title: A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

summary: To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

ReferenceCitation: Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

ReferenceCitation: Madan Cohen J, Checketts D, Dunayevich E, Gunning B, Hyslop A, Madhavan D, Villanueva V, Zolnowska M, Zuberi SM. Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials. Epilepsia. 2021 Sep;62(9):2218-2227. doi: 10.1111/epi.16974. Epub 2021 Jul 15.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Poland
United States
United Kingdom
France


ipd_sharing: No

status: Terminated

primary_purpose: Treatment

intervention_type: Drug

title: A Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Dystrophinopathy

study_completion_date_type: Actual

lead_sponsor: PTC Therapeutics

source: euctr

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Thangarajh M, Elfring GL, Trifillis P, McIntosh J, Peltz SW; Ataluren Phase 2b Study Group. The relationship between deficit in digit span and genotype in nonsense mutation Duchenne muscular dystrophy. Neurology. 2018 Sep 25;91(13):e1215-e1219. doi: 10.1212/WNL.0000000000006245. Epub 2018 Aug 22.

enrollment_type: Actual

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

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

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Child Neurology Center of Northwest Florida

location_facility: Universitat Munchen - von Haunersche Kinder Clinic

location_facility: University College London Institute of Child Health

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

location_facility: Columbia University College of Physicians & Surgeons

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

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Hospital Universitari i Politecnic la Fe

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

summary:
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study.

This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

summary: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Jiang X, Wada R, Poland B, Kleijn HJ, Fan B, Liu G, Liu H, Kapsalis S, Yang H, Le K. Population pharmacokinetic and exposure-response analyses of ivosidenib in patients with IDH1-mutant advanced hematologic malignancies. Clin Transl Sci. 2021 May;14(3):942-953. doi: 10.1111/cts.12959. Epub 2021 Jan 25.

ReferenceCitation: Choe S, Wang H, DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Watts JM, Pollyea DA, Fathi AT, Tallman MS, Kantarjian HM, Stone RM, Quek L, Konteatis Z, Dang L, Nicolay B, Nejad P, Liu G, Zhang V, Liu H, Goldwasser M, Liu W, Marks K, Bowden C, Biller SA, Attar EC, Wu B. Molecular mechanisms mediating relapse following ivosidenib monotherapy in IDH1-mutant relapsed or refractory AML. Blood Adv. 2020 May 12;4(9):1894-1905. doi: 10.1182/bloodadvances.2020001503.

ReferenceCitation: Fan B, Dai D, DiNardo CD, Stein E, de Botton S, Attar EC, Liu H, Liu G, Lemieux I, Agresta SV, Yang H. Clinical pharmacokinetics and pharmacodynamics of ivosidenib in patients with advanced hematologic malignancies with an IDH1 mutation. Cancer Chemother Pharmacol. 2020 May;85(5):959-968. doi: 10.1007/s00280-020-04064-6. Epub 2020 Apr 15.

ReferenceCitation: Roboz GJ, DiNardo CD, Stein EM, de Botton S, Mims AS, Prince GT, Altman JK, Arellano ML, Donnellan W, Erba HP, Mannis GN, Pollyea DA, Stein AS, Uy GL, Watts JM, Fathi AT, Kantarjian HM, Tallman MS, Choe S, Dai D, Fan B, Wang H, Zhang V, Yen KE, Kapsalis SM, Hickman D, Liu H, Agresta SV, Wu B, Attar EC, Stone RM. Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia. Blood. 2020 Feb 13;135(7):463-471. doi: 10.1182/blood.2019002140.

ReferenceCitation: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. doi: 10.1056/NEJMoa1716984. Epub 2018 Jun 2.

ReferenceCitation: Birendra KC, DiNardo CD. Evidence for Clinical Differentiation and Differentiation Syndrome in Patients With Acute Myeloid Leukemia and IDH1 Mutations Treated With the Targeted Mutant IDH1 Inhibitor, AG-120. Clin Lymphoma Myeloma Leuk. 2016 Aug;16(8):460-5. doi: 10.1016/j.clml.2016.04.006. Epub 2016 May 5.

ipd_sharing: Yes

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
France

location_facility: Northwestern University Medical Hospital

status_simplified: Ongoing


type: Other Identifier

title: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

summary:
The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Additionally, the utilization of Guide XT (GXT) System when used as a planning tool for the programming of patients with the Boston Scientific's Vercise DBS Systems is also evaluated.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: Hadassah Hebrew University Medical Center

location_facility: Wake Forest University School of Medicine

location_facility: University of Texas Health Medical Arts and Research Center

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Texas Institute for Neurological Disorders

location_facility: Azienda Ospedaliero-Universitaria di Ferrara

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University Berlin, Charite Virchow Standort, Wedding

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

intervention_type: Device


title: A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs

summary: This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

status: Completed

design_allocation: Randomized

ReferenceCitation: Jeyaratnam J, Simon A, Calvo I, Constantin T, Shcherbina A, Hofer M, Gattorno M, Martini A, Bader-Meunier B, Vastert B, Levy J, Dekker E, de Benedetti F, Frenkel J. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial. Rheumatology (Oxford). 2022 May 5;61(5):2088-2094. doi: 10.1093/rheumatology/keab696.

