title: Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window: a Randomized, Controlled Trial

acronym: Tension

summary: TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

ReferenceCitation: Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.

ReferenceCitation: Bendszus M, Bonekamp S, Berge E, Boutitie F, Brouwer P, Gizewski E, Krajina A, Pierot L, Randall G, Simonsen CZ, Zeleňák K, Fiehler J, Thomalla G. A randomized controlled trial to test efficacy and safety of thrombectomy in stroke with extended lesion and extended time window. Int J Stroke. 2019 Jan;14(1):87-93. doi: 10.1177/1747493018798558. Epub 2018 Aug 29.

lead_sponsor: University Hospital Heidelberg

location_country: Denmark Spain Austria Canada France Norway Germany Slovakia Czechia

location_facility: Comenius University's Jessenius Faculty of Medicine and University Hospital

location_facility: Universitätsklinikum KK Bochum-Langendreer Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Technische Universität München / Klinikum rechts der Isar

location_facility: Division of Neuroradiology, Vascular and Interventional Radiology, Department of Radiology, Medical University Graz

location_facility: CHU de Rennes/Centre Urgences-Réanimations

location_facility: CHRU Hôpiteaux de Tours / Hôpital Bretonneau

location_facility: Klinik für Radiologie und Neuroradiologie am Klinikum Mitte

location_facility: Comprehensive stroke center,University Hospital Ostrava

location_facility: Neuroradiology, Keppler University Hospital Linz

location_facility: Hôpiteaux Universitaires Paris-Sud, Hôpital Bicêtre

location_facility: Gesundheit Nord gGmbH Klinikverbund Bremen

location_facility: Universitätsinstitut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin Johannes Wesling Klinikum Minden

location_facility: Université Reims Champagne Ardenne/ Department of Neuroradiology, Hôpital Maison Blanche

location_facility: Department of Neurology, Reseach Institute of Neurointervention, Christian Doppler Clinic, Paracelsus Medical University Salzburg

lead_sponsor_type: academique


type: EudraCT Number

title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

summary: A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horváth G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbánek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.

ipd_sharing: Yes

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

lead_sponsor: AbbVie

location_country:
Poland
Taiwan
Portugal
Spain
Greece
Ireland
Italy
Russian Federation
Canada
United Kingdom
Vietnam
Hungary
Puerto Rico
United States
France
Israel
Romania
Bulgaria
Czechia

location_facility: The Ottawa Hospital Research /ID# 161179

location_facility: General and Oncology Hospital /ID# 162784

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 162645

location_facility: Stanford University School of Med /ID# 162209

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 163785

location_facility: HepID - Diagnostyka I Terapia /ID# 162761

location_facility: Texas Digestive Disease Consul /ID# 162648

location_facility: Duke University Medical Center /ID# 162299

location_facility: VA Long Beach Healthcare System /ID# 162298

location_facility: University Hospitals Cleveland /ID# 162243

location_facility: Northwestern University Feinberg School of Medicine /ID# 162208

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 162241

location_facility: Carolinas Center for Liver Dis /ID# 162569

location_facility: General Hospital of Athens Laiko /ID# 162786

location_facility: CHI Health Alegent Creighton /ID# 162286

location_facility: Institutul Nat. de Boli Infectioase /ID# 163488

location_facility: The University of Iowa Hospita /ID# 162214

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949

location_facility: Universita della Campania Luigi Vanvitelli /ID# 162337

location_facility: Central Clinical Hospital of R /ID# 163434

location_facility: Institut Klinicke a Experimeth /ID# 162900

location_facility: James J. Peters VA Medical Center /ID# 162644

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335

location_facility: St. Josephs Hosp and Med Ctr /ID# 162762

location_facility: Hospital Univ Central Asturias /ID# 162195

location_facility: Instituto de Investigacion Cientifica del Sur /ID# 162566

location_facility: Basildon University Hospital /ID# 162616

location_facility: Uniwersytecki Szpital Kliniczn /ID# 162757

location_facility: Polo Universitario Luigi Sacco /ID# 162339

location_facility: Percuro Clinical Research, Ltd /ID# 161184

location_facility: Lehigh Valley Health Network /ID# 162603

location_facility: Hospital Universitario Reina S /ID# 162200

location_facility: Icahn School of Med Mt. Sinai /ID# 162294

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 162340

location_facility: CBSI Central scientific and research institute of epidemiology /ID# 161996

location_facility: CHR Orleans - Hopital de la Source /ID# 163072

location_facility: China Medical University Hosp /ID# 162950

location_facility: Weill Cornell Medical College /ID# 161051

location_facility: RSAHI Consulting and Diagnostic Centre /ID# 161995

location_facility: Centro Hosp de Lisboa Central /ID# 163770

location_facility: National Hospital of Tropical Diseases /ID# 167974

location_facility: Centro Hospitalar do Porto EPE /ID# 163765

location_facility: Center for Liver Diseases, Oakland /ID# 162568

location_facility: Taipei Veterans General Hosp /ID# 162776

location_facility: Kaiser Permanente - San Diego (Palm Ave) /ID# 162289

location_facility: Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760

location_facility: Klinical Investigations Group /ID# 162565

location_facility: Stavropol State Medical Univ /ID# 161999

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 162185

location_facility: Hospital Parc de Salut del Mar /ID# 162198

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449

location_facility: LLC Medical Company Hepatolog /ID# 161998

location_facility: Centro Hospitalar de Sao Joao /ID# 163766

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 162313

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients With Heart Failure

summary: Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceCitation: Shah SJ, Borlaug BA, Chung ES, Cutlip DE, Debonnaire P, Fail PS, Gao Q, Hasenfuß G, Kahwash R, Kaye DM, Litwin SE, Lurz P, Massaro JM, Mohan RC, Ricciardi MJ, Solomon SD, Sverdlov AL, Swarup V, van Veldhuisen DJ, Winkler S, Leon MB; REDUCE LAP-HF II investigators. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. Lancet. 2022 Mar 19;399(10330):1130-1140. doi: 10.1016/S0140-6736(22)00016-2. Epub 2022 Feb 1.

ipd_sharing: No

lead_sponsor: Corvia Medical

location_country:
Denmark
Croatia
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
United States
France
Belgium
Japan
Germany

location_facility: University of Arizona College of Medicine

location_facility: Ohio State University College of Medicine

location_facility: Baylor University Medical Center, Dallas

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Kaiser Permanente San Francisco Medical Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: National Cerebral and Cardiovascular Center

location_facility: Christ Hospital Ohio Heart and Vascular Institute

location_facility: Virginia Commonwealth University Medical Center

location_facility: Heart Center of the University of Leipzig

intervention_type: Other

status_simplified: Ongoing


acronym: TAHOE

title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

source: euctr

ReferenceType: background

ReferenceCitation: Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10.

ReferenceCitation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Russian Federation
Australia
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Latvia
Korea, Republic of
France
Netherlands

location_facility: Universitair Medisch Centrum Groningen /ID# 158088

location_facility: National Medical Research Cntr /ID# 207436

location_facility: UT Southwestern Medical Center /ID# 158150

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 157001

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537

location_facility: Kaluga Regional Clinical Oncol /ID# 160179

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021

location_facility: N.N. Petrov Research Inst Onc /ID# 159312

location_facility: Institut za onkologiju i radio /ID# 160058

location_facility: National Cancer Ctr Singapore /ID# 158803

location_facility: Hospital Santa Creu i Sant Pau /ID# 159028

location_facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868

location_facility: Guy's and St Thomas' NHS Found /ID# 159581

location_facility: Kyungpook National University Chilgok Hospital /ID# 159292

location_facility: IFO Istituto Nazionale Tumori /ID# 158941

location_facility: Christiana Care Health Service /ID# 158171

location_facility: Ege University Medical Faculty /ID# 159239

location_facility: Evangelische Lungenklinik Berl /ID# 159168

location_facility: Volyn Regional Medical Oncology Centre /ID# 159124

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017

location_facility: Oregon Health and Science University /ID# 157055

location_facility: AUSL 8 Arezzo Ospedale San Don /ID# 160967

location_facility: Istituto Europeo di Oncologia /ID# 158942

location_facility: Hospital Clinico Universitario de Valencia /ID# 159027

location_facility: National University Hospital /ID# 158802

location_facility: West Virginia Univ School Med /ID# 155872

location_facility: Krajska nemocnice Liberec a.s. /ID# 159653

location_facility: Korea University Guro Hospital /ID# 159293

location_facility: James Cook University Hospital /ID# 159583

location_facility: Riga East Clinical University /ID# 158714

location_facility: Rigshospitalet, Finsen Centre /ID# 158051

location_facility: Cliniques universitaires Saint /ID# 158751

location_facility: Centro de Investigación Clinica Chapultepec /ID# 161000

location_facility: Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 160536

location_facility: The Cancer Institute Hospital Of JFCR /ID# 166249

location_facility: Bobruysk Interdistrict Onco. /ID# 169394

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 159169

location_facility: Hopital du Sacre Coeur Montreal /ID# 159515

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 155828

location_facility: Hospital Universitario HM Sanchinarro /ID# 159024

location_facility: Liga Norte Rio Grandense Cont. /ID# 159015

location_facility: Duplicate_Kanazawa University Hospital /ID# 165129

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 159641

location_facility: Assistance Publique- Hopitaux /ID# 160552

location_facility: Moore UC San Diego Cancer Center /ID# 156965

location_facility: Unidade Local Saude Matosinhos /ID# 158682

location_facility: Arkhangelsk clinical oncology /ID# 159309

location_facility: Asklepios Fachkliniken M. Gaut /ID# 158791

location_facility: Ataturk Gogus Hastaliklari ve /ID# 160056

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 158811

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 157054

location_facility: Municipal institution Multifie /ID# 159121

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665

location_facility: Southern Medical Day Care Ctr /ID# 158853

location_facility: Petz Aladar Megyei Oktato Korh /ID# 158978

location_facility: Klinika za plucne bolesti Jordanovac /ID# 159502

location_facility: Nemocnice Rudolfa a Stefanie /ID# 159652

location_facility: National Cheng Kung University Hospital /ID# 158844

location_facility: Taichung Veterans General Hosp /ID# 158866

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 159125

location_facility: National Taiwan University Hospital /ID# 158865

location_facility: St Jude Hospital dba St Joseph /ID# 155899

location_facility: Veszprem Megyei Tuedoegyogyint /ID# 162607

location_facility: National Cancer Center Hospital /ID# 166768

location_facility: Duplicate_Showa University Hospital /ID# 165574

location_facility: University of Vermont Medical Center /ID# 162317

location_facility: University Hospital of Ioannin /ID# 159163

location_facility: United Lincolnshire Hospitals /ID# 159579

location_facility: Kansai Medical University Hospital /ID# 165055

location_facility: Chungbuk National University /ID# 159291

location_facility: Los Angeles Hematology Oncolog /ID# 155879

location_facility: Odense Universitets Hospital /ID# 158050

location_facility: Inonu Universitesi Turgut Ozal /ID# 159241

location_facility: Yokohama City University Hospital /ID# 165748

location_facility: Aichi Cancer Center Hospital /ID# 164975

location_facility: Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668

location_facility: Institute For Pulmonary Diseas /ID# 158813

location_facility: Nebraska Hematology Oncology /ID# 155900

location_facility: Tokushima University Hospital /ID# 165812

location_facility: Yonsei University Health System, Severance Hospital /ID# 159288

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 158687

location_facility: Goshen Center for Cancer Care /ID# 155946

location_facility: St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550

location_facility: Tri-Service General Hospital /ID# 158985

location_facility: Copernicus PL Sp. z o. o., WCO /ID# 160538

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165

location_facility: Dup_Debreceni Egyetem Klinikai Központ /ID# 161209

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847

location_facility: CHU de Quebec-Universite Laval /ID# 159093

location_facility: Centre Hosp Intercommunal de Creteil /ID# 162684

location_facility: ME Kryviy Rih Oncology Dispensary /ID# 159119

location_facility: Smolensk Regional Onc Clin Dis /ID# 159314

location_facility: Chonnam National University Hospital /ID# 159294

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325

location_facility: Mogilev Reg. Oncologic dispe /ID# 159326

location_facility: Health Pharma Professional Research S.A de C.V /ID# 160020

location_facility: Klinicki bolnicki centar Rijeka /ID# 159501

location_facility: Hospital General Universitario Gregorio Maranon /ID# 159025

location_facility: CHA Bundang Medical center CHA University /ID# 204416

location_facility: Christie NHS Foundation Trust /ID# 159099

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 164374

location_facility: Spitalul Judetean de Urgenta A /ID# 160846

location_facility: Oncocenter Oncologie Clinica S /ID# 160848

location_facility: National Cancer Center Hospital East /ID# 165726

location_facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122

location_facility: Japanese Red Cross Okayama Hospital /ID# 165156

location_facility: Univ Medical Ctr Brackenridge /ID# 156967

location_facility: Dana-Farber Cancer Institute /ID# 160210

location_facility: Gabrail Cancer Center Research /ID# 155920

location_facility: Hacettepe University Medical Faculty /ID# 159238

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 158967

location_facility: Torokbalinti Tudogyogyintezet /ID# 207053

location_facility: Ospedale Santa Maria delle Cro /ID# 158940

summary: The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

summary: The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

ReferenceCitation: Kulasekararaj AG, Hill A, Rottinghaus ST, Langemeijer S, Wells R, Gonzalez-Fernandez FA, Gaya A, Lee JW, Gutierrez EO, Piatek CI, Szer J, Risitano A, Nakao S, Bachman E, Shafner L, Damokosh AI, Ortiz S, Röth A, Peffault de Latour R. Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2019 Feb 7;133(6):540-549. doi: 10.1182/blood-2018-09-876805. Epub 2018 Dec 3.

ReferenceCitation: Schwartz CE, Stark RB, Borowiec K, Nolte S, Myren KJ. Norm-based comparison of the quality-of-life impact of ravulizumab and eculizumab in paroxysmal nocturnal hemoglobinuria. Orphanet J Rare Dis. 2021 Sep 15;16(1):389. doi: 10.1186/s13023-021-02016-8.

ReferenceCitation: Ishiyama K, Nakao S, Usuki K, Yonemura Y, Ikezoe T, Uchiyama M, Mori Y, Fukuda T, Okada M, Fujiwara SI, Noji H, Rottinghaus S, Aguzzi R, Yokosawa J, Nishimura JI, Kanakura Y, Okamoto S. Results from multinational phase 3 studies of ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: subgroup analysis of Japanese patients. Int J Hematol. 2020 Oct;112(4):466-476. doi: 10.1007/s12185-020-02934-6. Epub 2020 Aug 31.

ReferenceCitation: Brodsky RA, Peffault de Latour R, Rottinghaus ST, Röth A, Risitano AM, Weitz IC, Hillmen P, Maciejewski JP, Szer J, Lee JW, Kulasekararaj AG, Volles L, Damokosh AI, Ortiz S, Shafner L, Liu P, Hill A, Schrezenmeier H. Characterization of breakthrough hemolysis events observed in the phase 3 randomized studies of ravulizumab versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria. Haematologica. 2021 Jan 1;106(1):230-237. doi: 10.3324/haematol.2019.236877.

lead_sponsor: Alexion Pharmaceuticals

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

intervention_type: Biological


title: A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

acronym: COMPETE

summary: The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

lead_sponsor: ITM Solucin GmbH

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Switzerland
United States
France
South Africa
Belgium
Germany
Czechia

location_facility: Klinikum rechts der Isar Technische Universität München

location_facility: University and Polytechnic Hospital La Fe

location_facility: Institut de Recherche en Cancérologie de Montpellier (IRCM)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Azienda Ospedaliera Universitaria (AOU) Policlinico "Gaetano Martino"

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl

location_facility: Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: Olivia Newton-John Cancer & Wellness Centre, Austin Hospital

location_facility: University Medical Center, Abteilung für Nuklearmedizin

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Banner Health d.b.a. Banner MD Anderson Cancer Center

location_facility: University Cape Town (UCT), Groote Schuur Hospital

location_facility: Moffitt Cancer Center & Research Institute

location_facility: University of Pretoria & Steve Biko Academic Hospital

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Central University Hospital de Asturias (HUCA)


title: A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)

acronym: CASPIAN

summary: This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer

ReferenceCitation: Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Özgüroğlu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Każarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.

ReferenceCitation: Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Özgüroğlu M, Ji JH, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Shire N, Jiang H, Goldman JW; CASPIAN investigators. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1929-1939. doi: 10.1016/S0140-6736(19)32222-6. Epub 2019 Oct 4.

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

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Ukraine
United States
Romania
Japan
Czechia
Poland
Austria
Russian Federation
Argentina
Israel
Turkey
Slovakia
Brazil
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Netherlands


title: Heart Failure Optimization Study

acronym: HF-Opt

summary: This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Zoll Medical Corporation

location_country:
Austria
Germany
United States
France

location_facility: CHU de Clermont-Ferrand- Hopital Albert Michallon

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Klinik u. Polikllinik Fur Innere Med. II Kardiologie

location_facility: Amper Kliniken AG, Heliios Amper-Klinikum Dachau

location_facility: Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)

location_facility: Methodist South (MS) University Hospital

location_facility: Texas Health Research & Education Institute

location_facility: CHU de Grenoble site Nord- Hopital Albert Michallon

intervention_type: Device


title: A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) in Subjects With Locally Advanced, Unresectable, or Metastatic Solid Tumors

acronym: COMBO

summary: The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV).

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Spain
Italy
Hungary
United States
France
Belgium
Netherlands

location_facility: Hematology - Oncology Associates of the Treasure Coast

location_facility: Centre Hospitalier de l'Ardenne - Pharmacie

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Yale University Institutional Review Board

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

status_simplified: Unknown


title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

ReferenceCitation: Höglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0.

location_country:
Spain
Italy
Australia
Canada
United States
France
Japan
Germany

location_facility: Neurodegenerative Disorders Re /ID# 153770

location_facility: Oregon Health and Science University /ID# 149774

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155092

location_facility: Hopital Universitaire Purpan /ID# 153152

location_facility: CHU Strasbourg Hautepierre Hos /ID# 206942

location_facility: University of Florida - Archer /ID# 144906

location_facility: COLUMBIA University Medical Center /ID# 149037

location_facility: St. Luke's Hosp. of Kansas Cit /ID# 168629

location_facility: National Hospital Organization Utano National Hospital /ID# 201979

location_facility: National Hospital Organization Higashinagoya National Hospital /ID# 201514

location_facility: Univ California, San Francisco /ID# 144897

location_facility: Rocky Mountain Movement Disorders Center /ID# 153397

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 201982

location_facility: University of Kentucky Chandler Medical Center /ID# 144891

location_facility: Central Texas Neurology Consul /ID# 167417

location_facility: Montreal Neurological Institut /ID# 156413

location_facility: Universitaetsklinikum Leipzig /ID# 201761

location_facility: Hospital General Universitario Gregorio Maranon /ID# 200876

location_facility: Policlinico Agostino Gemelli /ID# 153104

location_facility: National Center of Neurology and Psychiatry /ID# 202037

location_facility: University of California, Los Angeles /ID# 144896

location_facility: Rush University Medical Center /ID# 144894

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 201585

location_facility: Cleveland Clinic Lou Ruvo Cent /ID# 148919

location_facility: Universita di Catanzaro Magna Graecia /ID# 166322

location_facility: Cleveland Clinic Main Campus /ID# 144885

location_facility: NHO Sendai Nishitaga National Hospital /ID# 202132

location_facility: Juntendo University Hospital /ID# 200870

location_facility: Istituto Neuro Mediterraneo IR /ID# 153106

location_facility: Niigata University Medical & Dental Hospital /ID# 201680

location_facility: University of Alabama at Birmingham - Main /ID# 144892

summary: The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).


title: LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure

summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Giladi M, Weinberg U, Schneiderman RS, Porat Y, Munster M, Voloshin T, Blatt R, Cahal S, Itzhaki A, Onn A, Kirson ED, Palti Y. Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo. Semin Oncol. 2014 Oct;41 Suppl 6:S35-41. doi: 10.1053/j.seminoncol.2014.09.006. Epub 2014 Sep 8.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

ReferenceCitation: Voloshin T, Kaynan N, Davidi S, Porat Y, Shteingauz A, Schneiderman RS, Zeevi E, Munster M, Blat R, Tempel Brami C, Cahal S, Itzhaki A, Giladi M, Kirson ED, Weinberg U, Kinzel A, Palti Y. Tumor-treating fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy. Cancer Immunol Immunother. 2020 Jul;69(7):1191-1204. doi: 10.1007/s00262-020-02534-7. Epub 2020 Mar 6.

ipd_sharing: Undecided

lead_sponsor: NovoCure GmbH

location_country:
Croatia
Poland
Hong Kong
Serbia
Spain
Italy
Austria
Netherlands
Canada
Switzerland
Hungary
United States
France
China
Belgium
Germany
Bulgaria
Czechia

location_facility: INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier de Saint-Quentin Service de pneumologie

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

location_facility: Hospital Regional Universitario Carlos Haya Medical Oncology Department

location_facility: Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

location_facility: Baylor Scott & White Health/McClinton Cancer Center

location_facility: Complex Oncology Center (COC) - Plovdiv EOOD,

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: HealthPartners Institute, Regions Cancer Care Center

location_facility: Bezanijska kosa Clinical Hospital Center

location_facility: University Medical Center, Inc; DBA University of Louisville

location_facility: The University of Texas Southwestern Medical Center

location_facility: Thomayerova Nemocnice Dept. of Pneumology

location_facility: Tolna County, Balassa Janos Hospital, Department of oncology

location_facility: Redlands Community Hospital (Emad Ibrahim, MD, Inc.)

location_facility: California Cancer Associates for Research and Excellence, Inc. cCARE

location_facility: Tufts Medical Center, Division of Hematology and Oncology

location_facility: Renown Regional Medical Center Institute for Cancer

location_facility: University of Maryland School of Medicine

location_facility: Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

location_facility: Medical University Salzburg, State Hospital, University hospital for internal medicine III / PMU

location_facility: Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology

location_facility: New York-Presbyterian/Queens Radiation Oncology

location_facility: Hospital Universitari i Politécnic La Fe

location_facility: UOC Oncologia Medica Presidio Ospedaliero di Ravenna AUSL della Romagna

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Affiliated Cancer Hospital of Guangzhou Medical University

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: Kantonsspital Winterthur Tumorzentrum Winterthur

location_facility: Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Associated Neurologists of Southern CT, P.C.

location_facility: Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

location_facility: Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Innere Medizin IV

location_facility: Cancer Center at St. Joseph Hospital and Medical Center

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine


title: Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

summary: The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.

ReferenceType: result

ReferenceCitation: Barbour T, Scully M, Ariceta G, Cataland S, Garlo K, Heyne N, Luque Y, Menne J, Miyakawa Y, Yoon SS, Kavanagh D; 311 Study Group Members. Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults. Kidney Int Rep. 2021 Mar 24;6(6):1603-1613. doi: 10.1016/j.ekir.2021.03.884. eCollection 2021 Jun.

ReferenceCitation: Cammett TJ, Garlo K, Millman EE, Rice K, Toste CM, Faas SJ. Exploratory Prognostic Biomarkers of Complement-Mediated Thrombotic Microangiopathy (CM-TMA) in Adults with Atypical Hemolytic Uremic Syndrome (aHUS): Analysis of a Phase III Study of Ravulizumab. Mol Diagn Ther. 2022 Nov 4. doi: 10.1007/s40291-022-00620-3. [Epub ahead of print]

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

ReferenceCitation: Gäckler A, Schönermarck U, Dobronravov V, La Manna G, Denker A, Liu P, Vinogradova M, Yoon SS, Praga M. Efficacy and safety of the long-acting C5 inhibitor ravulizumab in patients with atypical hemolytic uremic syndrome triggered by pregnancy: a subgroup analysis. BMC Nephrol. 2021 Jan 6;22(1):5. doi: 10.1186/s12882-020-02190-0. Erratum in: BMC Nephrol. 2021 Feb 2;22(1):49.

location_country:
Taiwan
Spain
Italy
Austria
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
United States
France
Belgium
Japan
Germany


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).

ReferenceCitation: Lee JW, Sicre de Fontbrune F, Wong Lee Lee L, Pessoa V, Gualandro S, Füreder W, Ptushkin V, Rottinghaus ST, Volles L, Shafner L, Aguzzi R, Pradhan R, Schrezenmeier H, Hill A. Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. Blood. 2019 Feb 7;133(6):530-539. doi: 10.1182/blood-2018-09-876136. Epub 2018 Dec 3.

ReferenceCitation: Schwartz CE, Stark RB, Borowiec K, Nolte S, Myren KJ. Norm-based comparison of the quality-of-life impact of ravulizumab and eculizumab in paroxysmal nocturnal hemoglobinuria. Orphanet J Rare Dis. 2021 Sep 15;16(1):389. doi: 10.1186/s13023-021-02016-8.

ReferenceCitation: Schrezenmeier H, Kulasekararaj A, Mitchell L, Sicre de Fontbrune F, Devos T, Okamoto S, Wells R, Rottinghaus ST, Liu P, Ortiz S, Lee JW, Socié G. One-year efficacy and safety of ravulizumab in adults with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy: open-label extension of a randomized study. Ther Adv Hematol. 2020 Oct 24;11:2040620720966137. doi: 10.1177/2040620720966137. eCollection 2020.

ReferenceCitation: Ishiyama K, Nakao S, Usuki K, Yonemura Y, Ikezoe T, Uchiyama M, Mori Y, Fukuda T, Okada M, Fujiwara SI, Noji H, Rottinghaus S, Aguzzi R, Yokosawa J, Nishimura JI, Kanakura Y, Okamoto S. Results from multinational phase 3 studies of ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: subgroup analysis of Japanese patients. Int J Hematol. 2020 Oct;112(4):466-476. doi: 10.1007/s12185-020-02934-6. Epub 2020 Aug 31.

ReferenceCitation: Brodsky RA, Peffault de Latour R, Rottinghaus ST, Röth A, Risitano AM, Weitz IC, Hillmen P, Maciejewski JP, Szer J, Lee JW, Kulasekararaj AG, Volles L, Damokosh AI, Ortiz S, Shafner L, Liu P, Hill A, Schrezenmeier H. Characterization of breakthrough hemolysis events observed in the phase 3 randomized studies of ravulizumab versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria. Haematologica. 2021 Jan 1;106(1):230-237. doi: 10.3324/haematol.2019.236877.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Sweden
Malaysia
Singapore
Brazil
Canada
Germany
Taiwan
Estonia
Thailand
Korea, Republic of
France


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy - (FIGHT-202)

summary: The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

ReferenceCitation: Bibeau K, Féliz L, Lihou CF, Ren H, Abou-Alfa GK. Progression-Free Survival in Patients With Cholangiocarcinoma With or Without FGF/FGFR Alterations: A FIGHT-202 Post Hoc Analysis of Prior Systemic Therapy Response. JCO Precis Oncol. 2022 Apr;6:e2100414. doi: 10.1200/PO.21.00414.

ReferenceCitation: Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, Paulson AS, Borad MJ, Gallinson D, Murphy AG, Oh DY, Dotan E, Catenacci DV, Van Cutsem E, Ji T, Lihou CF, Zhen H, Féliz L, Vogel A. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May;21(5):671-684. doi: 10.1016/S1470-2045(20)30109-1. Epub 2020 Mar 20.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Taiwan
Spain
Italy
United Kingdom
Thailand
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany


title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism

summary: This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
Austria
Netherlands
United States
France
Belgium
Germany

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

location_facility: University of California, San Diego (UCSD) Medical Center

location_facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme

location_facility: Universit degli Studi di Perugia - Azienda Ospedaliera di Perugia

location_facility: Klinikum rechts der Isar, Technische Universität München

location_facility: CHU de Brest - Hopital de la Cavale Blanche


title: A Randomised Multi-centre Non-inferiority Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin

summary:
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.

212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization

lead_sponsor: Molnlycke Health Care AB

location_country: Denmark Poland Sweden France Germany Czechia

location_facility: St. Ann University Hospital Dep of Dermatovenereology

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.

location_facility: Regional hospital Pardubice Dermatology Department

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul.

location_facility: Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro

location_facility: Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3


acronym: ATTAIN

title: A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

lead_sponsor: Nektar Therapeutics

ReferenceCitation: Tripathy D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Diéras V, Müller V, Du Y, Currie SL, Hoch U, Tagliaferri M, Hannah AL, Cortés J; ATTAIN Investigators. Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase 3 ATTAIN Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1047-1052. doi: 10.1001/jamaoncol.2022.0514.

ReferenceCitation: Tripathy D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Müller V, Tagliaferri M, Hannah AL, Cortés J. ATTAIN: Phase III study of etirinotecan pegol versus treatment of physician's choice in patients with metastatic breast cancer and brain metastases. Future Oncol. 2019 Jul;15(19):2211-2225. doi: 10.2217/fon-2019-0180. Epub 2019 May 10.

location_country:
Portugal
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Israel
Belgium

location_facility: Investigator Site - Woluwe- Saint-Lambert

location_facility: Investigator Site - Santa Cruz de Tenerife

summary: This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).


title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)

lead_sponsor: Akebia Therapeutics

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.

ReferenceCitation: Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi: 10.1056/NEJMoa2025956.

location_country:
Poland
Brazil
Portugal
Serbia
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
Ukraine
Korea, Republic of
United States
France
Israel
Mexico
Germany
Bulgaria

location_facility:
Research Site #2
Research Site #1
Research Site #4
AMPM Research Clinic
Research Site
Research Site #3

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)


primary_purpose: Prevention

acronym: MEDI8897 Ph2b

title: A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

lead_sponsor: MedImmune LLC

ReferenceCitation: Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simões EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum in: N Engl J Med. 2020 Aug 13;383(7):698.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
South Africa
Belgium
Czechia
Poland
Australia
Argentina
Turkey
Sweden
Brazil
Canada
Hungary
Bulgaria
Latvia
Estonia
New Zealand
Finland
France
Chile

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.


title: A Randomized, Open-Label, Multi-Center, International Phase 2 Study of TAS-114 in Combination With S-1 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary:
This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC.

The study will be conducted internationally in 2 regions: Asian [Japan] and Western [Europe and US]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.

ReferenceCitation: Yamamoto N, Hayashi H, Planchard D, Morán T, Gregorc V, Dowell J, Sakai H, Yoh K, Nishio M, Cortot AB, Benhadji KA, Soni N, Huang J, Makris L, Cedres S. A randomized, phase 2 study of deoxyuridine triphosphatase inhibitor, TAS-114, in combination with S-1 versus S-1 alone in patients with advanced non-small-cell lung cancer. Invest New Drugs. 2020 Oct;38(5):1588-1597. doi: 10.1007/s10637-020-00930-5. Epub 2020 Apr 3.

lead_sponsor: Taiho Oncology, Inc.

location_country:
Poland
Spain
Italy
United States
France
Japan


title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

summary: CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.

status: Recruiting

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

lead_sponsor: Celgene

location_country:
Spain
United Kingdom
Canada
United States
France
Norway

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Princess Margaret Hospital University Health Network

location_facility: Washington University Siteman Cancer Center

location_facility: Oslo University Hospital, Rikshospitalet HF


acronym: Gemini I

title: A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naïve Adults

lead_sponsor: ViiV Healthcare

ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum in: Lancet. 2018 Nov 28;:.

ReferenceCitation: Ait-Khaled M, Sierra Madero J, Estrada V, Gulminetti R, Hagins D, Tsai HC, Man C, Sievers J, Grove R, Zolopa A, Wynne B, van Wyk J. Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies. HIV Res Clin Pract. 2021 Dec 9;23(1):9-14. Epub 2021 Dec 16.

location_country:
Taiwan
Portugal
Romania
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Netherlands
United Kingdom
Korea, Republic of
United States
France
South Africa
Belgium
Germany

summary: This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (Tenofovir [TDF]/Emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received antiretroviral therapy. The study is designed to demonstrate the non-inferior antiviral activity of DTG plus 3TC regimen to that of DTG plus TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.


title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

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

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Hôpital Robert Debré Pôle: Pédiatrie Médicale Service: Neurologie Et Maladies Métaboliques

location_facility: Kleinwachau Saechsisches Epilepsiezentrum Radeberg gemeinnuetzige GmbH

location_facility: Institute of Neurology and Neurosurgery at St. Barnabus

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

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: U.O. Neurologia Dipartimento di Neuroscienze Ospedale Pediatrico Bambino Gesù

location_facility: MultiCare Institute for Research & Innovation

location_facility: Clinica Universitaria de Navarra Fase 4. Segunda planta, Consulta de Pediatria

location_facility: CHRU Lille Antenne Pédiatrique Du CIC - Hôpital Jeanne De Flandre

location_facility: Birmingham Children Hospital NHS Foundation Trust

location_facility: DRK Kliniken Berlin - Westend Epilepsiezentrum / Neuropaediatrie

location_facility: University Hospitals Cleveland Medical Center

location_facility: HOPITAL DEL LA TIMONE - HOPITAL HENRI GASTAUT Hôpital De La Timone Neurologie Pédiatrique Pneumologie Pédiatrique Et Médecine Infantile

location_facility: Miami Children's Hospital Brain Institute

location_facility: National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia

location_facility: CHU De Bordeaux Service De Pédiatrie Médicale

location_facility: Hospital Ruber Internacional Primera Planta Servicio de Neurologia

location_facility: Institute of Neurosciences Queen Elizabeth University Hospital

location_facility: Krankenhaus Mara Epilepsie-Zentrum Bethel

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel Klinik fuer Neuropaediatrie

location_facility: CHU Amiens-Picardie Service De Neurologie Pediatrique

location_facility: Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique Centre de référence épilepsies rares (CReER)

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology

location_facility: Universitaetsklinik fuer Kinder- und Jugendmedizin Abteilung III

location_facility: Schoen Klinik Vogtareuth Neuropaediatrie und Neurologische Rehabilitation, Epilepsiezentrum fuer Kinder und Jugendlische, Tagesklinik fuer Neuropaediatrie

location_facility: Tokyo Women's Medical University Hospital

location_facility: AOU Anna Meyer Clinica di Neurologia Pediatrica

location_facility: Universitaetsklinikum Freiburg Zentrum fuer Kinder- und Jugendmedizin

location_facility: Ospedale Civile Maggiore di Borgo Trento - Ospedale della Donna e del Bambino

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie

location_facility: The Children's Hospital Westmead Dept. of Neurology and Neurosurgery

summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.


title: A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis

acronym: SEGMENT

summary: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 2 doses of GED-0507-34-Levo in subjects with active, mild-to-moderate UC.

lead_sponsor: PPM Services S.A.

location_country:
Poland
Italy
Latvia
Canada
Ukraine
Hungary
United States
France
Bulgaria
Slovakia

location_facility: Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC

location_facility: Cabinet Médical de Gastro-entérologie Dr.Lesage

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly

location_facility: Cabinet Médical de Gastroentérologie Dr. Bismuth

location_facility: Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche

location_facility: Pauls Stradins Clinical University Hospital SLLC

location_facility: CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie

location_facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

location_facility: Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU

location_facility: B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: CI Odesa Regional Clinical Hospital, Center of Gastroenterology

location_facility: Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Center for Advanced Gastroenterology, PLLC

location_facility: Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office

location_facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna

location_facility: Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille

location_facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE

location_facility: Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU

location_facility: Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Cabinet Médical de Gastroentérologie Dr. Ben Ali

location_facility: Clinical Applications Laboratories, Inc.

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital


title: A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis

summary: This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Greece
Austria
Italy
Indonesia
France
Turkey
United Arab Emirates


title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.

acronym: TULIP SLE LTE

summary: The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

ReferenceCitation: Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2022 Nov 11. doi: 10.1002/art.42392. [Epub ahead of print]

location_country:
Spain
United Kingdom
Lithuania
Ukraine
United States
Peru
Romania
Japan
South Africa
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Canada
Hungary
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Chile
Colombia


title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study

summary: The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

ReferenceCitation: Hájek R, Minařík J, Straub J, Pour L, Jungova A, Berdeja JG, Boccadoro M, Brozova L, Spencer A, van Rhee F, Vela-Ojeda J, Thompson MA, Abonour R, Chari A, Cook G, Costello CL, Davies FE, Hungria VT, Lee HC, Leleu X, Puig N, Rifkin RM, Terpos E, Usmani SZ, Weisel KC, Zonder JA, Bařinová M, Kuhn M, Šilar J, Čápková L, Galvez K, Lu J, Elliott J, Stull DM, Ren K, Maisnar V. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: effectiveness in relapsed/refractory multiple myeloma. Future Oncol. 2021 Jul;17(19):2499-2512. doi: 10.2217/fon-2020-1225. Epub 2021 Mar 26.

ReferenceCitation: Costello C, Davies FE, Cook G, Vela-Ojeda J, Omel J, Rifkin RM, Berdeja J, Puig N, Usmani SZ, Weisel K, Zonder JA, Terpos E, Spencer A, Leleu X, Boccadoro M, Thompson MA, Romanus D, Stull DM, Hungria V. INSIGHT MM: a large, global, prospective, non-interventional, real-world study of patients with multiple myeloma. Future Oncol. 2019 May;15(13):1411-1428. doi: 10.2217/fon-2019-0013. Epub 2019 Feb 28.

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

lead_sponsor: Takeda

location_country:
Taiwan
Brazil
Belgium
Spain
Greece
Italy
Mexico
United Kingdom
United States
France
China
Israel
Colombia
Turkey
Germany

location_facility: First Affiliated Hospital of Soochow University

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: University of Arkansas For Medical Sciences

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Rocky Mountain Cancer Centers (Williams) - USOR

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Johns Hopkins Medicine - Anadolu Saglik Merkezi

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: CEHON - Centro de Hematologia e Oncologia da Bahia Ltda

location_facility: Yakima Valley Memorial Hospital North Star Lodge - USOR

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut fur Versorgungsforschung in der Onkologie GbR

location_facility: Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho

location_facility: Northwest Cancer Specialists (Broadway) - USOR

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Gefos - Gesellschaft fur onkologische Studien mbH

location_facility: Illinois Cancer Specialists (Niles) - USOR

location_facility: Maryland Oncology Hematology (Columbia) - USOR

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: Fundacion Oftalmologica de Santander Foscal

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Internistisch Hamatologische und Internistische Praxis

location_facility: Greenville Health System Cancer Institute

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Hospital Das Clinicas Da Universidade Federal de Goias

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Unicamp Universidade Estadual de Campinas

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi


title: An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2

summary: This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
United Kingdom
Finland
Canada
Guatemala
Costa Rica
France
Panama
Mexico
Sweden


acronym: JASMINE

title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)

lead_sponsor: Amgen

ReferenceCitation: Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, Hanes V, Delwail V, Hajek R, Chien D. Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. Target Oncol. 2020 Oct;15(5):599-611. doi: 10.1007/s11523-020-00748-4. Erratum in: Target Oncol. 2020 Dec;15(6):807.

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

location_country:
Poland
Romania
Spain
Greece
Georgia
Australia
Italy
Canada
Mexico
Ukraine
Korea, Republic of
United States
France
India
Israel
Colombia
Japan
Germany
Bulgaria
Czechia

summary:
This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden.

Subjects were randomized in a 1:1 ratio to receive a 375 mg/m^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.


acronym: BRIGHT

title: A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

lead_sponsor: Sanofi

type: Other Identifier

ReferenceCitation: Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frías JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.

location_country:
Denmark
Croatia
Serbia
United Kingdom
Greece
Italy
Switzerland
Hungary
United States
France
Israel
Romania
Sweden
Bulgaria
Slovakia
Czechia

location_facility:
Investigational Site Number 840027
Investigational Site Number 840006
Investigational Site Number 840058
Investigational Site Number 840022
Investigational Site Number 840012
Investigational Site Number 380015
Investigational Site Number 380012
Investigational Site Number 840040
Investigational Site Number 703003
Investigational Site Number 840030
Investigational Site Number 840051
Investigational Site Number 840044
Investigational Site Number 840094
Investigational Site Number 840091
Investigational Site Number 380010
Investigational Site Number 840098
Investigational Site Number 840053
Investigational Site Number 642003
Investigational Site Number 376002
Investigational Site Number 840085
Investigational Site Number 840024
Investigational Site Number 826001
Investigational Site Number 840077
Investigational Site Number 840018
Investigational Site Number 380007
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Investigational Site Number 840064
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Investigational Site Number 100003
Investigational Site Number 752102
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Investigational Site Number 688001
Investigational Site Number 642012
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Investigational Site Number 703005
Investigational Site Number 203001
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Investigational Site Number 840101
Investigational Site Number 300001
Investigational Site Number 703002
Investigational Site Number 840079
Investigational Site Number 348001
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Investigational Site Number 191001
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summary:
Primary Objective:

To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.

Secondary Objectives:

Change From Baseline in HbA1c to Week 12

To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:

Change in Fasting plasma glucose (FPG);
Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
Percentage of participants reaching HbA1c targets <7% or ≤6.5%;
Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.

To assess the safety in each treatment group.

To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

Percentage of participants requiring rescue therapy.


title: A Phase IIIB, 24-week Randomised, Double-blind Study to Compare 'Closed' Triple Therapy (FF/UMEC/VI) With 'Open' Triple Therapy (FF/VI + UMEC), in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Bremner PR, Birk R, Brealey N, Ismaila AS, Zhu CQ, Lipson DA. Single-inhaler fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol plus umeclidinium using two inhalers for chronic obstructive pulmonary disease: a randomized non-inferiority study. Respir Res. 2018 Jan 25;19(1):19. doi: 10.1186/s12931-018-0724-0.

ReferenceCitation: Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.

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

location_country:
Poland
Romania
Spain
Italy
Russian Federation
Australia
Argentina
Korea, Republic of
France
Mexico
Japan
Germany

summary: This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.


acronym: MAXIMISE

title: MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

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

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

location_country:
Poland
Romania
Spain
Greece
Ireland
Estonia
Italy
Finland
Russian Federation
Switzerland
United Kingdom
Hungary
France
Israel
Belgium
Germany
Bulgaria
Czechia

summary: The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).


acronym: COAST-W

title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis

lead_sponsor: Eli Lilly and Company

ReferenceCitation: van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.

ReferenceCitation: Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Østergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Feb 21. pii: keac104. doi: 10.1093/rheumatology/keac104. [Epub ahead of print]

ReferenceCitation: Heijde DV, Østergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.

ReferenceCitation: Deodhar AA, Mease PJ, Rahman P, Navarro-Compán V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.

ReferenceCitation: Dougados M, Wei JC, Landewé R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4. Erratum in: Ann Rheum Dis. 2020 Jun;79(6):e75.

ReferenceCitation: Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.

ReferenceCitation: Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Järvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.

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:
Poland
Brazil
Spain
Italy
United Kingdom
Netherlands
Finland
Argentina
Canada
Korea, Republic of
United States
France
Israel
Puerto Rico
Mexico
Japan
Germany

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Univ of Texas Health Science Center - Houston

location_facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

summary: The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).


title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

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

lead_sponsor: Pfizer

location_country:
Spain
Canada
United States
France
Japan
Germany

location_facility: Associated Neurologists of Southern Connecticut, PC

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Montreal Neurological Institute and Hospital

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

location_facility: AS Clinical Research Consultants of North Texas, PLLC

location_facility: Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute

location_facility: Medical Corporation Abe Neurology Clinic

location_facility: Hospital Universitario y Politecnico la Fe

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Rhode Island Hospital/ Brown University Medical School

location_facility: Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie

location_facility: Duke University/Duke Neurology/Department of Neurology

location_facility: Vero Beach Neurology and Research Institute

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Indiana University Health Neuroscience Center


title: Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)

ReferenceCitation: Shahid S, Kushner BH, Modak S, Basu EM, Rubin EM, Gundem G, Papaemmanuil E, Roberts SS. Association of BRAF V600E mutations with vasoactive intestinal peptide syndrome in MYCN-amplified neuroblastoma. Pediatr Blood Cancer. 2021 Oct;68(10):e29265. doi: 10.1002/pbc.29265. Epub 2021 Jul 31.

location_country:
Denmark
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Finland
Switzerland
Sweden
United States
France
Israel
United Kingdom
Belgium
Japan
Germany
Czechia

location_facility: Cincinnati Children's Hospital Medical Center Cancer & Blood Disease Inst.

location_facility: Texas Children s Hospital Baylor College of Medicine

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Johns Hopkins University IDS Pharmacy John Hopkins Hospital

location_facility: Washington University School of Medicine SC

summary: The purpose of this study is to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma or relapsed or refractory high grade glioma.


title: A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

summary: The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

lead_sponsor: Shield Therapeutics

location_country:
Spain
Hungary
United States
France
Belgium
Germany