title: Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

acronym: STAGED-PKD

summary:
Primary Objective:

To determine the effect of venglustat on the rate of total kidney volume (TKV) growth (Stage 1) and estimated glomerular filtration rate (eGFR) decline in participants at risk of rapidly progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Stage 2).

Secondary Objectives:

To determine the effect of venglustat on the rate of renal function decline (Stage 1) and on the rate of TKV growth (Stage 2).
To evaluate the pharmacokinetics (PK) of venglustat in ADPKD participants (Stages 1 and 2).
To determine the effect of venglustat on pain and fatigue, based on participant reported diary (Stages 1 and 2).
Safety/tolerability objectives:
To characterize the safety profile of venglustat (Stages 1 and 2).
To evaluate the effect of venglustat on mood using Beck Depression Inventory II (BDI-II) (Stages 1 and 2).
To evaluate the effect of venglustat on the lens by ophthalmological examination (Stages 1 and 2).

ReferenceCitation: Gansevoort RT, Hariri A, Minini P, Ahn C, Chapman AB, Horie S, Knebelmann B, Mrug M, Ong ACM, Pei YPC, Torres VE, Modur V, Antonshchuk I, Perrone RD. Venglustat, a Novel Glucosylceramide Synthase Inhibitor, in Patients at Risk of Rapidly Progressing ADPKD: Primary Results of a Double-Blind, Placebo-Controlled, Phase 2/3 Randomized Clinical Trial. Am J Kidney Dis. 2023 May;81(5):517-527.e1. doi: 10.1053/j.ajkd.2022.10.016. Epub 2022 Dec 17.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

version: acceptedVersion

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

ReferenceCitation: Perrone RD, Hariri A, Minini P, Ahn C, Chapman AB, Horie S, Knebelmann B, Mrug M, Ong ACM, Pei YPC, Torres VE, Modur V, Gansevoort RT. The STAGED-PKD 2-Stage Adaptive Study With a Patient Enrichment Strategy and Treatment Effect Modeling for Improved Study Design Efficiency in Patients With ADPKD. Kidney Med. 2022 Aug 27;4(10):100538. doi: 10.1016/j.xkme.2022.100538. eCollection 2022 Oct.

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://vivli.org

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

location_facility:
Investigational Site Number 7920002
Investigational Site Number 2760007
Investigational Site Number 8400008
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Investigational Site Number 2080001
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Investigational Site Number 6160003
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Investigational Site Number 1560002
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Investigational Site Number 5280003
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Investigational Site Number 2030001
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Investigational Site Number 3920009
Investigational Site Number 6420002
Investigational Site Number 3760002
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Investigational Site Number 1560001
Investigational Site Number 1240002
Investigational Site Number 0360003
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Investigational Site Number 2760004
Investigational Site Number 8400014
Investigational Site Number 3800002
Investigational Site Number 5280002
Investigational Site Number 2760002
Investigational Site Number 3920004
Investigational Site Number 6200004
Investigational Site Number 1580002
Investigational Site Number 3920010
Investigational Site Number 2760005
Investigational Site Number 8400003
Investigational Site Number 1560009
Investigational Site Number 2760011
Investigational Site Number 8400007
Investigational Site Number 8400010
Investigational Site Number 2760010
Investigational Site Number 3920006
Investigational Site Number 2760001
Investigational Site Number 7920003
Investigational Site Number 2760009
Investigational Site Number 6160002
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 3920005
Investigational Site Number 3920007
Investigational Site Number 6200001
Investigational Site Number 1560003
Investigational Site Number 4100001
Investigational Site Number 0400001
Investigational Site Number 2080002
Investigational Site Number 1560005
Investigational Site Number 6420001
Investigational Site Number 7920001
Investigational Site Number 0560002
Investigational Site Number 7240001
Investigational Site Number 0360001
Investigational Site Number 8400020
Investigational Site Number 3920003
Investigational Site Number 0320001
Investigational Site Number 8400004
Investigational Site Number 5280001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 7240002
Investigational Site Number 0400004
Investigational Site Number 8400017
Investigational Site Number 0320003
Investigational Site Number 3800001
Investigational Site Number 1560008
Investigational Site Number 2500003
Investigational Site Number 3920008


type: EudraCT Number

title: A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive

acronym: ILUSTRO

summary: The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab and in combination with fluorouracil, leucovorin or folinic acid, oxaliplatin and docetaxel (FLOT). This study will also evaluate the pharmacokinetics (PK) of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab and in combination with fluorouracil, leucovorin or folinic acid, oxaliplatin and docetaxel (FLOT) and PK of oxaliplatin, fluorouracil (5-FU), and pembrolizumab in combination with zolbetuximab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with mFOLFOX6 and nivolumab and in combination with FLOT.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
Japan
United States
Korea, Republic of
Taiwan
France

location_facility: The Angeles Clinic and Research Institute

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: REFALS

lead_sponsor: Orion Corporation, Orion Pharma

summary: This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

ReferenceType: derived

ReferenceCitation: Cudkowicz M, Genge A, Maragakis N, Petri S, van den Berg L, Aho VV, Sarapohja T, Kuoppamaki M, Garratt C, Al-Chalabi A; REFALS investigators. Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2021 Oct;20(10):821-831. doi: 10.1016/S1474-4422(21)00242-8.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

location_facility: Centre Hospitalier Affilie Universitaire de Quebec

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Colorado Springs Neurological Associates

location_facility: Neuromuscular Research Center and Neuromuscular Clinic of Arizona

location_facility: Neurosciences Institute - Neurology Charlotte

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau

location_facility: Montreal Neurological Institute and Hospital

location_facility: Neurologian Poliklinikka - Meilahden Tornisairaala 3

location_facility: University of Florida Health - Jacksonville

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Centre De Recherche Du Centre Hospitalier de l'Universite de Montreal - Hopital Notre-Dame

