title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

summary: The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.

primary_purpose: Prevention

ReferenceCitation: Vincenti F, Budde K, Merville P, Shihab F, Ram Peddi V, Shah M, Wyburn K, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Am J Transplant. 2018 Dec;18(12):2945-2954. doi: 10.1111/ajt.14925. Epub 2018 Jun 20.

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

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Germany
Australia
United States
Spain
Canada
France

location_facility:
Site CA15006
Site US10013
Site US10044
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Site ES34001
Site DE49005
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Site US10037
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Site FR33003
Site AU61001
Site US10023


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Parallel-Group, 26-Week, Phase 3 Study of 2 Doses of EVP-6124 or Placebo in Subjects With Mild to Moderate Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

summary: The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

status: Terminated

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: FORUM Pharmaceuticals Inc

location_country:
Germany
Italy
Poland
Australia
Mexico
Belgium
United States
Korea, Republic of
Spain
South Africa
Canada
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia

summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Regeneron Pharmaceuticals

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_country:
United States
Spain
Netherlands
France

status_simplified: Completed


title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure and Preserved Ejection Fraction (HFpEF)

summary: Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Muller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: Bayer

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Israel


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

summary: The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

ReferenceType: derived

ReferenceCitation: Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, Shalimar, Buti M, Cox S, Parhy B, Zhou E, Martin R, Chang S, Lin L, Flaherty JF, Kitrinos KM, Gaggar A, Izumi N, Lim YS. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, Chan HL. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol. 2018 Jun 20:S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. Online ahead of print.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

ReferenceCitation: Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22. Erratum In: Lancet Gastroenterol Hepatol. 2016 Nov;1(3):e2.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

lead_sponsor: Gilead Sciences

location_country:
Poland
New Zealand
Australia
Japan
Turkey
Canada
France
Hong Kong
United States
India
Romania
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Scientific Research Institute of Clinical Immunology

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: Severance Hospital Yonsei University Health System

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: SPZOZ, Wojewódzki Specjalistyczny Szpital

location_facility: Kaohsiung Med. College Hosp. Dept. of Internal Medicine

location_facility: Kobe City Medical Center General Hospital

location_facility: People's Friendship University of Russia

location_facility: University of Manitoba, Health Sciences Center

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Kyoto Prefectural University of Medicine

location_facility: Policlinico Universitario G. Martino via Consolare

location_facility: Institute of Clinical Immunology RAMS, Clinic of Immunopathology

location_facility: Keimyung University Dongsan Medical Center

location_facility: Waikato Hospital (District Health Board)

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"

location_facility: University Health Network / Toronto General Hospital

location_facility: Global Hospital Super Specialty & Transplant Centre

location_facility: MHAT Alexandrovska Medical University, Sofia

location_facility: Spitatul Clinic de Boli Infectioase Constanta

location_facility: Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Seth GS Medical College and KEM Hospital

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Government Medical College and Superspecialty Hospital

location_facility: S. R Kalla Memorial Gastro & General Hospital

location_facility: Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: YR Gaitonde Centre for AIDS Research and Education

location_facility: Seoul National University Bundang Hospital

location_facility: 1st Moscow State Medical University University Clinical Hospital #3

location_facility: Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine

location_facility: Limited Liability Company "Modern Medicine Clinic"

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Peerless Hospital & B.K.Roy Research Center

location_facility: Scientific Research Institute of Nutrition

location_facility: Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

location_facility: Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di

location_facility: Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Dicle University Medical Faculty Department of Infectious Diseases


lead_sponsor: Merz Pharmaceuticals GmbH

summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

ReferenceType: result

ReferenceCitation: Heinen F, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, Hanschmann A, Martinez-Torres FJ, Pulte I, Banach M, Gaebler-Spira D. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med. 2021;14(2):183-197. doi: 10.3233/PRM-210040. Erratum In: J Pediatr Rehabil Med. 2022;15(2):407-409.

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

unpaywall_oa_status: hybrid

publisher_dissemination: IOS Press

ReferenceCitation: Berweck S, Banach M, Gaebler-Spira D, Chambers HG, Schroeder AS, Geister TL, Althaus M, Hanschmann A, Vacchelli M, Bonfert MV, Heinen F, Dabrowski E. Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis. Toxins (Basel). 2022 Aug 25;14(9):585. doi: 10.3390/toxins14090585.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

repositories_concat: PubMed Central;epub.ub.uni-muenchen.de

unpaywall_oa_status: gold

publisher_dissemination: MDPI

location_facility:
Merz Investigational Site #040002
Merz Investigational Site #033055
Merz Investigational Site #372001
Merz Investigational Site #033056
Merz Investigational Site #048059
Merz Investigational Site #007015
Merz Investigational Site #034032
Merz Investigational Site #380003
Merz Investigational Site #421006
Merz Investigational Site #972002
Merz Investigational Site #007017
Merz Investigational Site #043036
Merz Investigational Site #007013
Merz Investigational Site #033052
Merz Investigational Site #007018
Merz Investigational Site #007019
Merz Investigational Site #090003
Merz Investigational Site #082019
Merz Investigational Site #972003
Merz Investigational Site #040001
Merz Investigational Site #421004
Merz Investigational Site #034026
Merz Investigational Site #048089
Merz Investigational Site #034031
Merz Investigational Site #048063
Merz Investigational Site #040003
Merz Investigational Site #043037
Merz Investigational Site #082021
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Merz Investigational Site #082020
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Merz Investigational Site #380005

title: Prospective, Multicenter, Randomized, Double-blind, Parallel-group, Dose-response Study of Three Doses Xeomin® (incobotulinumtoxinA, NT 201) for the Treatment of Lower Limb Spasticity in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy

source: euctr

location_country:
Germany
Poland
Slovakia
Israel
Romania
Austria
Korea, Republic of
Spain
Turkey
Czechia
Ukraine
Estonia
Russian Federation
France


