title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

acronym: JUNCTURE

summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

family: Houghton

full_name: Katherine Houghton

given: Katherine

family: Patil

full_name: Dhaval Patil

given: Dhaval

family: Gomez

full_name: Braulio Gomez

given: Braulio

family: Feldman

full_name: Steven R. Feldman

given: Steven R.

journal_name: Dermatology and Therapy

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. Epub 2016 Aug 30.

ReferenceCitation: Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S, Guindon C, You R, Papavassilis C; JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1082-90. doi: 10.1111/jdv.12751. Epub 2014 Sep 22.

name: Department of Dermatology; Paul Sabatier University; Toulouse France

family: Paul

full_name: C. Paul

given: C.

name: Department of Dermatology; University Hospital of Nice; Nice France

family: Lacour

full_name: J.-P. Lacour

family: Tedremets

full_name: L. Tedremets

given: L.

name: Städtische Kliniken Bielefeld; Bielefeld Germany

family: Kreutzer

full_name: K. Kreutzer

given: K.

name: Alliance Dermatology and MOHS Center; Phoenix Arizona USA

family: Jazayeri

full_name: S. Jazayeri

given: S.

name: University of Calgary; Calgary Alberta Canada

family: Adams

full_name: S. Adams

name: Novartis Pharmaceuticals Corporation; East Hanover New Jersey USA

family: Guindon

full_name: C. Guindon

name: Beijing Novartis Pharma Co. Ltd; Shanghai China

family: You

full_name: R. You

given: R.

family: Papavassilis

full_name: C. Papavassilis

journal_name: Journal of the European Academy of Dermatology and Venereology

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:
United States
France
Estonia
Germany
Canada


title: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

acronym: INSPIRE

summary: A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Díez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Lesèche G, Thomas P, Tudorache I, Kühn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9. Erratum in: Lancet Respir Med. 2018 Jun;6(6):e27.

family: Warnecke

full_name: Gregor Warnecke

given: Gregor

sequence: first

family: Van Raemdonck

full_name: Dirk Van Raemdonck

given: Dirk

sequence: additional

family: Smith

full_name: Michael A Smith

given: Michael A

family: Massard

full_name: Gilbert Massard

given: Gilbert

family: Kukreja

full_name: Jasleen Kukreja

given: Jasleen

family: Rea

full_name: Federico Rea

given: Federico

family: Loor

full_name: Gabriel Loor

given: Gabriel

family: De Robertis

full_name: Fabio De Robertis

given: Fabio

family: Nagendran

full_name: Jayan Nagendran

given: Jayan

family: Dhital

full_name: Kumud K Dhital

given: Kumud K

family: Moradiellos Díez

full_name: Francisco Javier Moradiellos Díez

given: Francisco Javier

family: Knosalla

full_name: Christoph Knosalla

given: Christoph

family: Bermudez

full_name: Christian A Bermudez

given: Christian A

family: Tsui

full_name: Steven Tsui

given: Steven

family: McCurry

full_name: Kenneth McCurry

given: Kenneth

family: Wang

full_name: I-Wen Wang

given: I-Wen

family: Deuse

full_name: Tobias Deuse

given: Tobias

family: Lesèche

full_name: Guy Lesèche

given: Guy

family: Thomas

full_name: Pascal Thomas

given: Pascal

family: Tudorache

full_name: Igor Tudorache

given: Igor

family: Kühn

full_name: Christian Kühn

given: Christian

family: Avsar

full_name: Murat Avsar

given: Murat

family: Wiegmann

full_name: Bettina Wiegmann

given: Bettina

ReferenceCitation: Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27.

name: Department of Surgery; University of Alberta; Edmonton AB Canada

name: Mazankowski Alberta Heart Institute; Edmonton AB Canada

name: Alberta Transplant Institute; Edmonton AB Canada

name: Canadian National Transplant Research Program; Edmonton AB Canada

title: Successful transplantation of extended criteria lungs after prolongedex vivolung perfusion performed on a portable device

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

location_facility: Groupe Hospitalier Hopitaux Universitaries

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of California at San Francisco


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

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

lead_sponsor: Hoffmann-La Roche

enrollment_type: Anticipated

location_country:
United States
France
Ireland
Spain
Germany
United Kingdom

acronym: POLARGO

location_facility: St James' Hospital; Cancer Clinical Trials Office

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

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Centre Henri Becquerel; Service Hématologie

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Memorial Sloan Kettering Cancer Center at Bergen

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: The Cancer Institute at St Francis Hospital

location_facility: Hospital Universitario Dr. Peset; Servicio de Hematologia

location_facility: Nebraska Cancer Specialists; Oncology Hematology West, PC

location_facility: Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

acronym: PEARLIV

summary: Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

ReferenceCitation: Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.