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: University of Kentucky Chandler Medical Center

location_facility: Washington University School of Medicine

location_facility: University of Utah - Imaging & Neurosciences Center

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Alberta Health Services - Neuromuscular Clinic

location_facility: Wake Forest University Baptist Medical Center

location_facility: Moncton Hospital, Southeast Regional Health Authority

location_facility: Hospital of the University of Pennsylvania

location_facility: Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Universitair Medisch Centrum Utrecht - Rudolf Magnus Instituut voor Neurowetenschappen

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

status: Completed

title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Germany
Ireland
Italy
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

status_simplified: Completed


title: Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure

acronym: ROADSAVER

summary: Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Kedev S, Muller-Hulsbeck S, Langhoff R. "Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)". Cardiovasc Intervent Radiol. 2022 Mar;45(3):277-282. doi: 10.1007/s00270-021-03051-5. Epub 2022 Jan 18.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ipd_sharing: No

lead_sponsor: Terumo Europe N.V.

location_country:
Germany
Poland
North Macedonia
Portugal
Slovakia
Hungary
Netherlands
Belgium
Latvia
Spain
Czechia
Serbia
France

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Polyclinique Louis Pasteur Essey Les Nancy

location_facility: Szent György Fejér County - University Teaching Hospital

location_facility: Hospital Universitario Clínico de Valladolid

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hospital Universitario Girona Josep Trueta

location_facility: Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg

location_facility: Paul Stradins Clinical University Hospital

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

location_facility: City General Hospital 8th September Skopje

location_facility: Semmelweis University Heart and Vascular Center

location_facility: GCS Centre de Cardiologie du Pays Basque

location_facility: Universitäts und Rehabilitationskliniken Ulm

intervention_type: Device


title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

acronym: PULSAR

summary: Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.

ReferenceType: result

ReferenceCitation: Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Ghofrani HA, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, de Oliveira Pena J, Badesch DB. Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Eur Respir J. 2023 Jan 6;61(1):2201347. doi: 10.1183/13993003.01347-2022. Print 2023 Jan.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: European Respiratory Society

ReferenceCitation: Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Israel
United Kingdom
Australia
Brazil
United States
Spain
France

location_facility: Banner-University Medical Center Phoenix

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: University of California, San Francisco Medical Center


title: ThRombosis ExclUsion STudy

acronym: TRUST

summary: The purpose of this study is to demonstrate the ability of new D-Dimer assay combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.

status: Unknown status

lead_sponsor: Diagnostica Stago

location_country:
Italy
Belgium
United States
Spain
France

location_facility: Duke Hemostasis and Thrombosis Research Center

intervention_type: Other

status_simplified: Unknown


acronym: EXPLORER-HCM

lead_sponsor: MyoKardia, Inc.

summary: This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

ReferenceCitation: Nassif M, Fine JT, Dolan C, Reaney M, Addepalli P, Allen VD, Sehnert AJ, Gosch K, Spertus JA. Validation of the Kansas City Cardiomyopathy Questionnaire in Symptomatic Obstructive Hypertrophic Cardiomyopathy. JACC Heart Fail. 2022 Aug;10(8):531-539. doi: 10.1016/j.jchf.2022.03.002. Epub 2022 May 4.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Reaney M, Addepalli P, Allen V, Spertus JA, Dolan C, Sehnert AJ, Fine JT. Longitudinal Psychometric Analysis of the Hypertrophic Cardiomyopathy Symptom Questionnaire (HCMSQ) Using Outcomes from the Phase III EXPLORER-HCM Trial. Pharmacoecon Open. 2022 Jul;6(4):575-586. doi: 10.1007/s41669-022-00340-8. Epub 2022 Jun 20.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

ReferenceCitation: Hegde SM, Lester SJ, Solomon SD, Michels M, Elliott PM, Nagueh SF, Choudhury L, Zemanek D, Zwas DR, Jacoby D, Wang A, Ho CY, Li W, Sehnert AJ, Olivotto I, Abraham TP. Effect of Mavacamten on Echocardiographic Features in Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy. J Am Coll Cardiol. 2021 Dec 21;78(25):2518-2532. doi: 10.1016/j.jacc.2021.09.1381.

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ReferenceCitation: Xie J, Wang Y, Xu Y, Fine JT, Lam J, Garrison LP. Assessing health-related quality-of-life in patients with symptomatic obstructive hypertrophic cardiomyopathy: EQ-5D-based utilities in the EXPLORER-HCM trial. J Med Econ. 2022 Jan-Dec;25(1):51-58. doi: 10.1080/13696998.2021.2011301.

evidence: open (via free pdf)

publisher_dissemination: Informa

ReferenceCitation: Burstein Waldman C, Owens A. A plain language summary of the EXPLORER-HCM study: mavacamten for obstructive hypertrophic cardiomyopathy. Future Cardiol. 2021 Oct;17(7):1269-1275. doi: 10.2217/fca-2021-0044. Epub 2021 May 21.