ReferenceCitation: De Benedetti F, Gattorno M, Anton J, Ben-Chetrit E, Frenkel J, Hoffman HM, Koné-Paut I, Lachmann HJ, Ozen S, Simon A, Zeft A, Calvo Penades I, Moutschen M, Quartier P, Kasapcopur O, Shcherbina A, Hofer M, Hashkes PJ, Van der Hilst J, Hara R, Bujan-Rivas S, Constantin T, Gul A, Livneh A, Brogan P, Cattalini M, Obici L, Lheritier K, Speziale A, Junge G. Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. N Engl J Med. 2018 May 17;378(20):1908-1919. doi: 10.1056/NEJMoa1706314.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Ireland
Italy
Netherlands
Russian Federation
Canada
United Kingdom
Switzerland
Hungary
United States
France
Israel
Turkey
Belgium
Japan
Germany

status_simplified: Completed


acronym: LixiLan-O

title: A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

lead_sponsor: Sanofi

type: EudraCT Number

ReferenceType: result

ReferenceCitation: Rosenstock J, Aronson R, Grunberger G, Hanefeld M, Piatti P, Serusclat P, Cheng X, Zhou T, Niemoeller E, Souhami E, Davies M; LixiLan-O Trial Investigators. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care. 2016 Nov;39(11):2026-2035. Epub 2016 Aug 15. Erratum in: Diabetes Care. 2017 Jun;40(6):809.

ReferenceCitation: Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.

ReferenceCitation: Davies MJ, Russell-Jones D, Barber TM, Lavalle-González FJ, Galstyan GR, Zhu D, Baxter M, Dessapt-Baradez C, McCrimmon RJ. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):1967-1972. doi: 10.1111/dom.13791. Epub 2019 Jun 18.

ReferenceCitation: Dailey G, Bajaj HS, Dex T, Groleau M, Stager W, Vinik A. Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world. BMJ Open Diabetes Res Care. 2019 Mar 21;7(1):e000581. doi: 10.1136/bmjdrc-2018-000581. eCollection 2019.

ReferenceCitation: Schmider W, Belder R, Lee M, Niemoeller E, Souhami E, Frias JP. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. Curr Med Res Opin. 2019 Jun;35(6):1081-1089. doi: 10.1080/03007995.2018.1558852. Epub 2019 Jan 11.

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

ReferenceCitation: Trujillo JM, Roberts M, Dex T, Chao J, White J, LaSalle J. Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone. Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 Aug 21.

ReferenceCitation: Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J. Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents. Diabetes Obes Metab. 2017 Dec;19(12):1798-1804. doi: 10.1111/dom.12980. Epub 2017 Jul 7.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
South Africa
Belgium
Poland
Russian Federation
Australia
Mexico
Sweden
Canada
Hungary
Germany
Denmark
Latvia
Estonia
Czech Republic
France
Chile

location_facility:
Investigational Site Number 616008
Investigational Site Number 840027
Investigational Site Number 152008
Investigational Site Number 428001
Investigational Site Number 840006
Investigational Site Number 826003
Investigational Site Number 643006
Investigational Site Number 840114
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Investigational Site Number 616002
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Investigational Site Number 440005
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Investigational Site Number 152003
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Investigational Site Number 616004
Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 642005
Investigational Site Number 642002
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Investigational Site Number 203004
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Investigational Site Number 840068
Investigational Site Number 724006
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Investigational Site Number 642006
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Investigational Site Number 036007
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Investigational Site Number 152009
Investigational Site Number 440007
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Investigational Site Number 724001
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Investigational Site Number 036005
Investigational Site Number 752004
Investigational Site Number 203001
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Investigational Site Number 643001
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Investigational Site Number 056001
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Investigational Site Number 348001
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Investigational Site Number 440003
Investigational Site Number 203003
Investigational Site Number 348004
Investigational Site Number 840095
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Investigational Site Number 840103

summary:
Primary Objective:

To compare the insulin glargine/lixisenatide fixed ratio combination to lixisenatide alone and to insulin glargine alone (on top of metformin treatment) in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine alone and to lixisenatide alone (on top of metformin treatment) over a 30 week treatment period in participants with type 2 diabetes.


title: A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant

lead_sponsor: Millennium Pharmaceuticals, Inc.

type: Registry Identifier

design_allocation: Non-Randomized

ReferenceCitation: Lim B, Potter DA, Salkeni MA, Silverman P, Haddad TC, Forget F, Awada A, Canon JL, Danso M, Lortholary A, Bourgeois H, Tan-Chiu E, Vincent S, Bahamon B, Galinsky KJ, Patel C, Neuwirth R, Leonard EJ, Diamond JR. Sapanisertib Plus Exemestane or Fulvestrant in Women with Hormone Receptor-Positive/HER2-Negative Advanced or Metastatic Breast Cancer. Clin Cancer Res. 2021 Jun 15;27(12):3329-3338. doi: 10.1158/1078-0432.CCR-20-4131. Epub 2021 Apr 5.

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:
United States
France
Belgium

location_facility: University of California at San Francisco (PARENT)

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: Eastchester Center for Cancer Care / BRANY

location_facility: Cancer Care Network of South Texas - SAT&BC

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Weill Cornell Medical College New York Presbyterian Hospital

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

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Oncology and Hematology Assoc. of SW VA, Inc.

summary: This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.


title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

summary:
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Denmark
Poland
Portugal
Romania
Spain
Italy
Austria
Australia
United Kingdom
Hungary
United States
France
Belgium
Czechia

location_facility: Institute of Hematology "L. e A. Seràgnoli"

location_facility: University of Debrecen HSC Institute of internal Medicine, Department of Hematology

location_facility: Washington University School of Medicine

location_facility: Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria

location_facility: Royal Liverpool & Broadgreen Univ. Hospitals

location_facility: SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga

location_facility: Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego

location_facility: Hospital of the University of Pennsylvania, Abramson Cancer Center

location_facility: Willamette Valley Cancer Center and Research Institute

location_facility: Hospital Clinico Universitario De Valencia (Chuv)

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

location_facility: Innsbruck University Hospital, Inner Medicine,

location_facility: Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie

location_facility: Emergency County Clinical Hospital Brasov

location_facility: University Hospital Southampton NHS Trust

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Hospital Universitario Marques de Valdecilla


title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation

lead_sponsor: Sucampo Pharma Americas, LLC

ReferenceCitation: Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7.

ipd_sharing_description: Basic results are provided here, with statistical results and discussion reserved for publications.

location_country:
Poland
United Kingdom
Canada
United States
France
Belgium
Netherlands

location_facility: UnityPoint Health Des Moines/ Blank Children's Clinic

location_facility: The Children's Hospital of the King's Daughter

location_facility: Great Ormond Street Hospital for children NHS Foundation Trust

location_facility: Pediatric Gastroenterology Carilion Medical Center

location_facility: Pediatric Research of Charlottesville, LLC

location_facility: Monroe Carell Junior Children's Hospital at Vanderbilt

location_facility: University of South Alabama Women's and Children's Hospital

location_facility: University of Alabama Pediatric Gastroenterology

location_facility: Children's Center for Digestive Healthcare/GI Care for Kids

location_facility: Midwest Children's Health Research Institute

location_facility: Arkansas Children's Hospital Research Institute

location_facility: St. Christopher's Hospital for Children/Drexel University

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: University of Oklahoma Health Sciences Center

location_facility: Coastal Pediatric Associates - James Island

location_facility: INOVA Pediatric Digestive Diseases Center

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: University of Mississippi Medical Center

location_facility: Digestive Diseases and Nutrition Center Women and Childrens Hospital of Buffalo

location_facility: Coastal Pediatrics Associates - Mount Pleasant

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit

location_facility: Morgan Stanley Children's Hospital of New York Presbyterian

location_facility: Texas Tech University Health Sciences Center

location_facility: Arizona Children's Center at Maricopa Medical Center

summary: Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.


acronym: CheckMate 140, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation

title: A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martín-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.

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

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

summary: The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.


acronym: CheckMate 139: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 139

title: A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT

ReferenceCitation: Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.

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

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Columbia University Medical Center (Cumc)

summary: The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT


title: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTS WITH DOWN SYNDROME (CLEMATIS)

summary: This multi-center, randomized, double-blind, 3-arm, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RG1662 in adults and adolescents with Down syndrome. Subjects will be randomized to receive RG1662 either at low or high dose or placebo orally twice daily for 26 weeks.

ReferenceCitation: Goeldner C, Kishnani PS, Skotko BG, Casero JL, Hipp JF, Derks M, Hernandez MC, Khwaja O, Lennon-Chrimes S, Noeldeke J, Pellicer S, Squassante L, Visootsak J, Wandel C, Fontoura P, d'Ardhuy XL; Clematis Study Group. A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABA(A)-α5 NAM (basmisanil) on intellectual disability associated with Down syndrome. J Neurodev Disord. 2022 Feb 5;14(1):10. doi: 10.1186/s11689-022-09418-0.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
New Zealand
Argentina
Canada
United States
France
Mexico
Singapore

location_facility: University of Wisconsin Madison, Waisman Center

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Emory University School of Medicine; Department of Human Genetics & Pediatrics

location_facility: Policlinico Universitario "Agostino Gemelli";Dip. Tutela Salute Donna Bambino Adolescente

location_facility: Mental Health of Learning Disability, Kent & Medway NHS and Social Care Partnership Trust

location_facility: KK Women's and Children's Hospital; Department of Neonatology

location_facility: UVaMID Hospital Santa Caterina;; Servicio de Neurología

location_facility: CHU de Saint Etienne; Service de Génétique

location_facility: Hospital Universitario de la Princesa; Medicina Interna

location_facility: Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon

location_facility: Institut Jérôme Lejeune; Neuropsychology

location_facility: University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

location_facility: University of Otago; Psychological Medicine Department

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Clínica Para la Atención del Neurodesarrollo

location_facility: IMIM, Human Pharmacology and Clinical Neurosciences,

location_facility: Ospedale Microcitemico; Clinica Pediatrica

location_facility: University of Utah School of Medicine; Department of Pediatrics

location_facility: Massachusette General Hospital; Medical Genetics

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust; Child Development and Family Support Centre

location_facility: Fundación Síndrome de Down; Fundación Síndrome de Down

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Cornwall Partnership NHS Foundation Trust

location_facility: Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary

location_facility: Hospital Infantil Universitario Niño Jesus; Pediatria Social


title: A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma

acronym: CheckMate 143

summary: The purpose of the study is to compare the efficacy and safety of nivolumab administered alone versus bevacizumab in patients diagnosed with recurrent glioblastoma (a type of brain cancer, also known as GBM), and to evaluate the safety and tolerability of nivolumab administered alone or in combination with ipilimumab in patients with different lines of GBM therapy.

status: Active, not recruiting

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170.

ReferenceCitation: Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bähr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Jul 1;6(7):1003-1010. doi: 10.1001/jamaoncol.2020.1024.

ReferenceCitation: Stupp R. Drug development for glioma: are we repeating the same mistakes? Lancet Oncol. 2019 Jan;20(1):10-12. doi: 10.1016/S1470-2045(18)30827-1. Epub 2018 Dec 3.

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

location_facility: Johns Hopkins University School Of Medicine

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: The Regents of the University of California, San Francisco

intervention_type: Biological


title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

summary:
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

ReferenceCitation: Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Müllhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18. Erratum in: Lancet Infect Dis. 2016 Jun;16(6):636.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
New Zealand
Switzerland
United Kingdom
France
Belgium
Germany

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie

location_facility: London Health Sciences Centre-University Hospital

location_facility: University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I

location_facility: Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,

location_facility: University Health Network // Toronto General Hospital

location_facility: IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: University of British Columbia and Vancouver General Hospital

location_facility: Division of Gastroenterology, University of Alberta, Edmonton

location_facility: McGill University Health Centre \\ Royal Victoria Hospital

location_facility: Kings College Hospital, Institute of Liver Studies

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh

location_facility: Royal Prince Alfred Hospital, University of Sydney

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre

location_facility: Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino

location_facility: Hospital Universitario y Politecnico La Fe de Valencia


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)

lead_sponsor: Alexion Pharmaceuticals

ReferenceType: background

ReferenceCitation: Howard JF Jr, Barohn RJ, Cutter GR, Freimer M, Juel VC, Mozaffar T, Mellion ML, Benatar MG, Farrugia ME, Wang JJ, Malhotra SS, Kissel JT; MG Study Group. A randomized, double-blind, placebo-controlled phase II study of eculizumab in patients with refractory generalized myasthenia gravis. Muscle Nerve. 2013 Jul;48(1):76-84. doi: 10.1002/mus.23839. Epub 2013 Apr 30.

ReferenceCitation: Howard JF Jr, Utsugisawa K, Benatar M, Murai H, Barohn RJ, Illa I, Jacob S, Vissing J, Burns TM, Kissel JT, Muppidi S, Nowak RJ, O'Brien F, Wang JJ, Mantegazza R; REGAIN Study Group. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017 Dec;16(12):976-986. doi: 10.1016/S1474-4422(17)30369-1. Epub 2017 Oct 20. Erratum in: Lancet Neurol. 2017 Dec;16(12 ):954.

ReferenceCitation: Monteleone JPR, Gao X, Kleijn HJ, Bellanti F, Pelto R. Eculizumab Pharmacokinetics and Pharmacodynamics in Patients With Generalized Myasthenia Gravis. Front Neurol. 2021 Nov 2;12:696385. doi: 10.3389/fneur.2021.696385. eCollection 2021.

ReferenceCitation: Siddiqi ZA, Nowak RJ, Mozaffar T, O'Brien F, Yountz M, Patti F; REGAIN Study Group. Eculizumab in refractory generalized myasthenia gravis previously treated with rituximab: subgroup analysis of REGAIN and its extension study. Muscle Nerve. 2021 Dec;64(6):662-669. doi: 10.1002/mus.27422. Epub 2021 Oct 14.

ReferenceCitation: Nowak RJ, Muppidi S, Beydoun SR, O'Brien FL, Yountz M, Howard JF Jr. Concomitant Immunosuppressive Therapy Use in Eculizumab-Treated Adults With Generalized Myasthenia Gravis During the REGAIN Open-Label Extension Study. Front Neurol. 2020 Nov 24;11:556104. doi: 10.3389/fneur.2020.556104. eCollection 2020.

ReferenceCitation: Mantegazza R, Wolfe GI, Muppidi S, Wiendl H, Fujita KP, O'Brien FL, Booth HDE, Howard JF Jr; REGAIN Study Group. Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension. Neurology. 2021 Jan 26;96(4):e610-e618. doi: 10.1212/WNL.0000000000011207. Epub 2020 Nov 23.

ReferenceCitation: Mantegazza R, O'Brien FL, Yountz M, Howard JF Jr; REGAIN study group. Consistent improvement with eculizumab across muscle groups in myasthenia gravis. Ann Clin Transl Neurol. 2020 Aug;7(8):1327-1339. doi: 10.1002/acn3.51121. Epub 2020 Jul 22.

ReferenceCitation: Jacob S, Murai H, Utsugisawa K, Nowak RJ, Wiendl H, Fujita KP, O'Brien F, Howard JF Jr. Response to eculizumab in patients with myasthenia gravis recently treated with chronic IVIg: a subgroup analysis of REGAIN and its open-label extension study. Ther Adv Neurol Disord. 2020 May 6;13:1756286420911784. doi: 10.1177/1756286420911784. eCollection 2020.

ReferenceCitation: Vissing J, Jacob S, Fujita KP, O'Brien F, Howard JF; REGAIN study group. 'Minimal symptom expression' in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab. J Neurol. 2020 Jul;267(7):1991-2001. doi: 10.1007/s00415-020-09770-y. Epub 2020 Mar 18.

ReferenceCitation: Andersen H, Mantegazza R, Wang JJ, O'Brien F, Patra K, Howard JF Jr; REGAIN Study Group. Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Aug;28(8):2247-2254. doi: 10.1007/s11136-019-02148-2. Epub 2019 Mar 23. Erratum in: Qual Life Res. 2019 May 21;:.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Australia
Argentina
Turkey
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: Southern Illinois University School of Medicine

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp.

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of California Davis Health System

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

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Wayne State University School of Medicine

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: Johns Hopkins University School Of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of California San Francisco-Fresno

location_facility: Azienda Ospedaliera Sant'Andrea - Università di Roma La Sapienza

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Seoul Metropolitan Government Seoul National University

location_facility: Hospital For Special Surgery/New York Presbyterian Hospital Cornell Campus

location_facility: HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

location_facility: University of Florida Health Science Center

summary: The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.


title: A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma

summary: This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Tilly H, Morschhauser F, Bartlett NL, Mehta A, Salles G, Haioun C, Munoz J, Chen AI, Kolibaba K, Lu D, Yan M, Penuel E, Hirata J, Lee C, Sharman JP. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study. Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14.

lead_sponsor: Genentech, Inc.

location_facility: Hopital Henri Mondor, Unite Hemopathies lymphoides

location_facility: Willamette Valley Clinical Studies; Cancer Institute

location_facility: Hopital Claude Huriez - CHU Lille; Service des maladies du sang


title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DNIB0600A Compared to Pegylated Liposomal Doxorubicin Administered Intravenously to Patients With Platinum-Resistant Ovarian Cancer

ReferenceCitation: Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, Moore KN, Mackowiak-Matejczyk B, Pikiel J, Ray-Coquard I, Trask P, Lin K, Schuth E, Vaze A, Choi Y, Marsters JC, Maslyar DJ, Lemahieu V, Wang Y, Humke EW, Liu JF. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Ann Oncol. 2018 Apr 1;29(4):917-923. doi: 10.1093/annonc/mdy023.

location_country:
Poland
Spain
United Kingdom
Canada
United States
France
Belgium

location_facility: Oklahoma University Health Sciences Center

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: University of California Irvine Medical Center

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Neumologia

summary: This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (RO5541081) in comparison with PLD in participants with PROC, primary peritoneal cancer or fallopian tube cancer. Participants will be randomized to receive either DNIB0600A 2.4 milligrams per kilogram (mg/kg) intravenously (IV) every 3 weeks or PLD 40 milligrams per meter-squared (mg/m^2) IV every 4 weeks.


title: A Phase IIB, Randomized, Blinded, Dose-ranging, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Dose Response Relationship of GSK1278863 Over the First 4 Weeks of Treatment and Evaluate the Safety and Efficacy of GSK1278863 Over 24 Weeks in Hemodialysis-Dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Switch From Recombinant Human Erythropoietin

summary: This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease (CKD) who are switched from a stable dose of recombinant human erythropoietin (rhEPO). The data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Poland
Spain
United Kingdom
Russian Federation
Australia
Canada
Sweden
Hungary
Korea, Republic of
United States
France
Norway
Japan
Germany
Czechia


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:
Spain
Australia
Canada
United States
France
Germany

location_facility:
Site AU61001
Site US10029
Site US10058
Site ES34003
Site FR33003
Site US10057
Site US10045
Site US10012
Site US10014
Site US10027
Site AU61004
Site ES34002
Site DE49002
Site US10030
Site US10015
Site US10047
Site US10049
Site US10031
Site DE49003
Site US10046
Site US10020
Site ES34004
Site US10048
Site CA15006
Site DE49001
Site US10041
Site AU61002
Site US10038
Site DE49008
Site US10036
Site FR33005
Site US10028
Site US10023
Site FR33004
Site US10026
Site US10037
Site ES34001
Site US10003
Site FR33001
Site US10050
Site CA15003
Site US10013
Site US10004
Site US10044
Site US10011
Site US10018
Site US10009
Site US10016
Site US10042
Site CA15004
Site CA15005
Site DE49005
Site US10001


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.

lead_sponsor: FORUM Pharmaceuticals Inc

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


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.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Netherlands
United States
Spain
France


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)

ReferenceCitation: Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller 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.

lead_sponsor: Bayer

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


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.

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). pii: e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

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. pii: S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. [Epub ahead of print]

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, Çelen 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.

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

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: University of Manitoba, Health Sciences Center

location_facility: SPZOZ, Wojewódzki Specjalistyczny Szpital

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

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di

location_facility: MHAT Alexandrovska Medical University, Sofia

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

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Pusan National University Yangsan Hospital

location_facility: Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Seth GS Medical College and KEM Hospital

location_facility: S. R Kalla Memorial Gastro & General Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

location_facility: Azienda Ospedaliero Universitaria Pisana

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

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

location_facility: Kyoto Prefectural University of Medicine

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

location_facility: Government Medical College and Superspecialty Hospital

location_facility: Dicle University Medical Faculty Department of Infectious Diseases

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

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Scientific Research Institute of Nutrition

location_facility: Waikato Hospital (District Health Board)

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Global Hospital Super Specialty & Transplant Centre

location_facility: Institute of Clinical Immunology RAMS, Clinic of Immunopathology

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

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

location_facility: University Health Network / Toronto General Hospital

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: YR Gaitonde Centre for AIDS Research and Education

location_facility: Spitatul Clinic de Boli Infectioase Constanta

location_facility: Policlinico Universitario G. Martino via Consolare

location_facility: Scientific Research Institute of Clinical Immunology

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Nottingham University Hospitals NHS Trust

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

location_facility: Limited Liability Company "Modern Medicine Clinic"

location_facility: Severance Hospital Yonsei University Health System

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

location_facility: People's Friendship University of Russia

location_facility: Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci


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

lead_sponsor: Merz Pharmaceuticals GmbH

ReferenceCitation: Heinen F, Kanovský 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.

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). pii: 585. doi: 10.3390/toxins14090585.

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

location_facility:
Merz Investigational Site #007014
Merz Investigational Site #048084
Merz Investigational Site #380002
Merz Investigational Site #420029
Merz Investigational Site #372001
Merz Investigational Site #048089
Merz Investigational Site #049329
Merz Investigational Site #048075
Merz Investigational Site #040001
Merz Investigational Site #972003
Merz Investigational Site #421004
Merz Investigational Site #034030
Merz Investigational Site #380003
Merz Investigational Site #043036
Merz Investigational Site #007018
Merz Investigational Site #082018
Merz Investigational Site #033054
Merz Investigational Site #033056
Merz Investigational Site #040002
Merz Investigational Site #082019
Merz Investigational Site #380005
Merz Investigational Site #380001
Merz Investigational Site #090002
Merz Investigational Site #421003
Merz Investigational Site #007019
Merz Investigational Site #007017
Merz Investigational Site #034026
Merz Investigational Site #420028
Merz Investigational Site #082020
Merz Investigational Site #048072
Merz Investigational Site #090005
Merz Investigational Site #972002
Merz Investigational Site #048061
Merz Investigational Site #034031
Merz Investigational Site #049326
Merz Investigational Site #421008
Merz Investigational Site #082021
Merz Investigational Site #421006
Merz Investigational Site #048063
Merz Investigational Site #049327
Merz Investigational Site #033055
Merz Investigational Site #040003
Merz Investigational Site #043037
Merz Investigational Site #049328
Merz Investigational Site #090003
Merz Investigational Site #372002
Merz Investigational Site #007015
Merz Investigational Site #007013
Merz Investigational Site #033052
Merz Investigational Site #049330
Merz Investigational Site #972001
Merz Investigational Site #048059
Merz Investigational Site #034032

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.


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.

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

location_facility:
Site DE49015
Site DE49007
Site BE32001
Site FR33010
Site US10021
Site DE49013
Site ES34003
Site AU43004
Site KR82003
Site KR82004
Site US10045
Site JP81003
Site US10012
Site US10007
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Site ES34007
Site US10027
Site JP81011
Site ES34002
Site DE49002
Site US10030
Site US10010
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Site SE46006
Site US10047
Site US10031
Site US10046
Site KR82001
Site US10020
Site JP81010
Site JP81004
Site DE49006
Site ES34004
Site AU43001
Site FR33011
Site DE49001
Site CA15002
Site ES34005
Site SE46003
Site DE49008
Site DE49014
Site US10036
Site FR33005
Site US10028
Site CA15001
Site ES34011
Site DE49010
Site US10023
Site US10039
Site US10026
Site US10035
Site US10019
Site KR82002
Site FR33009
Site JP81005
Site ES34001
Site JP81008
Site DE49012
Site BE32005
Site US10025
Site JP81001
Site SE46004
Site CA15003
Site US10013
Site TW88601
Site US10044
Site JP81007
Site JP81006
Site US10011
Site US10043
Site ES34010
Site TW88603
Site SE46005
Site US10042
Site US10016
Site BE32007
Site CA15004
Site TW88602
Site JP81009
Site US10002
Site SE46001
Site DE49005
Site US10024


acronym: ACOUSTICS

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.

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.

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

location_facility: National Hospital Organization Shimoshizu National Hospital

location_facility: SI Research Centre of Radiation Medicine of AMSU

location_facility: State Institution of Pediatrics Obstetrics and Gynecology of NAMSU

location_facility: Birmingham Children's Hospital NHS Foundation Trust

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

location_facility: Cincinnati Children's Hospital Medical Center

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

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: Dumfries and Galloway Royal Infirmary; Department of Paediatrics

location_facility: South Texas Allergy and Asthma Medical Professionals

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

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

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

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

location_facility: Clinical Research Inst. of Southern Oregon, Pc

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

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

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Consultorio Especialidad Alergologia Pediatrica

location_facility: Centre de Recherche Applique En Allergie de Quebec

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

location_facility: GCT Mercantile; Clinical Research Centre

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

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Instituto de Pesquisa Clínica e Medicina Avançada Ltda

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

location_facility: Investigaciones en Patologias Respiratorias

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

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Riley Hospital for Children; Pediatric Nephrology

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Colorado Children's Hospital; The Breathing Institute

location_facility: Hospital Dona Estefania; Servico de Imunoalergologia

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Cardinal Glennon Child's Hosp; Endrocrinology

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: National Hospital Organization Mie Hospital

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

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

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

location_facility: Centro Integral de Medicina Respiratoria (CIMER)

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: Hospital Particular do Algarve - Unidade de Faro

location_facility: National Jewish Medical and Research Center

location_facility: Municipal Institution Zaporizhzhya Regional Clinical Child Hospital

location_facility: Allergy & Asthma Medical Group; Clinical Research Division

location_facility: Hospital Infante D. Pedro; Servico de Imunoalergologia

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

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.


