on panobinostat to continue their treatment until discontinuation/completion criteria were met (patients were unblinded). Therefore, the study was completed as per this amendment. No secondary objectives were included for this trial from the amendment; this was a change from the original protocol.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Poland
New Zealand
Israel
Singapore
Australia
Brazil
Netherlands
Belgium
United States
Canada
Russian Federation
France

location_facility: Dana-Farber Cancer Institute Dana-Farber Cancer Institute

location_facility: Mayo Clinic - Rochester Hematology/Oncology Dept.

location_facility: Georgia Health Sciences University Medical College of Georgia

location_facility: Vanderbilt University Medical Center Vanderbilt Clinic - Oncology

location_facility: Medical University of South Carolina Oncology


title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

acronym: CANVAS

summary:
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin.

The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.

ReferenceCitation: Ferrannini E, Baldi S, Scozzaro T, Tsimihodimos V, Tesfaye F, Shaw W, Rosenthal N, Figtree GA, Neal B, Mahaffey KW, Perkovic V, Hansen MK. Fasting Substrate Concentrations Predict Cardiovascular Outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS). Diabetes Care. 2022 Aug 1;45(8):1893-1899. doi: 10.2337/dc21-2398.

evidence: open (via free pdf)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: American Diabetes Association

ReferenceCitation: Vaduganathan M, Sattar N, Xu J, Butler J, Mahaffey KW, Neal B, Shaw W, Rosenthal N, Pfeifer M, Hansen MK, Januzzi JL Jr. Stress Cardiac Biomarkers, Cardiovascular and Renal Outcomes, and Response to Canagliflozin. J Am Coll Cardiol. 2022 Feb 8;79(5):432-444. doi: 10.1016/j.jacc.2021.11.027.

license: publisher-specific-oa

license_normalized: publisher-specific

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Imperial College London - Spiral

ReferenceCitation: Waijer SW, Sen T, Arnott C, Neal B, Kosterink JGW, Mahaffey KW, Parikh CR, de Zeeuw D, Perkovic V, Neuen BL, Coca SG, Hansen MK, Gansevoort RT, Heerspink HJL. Association between TNF Receptors and KIM-1 with Kidney Outcomes in Early-Stage Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2022 Feb;17(2):251-259. doi: 10.2215/CJN.08780621. Epub 2021 Dec 7.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

license: public-domain

license_normalized: public-domain

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA1c, disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.

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

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

ReferenceCitation: Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum In: ESC Heart Fail. 2021 May 3;:

ReferenceCitation: Januzzi JL Jr, Butler J, Sattar N, Xu J, Shaw W, Rosenthal N, Pfeifer M, Mahaffey KW, Neal B, Hansen MK. Insulin-Like Growth Factor Binding Protein 7 Predicts Renal and Cardiovascular Outcomes in the Canagliflozin Cardiovascular Assessment Study. Diabetes Care. 2021 Jan;44(1):210-216. doi: 10.2337/dc20-1889. Epub 2020 Nov 6.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Januzzi JL Jr, Xu J, Li J, Shaw W, Oh R, Pfeifer M, Butler J, Sattar N, Mahaffey KW, Neal B, Hansen MK. Effects of Canagliflozin on Amino-Terminal Pro-B-Type Natriuretic Peptide: Implications for Cardiovascular Risk Reduction. J Am Coll Cardiol. 2020 Nov 3;76(18):2076-2085. doi: 10.1016/j.jacc.2020.09.004.

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.

repository_institution: University College London - UCL Discovery

ReferenceCitation: Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.

ReferenceCitation: Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.

ReferenceCitation: Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.

ReferenceCitation: Figtree GA, Radholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17. No abstract available.

ReferenceCitation: Zhou Z, Lindley RI, Radholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.

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

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.

ReferenceCitation: Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Radholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.

ReferenceCitation: Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.

ReferenceCitation: Yale JF, Xie J, Sherman SE, Garceau C. Canagliflozin in Conjunction With Sulfonylurea Maintains Glycemic Control and Weight Loss Over 52 Weeks: A Randomized, Controlled Trial in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2017 Nov;39(11):2230-2242.e2. doi: 10.1016/j.clinthera.2017.10.003. Epub 2017 Nov 3.