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

publisher_dissemination: Future Science Ltd

ReferenceCitation: Spertus JA, Fine JT, Elliott P, Ho CY, Olivotto I, Saberi S, Li W, Dolan C, Reaney M, Sehnert AJ, Jacoby D. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 26;397(10293):2467-2475. doi: 10.1016/S0140-6736(21)00763-7. Epub 2021 May 15.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Olivotto I, Oreziak A, Barriales-Villa R, Abraham TP, Masri A, Garcia-Pavia P, Saberi S, Lakdawala NK, Wheeler MT, Owens A, Kubanek M, Wojakowski W, Jensen MK, Gimeno-Blanes J, Afshar K, Myers J, Hegde SM, Solomon SD, Sehnert AJ, Zhang D, Li W, Bhattacharya M, Edelberg JM, Waldman CB, Lester SJ, Wang A, Ho CY, Jacoby D; EXPLORER-HCM study investigators. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Epub 2020 Aug 29. Erratum In: Lancet. 2020 Sep 12;396(10253):758.

repository_institution: University of Florence - Florence Research

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

ReferenceCitation: Ho CY, Olivotto I, Jacoby D, Lester SJ, Roe M, Wang A, Waldman CB, Zhang D, Sehnert AJ, Heitner SB. Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy. Circ Heart Fail. 2020 Jun;13(6):e006853. doi: 10.1161/CIRCHEARTFAILURE.120.006853. Epub 2020 Jun 5.

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Cincinnati Children's Hospital Medical Center

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

location_facility: Charité Campus Buch - Experimental and Clinical Research Center

location_facility: Washington University School of Medicine

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: University of Pennsylvania (Penn Heart and Vascular Center)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Cedars-Sinai Medical Center (Smidt Heart Institute)

location_facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of Texas Houston Medical School

location_facility: University of Texas Southwestern Medical Center

location_facility: University Of Iowa Hospitals And Clinics

location_facility: University of Pittsburgh Medical Center Presbyterian

title: A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Czechia
France


title: A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus

summary: To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).

primary_purpose: Basic Science

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

publisher_dissemination: Wiley

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

lead_sponsor: Amgen

location_country:
United States
Poland
Germany
France

location_facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

location_facility: Medycyna Kliniczna Marzena Waszczak - Jeka


title: A Phase Ia/Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Runimotamab Administered Intravenously as a Single Agent and in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-Expressing Cancers

summary: This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.

lead_sponsor: Genentech, Inc.

location_country:
Italy
United Kingdom
Singapore
Denmark
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Hospital Universitario Quironsalud Madrid; Servicio de Farmacia

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Fundacion Jimenez Diaz; Servicio de Farmacia

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Hospital Clinico Universitario de Valencia

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda


acronym: Morpheus-panBC

lead_sponsor: Hoffmann-La Roche

summary:
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.

The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study:

Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).

Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort).

Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort).

Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).

In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

sponsor_collaborators:
Hoffmann-La Roche
Seagen Inc.
Gilead Sciences

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Fiona Stanley Hospital - Medical Oncology

location_facility: Hackensack Univ Medical Center; John Theurer Cancer Ctr

location_facility: Barts Health NHS Trust - St Bartholomew's Hospital

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: University of Ulsan College of Medicine - Asan Medical Center

location_facility: NYU Langone Medical Center; NYU Perlmutter Cancer Center

location_facility: University of California San Diego Medical Center; Moores Cancer Center

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Vanderbilt University Medical Center; Vanderbilt University

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

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

collaborators:
Seagen Inc.
Gilead Sciences


title: A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease

summary: The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).

location_country:
United States
Belgium
France

location_facility: University of Colorado School of Medicine


lead_sponsor: La Jolla Pharmaceutical Company

summary: This study is a Phase 2 multicenter, randomized, placebo controlled, single-blind study. The primary objective of the study is to compare the effect of weekly dosing of LJPC-401 (synthetic human hepcidin) versus placebo on transferrin saturation (TSAT) in an adult hereditary hemochromatosis patient population.

sponsor_collaborators:
La Jolla Pharmaceutical Company
PRA Health Sciences

location_facility:
Investigational Site
Investigative Site

title: A Phase 2, Multi-Center, Randomized, Placebo Controlled, Single-Blind Study With LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

location_country:
United States
United Kingdom
Australia
France


lead_sponsor: Kite, A Gilead Company

summary: The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

ReferenceType: background

ReferenceCitation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

repository_institution: PubMed Central - Europe PMC

repository_institution: King's College London - Research Portal

repositories_concat: PubMed Central;kclpure.kcl.ac.uk

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.

ReferenceCitation: The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4. No abstract available.

ReferenceCitation: Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available.

ReferenceCitation: Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Munoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of Iowa Hospitals and Clinincs

location_facility: James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

location_facility: University of Maryland, Greenbaum Comprehensive Cancer Center

location_facility: IOSI, OSpedale Regionale Bellinzona e Valli

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

location_facility: University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

location_facility: CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus

location_facility: Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

location_facility: Universitatsklinikum Graz, Division of Hematology

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Uninversity Health Network - Princess Margaret Cancer Center

location_facility: Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique

location_facility: Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

status: Active, not recruiting

title: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

location_facility: California Research Trials DBA Orange Country Research Institute

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o.