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.

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

location_facility: Multiprofile Hospital For Active Treatment prof Kirkovich

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

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

location_facility: Quality of Life Medical & Research Center

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

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

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Hikarigaoka Spellman Hospital; Rheumatology

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

location_facility: CEMER Centro Médico de Enfermedades Respiratorias

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: University of Wisconsin;Allergy & Asthma Clinical Research

location_facility: Canterbury Respiratory Research Group; Respiratory

location_facility: Diagnostic and Consulting Centre Mladost - M OOD

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

location_facility: Municipal Institution Zaporizhzhia City Multifield Clinical Hospital #9

location_facility: Royal Hallamshire Hospital; Department of Oncology

location_facility: Instituto de Investigaciones Clinicas-Mar del Plata

location_facility: Allergy and Clinical Immunology Associates

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

location_facility: Dr Anil Dhar Professional Medicine Corporation

location_facility: Yokohama City University Medical Center; Neurology

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

location_facility: Yaroslavl State Medical Academy - Clinical Hospital #2

location_facility: Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Tohoku Medical and Pharmaceutical University Wakabayashi Hospital

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

location_facility: Consultorio Especialidad Alergologia Pediatrica

location_facility: Medical Research Inst. of New Zealand; Respiratory

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

location_facility: SHATPD Sveta Sofia; Clin Pulmonary Diseases

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

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

location_facility: Saratov State Medical Univ; Clinical Immun & Allerg

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Alergo Medical Specjalistyczna Przychodnia Lekarska

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

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

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROFILAKTYKA Wladyslaw Pierzchala

location_facility: Concord Repatriation General Hospital; Department Thoracic Medicine

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

location_facility: Hospital Universitario la Paz; Servicio de Alergologia

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

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

location_facility: Hospital Nacional Adolfo; Guevara Velasco Essalud

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

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

location_facility: National Multiprofile Hospital Tsar Boris III

location_facility: SP ZOZ Bienkowka- Osrodek Zdrowia w Bienkowce

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Limpopo Clinical Research Initiative; Tamboti Medical Centre

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

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

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

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Integrity People Services Research Company

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: Instituto Peruano de Investigacion en Ciencias Medicas

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

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

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Howard County Center for Lung and Sleep, LLC

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

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Selye János Kórház és Rendelőintézet; Allergológiai Szakrendelés

location_facility: Baylor College of Medicine; Dept of Medicine

location_facility: Spitalul Clinic de Pneumoftiziologie Palazu Mare Constanta

location_facility: Del Carpio Jaime Dr - Allergiste & Immunologue

location_facility: Ordinace pro tuberkulozu a respiracni nemoci

location_facility: Southern California Institute For Respiratory

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

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

location_facility: EPIMRD, Inc. DBA Western Sky Medical Research

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: Medical Center for Specialized Outpatient Medical Care for Pulmonary Diseases

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

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

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

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

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

location_facility: Hadassah Medical Center; Pulmonary Institute

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research LLC

location_facility: Upstate Pharmaceutical Research; Greenville

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

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


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.

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.

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

location_facility: Ospedale de Bellis; Reparto Medicina Generale

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Clinical Infectious Diseases Hospital Victor Babes

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

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

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

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

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

location_facility: The Eighth People's Hospital of Guangzhou

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

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

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

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

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

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

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

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

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

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

location_facility: University Hospital of Larissa; Pathological Clinic

location_facility: Samsung Medical Center; Gastroenterology

location_facility: The 1st Affiliated Hospital of Harbin Medical University

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

location_facility: General Hospital of Ningxia Medical University

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

location_facility: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

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

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

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

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

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

location_facility: Nanjing No.2 Hospital; Liver Disease Department

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

location_facility: Wojewodzki Szpital Zakazny; Klinika Chorob Zakaznych

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

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

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

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

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

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

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

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: The Second Affiliated Hospital, Chongqing Medical University

location_facility: Nanfang Hospital, Southern Medical University

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

location_facility: Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale

location_facility: Uni Di Cagliari; Dept. Di Scienze Mediche

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Hospital For Infectious Diseases; Infectiology

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

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

location_facility: Hippokratio Hospital; 4Th Internal Medicine Dpt

location_facility: The Third Hospital of Hebei Medical University

location_facility: Inje University Busan Paik Hospital; Nephrology

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: China Medical University Hospital; Department of Rheumatology

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

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

location_facility: Xiangya Hospital of Centre-South University