family: Donnez

full_name: Jacques Donnez

given: Jacques

full_name: Olivier Donnez

given: Olivier

family: Matule

full_name: Dace Matule

given: Dace

family: Ahrendt

full_name: Hans-Joachim Ahrendt

given: Hans-Joachim

family: Hudecek

full_name: Robert Hudecek

given: Robert

family: Zatik

full_name: Janos Zatik

given: Janos

family: Kasilovskiene

full_name: Zaneta Kasilovskiene

given: Zaneta

family: Dumitrascu

full_name: Mihai Cristian Dumitrascu

given: Mihai Cristian

family: Fernandez

full_name: Hervé Fernandez

given: Hervé

family: Barlow

full_name: David H. Barlow

given: David H.

family: Bouchard

full_name: Philippe Bouchard

given: Philippe

family: Fauser

full_name: Bart C.J.M. Fauser

given: Bart C.J.M.

family: Bestel

full_name: Elke Bestel

given: Elke

family: Loumaye

full_name: Ernest Loumaye

given: Ernest

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Fertility and Sterility

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.

location_country:
Italy
United Kingdom
France
Czechia
Lithuania
Romania
Hungary
Belgium
Germany
Latvia
Ukraine

location_facility: Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

location_facility: Centrum ambulantni gynekologie a primarni pece

location_facility: CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

location_facility: Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

location_facility: Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

location_facility: Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"

location_facility: FN Olomouc, Porodnicko-Gynekologicka klinika

location_facility: Hôpital Bichat, Service de Gynécologie Obstétrique

location_facility: FN Brno Gynekologicko - porodnická klinika

location_facility: Quantum Medical Center SRL Obstetrica-Ginecologie

location_facility: Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

location_facility: Policlinico Universitario "Agostino Gemelli"

location_facility: North Middlesex University Hospital NHS Trust

location_facility: Family Medicine Centre"Seimos Gydytojas"

location_facility: Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

location_facility: Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

location_facility: MRC Centre for Reproductive Health University of Edinburgh

location_facility: Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo

location_facility: Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

location_facility: Kharkiv City Perinatal Center Gynaecological Department #1

location_facility: Fortis Medical Center SRL Obstetrica Ginecologie

location_facility: Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

location_facility: CHU Bretonneau Service de Gynécologie Obstétrique

location_facility: Maternity Hospital#4 Department of Gynaecology

location_facility: Women's Health, Royal Victoria Infirmary

location_facility: Municipal Institution "Maternity Hospital #1" City Center of family planning


status: Active, not recruiting

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

location_country:
Peru
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Costa Rica
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Switzerland
Bulgaria
Singapore
China
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

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

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: VAASAN KESKUSSAIRAALA; Onkologian poliklinikka

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Instituto Regional de Enfermedades Neoplasicas

location_facility: Regional Oncology Center; Department of Mammology

location_facility: Poole General Hospital; Oncology Research Park View House

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Wellington Regional Hospital; Clinical Trials Unit

location_facility: China Medical University Hospital; Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Guangdong Provincial Traditional Chinese Medicine Hospital

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Medipol University MF; Oncology Department

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Kyungpook National University Medical Center

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Wake Forest University Baptist Medical Center

location_facility: Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

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

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Kaiser Permanente-SCPMG; Oncology Research

location_facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Universitätsspital Zürich; Klinik für Gynäkologie

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit - Level 1

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

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

location_facility: Centre de Sante & de Services Sociaux de Chicoutimi; Recherche Clinique Oncologie

location_facility: Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME

location_facility: Musgrove Park Hospital; Department Clinical Research, Beacon Centre

location_facility: Nottingham University Hospitals NHS Trust

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

title: A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

summary: This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.


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:
Italy
United States
France
Czechia
Israel
Belgium
Russian Federation
Spain
Canada

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: University of Wisconsin Hospital and Clinics

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: National Medical Research Center for Children's Health

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Azienda Ospedaliero Universitaria Di Cagliari

type: Other Identifier

title: A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

summary:
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.

The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.


title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

acronym: MERGE

summary: Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

status: Enrolling by invitation

ipd_sharing: No

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
United States
France
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: The Children's Memorial Health Institute

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

location_facility: Hospital Universitario La Paz- Hospital Materno Infantil

location_facility: Paediatric Liver Center, Kings College Hospital

status_simplified: Unknown


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Chile
South Africa
France
Israel
Norway
Australia
Spain
Germany
Korea, Republic of

location_facility: Northwest Medical Specialties, PLLC ( Site 0006)