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: CTI Clinical Trial and Consulting Services

location_facility: Centre Hospitalier Specialisé de Rouffach

title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder

type: Other Identifier

location_country:
Germany
Poland
Japan
Belgium
United States
France


title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

summary: The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

ReferenceCitation: Berke JM, Dehertogh P, Vergauwen K, Mostmans W, Vandyck K, Raboisson P, Pauwels F. Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02439-19. doi: 10.1128/AAC.02439-19. Print 2020 Apr 21.

publisher_dissemination: American Society for Microbiology

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Germany
Poland
Japan
Thailand
Turkey
Canada
France
Hong Kong
United States
Ukraine
Belgium
China
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Beiijing Friendship Hospital, Capital Medical University

location_facility: Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Queen Mary Hospital, University of Hong Kong

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

location_facility: SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Saglık Bilimleri University Şişli Trainig and Research Hospital,Department of Gastroenterology


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood Transfusion

acronym: Cadenza

summary: The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

ReferenceCitation: Roth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardecki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. doi: 10.1182/blood.2021014955.

publisher_dissemination: American Society of Hematology

lead_sponsor: Bioverativ, a Sanofi company

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: St Olavs Hospital, Avdeling for blodsykdommer

location_facility: Univ Ulm, Inst Klin. Transfusions. Immungen

location_facility: U.O.C. Ematologia- Policlinico "A. Gemelli"

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Hospital Clinci i Provincial de Barcelona

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Washington University School of Medicine

location_facility: New York Medical College at Westchester Medical Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico


title: Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

summary: This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Hungary
Argentina
Denmark
Japan
Netherlands
Austria
United States
China
Spain
Thailand
France

location_facility: James Cancer Hospital and Solove Research Institute Ohio State


title: A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

summary: This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Austria
Belgium
United States
Spain
Greece
Croatia
Bulgaria
Canada
France

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: University of North Carolina at Chapel Hill

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital d Instructions des Armees Percy

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: University of California, San Francisco Medical Center


type: Registry Identifier

title: An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients With Non-Small Cell Lung Cancer, Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy (HUDSON).

acronym: HUDSON

summary: This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

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

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

lead_sponsor: AstraZeneca

location_country:
Germany
Israel
Austria
United States
Korea, Republic of
Spain
Canada
France


title: A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone [rhPTH(1-84)]

summary:
Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism.

In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment.

Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant.

The study doctors will also check for side effects from the study treatments.

After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

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

lead_sponsor: Shire

location_country:
Germany
Italy
Portugal
Norway
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Nova Scotia Health Authority (Capital District Health Authority)

location_facility: Eastern Health - Health Sciences Center- General Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Universita di Firenze, Dipartimento di Chirurgia e Medicina Traslazionale (DCMT)

location_facility: Ohio State University Wexner Medical Center

location_facility: Oslo Universitetssykehus HF Rikshospitalet

intervention_type: Biological


acronym: A multi-centre, open-label, long term safety study of mepolizumab in subjects with HSE.

lead_sponsor: GlaxoSmithKline

summary: This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.

ReferenceCitation: Gleich GJ, Roufosse F, Chupp G, Faguer S, Walz B, Reiter A, Yancey SW, Bentley JH, Steinfeld J; HES Mepolizumab Study Group. Safety and Efficacy of Mepolizumab in Hypereosinophilic Syndrome: An Open-Label Extension Study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4431-4440.e1. doi: 10.1016/j.jaip.2021.07.050. Epub 2021 Aug 10.

title: A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622

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

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Romania
Brazil
Mexico
Belgium
United States
Spain
Russian Federation
France


type: U.S. FDA Grant/Contract

title: A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy

acronym: ACCOLADE

summary: The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD

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

lead_sponsor: ChemoCentryx

sponsor_collaborators:
ChemoCentryx
Medpace, Inc.

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Canada
France

location_facility:
Clinical Trial Site
Clinical Site


title: A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

summary: The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

ReferenceCitation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.

ReferenceCitation: Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24.

repository_institution: University College Cork, Ireland - Cork Open Research Archive

repositories_concat: PubMed Central;cora.ucc.ie

lead_sponsor: Aimmune Therapeutics, Inc.

location_country:
Ireland
Germany
Italy
United Kingdom
Sweden
Netherlands
United States
Spain
Canada
France

location_facility: Children's Clinical Research Facility, Royal Manchester Children's Hospital

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

location_facility: Guy & St Thomas' NHS Foundation Trust, Children Allergies Department

location_facility: Allergy & Asthma Medical Group and Research Center

location_facility: Texas Children's Hospital, Baylor College of Medicine

location_facility: Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

location_facility: UCSF, Benioff Children's Hospital - Allergy and Immunology

location_facility: Allergy & Asthma Associates of Santa Clara Valley Research Center

location_facility: Hopital Saint Vincent de Paul- Service d'Allergologie

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research

location_facility: Univ. of Rochester Medical Center, Golisano Children's Hosp.

location_facility: Sean N. Parker Center for Allergy and Asthma Research LPCH El Camino Hospital

location_facility: The University of Chicago Medicine, Comer Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Sher Allergy Specialists - Center for Cough

location_facility: H. Infantil Universitario Niño Jesús, Servicio de Alergia

location_facility: Madrid Hospital Clinico San Carlos, Servicio de Alergia

location_facility: University Hospitals Southampton Foundation NHS Trust

location_facility: Univ. of Michigan Health System, Div. of Allergy and Clinical Immunology

location_facility: Jaffe Food Allergy Institute Icahn School of Medicine at Mount Sinai

location_facility: Cork University Hospital, UCC Department of Paediatrics and Child Health

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Rady Children's Hospital, Div. of Allergy & Immunology

location_facility: Johns Hopkins Hospital, Pediatric Clinical Research Unit

location_facility: Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of South Florida, Asthma Allergy & Immunology Clinical Research Unit

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: St Mary's Hospital - Paediatric Research Unit

location_facility: Family Allergy & Asthma Research Institute

location_facility: Medical Research of Arizona, Allergy, Asthma & Immunology Associates

location_facility: Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg

location_facility: Le Bonheur Children's Hospital, Outpatient Bldg.

