title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma

acronym: COMMAND

summary: This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study.

ReferenceCitation: Fennell DA, Baas P, Taylor P, Nowak AK, Gilligan D, Nakano T, Pachter JA, Weaver DT, Scherpereel A, Pavlakis N, van Meerbeeck JP, Cedrés S, Nolan L, Kindler H, Aerts JGJV. Maintenance Defactinib Versus Placebo After First-Line Chemotherapy in Patients With Merlin-Stratified Pleural Mesothelioma: COMMAND-A Double-Blind, Randomized, Phase II Study. J Clin Oncol. 2019 Apr 1;37(10):790-798. doi: 10.1200/JCO.2018.79.0543. Epub 2019 Feb 20.

name: University of Leicester, Leicester, United Kingdom

family: Fennell

full_name: Dean A. Fennell

given: Dean A.

name: Netherlands Cancer Institute, Amsterdam, the Netherlands

family: Baas

full_name: Paul Baas

given: Paul

name: Wythenshawe Hospital, Manchester, United Kingdom

family: Taylor

full_name: Paul Taylor

name: University of Western Australia and Sir Charles Gairdner Hospital, Perth, WA, Australia

family: Nowak

full_name: Anna K. Nowak

given: Anna K.

name: Cambridge University Hospitals National Health Service Foundation Trust, Addenbrooke’s Hospital, Cambridge, United Kingdom

family: Gilligan

full_name: David Gilligan

given: David

family: Nakano

full_name: Takashi Nakano

given: Takashi

family: Pachter

full_name: Jonathan A. Pachter

given: Jonathan A.

family: Weaver

full_name: David T. Weaver

given: David T.

name: Calmette Hospital, Regional University Hospital of Lille, Lille Cedex, France

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

name: Northern Cancer Institute, St Leonards, NSW, Australia

family: Pavlakis

full_name: Nick Pavlakis

given: Nick

name: Universitair Ziekenuis, Antwerp, Belgium

family: van Meerbeeck

full_name: Jan P. van Meerbeeck

given: Jan P.

name: Karolinska University Hospital, Stockholm, Sweden

family: Cedrés

full_name: Susana Cedrés

given: Susana

name: University Hospital, Southampton, United Kingdom

family: Nolan

full_name: Luke Nolan

given: Luke

name: University of Chicago Medical Center, Chicago, IL

family: Kindler

full_name: Hedy Kindler

given: Hedy

name: Erasmus Medical College, Rotterdam, the Netherlands

family: Aerts

full_name: Joachim G.J.V. Aerts

given: Joachim G.J.V.

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Maintenance Defactinib Versus Placebo After First-Line Chemotherapy in Patients With Merlin-Stratified Pleural Mesothelioma: COMMAND—A Double-Blind, Randomized, Phase II Study

lead_sponsor: Verastem, Inc.

location_country:
Italy
United States
South Africa
Sweden
Netherlands
France
Japan
Poland
Norway
Belgium
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Canterbury Regional Cancer & Haematology Service

location_facility: Iatros International / Bloemfontein Medi-Clinic

location_facility: Kent Oncology Centre, Maidstone Hospital

location_facility: Institut Oncològic del Vallés Consorci Hospitalari Parc Tauli

location_facility: Universitaire Ziekenhuizen Leuven (University Hospitals Leuven)

location_facility: Centrum Pulmonologii Ii Torakochirurgii w Bystrej

location_facility: Mary Potter Oncology Center, Little Company of Mary Hospital

location_facility: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

location_facility: Hospital Madrid Norte- Sanchinarro, Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: University of California San Francisco Medical Center

location_facility: Princess Alexandra Hospital +61(0)7 3176 5054


summary: This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Tullman M, Chartier-Kastler E, Kohan A, Keppenne V, Brucker BM, Egerdie B, Mandle M, Nicandro JP, Jenkins B, Denys P. Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS. Neurology. 2018 Aug 14;91(7):e657-e665. doi: 10.1212/WNL.0000000000005991. Epub 2018 Jul 20.

lead_sponsor: Allergan

location_country:
United States
France
Czechia
Poland
Belgium
Russian Federation
Portugal
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


summary: This non-drug, longitudinal, multi-center, multi-national study will evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down Syndrome. Tests will be administered at clinic visits in Weeks 1, (4) and 24. The duration of the study for each individual will be between 24 and 27 weeks.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Spiridigliozzi GA, Goeldner C, Edgin J, Hart SJ, Noeldeke J, Squassante L, Visootsak J, Heller JH, Khwaja O, Kishnani PS, Liogier d'Ardhuy X. Adaptive behavior in adolescents and adults with Down syndrome: Results from a 6-month longitudinal study. Am J Med Genet A. 2019 Jan;179(1):85-93. doi: 10.1002/ajmg.a.60685. Epub 2018 Dec 20.

name: Department of Psychiatry and Behavioral Sciences; Duke University Medical Center; Durham North Carolina

family: Spiridigliozzi

full_name: Gail A. Spiridigliozzi

given: Gail A.

sequence: first

name: F. Hoffmann-La Roche; Roche Pharma Research and Early Development, Neuroscience, Roche Innovation Center Basel; Basel Switzerland

family: Goeldner

full_name: Celia Goeldner

given: Celia

sequence: additional

name: Department of Psychology; University of Arizona; Tucson Arizona

family: Edgin

full_name: Jamie Edgin

given: Jamie

name: Department of Pediatrics; Duke University Medical Center; Durham North Carolina

family: Hart

full_name: Sarah J. Hart

given: Sarah J.

family: Noeldeke

full_name: Jana Noeldeke

given: Jana

family: Squassante

full_name: Lisa Squassante

given: Lisa

name: F. Hoffmann-La Roche; Roche Pharma Research and Early Development, Neuroscience, Roche Innovation Center; New York New York

family: Visootsak

full_name: Jeannie Visootsak

given: Jeannie

family: Heller

full_name: James H. Heller

given: James H.

family: Khwaja

full_name: Omar Khwaja

given: Omar

family: Kishnani

full_name: Priya S. Kishnani

given: Priya S.

family: Liogier d'Ardhuy

full_name: Xavier Liogier d'Ardhuy

given: Xavier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Medical Genetics Part A

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Argentina
Spain
Canada
United Kingdom


type: EudraCT Number

title: An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

acronym: MEASURE 1 ext

summary: This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

ReferenceCitation: Baraliakos X, Van den Bosch F, Machado PM, Gensler LS, Marzo-Ortega H, Sherif B, Quebe-Fehling E, Porter B, Gaillez C, Deodhar A. Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Machado

full_name: Pedro M. Machado

given: Pedro M.