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101)

location_facility: Clinica Universitaria de Navarra. ( Site 0082)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0104)

location_facility: Istituto Europeo di Oncologia ( Site 2040)

location_facility: Seoul National University Hospital ( Site 1992)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0090)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 2005)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088)

location_facility: Universitaetsklinikum Regensburg ( Site 2007)

location_facility: Little Company of Mary Hospital ( Site 0100)

location_facility: Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0042)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0005)

location_facility: Clinical Research Unit - University of Pretoria ( Site 0102)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 2039)

location_facility: The Queen Elizabeth Hospital ( Site 0143)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0060)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0002)

location_facility: Severance Hospital Yonsei University Health System ( Site 1993)

location_facility: Centre Georges Francois Leclerc ( Site 2025)

location_facility: CHU de Grenoble Hopital Nord ( Site 2027)

title: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

summary: This is a Phase 2 study to assess the efficacy, safety, and tolerability of V937 administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that V937 administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone.


title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

acronym: PROTECTED TAVR

summary: To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

ipd_sharing: Undecided

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Germany
France
Australia
Denmark
United States

location_facility: University of California, Davis Medical Center

location_facility: Wake Forest University School of Medicine

location_facility: South Denver Cardiology Associates PC and Swedish medical center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Methodist Healthcare System of San Antonio dba Methodist Hospital

location_facility: Kaiser Foundation Hospital - San Francisco

intervention_type: Device


title: A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

acronym: MATIC

summary: A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

ReferenceCitation: Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4. Review.

family: Field

full_name: Kelsey Field

given: Kelsey

family: Blaiss

full_name: Michael S. Blaiss

given: Michael S.

journal_name: Current Allergy and Asthma Reports

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: ALK-Abelló A/S

location_country:
United States
France
Bulgaria
Lithuania
Poland
Slovakia
Russian Federation
Spain
Germany
Canada
Ukraine

location_facility: Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

location_facility: I.P. Pavlov Ryazan State Medical University

location_facility: All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases

location_facility: CHU de Montpellier - Service Pneumologie et Addictologie

location_facility: The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital

location_facility: West Ashley office: Charleston Allergy & Asthma

location_facility: North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation

location_facility: Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk

location_facility: Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse

location_facility: Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie

location_facility: Rostov-on-Don Clinical Diagnostic Center Zdorovie

location_facility: Centrum Alergologii Teresa Hofman Sp. z o.o.

location_facility: Dnipro City Children's Municipal Clinical Hospital #2

location_facility: Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

location_facility: Ambulancia klinickej imunologie a alergologie

location_facility: Medical Research Centre of Maimi ll, Inc.

location_facility: California Allergy and Asthma Medical Group

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Allergy, Asthma & Clinical Research Center

location_facility: Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska

location_facility: City Children's Clinical Hospital # 19" of Kharkiv City Council

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics

location_facility: Regional Children Clinical Hospital, Infectious-Diagnostic Department

location_facility: Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

location_facility: Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center

location_facility: Odesa Regional Children's Clinical Hospital" of Odesa Regional Council

location_facility: Allergy & Asthma Medical Group and Research Center, A P.C.

location_facility: State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

location_facility: Scientific Medical Center for General Therapy and Pharmacology

location_facility: University of South Florida Asthma, Allergy and Immunology

location_facility: Multiprofile Hospital for Active Treatment, Department of Pediatrics

location_facility: Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin

location_facility: Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

location_facility: Regional Children's Clinical Hospital of Vinnytsia Regional Council

location_facility: City Children's Clinic № 16" of Kharkiv City Council

location_facility: Joel Liem Medicine Professional Corporation

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.

location_facility: City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department

location_facility: Center of Allergy Diagnosis and Treatment

location_facility: Multiprofile Hospital for active treatment, Department of Pediatrics

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: Children's Clinical Hospital of Poltava Regional Council

location_facility: Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics

location_facility: O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear

location_facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

location_facility: Aeroallergy Research Labs of Savannah, Inc.

location_facility: Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology

location_facility: Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Clinique spécialisée en allergie de la capitale

location_facility: Allergy Partners of Western North Carolina

location_facility: Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine

location_facility: Allergy & Asthma Associates of Monmouth City

location_facility: Allergy & Asthma Specialists Medical Group and Research Center

location_facility: Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center

location_facility: Kingston General Hospital - Division of Allergy & Immunology

intervention_type: Other


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

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country:
United States
South Africa
Finland
France
Panama
Australia
New Zealand
Spain
Canada

acronym: RSV MAT-004

title: A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

summary: The purpose of this study is to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

status_simplified: Completed


title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5

summary: B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

ReferenceCitation: Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17. Review.

family: Hosoya

full_name: Hitomi Hosoya

given: Hitomi

family: Sidana

full_name: Surbhi Sidana

given: Surbhi

journal_name: Current Hematologic Malignancy Reports

ReferenceCitation: Nooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.