ReferenceCitation: Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

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

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

ReferenceCitation: Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW, Weiss R, Rosenstock J, Capuano G, Desai M, Shaw W, Vercruysse F, Meininger G, Neal B. Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Diabetes Ther. 2015 Sep;6(3):289-302. doi: 10.1007/s13300-015-0117-z. Epub 2015 Jun 17.

ReferenceCitation: Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Ways K, Desai M, Shaw W, Capuano G, Alba M, Jiang J, Vercruysse F, Meininger G, Matthews D; CANVAS Trial Collaborative Group. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015 Mar;38(3):403-11. doi: 10.2337/dc14-1237. Epub 2014 Dec 2.

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

ReferenceCitation: Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Stein P, Desai M, Shaw W, Jiang J, Vercruysse F, Meininger G, Matthews D. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial. Am Heart J. 2013 Aug;166(2):217-223.e11. doi: 10.1016/j.ahj.2013.05.007. Epub 2013 Jun 24.

collaborators: The George Institute for Global Health, Australia

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Luxembourg
Czechia
Canada
France
Colombia
Hungary
United States
Ukraine
India
Belgium
Malaysia
Estonia
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
Russian Federation
Israel


type: Registry Identifier

title: ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

acronym: ABSORB EXTEND

summary:
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System

ABSORB BVS is currently in development at Abbott Vascular.

ReferenceCitation: Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.

repository_normalized: University of Melbourne - Minerva Access

ReferenceCitation: Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.

ReferenceCitation: Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.

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

ReferenceCitation: Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.

ReferenceCitation: Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available.

ReferenceCitation: Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Canada
France
Denmark
Switzerland
India
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Spain
South Africa
Taiwan
Israel

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences

location_facility: Eastern Heart Clinic, The Prince of Wales Hospital

location_facility: Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein

location_facility: Escorts Heart Institute & Research Centre

location_facility: Saiseikai Yokohama City Eastern Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA


title: An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)

acronym: ENABLE-ALL

summary: The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Australia
United States
Spain
Greece
Pakistan
Canada
France


acronym: CLIPPER

summary: This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

ReferenceCitation: Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

repository_institution: Ghent University - Ghent University Academic Bibliography

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

title: A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis

location_country:
Germany
Poland
Australia
Serbia
Czech Republic
Slovenia
Lithuania
France
Colombia
Slovakia
Hungary
Latvia
Belgium
Italy
Norway
Netherlands
Mexico
Spain
Russian Federation


lead_sponsor: PTC Therapeutics

summary: Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting. The lack of FVIII/FIX can produce bleeding episodes that cause damage of the bone, muscles, joints, and tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 10-30% of participants with hemophilia and results in severe manifestations. Ataluren (PTC124) is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional FVIII/FIX. This study is a Phase 2a trial evaluating the safety and efficacy of ataluren in participants with HA or HB due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase FVIII/FIX activity levels.

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. doi: 10.1177/0091270006297140.

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. doi: 10.1038/nature05756. Epub 2007 Apr 22.

sponsor_collaborators:
PTC Therapeutics
Genzyme, a Sanofi Company

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Vanderbilt Hemostatis and Thrombosis Clinic

location_facility: A.Bianchi Bonomi Hemophilia and Thrombosis Center

location_facility: The Bleeding and Clotting Disorders Institute

location_facility: Azienda Ospedaliero-Universitaria Careggi Viale G.B. Morgagni

title: A Phase 2a Study of Ataluren (PTC124) as an Oral Treatment for Nonsense-Mutation-Mediated Hemophilia A and B

location_country:
United States
Italy
Canada
France


title: A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment

summary: This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.

ReferenceCitation: Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Slovakia
Denmark
Switzerland
Peru
Italy
Ecuador
Norway
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


lead_sponsor: Novartis

summary: This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.

ReferenceCitation: D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Kerwin E, Hebert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012 Nov;40(5):1106-14. doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.

location_facility:
Novartis Investigative Center
Novartis Investigative Site
Novartis Investigator Site
Novartis Investigative site

title: A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease

location_country:
Germany
Italy
Poland
New Zealand
Hungary
Argentina
Israel
Netherlands
Mexico
United States
Korea, Republic of
Chile
Peru
Canada
Russian Federation
France