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

family: Marzo-Ortega

full_name: Helena Marzo-Ortega

given: Helena

family: Sherif

full_name: Bintu Sherif

given: Bintu

family: Quebe-Fehling

full_name: Erhard Quebe-Fehling

given: Erhard

family: Porter

full_name: Brian Porter

given: Brian

family: Gaillez

full_name: Corine Gaillez

given: Corine

family: Deodhar

full_name: Atul Deodhar

given: Atul

journal_name: Rheumatology and Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Tseng JC, Wei JC, Deodhar A, Martin R, Porter B, McCreddin S, Talloczy Z. Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1. Front Immunol. 2020 Nov 26;11:561748. doi: 10.3389/fimmu.2020.561748. eCollection 2020.

family: Tseng

full_name: Jui-Cheng Tseng

given: Jui-Cheng

family: Wei

full_name: James Cheng-Chung Wei

given: James Cheng-Chung

family: Martin

full_name: Ruvie Martin

given: Ruvie

family: McCreddin

full_name: Suzanne McCreddin

ReferenceCitation: Baraliakos X, Braun J, Deodhar A, Poddubnyy D, Kivitz A, Tahir H, Van den Bosch F, Delicha EM, Talloczy Z, Fierlinger A. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019 Sep 3;5(2):e001005. doi: 10.1136/rmdopen-2019-001005. eCollection 2019.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Braun J, Baraliakos X, Deodhar A, Poddubnyy D, Emery P, Delicha EM, Talloczy Z, Porter B. Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study. Rheumatology (Oxford). 2019 May 1;58(5):859-868. doi: 10.1093/rheumatology/key375.

name: Rheumazentrum Ruhrgebiet, Herne and Ruhr-University Bochum, Germany

name: Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, OR, USA

name: Department of Rheumatology, Med. Department I, Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany

name: Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

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

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

location_country:
Italy
United States
Peru
Mexico
Netherlands
Germany
France
Bulgaria
Belgium
Russian Federation
Turkey
Canada
United Kingdom
Taiwan


design_allocation: Non-Randomized

intervention_type: Biological

location_country:
Italy
United States
France
Czechia
Poland
Belgium
Turkey
Canada

location_facility: Children's Hospital of Wisconsin Department of Pediatric Urology

location_facility: William Beaumont Hospital Research Institute

location_facility: CHU de Limoges - HÃ´pital MÃ¨re et l'Enfant

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: St. Louis Children's Hospital Division of Urology

location_facility: University of Alabama at Birmingham Division of Urology Research Office

location_facility: Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed

location_facility: Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic

source: euctr

title: Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

summary: This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).


title: Dose Finding and Phase II Study of STI 571 in Advanced Soft Tissue Sarcoma

summary:
RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma.

PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.

ReferenceType: result

ReferenceCitation: van Erp N, Gelderblom H, van Glabbeke M, Van Oosterom A, Verweij J, Guchelaar HJ, Debiec-Rychter M, Peng B, Blay JY, Judson I. Effect of cigarette smoking on imatinib in patients in the soft tissue and bone sarcoma group of the EORTC. Clin Cancer Res. 2008 Dec 15;14(24):8308-13. doi: 10.1158/1078-0432.CCR-08-1303.

family: van Erp

full_name: N. van Erp

given: N.

family: Gelderblom

full_name: H. Gelderblom

given: H.

family: van Glabbeke

full_name: M. van Glabbeke

given: M.

family: Van Oosterom

full_name: A. Van Oosterom

given: A.

family: Verweij

full_name: J. Verweij

given: J.

family: Guchelaar

full_name: H.-J. Guchelaar

family: Debiec-Rychter

full_name: M. Debiec-Rychter

family: Peng

full_name: B. Peng

given: B.

family: Blay

full_name: J.-Y. Blay

family: Judson

full_name: I. Judson

given: I.

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Association for Cancer Research (AACR)

title: Effect of Cigarette Smoking on Imatinib in Patients in the Soft Tissue and Bone Sarcoma Group of the EORTC

ReferenceCitation: Judson I, Ma P, Peng B, Verweij J, Racine A, di Paola ED, van Glabbeke M, Dimitrijevic S, Scurr M, Dumez H, van Oosterom A. Imatinib pharmacokinetics in patients with gastrointestinal stromal tumour: a retrospective population pharmacokinetic study over time. EORTC Soft Tissue and Bone Sarcoma Group. Cancer Chemother Pharmacol. 2005 Apr;55(4):379-386. doi: 10.1007/s00280-004-0876-0. Epub 2004 Dec 9.

full_name: Ian Judson

given: Ian

family: Ma

full_name: Peiming Ma

given: Peiming

full_name: Bin Peng

given: Bin

full_name: Jaap Verweij

given: Jaap

family: Racine

full_name: Amy Racine

given: Amy

family: di Paola

full_name: Eugenio Donato di Paola

given: Eugenio Donato

full_name: Martine van Glabbeke

given: Martine

family: Dimitrijevic

full_name: Sasa Dimitrijevic

given: Sasa

family: Scurr

full_name: Michelle Scurr

given: Michelle

family: Dumez

full_name: Herlinde Dumez

given: Herlinde

family: van Oosterom

full_name: Allan van Oosterom

given: Allan

bso_classification: Chemistry

ReferenceCitation: Debiec-Rychter M, Dumez H, Judson I, Wasag B, Verweij J, Brown M, Dimitrijevic S, Sciot R, Stul M, Vranck H, Scurr M, Hagemeijer A, van Glabbeke M, van Oosterom AT; EORTC Soft Tissue and Bone Sarcoma Group. Use of c-KIT/PDGFRA mutational analysis to predict the clinical response to imatinib in patients with advanced gastrointestinal stromal tumours entered on phase I and II studies of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2004 Mar;40(5):689-95.

ReferenceCitation: Verweij J, van Oosterom A, Blay JY, Judson I, Rodenhuis S, van der Graaf W, Radford J, Le Cesne A, Hogendoorn PC, di Paola ED, Brown M, Nielsen OS. Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target. Results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study. Eur J Cancer. 2003 Sep;39(14):2006-11.

ReferenceCitation: van Oosterom AT, Judson IR, Verweij J, Stroobants S, Dumez H, Donato di Paola E, Sciot R, Van Glabbeke M, Dimitrijevic S, Nielsen OS; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Update of phase I study of imatinib (STI571) in advanced soft tissue sarcomas and gastrointestinal stromal tumors: a report of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2002 Sep;38 Suppl 5:S83-7.

ReferenceCitation: van Oosterom AT, Judson I, Verweij J, Stroobants S, Donato di Paola E, Dimitrijevic S, Martens M, Webb A, Sciot R, Van Glabbeke M, Silberman S, Nielsen OS; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001 Oct 27;358(9291):1421-3.