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Center

location_facility: Allergy & Asthma Associates of Southern California

location_facility: National Children's Research Centre, Our Lady's Children's Hospital Crumlin

location_facility: 'Specially for Children Allergy, Asthma and Immunology Clinic

location_facility: National Allergy and Asthma Research, LLC

location_facility: Jeanne de Flandre Hospital -Paediatric Allergy and Pulmonology Center


acronym: NTHI MCAT-002

summary:
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response.

In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care.

The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at pre-defined timepoints (scheduled study visits).

In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.

ReferenceCitation: Arora AK, Chinsky K, Keller C, Mayers I, Pascual-Guardia S, Vera MP, Lambert C, Lombardi S, Rondini S, Tian S, Ulloa-Montoya F, Moraschini L, Casula D; NTHi-Mcat-002 study group. A detailed analysis of possible efficacy signals of NTHi-Mcat vaccine against severe COPD exacerbations in a previously reported randomised phase 2b trial. Vaccine. 2022 Sep 29;40(41):5924-5932. doi: 10.1016/j.vaccine.2022.08.053. Epub 2022 Sep 6.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

ReferenceCitation: Andreas S, Testa M, Boyer L, Brusselle G, Janssens W, Kerwin E, Papi A, Pek B, Puente-Maestu L, Saralaya D, Watz H, Wilkinson TMA, Casula D, Di Maro G, Lattanzi M, Moraschini L, Schoonbroodt S, Tasciotti A, Arora AK, Maltais F; NTHi-Mcat-002 study group. Non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine for the prevention of exacerbations in chronic obstructive pulmonary disease: a multicentre, randomised, placebo-controlled, observer-blinded, proof-of-concept, phase 2b trial. Lancet Respir Med. 2022 May;10(5):435-446. doi: 10.1016/S2213-2600(21)00502-6. Epub 2022 Jan 10. Erratum In: Lancet Respir Med. 2022 Aug;10(8):e77.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

title: An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients

primary_purpose: Prevention

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
Canada
France


title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 986 in Healthy Subjects and Heart Failure Patients

summary: To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).

status: Terminated

ReferenceCitation: Winkle P, Goldsmith S, Koren MJ, Lepage S, Hellawell J, Trivedi A, Tsirtsonis K, Abbasi SA, Kaufman A, Troughton R, Voors A, Hulot JS, Donal E, Kazemi N, Neutel J. A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients. Cardiovasc Drugs Ther. 2023 Aug;37(4):743-755. doi: 10.1007/s10557-022-07328-w. Epub 2022 Apr 23.

location_country:
Germany
Poland
New Zealand
Singapore
Australia
Netherlands
United States
Canada
France


title: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

summary: The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.

ReferenceCitation: Henry DH, Glaspy J, Harrup R, Mittelman M, Zhou A, Carraway HE, Bradley C, Saha G, Modelska K, Bartels P, Leong R, Yu KP. Roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndrome: Open-label, dose-selection, lead-in stage of a phase 3 study. Am J Hematol. 2022 Feb 1;97(2):174-184. doi: 10.1002/ajh.26397. Epub 2021 Nov 9.

lead_sponsor: FibroGen

collaborators:
AstraZeneca
Astellas Pharma Inc

sponsor_collaborators:
FibroGen
AstraZeneca
Astellas Pharma Inc

location_country:
Germany
Italy
Poland
India
Israel
United Kingdom
Denmark
Australia
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
Russian Federation
France

location_facility:
Investgational site
Investiational Site
Investigational Site
Investigational site


title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial

acronym: HEMOTION

summary: Most trauma deaths are related to traumatic brain injury (TBI). Although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe TBI are left with major functional impairment. Current management guidelines are based on limited evidence and practice is highly variable. Most acutely ill patients with TBI will develop anemia, which may decrease oxygen delivery to a fragile brain. While clinical practice is moving towards transfusing at low hemoglobin (Hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in TBI. Our primary objective is to evaluate the effect of red blood cell (RBC) transfusion thresholds on neurological functional outcome. We hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.

ReferenceCitation: Turgeon AF, Fergusson DA, Clayton L, Patton MP, Zarychanski R, English S, Docherty A, Walsh T, Griesdale D, Kramer AH, Scales D, Burns KEA, Boyd JG, Marshall JC, Kutsogiannis DJ, Ball I, Hebert PC, Lamontagne F, Costerousse O, St-Onge M, Lessard Bonaventure P, Moore L, Neveu X, Rigamonti A, Khwaja K, Green RS, Laroche V, Fox-Robichaud A, Lauzier F; HEMOTION Trial Team, the Canadian Critical Care Trials Group, the Canadian Perioperative Anesthesia Clinical Trials Group and the Canadian Traumatic Brain Injury Research Consortium. Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol. BMJ Open. 2022 Oct 10;12(10):e067117. doi: 10.1136/bmjopen-2022-067117.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_concat: PubMed Central;pure.ed.ac.uk

publisher_dissemination: British Medical Journal

lead_sponsor: CHU de Quebec-Universite Laval

collaborators: Canadian Institutes of Health Research (CIHR)

collaborators: Canadian Perioperative Anesthesia Clinical Trials (PACT) Group

location_country:
United Kingdom
Canada
Brazil
France

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: St. Mary's Hospital (Imperial College Healthcare)

location_facility: CHU de Québec-Université Laval (Hôpital de l'Enfant-Jésus), Université Laval

location_facility: The Hospital das Clinicas da Facudade de Medicina da USP

intervention_type: Procedure

lead_sponsor_type: academique


title: A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)

acronym: REFINE

summary: This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

ReferenceCitation: Pemmaraju N, Garcia JS, Potluri J, Harb JG, Sun Y, Jung P, Qin QQ, Tantravahi SK, Verstovsek S, Harrison C. Addition of navitoclax to ongoing ruxolitinib treatment in patients with myelofibrosis (REFINE): a post-hoc analysis of molecular biomarkers in a phase 2 study. Lancet Haematol. 2022 Jun;9(6):e434-e444. doi: 10.1016/S2352-3026(22)00116-8. Epub 2022 May 13.