name: Winship Cancer Institute, Emory University, Atlanta, GA 30322, USA

family: Nooka

full_name: Ajay K Nooka

given: Ajay K

name: Department of Oncology, Hematology & Bone Marrow Transplantation, University Medical Center of Hamburg-Eppendorf, Hamburg, 20246, Germany

family: Weisel

full_name: Katja Weisel

given: Katja

name: Department of Hematology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, 1081 HV, The Netherlands

family: van de Donk

full_name: Niels WCJ van de Donk

given: Niels WCJ

name: Peter MacCallum Cancer Centre & Royal Melbourne Hospital, Melbourne, VIC 3000, Australia

family: Routledge

full_name: David Routledge

given: David

name: Centro de Investigación Médica Aplicada, Clínica Universidad de Navarra-Pamplona, Navarra, 31008, Spain

family: Otero

full_name: Paula Rodriguez Otero

given: Paula Rodriguez

name: Vancouver General Hospital, Vancouver, BC V5Z 1M9, Canada

family: Song

full_name: Kevin Song

given: Kevin

name: Department of Haematology, University of Melbourne, St. Vincent’s Hospital Melbourne, Melbourne, VIC 3065, Australia

family: Quach

full_name: Hang Quach

given: Hang

name: Carbone Cancer Center, University of Wisconsin, Madison, WI WI 53705, USA

family: Callander

full_name: Natalie Callander

given: Natalie

name: Department of Hematology, University Medical Center Utrecht, Utrecht, 3584 CX, The Netherlands

family: Minnema

full_name: Monique C Minnema

given: Monique C

name: Department of Medicine, Division of Medical Oncology & Hematology, Princess Margaret Cancer Centre, Toronto, ON M5G 2C1, Canada

family: Trudel

full_name: Suzanne Trudel

given: Suzanne

name: GlaxoSmithKline, Stockley Park, UB11 1BT, UK

family: Jackson

full_name: Nicola A Jackson

given: Nicola A

name: GlaxoSmithKline, Upper Providence, PA 19426, USA

family: Ahlers

full_name: Christoph M Ahlers

given: Christoph M

family: Im

full_name: Ellie Im

given: Ellie

name: SpringWorks Therapeutics, Stamford, CT 06902, USA

family: Cheng

full_name: Shinta Cheng

given: Shinta

family: Smith

full_name: L Smith

given: L

name: Department of Medicine, Karolinska University Hospital, Stockholm, SE 171 76, Sweden

family: Hareth

full_name: Nahi Hareth

given: Nahi

family: Ferron-Brady

full_name: Geraldine Ferron-Brady

given: Geraldine

family: Brouch

full_name: Maria Brouch

given: Maria

family: de Oca

full_name: Rocio Montes de Oca

name: Department of Medical Oncology, Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA 02215, USA

repository_institution: University of Melbourne - Minerva Access

location_country:
United States
Sweden
Netherlands
Germany
France
Australia
Spain
Canada
Korea, Republic of


title: A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

summary: This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

study_type: Observational

time_perspective: Other

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

lead_sponsor: Ethicon, Inc.

location_country:
United States
Netherlands
France
Germany
United Kingdom
Korea, Republic of

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: University of Miami, Miller School of Medicine


type: Registry Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

summary:
The main aims of the study are:

To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
To check what dose range provides adequate relief of narcolepsy symptoms.
To check how much TAK-994 stays in the blood of participants, over time.

The study will have 4 parts. Participants can only join 1 of the parts.

A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.

B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.

C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.

D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

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: Takeda

location_country:
Italy
Netherlands
Spain
Finland
France
Czechia
Japan
Korea, Republic of
Hungary
China
United States
Canada

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: Ospedale San Raffaele (San Raffaele Turro)

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

location_facility: Stichting Epilepsie Instelling Nederland, Heemstede

location_facility: Hospital Universitario Araba Sede Santiago

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

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

location_facility: Hospital Vithas Nuestra Senora de America

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Delta Waves Sleep Disorders and Research Center

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

location_facility: Neurocare, Inc., dba Neurocare Center for Research

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

location_facility: Sleep Medicine Specialists of South Florida

location_facility: Medical University of South Carolina (MUSC)


title: A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma

acronym: DREAMM 9

summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. This will be every cycle of VRd, every other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split' dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

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


ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Greece
Australia
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Colombia
Saudi Arabia
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Lebanon
Israel
Spain
Estonia
Latvia

acronym: DEVOTE

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: London Health Sciences Centre (LHSC) - Children's Hospital

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: Fundacion Hospitalaria San Vicente de Paul

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz

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

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Fondazione Serena Onlus - Centro Clinico Nemo

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Saint George University Hospital Medical Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: The University of Texas Southwestern Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: HC-UFMG - Hospital das Clinicas da Universidade Federal de Minas Gerais

location_facility: Tokyo Women's Medical University Hospital

location_facility: Great Ormond Street Hospital for Children

location_facility: Russian Children Neuromuscular Center of Veltischev

title: Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

summary:
The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C).