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

location_country:
Netherlands
France
Belgium
Denmark
United Kingdom

location_facility: Herlev Hospital - University Hospital of Copenhagen


title: A Phase 3 Study of PTC923 in Subjects With Phenylketonuria

summary: The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: PTC Therapeutics

location_country:
Italy
Brazil
United States
Mexico
Netherlands
Germany
Spain
France
Georgia
Australia
Portugal
Turkey
Denmark
Canada
United Kingdom

location_facility: The Hospital for Sick Children University of Toronto, Adult Clinic: The Fred A Litwin Family Centre in Genetic Medicine University Health Network & Mt. Sinai Hospital

location_facility: Centro Hospitalar Universitário Do Porto, Epe

location_facility: Icahn School of Medicine at Mount Sinai (ISMMS)

location_facility: University of Texas Health Science Center of Texas

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: CHRU de Tours- Hôpital Pédiatrique de Clocheville

location_facility: University of Utah, Division of Medical Genetics (pediatric and adult clinic)

location_facility: University of Colorado and the Children's Hospital CO

location_facility: Division of Inherited Metabolic Diseases, Azienda Ospedaliera-Università Padova

location_facility: Ege University Faculty of Medicine Children Hospital

location_facility: CENTRO HOSPITALAR UNIVERSITÁRIO LISBOA NORTE Hospital de Santa Maria,

location_facility: Cukurova Üniversity Balcali Hospital Health Application and Research Center

location_facility: University Children's Hospital Hamburg Eppendorf (Kinder-UKE)

location_facility: Metabolics and Genetics in Calgary (MAGIC) Clinic, Ltd.

location_facility: UF College of Medicine, Department of Pediatrics Division of Genetics and Metabolism

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: Copenhagen University Hospital, Rigshospitalet

status_simplified: Ongoing


type: Other Identifier

title: A Phase 1b Study to Evaluate the Efficacy and Safety of JNJ-64251330, a Janus Kinase (JAK) Inhibitor, in Participants With Familial Adenomatous Polyposis

summary: The purpose of this study is to determine the effect of JNJ-64251330 in participants with Familial Adenomatous Polyposis (FAP) on colorectal polyp burden (sum of the polyp diameters).

ipd_sharing: Yes

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Sweden
Netherlands
France
Puerto Rico
Spain
Germany
Korea, Republic of

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Pan American Center for Oncology Trials LLC

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Wexner Medical Center at the Ohio State University


title: A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

acronym: CAPITAL

summary: This study is an open-label, multicenter Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

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

lead_sponsor: AstraZeneca

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


title: A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma

summary: This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Netherlands
Poland
France
Spain
Denmark
United States

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: City of Hope Comprehensive Cancer Center

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Aarhus Universitetshospital Skejby; Blodsygdomme

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Szpital Kliniczny; Oddzial Hematologii i Transplantacji Szpiku

location_facility: Morristown Medical Center;Hematology-Oncology Assoc

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia


title: A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

summary: This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Germany
France
Japan
Poland
Belgium
Argentina
Russian Federation
China
Canada


title: A Randomized, Parallel Group, Double Blind, Placebo Controlled Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg Administered Subcutaneously Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

summary: This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Switzerland
Spain
France
Poland
Hungary
Australia
Portugal
United States

intervention_type: Other


title: APPROACH-IS II: Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II

acronym: APPROACH-IS II

summary: This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and that aims to explore the profile and healthcare needs of adults with congenital heart diseases.

time_perspective: Cross-Sectional

ipd_sharing: No

ipd_sharing_description: Well-argued and reasonable requests can be directed to the Principal Investigator (Prof. Philip Moons) of the study.

lead_sponsor: KU Leuven

location_country:
Malaysia
Greece
Australia
Belgium
Denmark
Ethiopia
Taiwan
India
Pakistan
France
Japan
Norway
Argentina
Senegal
Canada
Korea, Republic of
Colombia
Chile
Sweden
Saudi Arabia
Switzerland
Netherlands
Bulgaria
Malta
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Botswana
Cameroon
Turkey

location_facility: Hospital Público Descentralizado Dr. Guillermo Rawson

location_facility: Taussig Heart Center of John Hopkins Hospital

location_facility: University of Southwestern Medical Center

location_facility: Ege University Health Application and Research Center, Cardiology Department

location_facility: Montreal Heart Institute, Université de Montréal

location_facility: Chiba Cerebral and Cardiovascular Center

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Lucile Packard Children's Hospital and Stanford Health Care

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: University of Thiés, UFR des sciences de la santé

location_facility: Toronto Congenital Cardiac Centre for Adults

location_facility: Addis Ababa University Faculty of Medicine

location_facility: Paediatric & Congenital Heart Centre, IJN (National Heart Institute)

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: Children's hospital Medical Center Omaha

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto

location_facility: Centre Hospitalier universitaire vaudois

location_facility: Centro de Referência em Cardiopatias Congénitas, Centro Hospitalar Universitaria de Lisboa centro S. João


title: ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

acronym: ELEVATE

summary: This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
United States
France


title: A Modular Phase I/II, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD0466 Monotherapy or in Combination in Patients With Advanced Haematological Malignancies

summary: The purpose of the study is to the evaluate safety, tolerability, pharmacokinetics (PK), and efficacy of AZD0466 as monotherapy in partciapants with advanced haematological malignancies and also to assess drug-drug interaction (DDI) potential between AZD0466 and the azole antifungal voriconazole.

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


title: A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

summary: A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292).

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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

location_country:
United States
Sweden
France
Poland
Belgium
Australia
China
Denmark
Canada


location_country:
Italy
Brazil
United States
South Africa
Mexico
Spain
Germany
France
Japan
Poland
Hungary
Belgium
China
Turkey
Canada

acronym: COMMUTE-a

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Nefrologia

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia

location_facility: Medizinische Hochschule Hannover; Klinik für Nieren- und Hochdruckerkrankungen

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Peking University First Hospital; NEPHROLOGY

location_facility: Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique

location_facility: Hospital Universitario 12 de Octubre; Servicio de Nefrologia

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Az. Osp. Careggi; Reparto Di Nefrologia, Dialisi E Trapianti

location_facility: Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii

location_facility: Inkosi Albert Luthuli Central Hospital; Pediatric Nephrology

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia

location_facility: Klinik für Nephrologie des Universitätsklinikum Essen; Klinik für Infektiologie - MFZ

location_facility: Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii

title: A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

summary: This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.