ReferenceCitation: Harrison CN, Garcia JS, Somervaille TCP, Foran JM, Verstovsek S, Jamieson C, Mesa R, Ritchie EK, Tantravahi SK, Vachhani P, O'Connell CL, Komrokji RS, Harb J, Hutti JE, Holes L, Masud AA, Nuthalapati S, Potluri J, Pemmaraju N. Addition of Navitoclax to Ongoing Ruxolitinib Therapy for Patients With Myelofibrosis With Progression or Suboptimal Response: Phase II Safety and Efficacy. J Clin Oncol. 2022 May 20;40(15):1671-1680. doi: 10.1200/JCO.21.02188. Epub 2022 Feb 18.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Poland
Australia
Japan
Turkey
Croatia
Canada
Serbia
France
Hungary
United States
Belgium
Puerto Rico
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: University General Hospital Attikon /ID# 230395

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230681

location_facility: Aneurin Bevan University Health Board /ID# 230332

location_facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544

location_facility: Colorado Blood Cancer Institute /ID# 224250

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 162683

location_facility: University Clinical Center Kragujevac /ID# 230550

location_facility: Cancer Specialists of North Florida /ID# 230917

location_facility: Dana-Farber Cancer Institute /ID# 162675

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 230504

location_facility: Leningrad Regional Clinical Hospital /ID# 230507

location_facility: McGill University Health Center Research Institute /ID# 223976

location_facility: Hospital Clinic de Barcelona /ID# 231538

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 164110

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718

location_facility: Ondokuz mayis University Facul /ID# 230314

location_facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094

location_facility: Hematology Oncology Associates of Fredericksburg /ID# 231372

location_facility: Belfast Health and Social Care Trust /ID# 216991

location_facility: Aomori Prefectural Central Hospital /ID# 221773

location_facility: Juntendo University Hospital /ID# 221484

location_facility: Medical University of South Carolina /ID# 222597

location_facility: General Hospital of Athens Laiko /ID# 230394

location_facility: Fujita Health University Hospital /ID# 221539

location_facility: Indiana Blood & Marrow Transpl /ID# 165075

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719

location_facility: University of Chicago Medicine /ID# 164115

location_facility: Ankara Universitesi Fakultesi /ID# 230317

location_facility: Dokuz Eylul University Medical Faculty /ID# 231321

location_facility: UAB Comprehensive Cancer Cente /ID# 165464

location_facility: ASST Spedali civili di Brescia /ID# 230420

location_facility: Assuta Ashdod Medical Center /ID# 230396

location_facility: University Clinical Center Serbia /ID# 230629

location_facility: University of Alberta Hospital - Division of Hematology /ID# 217698

location_facility: Hospital Universitario Central de Asturias /ID# 230884

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet /ID# 230306

location_facility: Centre Hospitalier de CHAMBERY /ID# 230889

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159

location_facility: Hadassah Medical Center-Hebrew University /ID# 230310

location_facility: Grande Ospedale Metropolitano-Bianchi-Melacrino /ID# 230011

location_facility: Memorial Hospital of South Bend /ID# 230912

location_facility: Klinicki bolnicki centar Zagreb /ID# 230602

location_facility: Northwest Medical Specialties /ID# 230926

location_facility: Prairie Lakes Healthcare System /ID# 224358

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230393

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 214704

location_facility: Tennessee Oncology-Nashville Centennial /ID# 221410

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 214555

location_facility: University of Yamanashi Hospital /ID# 221700

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214709

location_facility: Southeastern Medical Oncology Center /ID# 230954

location_facility: Community Cancer Trials of Utah /ID# 230914

location_facility: Moore UC San Diego Cancer Center /ID# 164084

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: Univ Hosp Cleveland: Seidman Cancer Center /ID# 230938

location_facility: University Cancer & Blood Center /ID# 230939

location_facility: Szabolcs - Szatmar - Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras /ID# 230585

location_facility: Ascension Providence Southfield Cancer Center /ID# 223876

location_facility: New Jersey Cancer Care & Blood Disorders /ID# 230925

location_facility: Princess Margaret Cancer Centre /ID# 214483

location_facility: VA Caribbean Healthcare System /ID# 222416

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214549

location_facility: Hospital Universitario Vall d'Hebron /ID# 222415

location_facility: St. Joseph Heritage Healthcare /ID# 230935

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 230318

location_facility: Seoul National University Hospital /ID# 230380

location_facility: City Clinical Hospital named after S.P. Botkin /ID# 230508

location_facility: St Joseph Heritage Healthcare /ID# 230936

location_facility: Eastern Connecticut Hematology and Oncology Associates /ID# 230918

location_facility: Heart Blood and Endocrinology Federal Center n.a. V.A. Almazov /ID# 230506

location_facility: Universtiy of Southern California /ID# 164095

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222332

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 222806

location_facility: Heartland Regional Medical Center, St.Joseph Mosaic Life Care Cancer Care / ID# 230924

location_facility: Hospital Universitario 12 de Octubre /ID# 214710

location_facility: University of Massachusetts Wo /ID# 222547

location_facility: Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548

location_facility: Klinicki bolnicki centar Split /ID# 230601

location_facility: Southcoast Health Cancer Center /ID# 230934

location_facility: Nippon Medical School Hospital /ID# 222692

location_facility: Capital Region Medical Center /ID# 232627

location_facility: Tel Aviv Sourasky Medical Center /ID# 230311

location_facility: The Center for Cancer and Blood Disorders a division of American Oncology Partners of Maryland, PA /ID# 231299