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

acronym: HELIOS

summary: The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

ReferenceCitation: Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_normalized: HAL

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

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central

sponsor_collaborators: Astellas Pharma Global Development, Inc.

location_country:
Germany
Australia
Japan
Sweden
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility:
Site US10025
Site DE49014
Site SE46001
Site KR82004
Site FR33010
Site US10035
Site FR33005
Site US10020
Site CA15004
Site US10012
Site CA15003
Site US10021
Site US10027
Site JP81010
Site US10030
Site ES34009
Site JP81006
Site US10043
Site US10013
Site US10026
Site JP81011
Site ES34003
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acronym: ACOUSTICS

lead_sponsor: Hoffmann-La Roche

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

ReferenceCitation: Szefler SJ, Roberts G, Rubin AS, Zielen S, Kuna P, Alpan O, Anzures-Cabrera J, Chen Q, Holweg CTJ, Kaminski J, Putnam WS, Matthews JG, Kamath N. Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). Clin Transl Allergy. 2022 Jul 14;12(7):e12176. doi: 10.1002/clt2.12176. eCollection 2022 Jul.

oa_host_type: repository

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

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

unpaywall_oa_status: green

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Jewish Medical and Research Center

location_facility: South Texas Allergy and Asthma Medical Professionals

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Centre de Recherche Applique En Allergie de Quebec

location_facility: Instituto de Pesquisa Clínica e Medicina Avançada Ltda

location_facility: Azienda Policlinico Umberto I; Dipartimento Integrato di Pediatria e Neuropsichiatria Infantile

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: National Hospital Organization Mie Hospital

location_facility: Municipal Medical Institution; Chernivtsi Regional Children's Hospital

location_facility: Hospital Infante D. Pedro; Servico de Imunoalergologia

location_facility: Allergy & Asthma Medical Group; Clinical Research Division

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Riley Hospital for Children; Pediatric Nephrology

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Centro de Referencia em Enfermidades Respiratorias e Alergia - CEAR

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

location_facility: Colorado Children's Hospital; The Breathing Institute

location_facility: Dumfries and Galloway Royal Infirmary; Department of Paediatrics

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Municipal Institution "Kryvyi Rih City Clinical Hospital #8" of Dnipropetrovsk Regional Council

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Hospital Particular do Algarve - Unidade de Faro

location_facility: National Hospital Organization Shimoshizu National Hospital

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Investigaciones en Patologias Respiratorias

location_facility: State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

location_facility: Allergy, Asthma, & Dermatology Research Center, Llc

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: SI Research Centre of Radiation Medicine of AMSU

location_facility: Clinical Research Inst. of Southern Oregon, Pc

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: GCT Mercantile; Clinical Research Centre

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Consultorio Especialidad Alergologia Pediatrica

location_facility: Hospital Dos de Mayo; Parque Historia De la Medicina Peruana S/n

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

location_facility: Hospital Dona Estefania; Servico de Imunoalergologia

location_facility: Cardinal Glennon Child's Hosp; Endrocrinology

location_facility: Hospital Universitario Germans Trias i Pujol; Servicio de Farmacia

location_facility: SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

location_facility: Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas

title: A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma who are on inhaled corticosteroids and second controller medication.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
United States
Ukraine
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Israel


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

ReferenceCitation: Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

ReferenceCitation: N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Czechia
Canada
Serbia
France
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: Del Carpio Jaime Dr - Allergiste & Immunologue

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research LLC

location_facility: KASMED, s.r.o.; Alergologie a klinicka imunologie

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta

location_facility: Hospital Nacional Adolfo; Guevara Velasco Essalud

location_facility: Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

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

location_facility: Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9

location_facility: SHATPD Sveta Sofia; Clin Pulmonary Diseases

location_facility: Canterbury Respiratory Research Group; Respiratory

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Ordinace pro tuberkulozu a respiracni nemoci

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Alergo Medical Specjalistyczna Przychodnia Lekarska

location_facility: SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: GRAŻYNA JASIENIAK-PINIS ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

location_facility: Complexo Hospitalario Universitario de Santiago CHUS - Hospital de Conxo

location_facility: Instituto Peruano de Investigacion en Ciencias Medicas

location_facility: Municipal Budgetery Clinical Institution of Healthcare; NA Semashko City Hospital

location_facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

location_facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: Hospital Universitario la Paz; Servicio de Alergologia

location_facility: Howard County Center for Lung and Sleep, LLC

location_facility: Allergy & Asthma Medical Group; Clinical Research Division

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Seoul National University Hospital; Division of Allergy and Clinical Immunology

location_facility: Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

location_facility: Clinical Research Center of Alabama, LLC

location_facility: University of Wisconsin;Allergy & Asthma Clinical Research

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Cotton O'Neil Clinic; Stormont-Vail Hlth Care

location_facility: Yokohama City University Medical Center; Neurology

location_facility: EPIMRD, Inc. DBA Western Sky Medical Research

location_facility: Upstate Pharmaceutical Research; Greenville

location_facility: Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

location_facility: Baylor College of Medicine; Dept of Medicine

location_facility: Allergy and Clinical Immunology Associates

location_facility: Saratov State Medical Univ; Clinical Immun & Allerg

location_facility: Municipal Institution of Health Care City Clinical Hospital #13

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: MI Dnipropetrovsk clinical association of emergency care of Dnipropetrovsk regional council

location_facility: Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases

location_facility: Concord Repatriation General Hospital; Department Thoracic Medicine

location_facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

location_facility: Takatsuki Red Cross Hospital; Division of Diabetes / Endocrinology / Lifestyle-Related Disease

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: Multiprofile Hospital For Active Treatment prof Kirkovich

location_facility: Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov

location_facility: Groupe Hospitalier Cochin St Vincent de Paul La Roche Guyon

location_facility: Royal Hallamshire Hospital; Department of Oncology

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Yaroslavl State Medical Academy - Clinical Hospital #2

location_facility: Medical Research Inst. of New Zealand; Respiratory

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología

location_facility: Niepubliczny Zespol Poradni Specjalistycznych PULS Poradnia Chorob Pluc i Gruzlic

location_facility: Diagnostic and Consulting Centre Mladost - M OOD

location_facility: City Clinical Hospital No.1; Therap Ukr Med Stom Acad

location_facility: Medical Research of Arizona; Allergy, Asthma & Immu

location_facility: Scientific and Research Institute of Invalid Rehabilitation of Moh of Ukraine

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Southern California Institute For Respiratory

location_facility: Penza Regional Clinical Hospital Named After N. N. Burdenko; Therapy Department

location_facility: Donetsk Municipal Treatment and Prophylactic Institution Central City Clinical Hospital #1

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Quality of Life Medical & Research Center

location_facility: National Multiprofile Hospital Tsar Boris III

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

location_facility: Hadassah Medical Center; Pulmonary Institute

location_facility: SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

location_facility: Integrity People Services Research Company

location_facility: Università Cattolica del Sacro Cuore UOC Allergologia- Policlinico Gemelli

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: St.Petersburg State Budget Healthcare Institution City Hospital of Saint Venerable Martyr Elizabeth

location_facility: Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases

location_facility: Hikarigaoka Spellman Hospital; Rheumatology


title: A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue

summary: This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.

study_type: Observational

time_perspective: Other

ReferenceCitation: Wei L, Pavlovic V, Bansal AT, Chen X, Foster GR, He H, Kao JH, Lampertico P, Liaw YF, Motoc A, Papatheodoridis GV, Piratvisuth T, Plesniak R, Wat C. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B. J Viral Hepat. 2019 Sep;26(9):1040-1049. doi: 10.1111/jvh.13107. Epub 2019 Jul 23.

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

location_country:
Germany
Italy
Poland
Portugal
New Zealand
United Kingdom
Romania
Austria
Korea, Republic of
China
Thailand
Greece
Taiwan
Bulgaria
France

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

location_facility: National Taiwan Uni Hospital; Gastro-Enterology Dept.

location_facility: Nanjing No.2 Hospital; Liver Disease Department

location_facility: Samsung Medical Center; Gastroenterology

location_facility: The Eighth People's Hospital of Guangzhou

location_facility: Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hospital For Infectious Diseases; Infectiology

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale

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

location_facility: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

location_facility: Beijing 302 Hospital; No. 2 Infectious Disease Section

location_facility: Clinical Infectious Diseases Hospital Victor Babes

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

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

location_facility: Az. Osp. Uni Ria Di Parma; Gastro-Enterology

location_facility: Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia

location_facility: Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.

location_facility: The Third Hospital of Hebei Medical University

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie

location_facility: The 1st Affiliated Hospital of Harbin Medical University

location_facility: Ifi- Studien und Projekte GmbH, An der Asklepios Klinik St. Georg

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

location_facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby

location_facility: Uni Di Cagliari; Dept. Di Scienze Mediche

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

location_facility: Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

location_facility: Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Inje University Busan Paik Hospital; Nephrology

location_facility: University Hospital of Larissa; Pathological Clinic

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Xiangya Hospital of Centre-South University

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

location_facility: Az. Osp. S. Sebastiano; Divisione Malattie Infettive

location_facility: Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: Hippokratio Hospital; 4Th Internal Medicine Dpt

location_facility: Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia

location_facility: Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive

location_facility: Ospedale de Bellis; Reparto Medicina Generale

location_facility: China Medical University Hospital; Department of Rheumatology

location_facility: Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology

location_facility: Tri-Service Hospital; Dept. of Internal Medicine

location_facility: General Hospital of Ningxia Medical University

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

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

location_facility: The Second Affiliated Hospital, Chongqing Medical University


title: GSK2302032A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

acronym: PEARL

summary:
The purpose of this study was to test a potential new kind of anti-cancer treatment, called PRAME immunotherapy in resected patients with lung cancer.

Based on scientific and medical relevance, the clinical study was ended on 24 August 2016. The participants were no longer enrolled in the study, the follow ups on subjects were stopped and the collection and analysis of samples for further research purposes was stopped.

After the stop to recruitment, the study was unblinded, as per the amended protocol, the study treatment was continued and completed with the subjects of the active treatment group who were willing to continue. Subjects in the placebo group were withdrawn.

There was no longer an active follow-up of patients after discontinuation or completion of the treatment. The study ended 30 days after the last dose was administered.

As a result, primary and secondary objectives were not assessed as planned. All clinical and safety data collected in the study were analysed descriptively. For each biological sample already collected in the scope of this study and not tested yet, testing was not performed by default, except if a scientific rationale remained relevant despite the premature termination of the study.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United Kingdom
Japan
United States
Korea, Republic of
Estonia
Russian Federation
France

intervention_type: Biological


lead_sponsor: Allergan

summary: This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.

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

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: William Beaumont Hospital Research Institute

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: CHU de Limoges - Hopital Mere et l'Enfant

location_facility: Washington University School of Medicine

location_facility: Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

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

location_country:
Italy
Poland
Belgium
United States
Turkey
Czechia
Canada
France


title: Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE

acronym: DASFREE

summary: The study purpose is to test the hypothesis that Chronic Phase Chronic Myeloid Leukemia (CP-CML) patients with stable Complete Molecular Response (CMR) who discontinue Dasatinib treatment are able to maintain a sustained remission in the long-term, with undetectable or minimally detectable BCR-ABL residual disease.

primary_purpose: Other

lead_sponsor: Bristol-Myers Squibb

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

location_country:
Germany
Italy
United States
Spain
Canada
France

location_facility:
Local Institution - 0017
Local Institution - 0029
Local Institution - 0030
Local Institution - 0003
Local Institution - 0021
Local Institution - 0018
Local Institution - 0011
Local Institution - 0009
Local Institution - 0015
Local Institution - 0027
Local Institution - 0002
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0014
Local Institution - 0012
Local Institution - 0016
Local Institution - 0020
Local Institution - 0023
Local Institution - 0001
Local Institution - 0022
Local Institution - 0008
Local Institution - 0013
Local Institution - 0025
Local Institution - 0026
Local Institution - 0010
Local Institution - 0019
Local Institution - 0006


lead_sponsor: Novartis Pharmaceuticals

summary: To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

location_country:
Germany
Australia
Turkey
Canada
Czech Republic
France
Slovakia
Hungary
Switzerland
Latvia
Belgium
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Russian Federation
Israel


acronym: DIALOG

summary: To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).

ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Patterson B, Samis J, Aimone P, Allepuz A, Titorenko K, Sosothikul D. A phase 2 study of nilotinib in pediatric patients with CML: long-term update on growth retardation and safety. Blood Adv. 2021 Jul 27;5(14):2925-2934. doi: 10.1182/bloodadvances.2020003759.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

publisher_dissemination: American Society of Hematology

ReferenceCitation: Hijiya N, Maschan A, Rizzari C, Shimada H, Dufour C, Goto H, Kang HJ, Guinipero T, Karakas Z, Bautista F, Ducassou S, Yoo KH, Zwaan CM, Millot F, Aimone P, Allepuz A, Quenet S, Hourcade-Potelleret F, Hertle S, Sosothikul D. Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Blood. 2019 Dec 5;134(23):2036-2045. doi: 10.1182/blood.2019000069.

location_facility: University of Texas Southwestern Medical Center Oncology

location_facility: Lucile Salter Packard Children's Hospital at Stanford

title: A Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib

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

design_allocation: Non-Randomized

location_country:
Italy
Hungary
United Kingdom
Japan
Netherlands
United States
Korea, Republic of
Spain
Thailand
Malaysia
Turkey
Russian Federation
France


acronym: ACT DMD

lead_sponsor: PTC Therapeutics

summary: Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which 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. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.

ReferenceCitation: Shieh PB, Elfring G, Trifillis P, Santos C, Peltz SW, Parsons JA, Apkon S, Darras BT, Campbell C, McDonald CM; Members of the Ataluren Phase IIb Study Group; Members of the Ataluren Phase IIb Study Clinical Evaluator Training Group; Members of the ACT DMD Study Group; Members of the ACT DMD Clinical Evaluator Training Group. Meta-analyses of deflazacort versus prednisone/prednisolone in patients with nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2021 Dec;10(18):1337-1347. doi: 10.2217/cer-2021-0018. Epub 2021 Oct 25.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Western University - Scholarship@Western

version: submittedVersion

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: McDonald CM, Wei LJ, Flanigan KM, Elfring G, Trifillis P, Muntoni F; ACT DMD Clinical Evaluator Training Group; ACT DMD Study Group. Evaluating longitudinal therapy effects via the North Star Ambulatory Assessment. Muscle Nerve. 2021 Nov;64(5):614-619. doi: 10.1002/mus.27396. Epub 2021 Sep 2.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
UCL Discovery
escholarship.org

ReferenceCitation: Campbell C, Barohn RJ, Bertini E, Chabrol B, Comi GP, Darras BT, Finkel RS, Flanigan KM, Goemans N, Iannaccone ST, Jones KJ, Kirschner J, Mah JK, Mathews KD, McDonald CM, Mercuri E, Nevo Y, Pereon Y, Renfroe JB, Ryan MM, Sampson JB, Schara U, Sejersen T, Selby K, Tulinius M, Vilchez JJ, Voit T, Wei LJ, Wong BL, Elfring G, Souza M, McIntosh J, Trifillis P, Peltz SW, Muntoni F; PTC124-GD-007-DMD Study Group; ACT DMD Study Group; Clinical Evaluator Training Groups. Meta-analyses of ataluren randomized controlled trials in nonsense mutation Duchenne muscular dystrophy. J Comp Eff Res. 2020 Oct;9(14):973-984. doi: 10.2217/cer-2020-0095. Epub 2020 Aug 27.

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

repositories_concat: LIRIAS (KU Leuven);UCL Discovery;University of Melbourne - Minerva Access;air.unimi.it;escholarship.umassmed.edu;ir.lib.uwo.ca

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

ReferenceCitation: McDonald CM, Campbell C, Torricelli RE, Finkel RS, Flanigan KM, Goemans N, Heydemann P, Kaminska A, Kirschner J, Muntoni F, Osorio AN, Schara U, Sejersen T, Shieh PB, Sweeney HL, Topaloglu H, Tulinius M, Vilchez JJ, Voit T, Wong B, Elfring G, Kroger H, Luo X, McIntosh J, Ong T, Riebling P, Souza M, Spiegel RJ, Peltz SW, Mercuri E; Clinical Evaluator Training Group; ACT DMD Study Group. Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Sep 23;390(10101):1489-1498. doi: 10.1016/S0140-6736(17)31611-2. Epub 2017 Jul 17.

repositories_concat: UCL Discovery

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: Columbia University College of Physicians & Surgeons

location_facility: Fondazione IRCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: University Hospital Medical Center Freiburg

location_facility: University College London Institute of Child Health

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: Universidade Federal do Rio de Janeiro - Instituto de Puericultura e Pediatria Martagao Gesteira

location_facility: Seattle Children's Hospital - Childhood Cancer and Blood Disorders

location_facility: Child Neurology Center of Northwest Florida

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Hospital Universitari i Politecnic la Fe

title: A Phase 3 Efficacy and Safety Study of Ataluren in Patients With Nonsense Mutation Dystrophinopathy

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Sweden
Switzerland
Belgium
United States
Korea, Republic of
Spain
Turkey
Chile
Czechia
Canada
France


lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie-Prokocimiu

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: Shizuoka Prefectural Children's Hospital

location_facility: Hopital Haut Leveque - Group hospitalier Sud

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Istituto Giannina Gaslini Ospedale Pediatrico I.R.C.C.S.

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Okinawa Prefectural Nanbu Medical Center & Children's Med Ct

location_facility: National Center For Child Health And Development

location_facility: Pronto Socorro Cardiologico de Pernambuco-PROCAPE

location_facility: Hacettepe University Faculty of Medicine

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

title: A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension

type: Other Identifier

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

location_country:
Germany
Italy
Poland
Israel
Japan
Brazil
Netherlands
Austria
Belgium
Mexico
United States
Spain
Turkey
France


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary:
This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .

ReferenceCitation: Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.

ReferenceCitation: Gulley JL, Rajan A, Spigel DR, Iannotti N, Chandler J, Wong DJL, Leach J, Edenfield WJ, Wang D, Grote HJ, Heydebreck AV, Chin K, Cuillerot JM, Kelly K. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):599-610. doi: 10.1016/S1470-2045(17)30240-1. Epub 2017 Mar 31.

ReferenceCitation: Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marte JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017 May;18(5):587-598. doi: 10.1016/S1470-2045(17)30239-5. Epub 2017 Mar 31.

ReferenceCitation: Guigay J, Lee KW, Patel MR, Daste A, Wong DJ, Goel S, Gordon MS, Gutierrez M, Balmanoukian A, Le Tourneau C, Mita A, Vansteene D, Keilholz U, Schoffski P, Grote HJ, Zhou D, Bajars M, Penel N. Avelumab for platinum-ineligible/refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2021 Oct;9(10):e002998. doi: 10.1136/jitc-2021-002998.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2):e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Verschraegen CF, Jerusalem G, McClay EF, Iannotti N, Redfern CH, Bennouna J, Chen FL, Kelly K, Mehnert J, Morris JC, Taylor M, Spigel D, Wang D, Grote HJ, Zhou D, Munshi N, Bajars M, Gulley JL. Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study. J Immunother Cancer. 2020 Sep;8(2):e001064. doi: 10.1136/jitc-2020-001064.

ReferenceCitation: Del Rivero J, Donahue RN, Marte JL, Gramza AW, Bilusic M, Rauckhorst M, Cordes L, Merino MJ, Dahut WL, Schlom J, Gulley JL, Madan RA. A Case Report of Sequential Use of a Yeast-CEA Therapeutic Cancer Vaccine and Anti-PD-L1 Inhibitor in Metastatic Medullary Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Aug 7;11:490. doi: 10.3389/fendo.2020.00490. eCollection 2020.

publisher_dissemination: Frontiers

ReferenceCitation: Vaishampayan U, Schoffski P, Ravaud A, Borel C, Peguero J, Chaves J, Morris JC, Kotecki N, Smakal M, Zhou D, Guenther S, Bajars M, Gulley JL. Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Oct 24;7(1):275. doi: 10.1186/s40425-019-0746-2.

ReferenceCitation: Rajan A, Heery CR, Thomas A, Mammen AL, Perry S, O'Sullivan Coyne G, Guha U, Berman A, Szabo E, Madan RA, Ballester LY, Pittaluga S, Donahue RN, Tsai YT, Lepone LM, Chin K, Ginty F, Sood A, Hewitt SM, Schlom J, Hassan R, Gulley JL. Efficacy and tolerability of anti-programmed death-ligand 1 (PD-L1) antibody (Avelumab) treatment in advanced thymoma. J Immunother Cancer. 2019 Oct 21;7(1):269. doi: 10.1186/s40425-019-0723-9.

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

ReferenceCitation: Chung HC, Arkenau HT, Lee J, Rha SY, Oh DY, Wyrwicz L, Kang YK, Lee KW, Infante JR, Lee SS, Kemeny M, Keilholz U, Melichar B, Mita A, Plummer R, Smith D, Gelb AB, Xiong H, Hong J, Chand V, Safran H. Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Feb 4;7(1):30. doi: 10.1186/s40425-019-0508-1.

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Disis ML, Taylor MH, Kelly K, Beck JT, Gordon M, Moore KM, Patel MR, Chaves J, Park H, Mita AC, Hamilton EP, Annunziata CM, Grote HJ, von Heydebreck A, Grewal J, Chand V, Gulley JL. Efficacy and Safety of Avelumab for Patients With Recurrent or Refractory Ovarian Cancer: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):393-401. doi: 10.1001/jamaoncol.2018.6258.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Keilholz U, Mehnert JM, Bauer S, Bourgeois H, Patel MR, Gravenor D, Nemunaitis JJ, Taylor MH, Wyrwicz L, Lee KW, Kasturi V, Chin K, von Heydebreck A, Gulley JL. Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Jan 16;7(1):12. doi: 10.1186/s40425-018-0459-y.

ReferenceCitation: Hassan R, Thomas A, Nemunaitis JJ, Patel MR, Bennouna J, Chen FL, Delord JP, Dowlati A, Kochuparambil ST, Taylor MH, Powderly JD, Vaishampayan UN, Verschraegen C, Grote HJ, von Heydebreck A, Chin K, Gulley JL. Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):351-357. doi: 10.1001/jamaoncol.2018.5428.

ReferenceCitation: Le Tourneau C, Hoimes C, Zarwan C, Wong DJ, Bauer S, Claus R, Wermke M, Hariharan S, von Heydebreck A, Kasturi V, Chand V, Gulley JL. Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial. J Immunother Cancer. 2018 Oct 22;6(1):111. doi: 10.1186/s40425-018-0424-9.

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

ReferenceCitation: Patel MR, Ellerton J, Infante JR, Agrawal M, Gordon M, Aljumaily R, Britten CD, Dirix L, Lee KW, Taylor M, Schoffski P, Wang D, Ravaud A, Gelb AB, Xiong J, Rosen G, Gulley JL, Apolo AB. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5. Erratum In: Lancet Oncol. 2018 Jul;19(7):e335.

ReferenceCitation: Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, Heery CR, Gulley JL, Schlom J. Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody. J Immunother Cancer. 2017 Feb 21;5:20. doi: 10.1186/s40425-017-0220-y. eCollection 2017.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Poland
United Kingdom
Belgium
United States
Korea, Republic of
Taiwan
Czechia
France

location_facility: Georgetown University Medical Center- Research Parent

location_facility: California Cancer Associates for Research & Excellence, Inc

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

location_facility: Kansas City Research Institute, LLC - Phase I Unit

location_facility: Centre Paul Strauss - Service de Médecine Oncologique

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH - Innere Medizin II Haematologie / Onkologie

location_facility: Peachtree Hematology-Oncology Consultants, PC

location_facility: University of California Davis Health System

location_facility: Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology

location_facility: Nemocnice Rudolfa a Stefanie Benesov, a.s.

location_facility: Augusta University - formerly Georgia Regents University

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: Seoul National University Bundang Hospital

location_facility: Scripps Health dba Scripps Clinical Research Services

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.

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

location_facility: Derriford Hospital - Dept of Oncology Clinical Trials

location_facility: University of North Carolina at Chapel Hill

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie - Dept of Digestive System Oncology

location_facility: University Hospitals Case Medical Center - Case Comprehensive Cancer Center

location_facility: OSU - James Comprehensive Cancer Center - Division of Hematology

location_facility: Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center

location_facility: Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center

location_facility: Columbia University College of Phys & Surgeons

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus


acronym: RESPIRE 1

summary: The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

ReferenceCitation: De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher_dissemination: European Respiratory Society

ReferenceCitation: Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.

evidence: open (via crossref license)

sponsor_collaborators: Bayer Novartis

title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.

location_country:
Germany
Italy
New Zealand
Slovakia
Israel
Argentina
Denmark
Australia
Japan
United Kingdom
United States
Latvia
Spain
France


title: BEL114674: A 2 Year Study of Efficacy and Safety of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy

summary: The main clinical study will be a randomized, double-blind, placebo-controlled, long term study involving a 100 week treatment period. The purpose of this study is to test for superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study is also to investigate the effect of initiating earlier treatment with belimumab compared to delayed treatment with current immunosuppressive treatment regimens. The study will also determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of action of Belimumab as well as effects on quality of life. All subjects (on either active treatment or placebo) will receive background supportive therapy throughout the main clinical study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a total of 27 doses (giving 104 weeks of drug exposure). The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of belimumab in the urine. Subjects who are withdrawn from study treatment at any time during the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to week 104. A subject will be regarded as having completed the main clinical study if they complete all phases of the main clinical study (screening, treatment period, 4 week and 16 week post last dose short term safety follow-up). Subjects who complete the main clinical study will therefore participate in the main clinical study for approximately 28 months. After the main clinical study, there will be a 5 year (long term) follow-up phase to assess long term outcomes.

status: Withdrawn

ReferenceCitation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Spain
Canada
Czech Republic
France


title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome

acronym: MAESTRO

summary: Clinical study to assess the efficacy, safety, and tolerability of macitentan in subjects with Eisenmenger Syndrome.

ReferenceCitation: Gatzoulis MA, Landzberg M, Beghetti M, Berger RM, Efficace M, Gesang S, He J, Papadakis K, Pulido T, Galie N; MAESTRO Study Investigators. Evaluation of Macitentan in Patients With Eisenmenger Syndrome. Circulation. 2019 Jan 2;139(1):51-63. doi: 10.1161/CIRCULATIONAHA.118.033575.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Université de Lausanne - SERVAL

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Actelion

location_country:
Germany
Poland
Vietnam
Turkey
Chile
Serbia
France
Portugal
United States
Romania
China
Malaysia
Philippines
United Kingdom
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Sci Institute Systemic Problems Cardio Diseases Kemerovo

location_facility: Bristol Univ Hosp Congenital Heart Centre

location_facility: Hosp La Timone - Dept Pediatric Cardiology

location_facility: Texas Children'S Hosp - Dept of Cardiology

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr

location_facility: Inst Nat Torax, Unidad Cardiopatia Congenitas Del Adulto

location_facility: Unidad de Investigacion Clin En Med, Sc (Udicem)

location_facility: Hosp Univ Virgen Macarena - Dpt Cardiology

location_facility: Clin Hosp For Inf and Pulm Dis Victor Babes - Ii Pulm

location_facility: Hosp Univ Vall D'Hebron - Dpt Congenital Heart Disease Adult

location_facility: Hosp Cardiology Haut Leveque - Dept Congenital Diseases

location_facility: The General Hosp of Shenyang Military Region

location_facility: Mhat Nat Card Hosp - Pediatric Clin / Ped Card Dept

location_facility: Universitätsklinikum Giessen - Pediatric Heart Center

location_facility: Barnes-Jewish Hosp/Wash Univ School of Med

location_facility: Emory University Hospital/the Emory Clinic

location_facility: Instituto Nacional de Cardiologia (Inc) Ignacio Chavez

location_facility: Mother and Child Health Care Inst "Dr Vukan Cupic"

location_facility: Er Inst For Cardvasc Dis "Prof Dr Cc Iliescu" - Card Ii

location_facility: Hosp Pompidou - Dept Congenital Cardiac Diseases

location_facility: Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

location_facility: Guangdong General Hospital, Cardiology Dpt


title: Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

acronym: MAESTRO-OL

summary: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

location_country:
Germany
Poland
Vietnam
Chile
Serbia
France
Portugal
United States
Romania
China
Malaysia
Philippines
United Kingdom
Austria
Mexico
Spain
Greece
Bulgaria
Russian Federation

location_facility: Bristol Univ Hosp Congenital Heart Centre

location_facility: Hosp La Timone - Dept Pediatric Cardiology

location_facility: Texas Children'S Hosp - Dept of Cardiology

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Dedinje Cardiovasc Inst - Cardiovasc Research Ctr

location_facility: Mother and Child Health Care Institute Dr. Vukan Cupic

location_facility: Sci Institute Systemic Poriblems Cardio Diseases Kemerovo


title: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)

acronym: SABLE

summary: The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

status: Active, not recruiting

time_perspective: Prospective

ipd_sharing: No

location_country:
Germany
Italy
Portugal
Slovakia
Israel
Argentina
Sweden
Austria
Belgium
United States
Spain
Canada
France

intervention_type: Other

status_simplified: Ongoing


title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma

summary: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

ReferenceCitation: Kim YH, Bagot M, Pinter-Brown L, Rook AH, Porcu P, Horwitz SM, Whittaker S, Tokura Y, Vermeer M, Zinzani PL, Sokol L, Morris S, Kim EJ, Ortiz-Romero PL, Eradat H, Scarisbrick J, Tsianakas A, Elmets C, Dalle S, Fisher DC, Halwani A, Poligone B, Greer J, Fierro MT, Khot A, Moskowitz AJ, Musiek A, Shustov A, Pro B, Geskin LJ, Dwyer K, Moriya J, Leoni M, Humphrey JS, Hudgens S, Grebennik DO, Tobinai K, Duvic M; MAVORIC Investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018 Sep;19(9):1192-1204. doi: 10.1016/S1470-2045(18)30379-6. Epub 2018 Aug 9. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581.

repository_institution: University of Turin - Institutional Research Information System University of Turin

lead_sponsor: Kyowa Kirin, Inc.

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Japan
Netherlands
Switzerland
United States
Spain
France

location_facility: The Winship Cancer Institute (Emory University)

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Rochester School of Medicine

location_facility: Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: University of Pittsburgh School of Medicine

location_facility: Washington University School of Medicine

location_facility: Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna

location_facility: Boston Medical Center, Department of Medicine, Section of Hem/Onc

location_facility: The Christie Hospital Foundation NHS Trust


summary: This study assessed the effect on asthma control of different dose levels and regimens of QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2 agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab. Information from this study was planned to support the design of future studies.

title: A Multi-center, Randomized, Double-blind, Placebo and Active-controlled Study With Exploratory Dose-ranging to Investigate the Efficacy and Safety of 16 Weeks Treatment With Subcutaneous (s.c.) QGE031 in Asthma Patients Not Adequately Controlled With High-dose Inhaled Corticosteroids and Long Acting β2-agonists

location_country:
Finland
Germany
Poland
Argentina
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
United States
India
Romania
Italy
Guatemala
United Kingdom
Singapore
Mexico
Korea, Republic of
Panama
South Africa
Russian Federation
Israel


title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

summary: This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

ReferenceCitation: Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.

publisher_dissemination: COPD Foundation

location_country:
Slovenia
Guatemala
Colombia
Slovakia
Hungary
United States
Panama
Egypt
France


lead_sponsor: Takeda

summary: This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)

ReferenceCitation: Ansell SM, Radford J, Connors JM, Dlugosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM, Smolewski P, Savage KJ, Bartlett NL, Eom HS, Abramson JS, Dong C, Campana F, Fenton K, Puhlmann M, Straus DJ; ECHELON-1 Study Group. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2022 Jul 28;387(4):310-320. doi: 10.1056/NEJMoa2206125. Epub 2022 Jul 13.

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

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Evens AM, Connors JM, Younes A, Ansell SM, Kim WS, Radford J, Feldman T, Tuscano J, Savage KJ, Oki Y, Grigg A, Pocock C, Dlugosz-Danecka M, Fenton K, Forero-Torres A, Liu R, Jolin H, Gautam A, Gallamini A. Older patients (aged >/=60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. Haematologica. 2022 May 1;107(5):1086-1094. doi: 10.3324/haematol.2021.278438.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Straus DJ, Dlugosz-Danecka M, Connors JM, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2. Erratum In: Lancet Haematol. 2022 Feb;9(2):e91.

ReferenceCitation: Straus DJ, Dlugosz-Danecka M, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Connors JM, Radford J, Munoz J, Kim WS, Advani R, Ansell SM, Younes A, Miao H, Liu R, Fenton K, Forero-Torres A, Gallamini A. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020 Mar 5;135(10):735-742. doi: 10.1182/blood.2019003127.

ReferenceCitation: Ramchandren R, Advani RH, Ansell SM, Bartlett NL, Chen R, Connors JM, Feldman T, Forero-Torres A, Friedberg JW, Gopal AK, Gordon LI, Kuruvilla J, Savage KJ, Younes A, Engley G, Manley TJ, Fenton K, Straus DJ. Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clin Cancer Res. 2019 Mar 15;25(6):1718-1726. doi: 10.1158/1078-0432.CCR-18-2435. Epub 2019 Jan 7.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984. Epub 2017 Dec 10. Erratum In: N Engl J Med. 2018 Mar 1;378(9):878.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

ReferenceCitation: Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

sponsor_collaborators:
Takeda
Seagen Inc.

title: A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

type: Registry Identifier

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.

location_country:
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Hong Kong
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

acronym: ATLAS

summary: This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

ReferenceCitation: Calabrese JR, Jin N, Johnson B, Such P, Baker RA, Madera J, Hertel P, Ottinger J, Amatniek J, Kawasaki H. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018 Jun 10;6(1):14. doi: 10.1186/s40345-018-0122-z.

publisher_dissemination: Springer-Nature

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Hungary
Romania
Japan
United States
Korea, Republic of
Malaysia
Taiwan
Canada
France


title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1

summary: The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Germany
Poland
Switzerland
United States
Canada
France


acronym: WAVES

summary: The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

ReferenceCitation: Squires K, Kityo C, Hodder S, Johnson M, Voronin E, Hagins D, Avihingsanon A, Koenig E, Jiang S, White K, Cheng A, Szwarcberg J, Cao H. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016 Sep;3(9):e410-e420. doi: 10.1016/S2352-3018(16)30016-9. Epub 2016 May 27.

ReferenceCitation: Hodder S, Squires K, Gathe J, Kityo C, Supparatpinyo K, Moshkovich G, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Presented at Interscience Conference on Antimicrobial Agents and Chemotherapy and International Congress of Chemotherapy and Infection (ICAAC/ICC) 2015; September 17-21; San Diego, CA.

ReferenceCitation: Squires K, Kityo C, Hodder S, Hagins D, Avihingsanon A, Plotnikova Y, et al. Elvitegravir (EVG)/cobicistat (COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is superior to ritonavir (RTV)-boosted atazanavir (ATV) plus FTC/TDF in treatment-naive women with HIV-1 infection (WAVES study). Poster no. MOLBPE08. Presented at 8th International Antiviral Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, 2015; 19-22 July, Vancouver, BC, Canada.

ReferenceCitation: Hodder S, Kityo C, Koenig E, Mussini C, Post F, Romanova S, et al. Genotypic analysis of the global clinical trial of treatment-naive women. Abstract 16. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

ReferenceCitation: Squires K, Hodder S, Kityo C, Clumeck N, Johnson M, Plotnikova Y, et al. Enrollment in the Women's Antiretroviral Efficacy and Safety study (WAVES), a Phase 3 global study assessing antiretroviral regimen in treatment-naive women. Abstract 54. Presented at 5th International Workshop on HIV & Women, 2015; 21-22 February, Seattle, WA.

location_facility: Mortimer Market Centre and Central and North West London NHS Foundation Trust

location_facility: St.Petersburg GUZ "Center for Prevention and Control of AIDS and Infectious Diseases", Out-patient Department

location_facility: East Carolina University The Brody School of Medicine Div. of Infectious Diseases

location_facility: Sverdlovsk Regional Center for Prevention and control of AIDS and Infectious Diseases

location_facility: State Healthcare Institution Infectious Clinical Hospital #2 of Moscow City Healthcare Department

location_facility: St.Petersburg Center for Prevention and Control of AIDS and Infectious Diseases, In-patient Department

location_facility: GKUZ MO "Center for Prevention and Treatment of AIDS and Infectious Diseases" (Moscow Regional AIDS Center)

location_facility: Bamrasnaradura lnfectious Disease Institute

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Clinica Malattie Infettive, Azienda Ospedaliero Universitaria

location_facility: Hospital Dos Capuchos, Centro Hospitalar De Lisboa Central

location_facility: GUZ "Irkutsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Department of Health Sciences - University of Milan - San Paolo Hospital

location_facility: Temple University Hospital- Internal General Medicine

location_facility: Perm Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: Infectious Disease Specialists of Atlanta

location_facility: State Budget Healthcare Institution "Clinical Centre for AIDS and Infectious Diseases Fight and Prevention" of Krasnodar regio Department for Healthcare

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: Saratov Regional Centre for Treatment and Prevention of AIDS and Infectious Diseases

location_facility: Queen Elizabeth Hospital, South London Healthcare NHS Trust

location_facility: Federal State Budgetary Institution "Republic Clinical Infectious Hospital"

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Budgetary Medical Facility of the Orel Region "Orel Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: Hospital de Santa Maria - Serviço de Doenças Infecciosas

location_facility: University of California, Davis Medical Center

location_facility: Intituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Khabarovsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: Salvador B Gautier Hospital, Infectious Diseases Department

location_facility: GUZ "Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: George Washington University Medical Faculty Associates

location_facility: State Budget Health Institution of Nizhniy Novgorod "Nizhniy Novgorod Regional Center of prophylaxis and treatment of AIDS and Infectious Diseases

location_facility: Saint-Petersburg GUZ "Clinical Infectious Hospital named after S.P.Botkin"

location_facility: Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Instituto Dominicano de Estudio Virologicos - IDEV

location_facility: GUZ "Voronezh Regional Center for Prevention and Control of AIDS and Infectious Diseases"

location_facility: Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

location_facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

location_facility: Republic of Altay Center for Prevention and Control of AIDS and Infectious Diseases

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: GUZ "Krasnoyarsk Territorial Center for Prevention and Control of AIDS and Infectious Diseases"

title: A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women

location_country:
Italy
Uganda
Portugal
United Kingdom
Mexico
Belgium
United States
Thailand
Dominican Republic
Puerto Rico
Russian Federation
France


summary: The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab

ReferenceCitation: Geoerger B, Bergeron C, Gore L, Sender L, Dunkel IJ, Herzog C, Brochez L, Cruz O, Nysom K, Berghorn E, Simsek B, Shen J, Pappo A. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma. Eur J Cancer. 2017 Nov;86:358-363. doi: 10.1016/j.ejca.2017.09.032. Epub 2017 Nov 5.

location_facility: James Whitcomb Riley Hospital For Children

location_facility: University Of Pittsburgh Medical Center Cancer Center

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

title: Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage IV Malignant Melanoma

location_country:
Germany
United Kingdom
Denmark
Mexico
Belgium
United States
Spain
France