ReferenceCitation: Hari P, Paba-Prada CE, Voorhees PM, Frye J, Chang YL, Moreau P, Zonder J, Boccia R, Shain KH. Efficacy and safety results from a phase 1b/2, multicenter, open-label study of oprozomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. Leuk Res. 2019 Aug;83:106172. doi: 10.1016/j.leukres.2019.106172. Epub 2019 Jun 17.

family: Hari

full_name: Parameswaran Hari

given: Parameswaran

family: Paba-Prada

full_name: Claudia E. Paba-Prada

given: Claudia E.

family: Voorhees

full_name: Peter M. Voorhees

given: Peter M.

family: Frye

full_name: John Frye

given: John

family: Chang

full_name: Yu-Lin Chang

given: Yu-Lin

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Zonder

full_name: Jeffrey Zonder

given: Jeffrey

family: Boccia

full_name: Ralph Boccia

given: Ralph

family: Shain

full_name: Kenneth H. Shain

given: Kenneth H.

journal_name: Leukemia Research

oa_host_type: repository

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

status: Terminated

lead_sponsor: Amgen

location_country:
United States
France

location_facility: Division of Hematology/ Oncology, UNC at Chapel Hill

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: CHU Hotel Dieu - Service d'Hematologie Clinique

location_facility: CHRU, Hopital Huriez - Department of Hematology

location_facility: Froedtert Hospital and the Medical College of Wisconsin

title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

summary:
The primary objectives are:

Phase 1b:

To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules.
To evaluate safety and tolerability

Phase 2:

To estimate the overall response rate (ORR).
To evaluate safety and tolerability

status_simplified: Unknown


title: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

acronym: AURA

summary: This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

status: Active, not recruiting

ReferenceCitation: Martin ML, Correll J, Walding A, Rydén A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2021 May 31. doi: 10.1007/s11136-021-02882-6. [Epub ahead of print]

family: Martin

full_name: Mona L. Martin

given: Mona L.

family: Correll

full_name: Julia Correll

given: Julia

family: Walding

full_name: Andrew Walding

given: Andrew

family: Rydén

full_name: Anna Rydén

given: Anna

journal_name: Quality of Life Research

evidence: open (via crossref license)

ReferenceCitation: Ahn MJ, Han JY, Kim DW, Cho BC, Kang JH, Kim SW, Yang JC, Mitsudomi T, Lee JS. Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies. Cancer Res Treat. 2020 Jan;52(1):284-291. doi: 10.4143/crt.2019.200. Epub 2019 Jul 23.

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: Han

full_name: Ji-Youn Han

given: Ji-Youn

family: Kim

full_name: Dong-Wan Kim

given: Dong-Wan

family: Cho

full_name: Byoung Chul Cho

given: Byoung Chul

family: Kang

full_name: Jin-Hyoung Kang

given: Jin-Hyoung

full_name: Sang-We Kim

given: Sang-We

family: Yang

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

family: Mitsudomi

full_name: Tetsuya Mitsudomi

given: Tetsuya

family: Lee

full_name: Jong Seok Lee

given: Jong Seok

journal_name: Cancer Research and Treatment

oa_colors: green other

evidence: open (via page says license)

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

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Ahn MJ, Tsai CM, Shepherd FA, Bazhenova L, Sequist LV, Hida T, Yang JCH, Ramalingam SS, Mitsudomi T, Jänne PA, Mann H, Cantarini M, Goss G. Osimertinib in patients with T790M mutation-positive, advanced non-small cell lung cancer: Long-term follow-up from a pooled analysis of 2 phase 2 studies. Cancer. 2019 Mar 15;125(6):892-901. doi: 10.1002/cncr.31891. Epub 2018 Dec 4.

name: Section of Hematology‐Oncology Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul Korea

name: Department of Oncology, Taipei‐Veterans General Hospital and School of Medicine National Yang‐Ming University Taipei Taiwan

name: Department of Medical Oncology and Hematology Princess Margaret Cancer Center Toronto Ontario Canada

name: Department of Medicine University of California‐San Diego, Moores Cancer Center La Jolla California

name: Department of Hematology Oncology Massachusetts General Hospital Boston Massachusetts

name: Department of Thoracic Oncology Aichi Cancer Center Hospital Nagoya Japan

name: Department of Oncology National Taiwan University Hospital, National Taiwan University Cancer Center Taipei City Taiwan

name: Department of Hematology and Medical Oncology Emory University School of Medicine Atlanta Georgia

name: Department of Thoracic Surgery Kindai University Faculty of Medicine Osaka‐Sayama Japan

name: Lowe Center for Thoracic Oncology The Belfer Institute for Applied Cancer Science, Dana‐Farber Cancer Institute Boston Massachusetts

name: Biometrics and Information Science AstraZeneca Cambridge United Kingdom

name: Global Medicines Development, AstraZeneca Alderley ParkUnited Kingdom

name: Division of Medical Oncology The Ottawa Hospital Cancer Center, University of Ottawa Ottawa Ontario Canada

title: Osimertinib in patients with T790M mutation‐positive, advanced non–small cell lung cancer: Long‐term follow‐up from a pooled analysis of 2 phase 2 studies

ReferenceCitation: Oxnard GR, Hu Y, Mileham KF, Husain H, Costa DB, Tracy P, Feeney N, Sholl LM, Dahlberg SE, Redig AJ, Kwiatkowski DJ, Rabin MS, Paweletz CP, Thress KS, Jänne PA. Assessment of Resistance Mechanisms and Clinical Implications in Patients With EGFR T790M-Positive Lung Cancer and Acquired Resistance to Osimertinib. JAMA Oncol. 2018 Nov 1;4(11):1527-1534. doi: 10.1001/jamaoncol.2018.2969.

name: Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts

name: Levine Cancer Institute, Carolinas HealthCare System, Charlotte, North Carolina

name: Moores Cancer Center, University of California San Diego, La Jolla

name: Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Medical student, Tufts University School of Medicine, Boston, Massachusetts

name: Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Pathology, Brigham and Women’s Hospital, Boston, Massachusetts

name: Translational Sciences, Oncology IMED Biotech Unit, AstraZeneca, Boston, Massachusetts

title: Assessment of Resistance Mechanisms and Clinical Implications in Patients WithEGFRT790M–Positive Lung Cancer and Acquired Resistance to Osimertinib

ReferenceCitation: Kiura K, Yoh K, Katakami N, Nogami N, Kasahara K, Takahashi T, Okamoto I, Cantarini M, Hodge R, Uchida H. Osimertinib in patients with epidermal growth factor receptor T790M advanced non-small cell lung cancer selected using cytology samples. Cancer Sci. 2018 Apr;109(4):1177-1184. doi: 10.1111/cas.13511. Epub 2018 Feb 27.

name: Department of Allergy and Respiratory Medicine Okayama University Hospital Okayama Japan

name: Department of Thoracic Oncology National Cancer Center Hospital East Kashiwa Chiba Japan

name: Division of Integrated Oncology Institute of Biomedical Research and Innovation Kobe Japan

name: Shikoku Cancer Center Matsuyama City Japan

name: Department of Respiratory Medicine Kanazawa University Hospital Kanazawa Japan

name: Division of Thoracic Oncology Shizuoka Cancer Center Shizuoka Japan

name: Graduate School of Medical Sciences Research Institute for Diseases of the Chest Kyushu University Fukuoka Japan

name: Early Phase Clinical AstraZeneca Macclesfield UK

name: Biostatistics and Informatics AstraZeneca Cambridge UK

name: Research and Development AstraZeneca K.K Osaka Japan

title: Osimertinib in patients with epidermal growth factor receptor T790M advanced non‐small cell lung cancer selected using cytology samples

ReferenceCitation: Goss G, Tsai CM, Shepherd FA, Ahn MJ, Bazhenova L, Crinò L, de Marinis F, Felip E, Morabito A, Hodge R, Cantarini M, Johnson M, Mitsudomi T, Jänne PA, Yang JC. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials. Ann Oncol. 2018 Mar 1;29(3):687-693. doi: 10.1093/annonc/mdx820.

ReferenceCitation: Ramalingam SS, Yang JC, Lee CK, Kurata T, Kim DW, John T, Nogami N, Ohe Y, Mann H, Rukazenkov Y, Ghiorghiu S, Stetson D, Markovets A, Barrett JC, Thress KS, Jänne PA. Osimertinib As First-Line Treatment of EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Mar 20;36(9):841-849. doi: 10.1200/JCO.2017.74.7576. Epub 2017 Aug 25.

name: Suresh S. Ramalingam, Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA; James C.-H. Yang, National Taiwan University and National Taiwan University Cancer Center, Taipei, Taiwan; Chee Khoon Lee, St George Hospital, Sydney, New South Wales; Thomas John, Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Victoria, Australia; Takayasu Kurata, Kansai Medical University Hirakata Hospital, Osaka; Naoyuki Nogami, National Hospital Organization Shikoku Cancer Center...

publisher: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Osimertinib As First-Line Treatment of EGFR Mutation–Positive Advanced Non–Small-Cell Lung Cancer

ReferenceCitation: Thress KS, Jacobs V, Angell HK, Yang JC, Sequist LV, Blackhall F, Su WC, Schuler M, Wolf J, Gold KA, Cantarini M, Barrett JC, Jänne PA. Modulation of Biomarker Expression by Osimertinib: Results of the Paired Tumor Biopsy Cohorts of the AURA Phase I Trial. J Thorac Oncol. 2017 Oct;12(10):1588-1594. doi: 10.1016/j.jtho.2017.07.011. Epub 2017 Jul 24.

ReferenceCitation: Dearden S, Brown H, Jenkins S, Thress KS, Cantarini M, Cole R, Ranson M, Jänne PA. EGFR T790M mutation testing within the osimertinib AURA Phase I study. Lung Cancer. 2017 Jul;109:9-13. doi: 10.1016/j.lungcan.2017.04.011. Epub 2017 Apr 19.

ReferenceCitation: Ballard P, Yates JW, Yang Z, Kim DW, Yang JC, Cantarini M, Pickup K, Jordan A, Hickey M, Grist M, Box M, Johnström P, Varnäs K, Malmquist J, Thress KS, Jänne PA, Cross D. Preclinical Comparison of Osimertinib with Other EGFR-TKIs in EGFR-Mutant NSCLC Brain Metastases Models, and Early Evidence of Clinical Brain Metastases Activity. Clin Cancer Res. 2016 Oct 15;22(20):5130-5140. Epub 2016 Jul 19.

ReferenceCitation: Oxnard GR, Thress KS, Alden RS, Lawrance R, Paweletz CP, Cantarini M, Yang JC, Barrett JC, Jänne PA. Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Oct 1;34(28):3375-82. doi: 10.1200/JCO.2016.66.7162. Epub 2016 Jun 27.

name: Geoffrey R. Oxnard, Ryan S. Alden, Cloud P. Paweletz, and Pasi A. Jänne, Dana-Farber Cancer Institute, Boston; Kenneth S. Thress and J. Carl Barrett, AstraZeneca, Waltham, MA; Rachael Lawrance and Mireille Cantarini, AstraZeneca, Macclesfield, United Kingdom; and James Chih-Hsin Yang, National Taiwan University and National Taiwan University Hospital, Taipei, Taiwan.

title: Association Between Plasma Genotyping and Outcomes of Treatment With Osimertinib (AZD9291) in Advanced Non–Small-Cell Lung Cancer

ReferenceCitation: Thress KS, Brant R, Carr TH, Dearden S, Jenkins S, Brown H, Hammett T, Cantarini M, Barrett JC. EGFR mutation detection in ctDNA from NSCLC patient plasma: A cross-platform comparison of leading technologies to support the clinical development of AZD9291. Lung Cancer. 2015 Dec;90(3):509-15. doi: 10.1016/j.lungcan.2015.10.004. Epub 2015 Oct 9.

ReferenceCitation: Kim TM, Song A, Kim DW, Kim S, Ahn YO, Keam B, Jeon YK, Lee SH, Chung DH, Heo DS. Mechanisms of Acquired Resistance to AZD9291: A Mutation-Selective, Irreversible EGFR Inhibitor. J Thorac Oncol. 2015 Dec;10(12):1736-44. doi: 10.1097/JTO.0000000000000688.

title: Mechanisms of Acquired Resistance to AZD9291

ReferenceCitation: Yu HA, Tian SK, Drilon AE, Borsu L, Riely GJ, Arcila ME, Ladanyi M. Acquired Resistance of EGFR-Mutant Lung Cancer to a T790M-Specific EGFR Inhibitor: Emergence of a Third Mutation (C797S) in the EGFR Tyrosine Kinase Domain. JAMA Oncol. 2015 Oct;1(7):982-4. doi: 10.1001/jamaoncol.2015.1066.

name: Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York2Department of Medicine, Weill Cornell Medical College, New York, New York

name: Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York4Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, New York

title: Acquired Resistance ofEGFR-Mutant Lung Cancer to a T790M-Specific EGFR Inhibitor

ReferenceCitation: Jänne PA, Yang JC, Kim DW, Planchard D, Ohe Y, Ramalingam SS, Ahn MJ, Kim SW, Su WC, Horn L, Haggstrom D, Felip E, Kim JH, Frewer P, Cantarini M, Brown KH, Dickinson PA, Ghiorghiu S, Ranson M. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1689-99. doi: 10.1056/NEJMoa1411817.

title: AZD9291 in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer

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

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

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


title: A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody That Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

summary:
When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant.

OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring.

The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant.

Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft function of patients who have completed the 6-month post-transplant period under Part A or Part B of OPN305-102.

primary_purpose: Prevention

lead_sponsor: Opsona Therapeutics Ltd.

location_country:
Austria
Switzerland
Netherlands
United Kingdom
Germany
France
Poland
Belgium
Spain
United States
Czech Republic


title: WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

summary: The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

primary_purpose: Diagnostic

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Brazil
Netherlands
Germany
France
Argentina
Spain
Turkey
United States

location_facility: Grady Memorial Hospital/Emory University

location_facility: İstanbul Aydin University medical park florya hospital

intervention_type: Device


title: A Phase Ib/II Open-label, Multi-center Dose Escalation Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

summary: This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and spartalizumab) in advanced solid tumor patients. After the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and PK/PD of each regimen at the maximum tolerated dose / recommended dose.

location_country:
United States
Hong Kong
Netherlands
Spain
Germany
France
Japan
Singapore
Belgium
Australia
China
Denmark
Canada
Taiwan

location_facility: Emory University School of Medicine/Winship Cancer Institute Winship Cancer Center

location_facility: Massachusetts General Hospital Cancer Center


title: An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

acronym: INSTRUCT-UC

summary: The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study will last about 52 weeks.

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

lead_sponsor: Eli Lilly and Company

location_country:
Romania
Belgium
Australia
Russian Federation
Ukraine
India
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Hungary
China
United States
United Kingdom
Brazil
Czechia
Israel
Georgia
Latvia

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: London Health Science Centre - Victoria Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: The Ohio State University Wexner Medical Center

location_facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

location_facility: Medical Center of LLC Medical Center Clinic of Family Medicine

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Acad. F. Todua Medical Center - Research Institute of Clinical Medicine

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: CHU De Grenoble Hopital Albert Michallon

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Allen Whey Khye Lim Professional Corporation

location_facility: Shinseikai Sai Gastroenterology, proctology

location_facility: Vinnytsia War Veterans Regional Clinical Hospital

location_facility: Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Gastroenterology Research, Nova Scotia Health Authority

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: International Institute of Clinical Trials LLC

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Post Graduate Institute of Medical Education & Research

location_facility: Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology


ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Bioverativ, a Sanofi company

location_country:
Italy
United States
Netherlands
Spain
France
Poland
China
Germany
Canada

location_facility:
Investigational Site Number :1240002
Investigational Site Number :5280001
Investigational Site Number :2500001
Investigational Site Number :7240001
Investigational Site Number :8400003
Investigational Site Number :8400002
Investigational Site Number :1240001
Investigational Site Number :7240002
Investigational Site Number :1560001
Investigational Site Number :1560003
Investigational Site Number :1560004
Investigational Site Number :8400004
Investigational Site Number :5280002
Investigational Site Number :6160002
Investigational Site Number :7240003
Investigational Site Number :2500003
Investigational Site Number :6160001
Investigational Site Number :2760001
Investigational Site Number :1560002
Investigational Site Number :8400001
Investigational Site Number :3800001
Investigational Site Number :3800002

title: A Phase 2, Multicenter, Open-label, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of BIVV020 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

summary:
Primary Objective:

Part A: Efficacy of BIVV020 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive
Part B:Long-term safety and tolerability of BIVV020 in CIDP

Secondary Objective:

-Part A: Safety and tolerability of BIVV020 in CIDP

Immunogenicity of BIVV020
Efficacy of BIVV020 with overlapping SOC (SOC-Treated group)
Part B:

Durability of efficacy during long-term treatment with BIVV020 in CIDP Long-term immunogenicity of BIVV020 in CIDP


title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

summary: This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

lead_sponsor: Telios Pharma, Inc.

location_country:
Italy
Germany
France
Bulgaria
Poland
Hungary
Belgium
Australia
Spain
United States

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete

location_facility: Revive Research Institute - Sterling Heights

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: National Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: University of Texas, MD Anderson Cancer Center


title: Attain Performa(TM) Quadripolar Lead Study

summary: The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Denmark
India
France
Slovakia
Norway
Canada
Slovenia
South Africa
Chile
Saudi Arabia
Switzerland
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Serbia
Israel
Spain


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105

summary: The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

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.

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

location_country:
Malaysia
Greece
Romania
Russian Federation
Denmark
Ukraine
India
Spain
Croatia
France
Poland
Slovakia
Montenegro
Korea, Republic of
Philippines
Bulgaria
Hungary
China
United States
United Kingdom
Austria
Bosnia and Herzegovina
Serbia
Lebanon
Belarus
Turkey

location_facility: MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1

location_facility: The Barberry National Centre for Mental Health

location_facility: Multiprofile Hospital for Active Treatment Puls AD

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

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: University Hospital Center Split, Clinic for Neurology

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: Saint George Hospital - University Medical Center

location_facility: Celal Bayar University School of Medicine, Neurology Department

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

location_facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"

location_facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5

location_facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika

location_facility: The First Bethune Hospital of Jilin University

location_facility: St. Luke's Medical Center Cathedral Heights Building

location_facility: Eskisehir Osmangazi University Medical Faculty Department Of Neurology

location_facility: CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed

location_facility: RSBHI Smolensk Regional Clinical Hospital

location_facility: ABMU Local Health Board, Morriston Hospital

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"

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

location_facility: Barts Health NHS Foundation Trust, The Royal London Hospital

location_facility: LLC City Neurological Center "Sibneiromed"

location_facility: SPHI Leningrad Regional Psychoneurological Dispensary

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

location_facility: Shanghai Huashan Hospital, Neurology Department

location_facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z

location_facility: Cebu Doctors' University Hospital, Rm Ph 7

location_facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,

location_facility: Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları

location_facility: Military Medical Academy - Multiprofile Hospital for Active Treatment

location_facility: Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako

location_facility: Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"

location_facility: Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi

location_facility: Pediatric Epilepsy Center of Central Florida

location_facility: P D Hinduja National Hospital and Medical Research Centre

location_facility: Alexian Brothers Center for Psychiatric Research

location_facility: University General Hospital of Thessaloniki "AHEPA"

location_facility: State Budgetary Healthcare Institution of Stavropol region

location_facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii

location_facility: Institute for Child and Youth Healthcare of Vojvodina

location_facility: Regional State Budgetary Institution of Ministry of Health

location_facility: Neurologicka ambulancia MUDr. Eva Gasparova

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

location_facility: Public Health Institution Hospital Dr Mladen Stojanovic

location_facility: UZ Vitebsk Regional Childrens Clinical Centre

location_facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"

location_facility: The First Affiliated Hospital of Chongqing Medical University

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

location_facility: GBOU VPO Smolensk State Medical University

location_facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia

location_facility: Nemocnica s poliklinikou Hlohovec, s.r.o.

location_facility: Scott & White Memorial Hospital and Clinic

location_facility: GBOU VPO "Kazan State Medical University" of Roszdrav

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


title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's Disease

summary: WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.

lead_sponsor: Wave Life Sciences Ltd.

location_country:
Germany
France
Poland
Australia
Denmark
Canada
United Kingdom

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Queen Elizabeth University Hospital - PPDS


title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

acronym: EYEGUARD™-C

summary: The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

lead_sponsor: XOMA (US) LLC

location_country:
Armenia
Greece
Australia
Russian Federation
Taiwan
France
Poland
Argentina
Canada
South Africa
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Tunisia
Spain
Turkey


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

acronym: ASPEN

summary: The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

lead_sponsor: Insmed Incorporated

location_country:
Peru
Malaysia
Greece
Australia
Belgium
Denmark
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Chile
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
New Zealand
Spain
Turkey
Latvia


ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

lead_sponsor: Bayer

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Czechia
Japan
Poland
Slovakia
Hungary
Belgium
Argentina
Australia
Russian Federation
Turkey
Canada
United Kingdom
Taiwan

acronym: PAGANINI

location_facility: University of Occupational and Environmental Health

location_facility: Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Investigaciones en Patologías Respiratorias

location_facility: Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

location_facility: Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.

location_facility: Investigación en Alergias y Enfermedades Respiratorias-INAER

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: City Clinical Hospital n.a. D.D. Pletnev

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: California Allergy & Asthma Medical Group & Research Center

location_facility: Zentrum f. ambulante pneumologische Forschung Marburg GbR

location_facility: Japan community health care organization Kanazawa Hospital

location_facility: Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

location_facility: EKBC, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Bellingham Asthma, Allergy & Immunology Clinic

location_facility: City Consultative and Diagnostic Center #1

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Burlington Lung Clinic (BLC) Clinical Research

location_facility: Centro Médico Dra. De Salvo - Clinical Research Center

location_facility: Ordinace pro TBC a respiracni nemoci, s.r.o.

location_facility: Praxis f. Lungen- und Bronchialheilkunde,

location_facility: Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo

location_facility: King's College Hospital - NHS Foundation Trust

title: Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

summary:
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.

Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


title: ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

acronym: ConTTRibute

summary:
The purpose of this study is to:

Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
Characterize the safety and effectiveness of patisiran as part of routine clinical practice in the real-world clinical setting
Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) mutation

location_country:
United States
France
Portugal


title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

summary:
This clinical trial is evaluating a drug called BT8009 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.

The main goals of this study are to:

Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with nivolumab
Learn more about the side effects and effectiveness of BT8009 alone and in combination with nivolumab
Learn more about BT8009 alone and in combination with nivolumab
Learn more about BT8009 alone in patients with kidney disease

lead_sponsor: BicycleTx Limited

location_country:
Italy
France
Spain
United States
United Kingdom
Canada

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center

location_facility: Sarah Cannon Research Institute at HealthONE


title: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

acronym: ADAPT-PD

summary: The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

lead_sponsor: MedtronicNeuro

location_country:
United States
Canada
France
Netherlands

location_facility:
University of California San Francisco
UJF Grenoble
Stanford University Medical Center
Cleveland Clinic
University of Florida
Toronto Western Hospital
Duke University
Hôpital Pitie Salpetrière
Massachusetts General Hospital
Vanderbilt University Medical Center
Amsterdam UMC, location AMC


title: A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

summary: 160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 48 weeks.

lead_sponsor: Savara Inc.

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Greece
Poland
Romania
Ireland
Belgium
Australia
Russian Federation
Portugal
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: Tohoku University Hospital - Respiratory Tract Medicine

location_facility: Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Severance Hospital - Yonsei University Health System - Pulmonary

location_facility: UZ Leuven - Campus Gasthuisberg - Pneumologie

location_facility: National Hospital Organization Kinki-Chuo Chest medical Center

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Cincinnati Children'S Hospital Medical Center

location_facility: University of Pennsylvania Perelman School of Medicine - Pulmonology

location_facility: Health Sciences University Gulhane Training and Research Hos

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: GOU VPO St.Petersburg State Medical University "I.P.Pavlova"

location_facility: Ege University Hospital - Department of Pulmonology

location_facility: Institutul de Pneumoftiziologie "Marius Nasta"

location_facility: Chiba University Hospital - Respiratory Medicine

location_facility: Yedikule Chest Disease and Surgery Traning and Research Hosp

location_facility: U.Institute of Cardiology and Respirology of Quebec


title: A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

summary: The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Italy
Austria
Netherlands
Germany
France
Australia
Spain
United States
United Kingdom

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: University of Texas MD Anderson Cancer Center


title: A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

summary: This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 130 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

location_country:
Hong Kong
France
Japan
Singapore
Australia
Spain
United States
Korea, Republic of
Taiwan

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: University of Chicago Pritzker School of Medicine


title: Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study

acronym: ELITE

summary: Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.

location_country:
Switzerland
France
Puerto Rico
United States
United Kingdom
Canada

location_facility: Centre Hospitalier Universitaire De Rennes

location_facility: Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: Louisiana State University Health Sciences Center New Orleans

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic


lead_sponsor: AstraZeneca

location_country:
France
Belgium
Spain
United States
Korea, Republic of

acronym: AARDVARC

title: A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

summary: This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).


title: A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

acronym: STRUCTURE

summary: The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

ReferenceCitation: Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. Epub 2016 Jun 21.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Japan
Poland
Israel
Argentina
Russian Federation
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Gastrointestinal Specialists Of Georgia Pc

location_facility: Premier Medical Group Of The Hudson Valley, Pc


title: A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy

summary: The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

location_country:
Italy
Austria
Germany
France
United States

location_facility: Birmingham Hematology & Oncology Associates Llc

location_facility: Investigative Clinical Research Of Indiana, Llc


title: An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma

summary: This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

ReferenceCitation: Younes A, Salles G, Martinelli G, Bociek RG, Barrigon DC, Barca EG, Turgut M, Gerecitano J, Kong O, Pisal CB, Tavorath R, Kim WS. Pan-phosphatidylinositol 3-kinase inhibition with buparlisib in patients with relapsed or refractory non-Hodgkin lymphoma. Haematologica. 2017 Dec;102(12):2104-2112. doi: 10.3324/haematol.2017.169656. Epub 2017 Sep 29.

family: Younes

full_name: Anas Younes

given: Anas

family: Salles

full_name: Gilles Salles

given: Gilles

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Bociek

full_name: Robert Gregory Bociek

given: Robert Gregory

family: Barrigon

full_name: Dolores Caballero Barrigon

given: Dolores Caballero

family: Barca

full_name: Eva González Barca

given: Eva González

family: Turgut

full_name: Mehmet Turgut

given: Mehmet

family: Gerecitano

full_name: John Gerecitano

given: John

family: Kong

full_name: Oliver Kong

given: Oliver

family: Pisal

full_name: Chaitali Babanrao Pisal

given: Chaitali Babanrao

family: Tavorath

full_name: Ranjana Tavorath

given: Ranjana

full_name: Won Seog Kim

given: Won Seog

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

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

publisher: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Belgium
Spain
Turkey
Germany
Korea, Republic of

location_facility: University of Nebraska Medical Center Univ Nebraska

location_facility: Medical University of South Carolina -Hollings Cancer Center Medical Univ of South Carolina

location_facility: University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)


title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease

summary: The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease.

lead_sponsor: TauRx Therapeutics Ltd

location_country:
Italy
United States
Netherlands
Germany
Finland
Croatia
France
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Ruan Neurology Clinic and Research Center

location_facility: A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: University Medicine Berlin - Charité, CBF, Neurology

location_facility: Alzheimer Center Southwest Netherlands, Erasmus MC

location_facility: University Hospital Brussels Department of Neurology

location_facility: Discipline of Psychiatry, University of Queensland

location_facility: Kingshill Research Centre, Victoria Hospital

location_facility: Research Center for Clinical Studies, Inc

location_facility: University Hospital Gent Department of Neurology

location_facility: Neurological Associates of Albany, P. C.