location_facility: Weill Cornell Medical College /ID# 162679

location_facility: Hospital General Universitario Gregorio Maranon /ID# 214676

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 230012

location_facility: Long Beach Memorial Medical Ct /ID# 230148

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 230371

location_facility: Mary Crowley Cancer Research /ID# 230923

location_facility: Comprehensive Cancer Centers of Nevada /ID# 230916

location_facility: Ocala Oncology Florida Cancer Affiliates /ID# 230927

location_facility: National Cheng Kung University Hospital /ID# 230372

location_facility: Kansai Medical University Hospital /ID# 222690


title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

summary: A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

ReferenceCitation: Fontana RJ, Lens S, McPherson S, Elkhashab M, Ankoma-Sey V, Bondin M, Dos Santos AGP, Xue Z, Trinh R, Porcalla A, Zeuzem S. Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naive, HCV-Infected Patients with APRI </= 1 in a Single-Arm, Open-Label, Multicenter Study. Adv Ther. 2019 Dec;36(12):3458-3470. doi: 10.1007/s12325-019-01123-0. Epub 2019 Oct 23.

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_concat: PubMed Central;eprint.ncl.ac.uk

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Germany
Poland
United Kingdom
United States
Spain
Bulgaria
Canada
Puerto Rico
Russian Federation
France

location_facility: Liver Associates of Texas, P.A /ID# 161262

location_facility: Northwest Gastroenterology Cli /ID# 161257

location_facility: Digestive Disease Associates - Baltimore /ID# 161260

location_facility: Univ Maryland School Medicine /ID# 161157

location_facility: University of Vermont Medical Center /ID# 161263

location_facility: A.I. Evdokimov Moscow State Un /ID# 163162

location_facility: South Ural State Medical univ /ID# 163163

location_facility: Hosp Uni Virgen de la Victoria /ID# 164383

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 161395

location_facility: CHU de Besancon - Jean Minjoz /ID# 161485

location_facility: ICH Study Center GmbH & Co KG /ID# 161394

location_facility: Hospital Clinic de Barcelona /ID# 161437

location_facility: Digestive and Liver Disease Sp /ID# 161259

location_facility: Uniwersytecki Szpital Kliniczn /ID# 162216

location_facility: University of Michigan Hospitals /ID# 161265

location_facility: HepID - Diagnostyka I Terapia /ID# 162219

location_facility: Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396

location_facility: Universitätsklinikum Frankfurt /ID# 161397

location_facility: Complexo Hospitalario universi /ID# 165603

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 161492

location_facility: A. F. Agafonov Republican Clin /ID# 163164


title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma

summary:
Primary Objectives:

To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.
To compare the overall response of the combination of isatuximab and cemiplimab versus isatuximab alone in patients with RRMM based on International Myeloma Working Group (IMWG) criteria.

Secondary Objectives:

To evaluate the efficacy as assessed by clinical benefit rate (CBR), duration of response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).
To assess the pharmacokinetics (PK) of isatuximab and cemiplimab when given in combination.
To assess the immunogenicity of isatuximab and cemiplimab when given in combination.

lead_sponsor: Sanofi

location_country:
Italy
Hungary
Australia
Brazil
United States
Spain
Greece
Czechia
Canada
France

location_facility: Fox Chase Cancer Center-Site Number:8400004

location_facility: University of Kansas Medical Center-Site Number:8400003

location_facility: Memorial Sloan-Kettering Cancer Center-Site Number:8400002

location_facility: University of Colorado-Site Number:8400001


title: A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis

summary:
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.

CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

ReferenceCitation: Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jauregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.

publisher_dissemination: American Society for Clinical Investigation

lead_sponsor: ContraFect

location_country:
Germany
Italy
Guatemala
Israel
United Kingdom
Belgium
United States
Spain
Greece
Chile
Czechia
Bulgaria
Russian Federation
France

location_facility:
CF-301-102 Study Site #2
CF301-102 Study Site #3
CF0301-102 Study Site
CF301-102 Study site
CF-301-102 Study Site
Study Site #2
CF301-102 Study Site #2
CF-301 Study Site
CF301-102 Study Site
Cf-301-102
Cf301-102


title: An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens

acronym: SAFE-ICU

summary:
Adequate antifungal therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the body and removed from the body. Consequently, these changes can increase the risk of inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients receiving antifungal agents

The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics. This will be achieved through completion of the following aims:

i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.

This is a multi-national study and will enrol ICU patients who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at least 15 countries and up to 80 ICUs.

Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). Blood samples will be taken to measure drug concentration. Sampling will occur on two occasions, first during study days 1-3 and then a second time between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular access device already inserted for ICU patient care. Abdominal samples from abdominal indwelling drains already inserted peri operatively will also be collected on these two occasions in the subgroup of patients with intra-abdominal infection. Data on infection, various blood tests and patient specific data will be collected using a structured case report form (CRF). Patients will also be followed up 30 days after enrolment into the study to evaluate 30-day mortality.