The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).


title: A Phase 1/2A First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

summary: This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed acute myeloid leukemia (AML).

ReferenceCitation: Sasca D, Guezguez B, Kühn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673. Review.

family: Sasca

full_name: Daniel Sasca

given: Daniel

family: Guezguez

full_name: Borhane Guezguez

given: Borhane

family: Kühn

full_name: Michael W.M. Kühn

given: Michael W.M.

journal_name: Current Opinion in Hematology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Jiménez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.

family: Jiménez

full_name: Jennifer A. Jiménez

given: Jennifer A.

family: Apfelbaum

full_name: April A. Apfelbaum

given: April A.

family: Hawkins

full_name: Allegra G. Hawkins

given: Allegra G.

family: Svoboda

full_name: Laurie K. Svoboda

given: Laurie K.

family: Kumar

full_name: Abhijay Kumar

given: Abhijay

family: Ruiz

full_name: Ramon Ocadiz Ruiz

given: Ramon Ocadiz

family: Garcia

full_name: Alessandra X. Garcia

given: Alessandra X.

family: Haarer

full_name: Elena Haarer

given: Elena

family: Nwosu

full_name: Zeribe C. Nwosu

given: Zeribe C.

family: Bradin

full_name: Joshua Bradin

given: Joshua

family: Purohit

full_name: Trupta Purohit

given: Trupta

family: Chen

full_name: Dong Chen

given: Dong

family: Cierpicki

full_name: Tomasz Cierpicki

given: Tomasz

family: Grembecka

full_name: Jolanta Grembecka

given: Jolanta

family: Lyssiotis

full_name: Costas A. Lyssiotis

given: Costas A.

family: Lawlor

full_name: Elizabeth R. Lawlor

given: Elizabeth R.

journal_name: Molecular Cancer Research

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Kura Oncology, Inc.

location_country:
United States
France
Spain

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center


title: Extravascular ICD Pivotal Study (EV ICD)

acronym: EV ICD

summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

primary_purpose: Other

ReferenceCitation: Crozier I, O'Donnell D, Boersma L, Murgatroyd F, Manlucu J, Knight BP, Birgersdotter-Green UM, Leclercq C, Thompson A, Sawchuk R, Willey S, Wiggenhorn C, Friedman P. The extravascular implantable cardioverter-defibrillator: The pivotal study plan. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2371-2378. doi: 10.1111/jce.15190. Epub 2021 Aug 5.

name: Department of Cardiology Christchurch Hospital  Christchurch New Zealand

family: Crozier

full_name: Ian Crozier

given: Ian

name: Department of Cardiology Austin Health  Heidelberg Victoria Australia

family: O'Donnell

full_name: David O'Donnell

given: David

name: Department of Cardiology St. Antonius Hospital Nieuwegein and Amsterdam UMC  Amsterdam Netherlands

family: Boersma

full_name: Lucas Boersma

given: Lucas

name: Department of Cardiology King's College Hospital  London UK

family: Murgatroyd

full_name: Francis Murgatroyd

given: Francis

name: Division of Cardiology London Health Sciences Centre  London Ontario Canada

family: Manlucu

full_name: Jaimie Manlucu

given: Jaimie

name: Division of Cardiology Northwestern University  Chicago Illinois USA

family: Knight

full_name: Bradley P. Knight

given: Bradley P.

name: Division of Cardiology University of California San Diego  San Diego California USA

family: Birgersdotter‐Green

full_name: Ulrika Maria Birgersdotter‐Green

given: Ulrika Maria

name: Department of Cardiology CHU de Rennes—Hôpital Pontchaillou France  Rennes France

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

name: Department of Cardiac Rhythm Medtronic plc  Mounds View Minnesota USA

family: Thompson

full_name: Amy Thompson

given: Amy

family: Sawchuk

full_name: Robert Sawchuk

given: Robert

family: Willey

full_name: Sarah Willey

given: Sarah

family: Wiggenhorn

full_name: Christopher Wiggenhorn

given: Christopher

name: Department of Cardiovascular Medicine Mayo Clinic  Rochester Minnesota USA

family: Friedman

full_name: Paul Friedman

given: Paul

journal_name: Journal of Cardiovascular Electrophysiology

license: cc-by

license_normalized: cc-by

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

license_normalized: no license

repository_institution: Authorea - Authorea

repository_normalized: Authorea - Authorea

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: The extravascular implantable cardioverter‐defibrillator: The pivotal study plan

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Austria
United States
Saudi Arabia
Hong Kong
Netherlands
Switzerland
Germany
France
Poland
Norway
Hungary
Australia
Belgium
New Zealand
Spain
Denmark
Canada
United Kingdom

location_facility: AdventHealth Cardiovascular Research Institute

location_facility: Prairie Education & Research Cooperative

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: London Health Sciences Centre - University Campus

location_facility: The College of Medicine & King Khalid University Hospital, King Saud University

location_facility: Kepler Universitätsklinikum Med Campus III.

location_facility: University of Washington (UW) Medical Center

location_facility: OhioHealth Research and Innovation Institute (OHRI)

location_facility: University of California San Diego (UCSD)

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego

location_facility: University Hospitals Cleveland Medical Center

location_facility: HonorHealth Cardiac Arrhythmia Group - Osborn

location_facility: Saint Luke's Mid America Heart Institute

location_facility: University of Minnesota Medical Center Fairview


title: A Multi-center, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Efficacy of Subcutaneous and Intravenous Isatuximab (SAR650984) in Combination With Pomalidomide and Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

summary:
Primary Objectives:

To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV)
To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device
To evaluate the pharmacokinetics (PK) of SC and IV isatuximab

Secondary Objectives:

To estimate absolute bioavailability of SC and IV isatuximab
To measure receptor occupancy (RO) after isatuximab SC versus IV administration
To assess efficacy of isatuximab after SC and IV administration
To assess patient expectations prior to and patient experience and satisfaction after SC administration
To evaluate potential immunogenicity of SC or IV isatuximab

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

lead_sponsor: Sanofi

location_country:
France
Japan
Belgium
Australia
Spain
United States

location_facility:
Investigational Site Number :7240002
Investigational Site Number :0560001
Investigational Site Number :0360003
Investigational Site Number :2500001
Investigational Site Number :3920001
Investigational Site Number :7240003
Investigational Site Number :7240001
Investigational Site Number :0360001
Investigational Site Number :2500002
Investigational Site Number :0360004
Investigational Site Number :0360002
Investigational Site Number :8400001
Investigational Site Number :3920002
Investigational Site Number :8400002
Investigational Site Number :8400005


title: An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (Subcutaneous Use) in Patients With Primary Hyperoxaluria

summary: The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH.

lead_sponsor: Dicerna Pharmaceuticals, Inc.

location_country:
Italy
United States
Lebanon
Netherlands
Germany
France
Japan
Australia
Spain
Canada
United Kingdom

location_facility:
Clinical Trial Site
Clinical Research Site


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

acronym: PERSISTExt

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

lead_sponsor: Sunovion

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

location_facility: Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique

location_facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"

location_facility: Clinical Centre Kragujevac, Psychiatric Hospital

location_facility: Instituto Nacional de Psicopatología (INAPSI)

location_facility: Mental Health Research Institute of Siberian Branch of RAMS

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

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

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Clinical Hospital Centre Dragisa Misovic

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

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

location_facility: Centre Hospitalier Régional Universitaire

location_facility: Clinic for Mental Health Protection, Clinical Centre Nis

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: State Healthcare and Forensic Psychiatric Expertise Institution

location_facility: St Petersburg State Government Healthcare Institution

location_facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

location_facility: NZOZ Prywatna Klinika Psychiatryczna Inventiva

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

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

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

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


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

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

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
Poland
France
Lithuania
Germany

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


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

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

ReferenceType: result

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

lead_sponsor: Novo Nordisk A/S

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

intervention_type: Procedure


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

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

status: Terminated

ReferenceType: background

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

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

lead_sponsor: Celgene

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

location_facility: University of Texas Health Science Center at Houston

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

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

location_facility: Groupe Hospitalier Saint Vincent de Paul

location_facility: Georgetown University School of Medicine

location_facility: Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych

location_facility: Royal Brompton Hospital - Interstitial Lung Disease Unit

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

location_facility: Centrum Miriada Prywatny Gabinet Specjalistyczny Profesora Dra Stanislawa Sierakowskiego

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

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

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of Toledo College of Medicine

location_facility: Azienda Ospedaliera Universitaria S. Martino di Genova

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

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

location_facility: LaPorte County Institute for Clinical Research, Inc

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

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

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

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


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

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

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

name: Department of Pediatrics, University of California Davis School of Medicine, Davis, CA, USA

family: McDonald

full_name: Craig M McDonald

given: Craig M

name: Dubowitz Neuromuscular Centre & MRC Centre for Neuromuscular Diseases, University College London, Institute of Child Health & Great Ormond Street Hospital for Children Foundation Trust, London, UK

name: NIHR Great Ormond Street Hospital Biomedical Research Centre, Great Ormond Street Institute of Child Health, University College London, Great Ormond Street Hospital Trust, London, UK

family: Muntoni

full_name: Francesco Muntoni

given: Francesco

name: PTC Therapeutics, South Plainfield, NJ, USA

family: Penematsa

full_name: Vinay Penematsa

given: Vinay

family: Jiang

full_name: Joel Jiang

given: Joel

family: Kristensen

full_name: Allan Kristensen

given: Allan

family: Bibbiani

full_name: Francesco Bibbiani

family: Goodwin

full_name: Elizabeth Goodwin

given: Elizabeth

name: Center for Genetic Medicine, Children's National Health System & the George Washington, Washington, DC, USA

family: Gordish-Dressman

full_name: Heather Gordish-Dressman

given: Heather

name: Therapeutic Research in Neuromuscular Disorders Solutions, Pittsburgh, PA, USA

family: Morgenroth

full_name: Lauren Morgenroth

given: Lauren

name: PTC Therapeutics Germany GmbH, Frankfurt, Germany

family: Werner

full_name: Christian Werner

given: Christian

family: Li

full_name: James Li

given: James

family: Able

full_name: Richard Able

given: Richard

family: Trifillis

full_name: Panayiota Trifillis

given: Panayiota

name: Department of Pediatrics, Gothenburg University, Queen Silvia Children's Hospital, Gothenburg, Sweden

family: Tulinius

full_name: Már Tulinius

given: Már

family: Ryan

full_name: M Ryan

given: M

family: Jones

full_name: K Jones

given: K

family: Goemans

full_name: N Goemans

given: N

family: Campbell

full_name: C Campbell

given: C

family: Mah

full_name: JK Mah

given: JK

family: Selby

full_name: K Selby

family: Chabrol

full_name: B Chabrol

given: B

family: Pereon

full_name: Y Pereon

given: Y

family: Voit

full_name: T Voit

given: T

family: Gidaro

full_name: T Gidaro

family: Schara

journal_name: Journal of Comparative Effectiveness Research

repository_institution: University College London - UCL Discovery

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

location_facility: Hadassah Medical Center, Hebrew University Hospital

location_facility: University of Essen - Clinic for Children

location_facility: U.O. Complessa di Neuropsichiatria Infantile

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

location_facility: University of Newcastle Institute of Human Genetics

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

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


location_country:
South Africa
Mexico
Philippines
France
Bulgaria
Poland
Israel
Norway
Russian Federation
Spain
Turkey
United States
Colombia
Ukraine

acronym: Open-label Active-control Pediatric Safety, Efficacy, PK Study of MK-7655A

location_facility: Cukurova University Medical Faculty ( Site 0200)

location_facility: Hospital Universitario La Paz ( Site 0113)

location_facility: Morozovskaya Children City Clinical Hospital ( Site 0241)

location_facility: Rady Children's Hospital-San Diego ( Site 0347)

location_facility: Children's City Clinical Hospital #1 ( Site 0237)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0202)

location_facility: Eskisehir Osmangazi University Medical ( Site 0201)

location_facility: Ege Universitesi Tıp Fakultesi Hastanesi ( Site 0199)

location_facility: Municipal Enterprise Children's City Clinical Hospital in Poltava City Council ( Site 0122)

location_facility: Fundacion Hospital Infantil Universitario de San Jose ( Site 0268)

location_facility: Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0131)

location_facility: Miller Children's & Women's Hospital ( Site 0349)

location_facility: Empilweni Services and Research Unit ( Site 1557)

location_facility: PI Kryvorizka city clinical hospital 8 of Dnipropetrovsk Reg Council ( Site 0128)

location_facility: Children s City Clinical Hospital 5 n.a. N.F. Filatov ( Site 0235)

location_facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0121)

location_facility: Haukeland Universitetssjukehus ( Site 0500)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0265)

location_facility: Instytut Centrum Zdrowia Matki Polki ( Site 0223)

location_facility: SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0226)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0188)

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region City Childrens Clinical Emergency Hospi

location_facility: West Virginia University Ruby Memorial Hospital ( Site 0344)

location_facility: Hospital Infantil Universitario Nino Jesus ( Site 0114)

location_facility: St.Petersburg State Pediatric Medical University ( Site 0236)

location_facility: Fundacion Hospital San Vicente de Paul ( Site 0269)

location_facility: Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0290)

location_facility: SBU Sariyer Hamidiye Etfal Egitim ve Arastirma Hastanesi ( Site 0198)

location_facility: Chris Hani Baragwanath Academic Hospital ( Site 0156)

location_facility: Philippine Children s Medical Center ( Site 0317)

location_facility: University of the Philippines-Philippine General Hospital ( Site 0318)

location_facility: Regional Childrens Clinical Hospital ( Site 0400)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0115)

location_facility: Tufts Medical Center-Floating Hospital for Children ( Site 0350)

location_facility: Wojewodzki Szpital Zespolony im. Rydgiera ( Site 0220)

location_facility: Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 0233)

location_facility: Children's Hospital of Richmond at VCU ( Site 0359)

location_facility: MHAT City Clinic Sv. Georgi EOOD ( Site 0167)

location_facility: Kharkiv City Children Hospital 16 ( Site 0130)

location_facility: Hospital del Nino y Adolescente Morelense ( Site 0286)

location_facility: Hospital General de Tijuana ( Site 0284)

location_facility: Smolensk Regional Clinical Hospital ( Site 0231)

location_facility: Instituto Nacional de Pediatria ( Site 0291)

location_facility: UMHAT Dr. Georgi Stranski EAD ( Site 0174)

location_facility: Banner University Medical Center ( Site 0356)

location_facility: Schneider Children's Medical Center ( Site 0187)

title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

summary: The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.


title: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, Alone or in Combination With Other Agents, in HLA-A2+ Participants With NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

acronym: IGNYTE-ESO

summary: This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors.

design_allocation: Non-Randomized

location_country:
Italy
Netherlands
France
Spain
United States
United Kingdom
Canada


title: Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)

acronym: PANASH

summary: Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)

lead_sponsor: Promethera Biosciences

location_country: Belgium France Bulgaria Spain

location_facility: Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy

location_facility: University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"

location_facility: Hospital General Universitario Gregorio Marañon


lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Supportive Care

location_country:
Italy
Austria
United States
Sweden
Hong Kong
Germany
France
Czechia
Greece
Japan
Norway
Hungary
Argentina
Belgium
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: The Cancer Institute of New Jersey The Cancer Institute of NJ

location_facility: Emory University School of Medicine Winship Cancer Inst, Emory U.

location_facility: Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC- BCL201X2102C

location_facility: City of Hope National Medical Center Medical Oncology & Therapeutic

location_facility: Columbia University Medical Center New York Presbyterian

title: A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria

summary: This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.


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

lead_sponsor: Pfizer

location_country:
Russian Federation
Oman
Taiwan
India
Croatia
France
Japan
Canada
Korea, Republic of
Saudi Arabia
Hong Kong
Bulgaria
China
Germany
United States
Italy
Brazil
Serbia
Mexico
Spain
Turkey

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Gazi University Health Research and Practice Center Gazi Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Center for Child Health and Development

location_facility: University Multiprofile Hospital for Active Treatment ''Georgi Stranski'' EAD

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Severance Hospital, Yonsei University Health System

location_facility: USF Health Morsani Center For Advanced Healthcare

location_facility: National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia

location_facility: Institute of Hematology, Chinese Academy of Medical Sciences

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Karadeniz Technical University Medical Faculty

location_facility: Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital

location_facility: Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: FGBOU VO "Samara State Medical University" of MoH of Russia

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez"

location_facility: Università degli Studi di Roma "Sapienza"-Policlinico Umberto I

location_facility: Sahyadri Clinical Research and Development Center

location_facility: Gaziantep University Sahinbey Research and Training Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik II,

location_facility: Ondokuz Mayıs University Medical Faculty

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: Institute for Mother and Child healthcare "Dr Vukan Cupic"

location_facility: Daejeon Eulji Medical Center Eulji University

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis

summary: Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.


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

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

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

name: Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, 2725 Chemin Sainte-Foy, Québec, QC G1V 4G5, Canada

family: Maltais

full_name: François Maltais

given: François

name: Division of Respiratory Medicine, Department of Medicine, Queen’s University and Kingston General Hospital, Kingston, Ontario, Canada

family: O’Donnell

full_name: Denis O’Donnell

given: Denis

name: BioCruces Health Research Institute, Barakaldo, Spain

family: Gáldiz Iturri

full_name: Juan Bautista Gáldiz Iturri

given: Juan Bautista

name: Pulmonary Research Institute at LungClinic Grosshansdorf, Airway Research Center North, Grosshansdorf, Germany

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

name: Medicines Evaluation Unit, University of Manchester, Manchester, UK

family: Singh

full_name: Dave Singh

given: Dave

name: Boehringer Ingelheim, Burlington, Ontario, Canada

family: Hamilton

full_name: Alan Hamilton

given: Alan

name: Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, and Department of Sports Medicine, University of Tübingen, Tübingen, Germany

family: Tetzlaff

full_name: Kay Tetzlaff

given: Kay

name: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA

family: Zhao

full_name: Yihua Zhao

given: Yihua

name: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA

family: Casaburi

full_name: Richard Casaburi

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Respiratory Disease

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

repositories: California Digital Library - eScholarship

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Boehringer Ingelheim

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

location_facility: 1237.15.34501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01510 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35853 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01513 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01516 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44151 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44153 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44152 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44154 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34009 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34001 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44155 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01514 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44158 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36504 Boehringer Ingelheim Investigational Site


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

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

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Spain
United States
Canada


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

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

lead_sponsor: Debiopharm International SA

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

location_facility:
Novartis Investigational site
Novartis Investigative Site
Novartis Investigational Site