location_facility: Alzheimer's Research and Treatment Center

location_facility: Institute for Neurodegenerative Disorders

location_facility: Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa

location_facility: Xenoscience, Inc / 21st Century Neurology

location_facility: Alexian Brothers Neurosciences Institute

location_facility: Memory Assessment and Research Centre (MARC)

location_facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock

location_facility: Advanced Memory Research Institute of NJ PC

location_facility: Fondazione Universita 'G. D'Annunzio di Chieti

location_facility: Neurozentrum Achim Dr. med. Andreas Mahler

location_facility: Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia

location_facility: Neurological Research Center - Hattiesburg Clinic

location_facility: Clinical Neuroscience Solutions CNS Healthcare

location_facility: Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit

location_facility: University Hospital Centre Zagreb, Department of Neurology

location_facility: Research Foundation for Mental Hygiene, Inc.

location_facility: IRCCS San Giovanni di Dio - Fatebenefratelli

location_facility: University of Eastern Finland, Brain Research Unit Mediteknia

location_facility: Memory Enhancement Centers of America, Inc

location_facility: University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders

location_facility: Premiere Research Institute (Palm Beach Neurology)


title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry

summary: The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.

ReferenceCitation: De Potter T, Van Herendael H, Balasubramaniam R, Wright M, Agarwal SC, Sanders P, Khaykin Y, Latcu DG, Maury P, Pani A, Hayes J, Kalman J, Nery P, Duncan E. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018 Nov 1;20(FI_3):f410-f418. doi: 10.1093/europace/eux290.

name: Cardiovascular Center, OLV Hospital, Moorselbaan 169, Aalst, Belgium

family: De Potter

full_name: Tom De Potter

given: Tom

family: Van Herendael

full_name: Hugo Van Herendael

given: Hugo

name: Royal Bournemouth Hospital, Bournemouth, UK

family: Balasubramaniam

full_name: Richard Balasubramaniam

given: Richard

name: Division of Imaging Sciences and Biomedical Engineering, King‘s College London, London, UK

name: Department of Cardiology, St. Thomas’ Hospital, London, UK

family: Wright

full_name: Matthew Wright

given: Matthew

name: Papworth Hospital NHS Foundation Trust, Cambridge, UK

family: Agarwal

full_name: Sharad C Agarwal

given: Sharad C

name: Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia

family: Sanders

full_name: Prashanthan Sanders

given: Prashanthan

name: Southlake Regional Health Centre, Ontario, Canada

family: Khaykin

full_name: Yaariv Khaykin

given: Yaariv

name: Centre Hospitalier Princesse Grace, Monaco, Monaco

family: Latcu

full_name: Decebal-Gabriel Latcu

given: Decebal-Gabriel

name: University Hospital Rangueil, Toulouse, France

family: Maury

full_name: Philippe Maury

given: Philippe

family: Pani

full_name: Antonio Pani

given: Antonio

name: St. Andrew‘s War Memorial Hospital, Queensland, Australia

family: Hayes

full_name: John Hayes

name: Royal Melbourne Hospital and University of Melbourne, Victoria, Australia

family: Kalman

full_name: Jonathan Kalman

given: Jonathan

name: University of Ottawa Heart Institute, Ontario, Canada

family: Nery

full_name: Pablo Nery

given: Pablo

family: Duncan

full_name: Edward Duncan

given: Edward

journal_name: EP Europace

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Biosense Webster, Inc.

location_country:
Italy
United Kingdom
Germany
France
Belgium
Australia
Canada
Monaco

location_facility: OLV Hospital Aalst Cardiovascular Center

location_facility: Melbourne Health/Royal Melbourne Hospital

location_facility: University of Adelaide/Royal Adelaide Hospital


title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)

acronym: ILUMIEN I

summary: The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.

ReferenceCitation: Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.

family: Wijns

full_name: William Wijns

given: William

family: Shite

full_name: Junya Shite

given: Junya

family: Jones

full_name: Michael R. Jones

given: Michael R.

family: Lee

full_name: Stephen W.-L. Lee

given: Stephen W.-L.

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Fabbiocchi

full_name: Franco Fabbiocchi

given: Franco

family: Barbato

full_name: Emanuele Barbato

given: Emanuele

family: Akasaka

full_name: Takashi Akasaka

given: Takashi

family: Bezerra

full_name: Hiram Bezerra

given: Hiram

family: Holmes

full_name: David Holmes

given: David

journal_name: European Heart Journal

oa_colors: green hybrid

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

lead_sponsor: Abbott Medical Devices

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

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: University of Texas Medical Branch at Galveston

location_facility: Kobe University Graduate School of Medicine


title: A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B

summary: This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.

ReferenceCitation: Kenet G, Chambost H, Male C, Lambert T, Halimeh S, Chernova T, Mancuso ME, Curtin J, Voigt C, Li Y, Jacobs I, Santagostino E; PROLONG-9FP Investigator Study Group. Long-acting recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in children. Results of a phase 3 trial. Thromb Haemost. 2016 Sep 27;116(4):659-68. doi: 10.1160/TH16-03-0179. Epub 2016 Sep 1.

family: Chambost

full_name: Hervé Chambost

given: Hervé

family: Male

full_name: Christoph Male

given: Christoph

family: Lambert

full_name: Thierry Lambert

given: Thierry

family: Halimeh

full_name: Susan Halimeh

given: Susan

family: Chernova

full_name: Tatiana Chernova

given: Tatiana

family: Mancuso

full_name: Maria Elisa Mancuso

given: Maria Elisa

family: Curtin

full_name: Julie Curtin

given: Julie

family: Voigt

full_name: Christine Voigt

given: Christine

family: Li

full_name: Yanyan Li

given: Yanyan

family: Jacobs

full_name: Iris Jacobs

given: Iris

family: Santagostino

full_name: Elena Santagostino

given: Elena

family: Kenet

full_name: Gili Kenet

given: Gili

name: the PROLONG-9FP Investigator Study Group

journal_name: Thrombosis and Haemostasis

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

lead_sponsor: CSL Behring

location_country:
Italy
Austria
Germany
France
Israel
Australia
Russian Federation
Spain
Canada
Czech Republic

location_facility: FGU "Kirov Research Institute of Haemotology and Blood Trans)

location_facility: The Royal Children's Hospital, Melbourne

location_facility: IRCCS Ospendale Maggiore (Centro emofilia e Trombosi)

location_facility: C.R.T.H. Hopital de Bicentre (Hemophilie)


title: A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection

summary:
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection.

In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

ReferenceCitation: Protocol contains no citations

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
France
Bulgaria
Belgium
Puerto Rico
Germany


title: A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome

summary: multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

location_country:
United States
Netherlands
France
Belgium
Germany

location_facility: Stanford University Medical Center SC - SOM230X2203

location_facility: Ximed Center for Weight Management Ximed Research

location_facility: Texas Tech University Health Science Center