Collected samples will be frozen and stored locally and then shipped in large batches for processing at Burns Trauma and Critical Care Research Centre, The University of Queensland, Australia. Data analysis for development of antifungal dosing algorithms will also be undertaken at The University of Queensland, Australia.

lead_sponsor: The University of Queensland

location_country:
Finland
Italy
Portugal
Hong Kong
Australia
Netherlands
Belgium
United States
Spain
Greece
Malaysia
Canada
France

location_facility: International Islamic University Malaysia Medical Center

location_facility: The Health Sciences Center University of Manitoba

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centro Hospitalar Universitario de coimbra

location_facility: Radboud University Nijmegen Medical Centre


acronym: SELECT - PsA 2

summary:
The study objectives of Period 1 are to compare the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo for the treatment of signs and symptoms in adults with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic drug (bDMARD).

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants who have completed Period 1.

ReferenceCitation: Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021 Mar;80(3):312-320. doi: 10.1136/annrheumdis-2020-218870. Epub 2020 Dec 3.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

ReferenceCitation: Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

ReferenceCitation: Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
PubMed Central
research-repository.griffith.edu.au

ReferenceCitation: Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.

ReferenceCitation: Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.

ReferenceCitation: Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.

location_facility: Inland Rheum Clin Trials Inc. /ID# 159839

location_facility: Debreceni Egyetem Kenezy Gyula /ID# 162572

location_facility: Hospital de Clinicas de Porto Alegre /ID# 161795

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773

location_facility: Atlanta Research Center for Rheumatology /ID# 161201

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 165895

location_facility: St.Luke's International Hospital /ID# 162013

location_facility: MAV Korhaz ess Rendelointezet /ID# 162574

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 161019

location_facility: Clinical Research of West Florida, Inc /ID# 160069

location_facility: Juntendo University Hospital /ID# 162089

location_facility: PMG Research of Wilmington LLC /ID# 161403

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 157836

location_facility: Care Access Research, Huntingt /ID# 160049

location_facility: General Hospital of Athens Laiko /ID# 163474

location_facility: Kansai Medical University Hospital /ID# 162081

location_facility: Clinical Res of West FL, Inc. /ID# 159840

location_facility: AZ Arthritis & Rheum Research /ID# 160047

location_facility: Nagoya City University Hospital /ID# 162563

location_facility: Deerbrook Medical Associates /ID# 159815

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138

location_facility: C.V. Mehta MD, Med Corporation /ID# 161192

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 164126

location_facility: Rheumatology Consultants, PLLC /ID# 161408

location_facility: Arthritis & Osteoporosis Clinic /ID# 161400

location_facility: Luton & Dunstable University Hospital /ID# 162713

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 161409

location_facility: Unidade Local De Saude Do Alto Minho /ID# 165898

location_facility: Adriana Pop-Moody MD Clinic PA /ID# 160009

location_facility: Hospital Universitario Reina Sofia /ID# 170764

location_facility: Stanford University School of Med /ID# 161402

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 162571

location_facility: USF Health Morsani Center for /ID# 161291

location_facility: Gulf Region Clinical Res Inst /ID# 159860

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170911

location_facility: Asahikawa Medical University Hospital /ID# 200684

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462

location_facility: Revita Reumatologiai Rendelo /ID# 162575

location_facility: The Center for Rheumatology & Bone Research /ID# 159900

location_facility: Centro Inter Estud Clin CIEC /ID# 169543

location_facility: Clinical Investigation Specialists - Skokie /ID# 160068

location_facility: International Medical Research - Daytona /ID# 160051

location_facility: Osaka City University Hospital /ID# 162082

location_facility: Faculdade de Medicina do ABC /ID# 163489

location_facility: Percuro Clinical Research, Ltd /ID# 157835

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896

location_facility: Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897

location_facility: Trinity Health Med Arts Clinic /ID# 159811

location_facility: Diagnostic Group Integrated He /ID# 161406

location_facility: SunValley Arthritis Center, Lt /ID# 161203

location_facility: CIP - Centro Internacional de Pesquisa /ID# 161808

location_facility: Oribe Clinic of Rheumatism and Medicine /ID# 163704

location_facility: Ctr. de Recherche Musculo-Sque /ID# 163557

location_facility: Instituto Portugues De Reumatologia /ID# 165894

location_facility: Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 162589

location_facility: Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 162751

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 161294

location_facility: Kitakyushu Municipal Medical Center /ID# 163516

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 160006

title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2

location_country:
Italy
Portugal
New Zealand
Hungary
United Kingdom
Japan
Brazil
Netherlands
Belgium
United States
Spain
Greece
Chile
Czechia
Canada
Puerto Rico
France


title: An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

summary:
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of:

Xentuzumab in combination with abemaciclib
Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer.

Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib.

For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Denmark
Japan
United States
Korea, Republic of
Spain
France

location_facility: HUCH Comprehensive Cancer Center, building 2

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: The University of North Carolina at Chapel Hill


acronym: EMPHENE

summary: This study was designed to characterize dose response, and evaluate safety and efficacy of three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia (PHN).

ReferenceCitation: Rice ASC, Dworkin RH, Finnerup NB, Attal N, Anand P, Freeman R, Piaia A, Callegari F, Doerr C, Mondal S, Narayanan N, Ecochard L, Flossbach Y, Pandhi S. Efficacy and safety of EMA401 in peripheral neuropathic pain: results of 2 randomised, double-blind, phase 2 studies in patients with postherpetic neuralgia and painful diabetic neuropathy. Pain. 2021 Oct 1;162(10):2578-2589. doi: 10.1097/j.pain.0000000000002252.

publisher_dissemination: Wolters Kluwer Health

title: A Double-blind, Placebo-controlled, Randomized Dose Ranging Trial to Determine the Safety and Efficacy of Three Dose Levels of EMA401 in Reducing 24-hour Average Pain Intensity Score in Patients With Post-herpetic Neuralgia

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

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

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Belgium
Italy
Norway
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan