ReferenceCitation: Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9.

ReferenceCitation: Fidler MC, Barshop BA, Gangoiti JA, Deutsch R, Martin M, Schneider JA, Dohil R. Pharmacokinetics of cysteamine bitartrate following gastrointestinal infusion. Br J Clin Pharmacol. 2007 Jan;63(1):36-40.

ReferenceCitation: Levtchenko EN, van Dael CM, de Graaf-Hess AC, Wilmer MJ, van den Heuvel LP, Monnens LA, Blom HJ. Strict cysteamine dose regimen is required to prevent nocturnal cystine accumulation in cystinosis. Pediatr Nephrol. 2006 Jan;21(1):110-3. Epub 2005 Oct 27.

lead_sponsor: Horizon Pharma USA, Inc.

location_country:
United States
France
Netherlands

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (formerly Children's Memorial Hospital)

location_facility: Radboud University Nijmegen Medical Center

title: A Randomized, Crossover Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients With Nephropathic Cystinosis

summary: Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.


title: A Randomized, Double-Blind Placebo-Controlled Phase 2 Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

summary: Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

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:
Italy
France
Czechia
Poland
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin

location_facility: Russian Oncology Research Centre n.a. Blokhin, RAMS

location_facility: Institute for Cancer Research and Treatment - IRCC

location_facility: Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia

location_facility: St-Petersburg State Institution of Public Health

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

location_facility: Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


type: EudraCT Number

title: A Prospective, Randomized, Open-label, Parallel-group, Multi-center Study to Demonstrate the Superiority of MACI® Versus Arthroscopic Microfracture for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea.

acronym: SUMMIT

summary: The objective of this trial is to demonstrate superior efficacy and safety of MACI compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years) with symptomatic articular cartilage defects of the knee.

status: Completed

ReferenceType: result

ReferenceCitation: Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, Emans P, Podskubka A, Tsuchida A, Kili S, Levine D, Brittberg M; SUMMIT study group. Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Two-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2014 Jun;42(6):1384-94. doi: 10.1177/0363546514528093. Epub 2014 Apr 8.

name: University Medical Center Utrecht, Utrecht, the Netherlands

name: Reconstructive Medicine, Tissue Regeneration, MIRA Institute, University of Twente, Enschede, the Netherlands

family: Saris

full_name: Daniel Saris

given: Daniel

sequence: first

name: NIHR Biomedical Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

family: Price

full_name: Andrew Price

given: Andrew

sequence: additional

name: District Hospital of Orthopedics and Trauma Surgery, Department of Knee Surgery, Arthroscopy and Sports Traumatology, Piekary Slaskie, Poland

family: Widuchowski

full_name: Wojciech Widuchowski

given: Wojciech

name: Chirurgie Arthrose, Sport et Arthroscopie, Polyclinique Saint Roch, Montpellier, France

family: Bertrand-Marchand

full_name: Marion Bertrand-Marchand

given: Marion

name: St Elisabeth Ziekenhuis, Afdeling Orthopedie, Tilburg, the Netherlands

family: Caron

full_name: Jacob Caron

given: Jacob

name: Department of Orthopaedics, Trondheim University Hospital, Trondheim, Norway

family: Drogset

full_name: Jon Olav Drogset

given: Jon Olav

name: Academisch Ziekenhuis Maastricht, Afdeling Orthopedie, Maastricht, the Netherlands

family: Emans

full_name: Pieter Emans

given: Pieter

name: First Faculty of Medicine, Charles University in Prague, Hospital Bulovka, Prague, Czech Republic

family: Podskubka

full_name: Ales Podskubka

given: Ales

family: Tsuchida

full_name: Anika Tsuchida

given: Anika

name: Genzyme Biosurgery (now Sanofi Biosurgery), Oxford, UK

family: Kili

full_name: Sven Kili

given: Sven

name: Genzyme Biosurgery (now Sanofi Biosurgery), Cambridge, Massachusetts, USA

family: Levine

full_name: David Levine

given: David

name: Region Halland Orthopedics, Kungsbacka Hospital, Kungsbacka, Sweden

family: Brittberg

full_name: Mats Brittberg

given: Mats

family: Paša

full_name: Libor Paša

given: Libor

family: Trc

full_name: Tomas Trc

given: Tomas

family: Slynarski

full_name: Konrad Slynarski

given: Konrad

family: Sanson

full_name: Bernd-Jan Sanson

given: Bernd-Jan

family: Bezuidenhoudt

full_name: Mauritz Bezuidenhoudt

given: Mauritz

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Sports Medicine

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ipd_sharing: No

lead_sponsor: Vericel Corporation

location_country:
Sweden
Netherlands
Poland
France
Czechia
Norway
United Kingdom

location_facility: Regional Hospital of Traumatologic Surgery

location_facility: Hopital d'instruction des armees Robert Picque

location_facility: Chirurgien Orthopediste et Traumatologue du Sport, Institut de I'Appareil Locomoteur Nollet

location_facility: The South West London Elective Orthopaedic Centre (SWLEOC)

location_facility: Nuffield Dept. of Orthopaedic Surgery, University of Oxford

intervention_type: Procedure

status_simplified: Completed


title: A Multicentre, Multinational, Randomized, Double-blind, Parallel-group Study Comparing ACR16 Versus Placebo for the Symptomatic Treatment of Huntington's Disease

acronym: MermaiHD

summary: The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.

ReferenceType: derived

ReferenceCitation: de Yebenes JG, Landwehrmeyer B, Squitieri F, Reilmann R, Rosser A, Barker RA, Saft C, Magnet MK, Sword A, Rembratt A, Tedroff J; MermaiHD study investigators. Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Dec;10(12):1049-57. doi: 10.1016/S1474-4422(11)70233-2. Epub 2011 Nov 7.

family: de Yebenes

full_name: Justo Garcia de Yebenes

given: Justo Garcia

family: Landwehrmeyer

full_name: Bernhard Landwehrmeyer

given: Bernhard

family: Squitieri

full_name: Ferdinando Squitieri

given: Ferdinando

family: Reilmann

full_name: Ralf Reilmann

given: Ralf

family: Rosser

full_name: Anne Rosser

given: Anne

family: Barker

full_name: Roger A Barker

given: Roger A

family: Saft

full_name: Carsten Saft

given: Carsten

family: Magnet

full_name: Markus K Magnet

given: Markus K

family: Sword

full_name: Alastair Sword

given: Alastair

family: Rembratt

full_name: Åsa Rembratt

given: Åsa

family: Tedroff

full_name: Joakim Tedroff

given: Joakim

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Italy
Austria
Spain
France
Belgium
Portugal
Germany
United Kingdom

location_facility: LKH -Univ. Klinikum Graz, Universitaetsklinik fur Psychiatrie Graz

location_facility: Innsbruck Medical University, Anichstraße 35

location_facility: Universitätsklinik Ulm, Neurologie/ Oberer Eselberg 45/1

location_facility: Centro de Estudos Egas Moniz, Faculdade de Medicina de Lisboa, Av. Prof. Egas Moniz

location_facility: Department of Clinical Genetics, St Mary's Hospital, Hathersage Road

location_facility: First Floor Argyll House, Fosterhill, Cornhill Road

location_facility: Churchill Hospital, Old Road, Headington

location_facility: Cardiff University School of Medicine, Department of Neurology & Medical Genetics, Heath Park

location_facility: Cambridge Centre for Brain repair, Cambridge University

location_facility: Hospital Universitario La Fe, Avda. Campanar 21,

location_facility: Isar Amper Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils), Bräuhausstr.5

location_facility: Academic Neurology Unit, E Floor Medical School Beech Hill Road

location_facility: University Hospital of Coimbra, Av. Rissaya Barreto

location_facility: Institute of Human Genetics, Centre for Life, Central Parkway

location_facility: Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Schumannstrasse 20/21

location_facility: Hôpital Nord, CHU d'Amiens, Service de Neurologie

location_facility: St. Josef Hospital, Ruhr University Bochum, Gudrunstraße 56

location_facility: Hospital Clinic of Barcelona, Calle Villarroel, 170

location_facility: SE Scotland Genetic Service, Western General Hospital, Crewe Road

location_facility: Klinikum rechts der Isar der Technischen Universität München, Neurologische Klinik und Poliklinik, Ismaninger Str. 22

location_facility: Universitat Dresden, Klinikum Carl Gustav Carus, Fetscherstr. 74

location_facility: R&D Headquarters, Barberry Centre, 25 Vincent Drive

location_facility: Fondazione IRCCS Istituto Nazionale Neurologico "Carlos Besta", Department of Movement Disorders, 11 via Celoria

location_facility: Hôpital Purpan, Place Docteur-Baylac, Bâtiment F

location_facility: Westfaelische Wilhelms-Universitaet Muenster, Klinik fur Neurologie

location_facility: Hospital Ramon y Cajal, Carretera Colemenar km 9.100


title: A 24 Month Extension to a 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

summary: This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

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


title: Prospective, Randomized, Observer-blind, Parallel-group, Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA (Xeomin) in Patients With Upper Limb Spasticity

acronym: NT-Spin

summary: This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of arm tightness (upper limb spasticity) using two different dilutions of incobotulinumtoxinA (Xeomin).

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Italy
Austria
Switzerland
Spain
France
Portugal
Germany
United Kingdom


title: Phase IIb, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

summary:
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life.

The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Bone Therapeutics S.A

location_country: France Czechia Poland Hungary Belgium Spain Germany

intervention_type: Other

status_simplified: Ongoing


title: A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

summary: The purpose of this study is to evaluate if the addition of GSK3359609 to pembrolizumab in combination with 5FU-platinum based chemotherapy improves the efficacy of the pembrolizumab combination with 5FU-platinum based chemotherapy in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). This randomized, double-blinded, Phase II/III study will compare the combination of GSK3359609 with pembrolizumab and 5FU-platinum chemotherapy to placebo in combination with pembrolizumab and 5FU-platinum chemotherapy in participants with recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx or larynx.

status: Active, not recruiting

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
Sweden
Spain
Germany
France
Japan
Korea, Republic of
Poland
Romania
Ireland
Belgium
Argentina
Australia
China
Russian Federation
Denmark
United States
United Kingdom
Canada


title: A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 Months, and to Investigate the Bleeding Pattern Over a Double-Blind Treatment Period of One Year Compared With Continuous Combined 1 mg Estradiol and 5 mg Dydrogesterone

summary: To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

lead_sponsor: Solvay Pharmaceuticals

location_country:
Poland
Croatia
France
Romania
Russian Federation

location_facility:
Site 11
Site 44
Site 24
Site 21
Site 32
Site 52
Site 53
Site 51
Site 41
Site 31
Site 33
Site 34
Site 23
Site 42
Site 13
Site 12
Site 43
Site 22


title: A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures

summary: To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Finland France


ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Switzerland
Netherlands
Germany
France
Israel
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Charite Paediatric Pulmonology Department

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

location_facility: Great Ormond Street Hospital for Sick Children

source: euctr

title: A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

summary: This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).


title: Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection

summary:
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.

This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.

study_type: Observational

time_perspective: Other

lead_sponsor: Balt Extrusion

location_country: France Spain

location_facility: Hospital Universitario Marqués de Valdecilla (HUMV)

intervention_type: Device


title: A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

summary: This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.

time_perspective: Retrospective

lead_sponsor: NEAT ID Foundation

location_country:
Netherlands
France
Israel
Spain
United Kingdom

location_facility: Hospital Clinico Universitario San Carlos


type: Other Identifier

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02C

summary:
Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Switzerland
France
Israel
Australia
United States

location_facility: Oregon Health & Science University ( Site 3013)

location_facility: Tasman Oncology Research Pty Ltd ( Site 3403)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)

location_facility: Inova Schar Cancer Institute ( Site 3011)

location_facility: Melanoma Institute Australia ( Site 3402)

location_facility: West Cancer Center - East Campus ( Site 3014)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 3377)

location_facility: Universitaetsspital Zuerich ( Site 3601)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 3012)

location_facility: Hadassah Ein Karem Jerusalem ( Site 3702)

location_facility: The Angeles Clinic and Research Institute ( Site 3009)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 3107)

location_facility: Rambam Health Care Campus-Oncology ( Site 3704)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 3008)

location_facility: Istituto Europeo di Oncologia ( Site 3301)

location_facility: Providence Saint John's Health Center ( Site 3010)

location_facility: Centre Hospitalier Lyon Sud ( Site 3102)

intervention_type: Biological


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

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Peru
Costa Rica
Mexico
France
Panama
Poland
Thailand
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: National Taiwan University Hospital; Obstetrics & Gynecology

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

location_facility: Chelyabisnk regional clinical center for oncology and nuclear medicine

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie

location_facility: Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine Chiangmai University

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences

location_facility: Taichung Veterans General Hospital; Obstetrics and Gynecology

location_facility: Chang Gung Medical Foundation, Linkou Branch; Gynecologic Oncology

location_facility: Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

location_facility: McGill University Health Centre - Glen Site

location_facility: Mackay Memorial Hospital; Obstetrics & Gynaecology

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

title: A Phase II, Safety, and Efficacy Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Patients With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

summary: The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).


ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Peru
Greece
Romania
Australia
Belgium
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Philippines
Bulgaria
Hungary
Portugal
Germany
United States
Italy
Austria
Serbia
Mexico
Czechia
Spain

acronym: PHOENYCS GO

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

summary: The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.


title: ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study

acronym: PERSEPOLIS

summary: The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

primary_purpose: Other

lead_sponsor: MicroPort CRM

location_country:
Italy
France
Spain
United Kingdom
Portugal

location_facility: Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Azienda Ospedaliera Santa Maria degli Angeli

location_facility: Clinica Medica - Azienda Ospedaliero Universitaria Careggi

location_facility: Centro Hospitalar do Baixo Vouga, E.P.E.

location_facility: Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira

location_facility: Centro Hospitalar de Leiria - Hospital de Santo André

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho


title: A Phase 3b Open-label Study of the Anti-FGF23 Antibody, Burosumab (KRN23) in Adult Patients With X-linked Hypophosphatemia (XLH)

summary: This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Italy
Ireland
France
United Kingdom

location_facility: Royal National Orthopaedic Hospital NHS Trust

location_facility: Azienda ospedaliera universitaria Careggi

location_facility: National Hospital for Neurology and Neurosurgery-University College London Hospitals NHS Foundation Trust

location_facility: Nuffield Orthopaedic Centre - Oxford University Hospitals Nhs Trust


type: Registry Identifier

title: A Phase 1b, Multicenter, Open-label, Dose Finding Study to Assess the Safety, Tolerability, and Preliminary Efficacy of CC-90011 Given in Combination With Cisplatin and Etoposide in First -Line, Extensive Stage Subjects With Small Cell Lung Cancer

summary:
CC-90011-SCLC-001 is a multicenter, Phase 1b, open-label, dose finding study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently and sequentially to standard of care platinum-based, cisplatin and etoposide, carboplatin and etoposide and/or etoposide and Nivolumab to subjects with first line ES SCLC.

The dose finding part of the study will explore escalating oral doses of CC-90011 in combination with cisplatin, etoposide and/or carboplatin with or without Nivolumab (chemotherapy), to determine the maximum tolerated dose of CC- 90011 in combination with chemotherapy with or without Nivolumab to subjects with first line ES SCLC.

ReferenceCitation: Kanouni T, Severin C, Cho RW, Yuen NY, Xu J, Shi L, Lai C, Del Rosario JR, Stansfield RK, Lawton LN, Hosfield D, O'Connell S, Kreilein MM, Tavares-Greco P, Nie Z, Kaldor SW, Veal JM, Stafford JA, Chen YK. Discovery of CC-90011: A Potent and Selective Reversible Inhibitor of Lysine Specific Demethylase 1 (LSD1). J Med Chem. 2020 Dec 10;63(23):14522-14529. doi: 10.1021/acs.jmedchem.0c00978. Epub 2020 Oct 9.

name: Fount Therapeutics, LLC, San Diego, California 92130, United States

family: Kanouni

full_name: Toufike Kanouni

given: Toufike

name: Bristol Myers Squibb, 10300 Campus Point Drive, Suite 100, San Diego, California 92121, United States

family: Severin

full_name: Christophe Severin

given: Christophe

name: Quanticel Pharmaceuticels, San Francisco, California 94158, United States

family: Cho

full_name: Robert W. Cho

given: Robert W.

name: Oric Pharmaceuticals, South San Francisco, California 94080, United States

family: Yuen

full_name: Natalie Y.-Y. Yuen

given: Natalie Y.-Y.

family: Xu

full_name: Jiangchun Xu

given: Jiangchun

family: Shi

full_name: Lihong Shi

given: Lihong

family: Lai

full_name: Chon Lai

given: Chon

family: Del Rosario

full_name: Joselyn R. Del Rosario

given: Joselyn R.

name: 858 Therapeutics, Inc., San Diego, California 92121, United States

family: Stansfield

full_name: Ryan K. Stansfield

given: Ryan K.

name: Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States

family: Lawton

full_name: Lee N. Lawton

given: Lee N.

name: University of Chicago, Chicago, Illinois 60637, United States

family: Hosfield

full_name: David Hosfield

given: David

name: Pfizer Inc., San Diego, California 92121, United States

family: O’Connell

full_name: Shawn O’Connell

given: Shawn

name: Bristol Myers Squibb, Summit, New Jersey 07901, United States

family: Kreilein

full_name: Matt M. Kreilein

given: Matt M.

family: Tavares-Greco

full_name: Paula Tavares-Greco

given: Paula

name: Schrödinger, Inc., San Diego, California 92121, United States

family: Nie

full_name: Zhe Nie

given: Zhe

family: Kaldor

full_name: Stephen W. Kaldor

given: Stephen W.

family: Veal

full_name: James M. Veal

given: James M.

family: Stafford

full_name: Jeffrey A. Stafford

given: Jeffrey A.

family: Chen

full_name: Young K. Chen

given: Young K.

journal_name: Journal of Medicinal Chemistry

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: acs-specific: authorchoice/editors choice usage agreement

license_normalized: publisher-specific

version: publishedVersion

publisher: American Chemical Society (ACS)

publisher_dissemination: American Chemical Society

publisher_group: American Chemical Society

publisher_normalized: American Chemical Society

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti "Umberto I, G.M. Lancisi, G. Salesi"

location_facility: Hospital Clinico Universitario de Valencia


title: A Phase II Study Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes Failing Standard of Care Therapy

summary: This is an open-label, single-arm multicenter, phase II study. The primary objective is to assess the efficacy of bemcentinib (BGB324) a highly selective inhibitor of the AXL receptor tyrosine kinase for the treatment of AML and MDS patients failing or being refractory to first line hypomethylating agent (HMA) treatment. Furthermore, safety, disease progression, treatment failure will be assessed. A total of 43 patients will be included in the trial.

lead_sponsor: GWT-TUD GmbH

location_country: Germany France Netherlands

location_facility: CHU Hôtel Dieu Service d'Hématologie Clinique

location_facility: Technische Universität München, Klinikum rechts der Isar

location_facility: Hôpital Archet 1 Service d'Hématologie Clinique


title: Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector

acronym: FRIENDS

summary: The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

status: Unknown status

location_country: Italy Spain France Portugal

location_facility: Centro Hospitalar de Lisboa Norte - Santa Maria

location_facility: Hospital Universitari de Girona Doctor Josepj Trueta

location_facility: Hospital General Universitario de Alicante


title: Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)

acronym: ILLUMINA

summary: The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.

lead_sponsor: CID - Carbostent & Implantable Devices

location_country: Italy Germany France

location_facility:
San Raffaele Hospital
Polyclinique Les Fleurs
Universitäts-Herzzentrum Freiburg
Centre Privé Claude Galien
Maria Cecilia Hospital
Clinique Pasteur
IRCCS Policlinico San Matteo
St. Gertrauden Krankenhaus GmbH
Regiomed GefäBzentrum Sonneberg
Universitätsklinikum Leipzig


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 24 Months Study in Patients With Amnestic Mild Cognitive Impairment or Very Mild Alzheimer's Disease to Investigate the Safety, Tolerability and Immune Response of Repeated Subcutaneous Injections of ABvac40

summary:
Alzheimer's disease (AD) is the most common type of dementia, accounting for 50-75% of the estimated 47 million people with dementia worldwide. The amyloid cascade hypothesis of AD proposes that amyloid-β (Aβ) peptide accumulation in the brain, caused by an imbalance between Aβ production and clearance, is the initiating factor of a cascade ultimately leading to dementia.

Aβ peptides are generated from sequential cleavage of the amyloid precursor protein (APP), including Aβ40 and Aβ42. Aβ40 is the predominant variant (90%) among the secreted Aβ forms and although Aβ42 is more hydrophobic and prone to aggregate, and Aβ42 oligomers are regarded to be the most neurotoxic species, Aβ40 can also produce highly toxic diffusible aggregates, which can be prevented in vitro by specific anti-Aβ40 antibodies.

Several studies have proposed that a high concentration of Aβ40 in the brain distinguishes patients with AD from those who have senile plaques but are cognitively normal, pointing to the importance of Aβ40 in the onset of dementia. In keeping with this, previous studies have demonstrated that specific anti-Aβ40 antibodies label NFTs in the entorhinal cortex and the hippocampus of AD brains, and that these do not co-localize with tau NFTs, suggesting the presence of degenerating neuronal populations filled with C-terminal fragments of Aβx-40. In addition, Aβ40 is the main component of amyloid deposition around cerebral arteries causing cerebral amyloid angiopathy (CAA), which has a prevalence of about 80-90% in patients with AD (for more information see Lacosta et al. Alzheimer's Research & Therapy (2018) 10:12 DOI 10.1186/s13195-018-0340-8).

Considering those previous results suggesting that strategies targeting Aβ40 could represent novel disease-modifying therapies, we have developed ABvac40, the first active vaccine targeting the C-terminal end of the Aβ40 peptide.

The purpose of this Phase II study is to confirm in patients with a-MCI or vm-AD the level of safety and tolerability obtained in the ABvac40 Phase I clinical trial in patients with mm-AD. In addition, the study is aimed to better characterize the immune response elicited by ABvac40 and to explore its effects on AD biomarkers.

ReferenceCitation: Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Pérez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleón I, San-José I, Munuera J, Rodríguez-Gómez O, Abdelnour C, Lafuente A, Buendía M, Boada M, Tárraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Aβ(40) vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8.

family: Lacosta

full_name: Ana-María Lacosta

given: Ana-María

family: Pascual-Lucas

full_name: María Pascual-Lucas

given: María

family: Pesini

full_name: Pedro Pesini

given: Pedro

family: Casabona

full_name: Diego Casabona

given: Diego

family: Pérez-Grijalba

full_name: Virginia Pérez-Grijalba

given: Virginia

family: Marcos-Campos

full_name: Iván Marcos-Campos

given: Iván

family: Sarasa

full_name: Leticia Sarasa

given: Leticia

family: Canudas

full_name: Jesus Canudas

given: Jesus

family: Badi

full_name: Hassnae Badi

given: Hassnae

family: Monleón

full_name: Inmaculada Monleón

given: Inmaculada

family: San-José

full_name: Itziar San-José

given: Itziar

family: Munuera

full_name: Josep Munuera

given: Josep

family: Rodríguez-Gómez

full_name: Octavio Rodríguez-Gómez

given: Octavio

family: Abdelnour

full_name: Carla Abdelnour

given: Carla

family: Lafuente

full_name: Asunción Lafuente

given: Asunción

family: Buendía

full_name: Mar Buendía

given: Mar

family: Boada

full_name: Mercè Boada

given: Mercè

family: Tárraga

full_name: Lluis Tárraga

given: Lluis

family: Ruiz

full_name: Agustín Ruiz

given: Agustín

full_name: Manuel Sarasa

given: Manuel

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

title: Safety, tolerability and immunogenicity of an active anti-Aβ40 vaccine (ABvac40) in patients with Alzheimer’s disease: a randomised, double-blind, placebo-controlled, phase I trial

location_facility: BarcelonaBeta Brain Research Center (BBRC)

location_facility: Centre de Recherche Clinique du Gérontopôle


title: Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

acronym: CATALYST

summary:
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Hong Kong
Netherlands
Switzerland
Germany
France
Czechia
Poland
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Institute Cardio. Paris-Sud - Institut Jacques Cartier

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

location_facility: Baylor All Saints Medical Center at Fort Worth

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: CHI Health Creighton University Medical Center-Bergan Mercy

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Cardiovascular Research Institute of Kansas

location_facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: St. Cloud Hospital - Central MN Heart Clinic

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: Cardioangiologisches Centrum am Bethanien Krankenhaus


location_country:
Italy
Austria
United States
Hong Kong
Spain
Germany
France
Bulgaria
Czechia
Poland
Romania
Belgium
Russian Federation
China
Turkey
Denmark
Canada
United Kingdom
Taiwan
Ukraine

title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

summary: The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).


title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients With Primary Hyperoxaluria Type 1

summary: The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in patients with Primary Hyperoxaluria Type 1.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Netherlands
France
Israel
Germany
United Kingdom


ReferenceType: background

ReferenceCitation: Ben-Neriah Y, Daley GQ, Mes-Masson AM, Witte ON, Baltimore D. The chronic myelogenous leukemia-specific P210 protein is the product of the bcr/abl hybrid gene. Science. 1986 Jul 11;233(4760):212-4.

ReferenceCitation: Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990 Feb 16;247(4944):824-30.

ReferenceCitation: Perrotti D, Jamieson C, Goldman J, Skorski T. Chronic myeloid leukemia: mechanisms of blastic transformation. J Clin Invest. 2010 Jul;120(7):2254-64. doi: 10.1172/JCI41246. Epub 2010 Jul 1. Review.

ReferenceCitation: Saussele S, Lauseker M, Gratwohl A, Beelen DW, Bunjes D, Schwerdtfeger R, Kolb HJ, Ho AD, Falge C, Holler E, Schlimok G, Zander AR, Arnold R, Kanz L, Dengler R, Haferlach C, Schlegelberger B, Pfirrmann M, Müller MC, Schnittger S, Leitner A, Pletsch N, Hochhaus A, Hasford J, Hehlmann R; German CML Study Group. Allogeneic hematopoietic stem cell transplantation (allo SCT) for chronic myeloid leukemia in the imatinib era: evaluation of its impact within a subgroup of the randomized German CML Study IV. Blood. 2010 Mar 11;115(10):1880-5. doi: 10.1182/blood-2009-08-237115. Epub 2009 Nov 18.

ReferenceCitation: Hochhaus A, O'Brien SG, Guilhot F, Druker BJ, Branford S, Foroni L, Goldman JM, Müller MC, Radich JP, Rudoltz M, Mone M, Gathmann I, Hughes TP, Larson RA; IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61. doi: 10.1038/leu.2009.38. Epub 2009 Mar 12. Erratum in: Leukemia. 2010 May;24(5):1102.

ReferenceCitation: Larson RA, Hochhaus A, Hughes TP, Clark RE, Etienne G, Kim DW, Flinn IW, Kurokawa M, Moiraghi B, Yu R, Blakesley RE, Gallagher NJ, Saglio G, Kantarjian HM. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203. doi: 10.1038/leu.2012.134. Epub 2012 May 18.

ReferenceCitation: Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boqué C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

name: The University of Texas MD Anderson Cancer Center, Houston, TX;

family: Jabbour

full_name: Elias Jabbour

given: Elias

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

name: University of Torino, Ospedale San Luigi Gonzaga, Orbassano-Torino, Italy;

family: Saglio

full_name: Giuseppe Saglio

given: Giuseppe

family: Steegmann

full_name: Juan Luis Steegmann

given: Juan Luis

name: University of California, San Francisco School of Medicine, San Francisco, CA;

family: Shah

full_name: Neil P. Shah

given: Neil P.

name: Department of Clinical Hematology, Institut Català d’Oncologia, Hospitalet de Llobregat, Barcelona, Spain;

family: Boqué

full_name: Concepción Boqué

given: Concepción

name: Singapore General Hospital and Duke-National University of Singapore Graduate Medical School, Singapore;

family: Chuah

full_name: Charles Chuah

given: Charles

name: Fundación Para Combatir la Leucemia, Angelica Ocampo Hospitalization and Clinical Research Center, Buenos Aires, Argentina;

family: Pavlovsky

full_name: Carolina Pavlovsky

given: Carolina

name: University Hospital Brno and Central European Institute of Technology Masaryk University, Brno, Czech Republic;

family: Mayer

full_name: Jiří Mayer

given: Jiří

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Baccarani

full_name: Michele Baccarani

given: Michele

name: The Catholic University of Korea, Seoul, Korea;

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

family: Bradley-Garelik

full_name: M. Brigid Bradley-Garelik

given: M. Brigid

name: Bristol-Myers Squibb, Princeton, NJ; and

family: Mohamed

full_name: Hesham Mohamed

given: Hesham

family: Wildgust

full_name: Mark Wildgust

given: Mark

name: Universitätsklinikum Jena, Jena, Germany

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

journal_name: Blood

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

title: Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION)

ReferenceCitation: Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Müller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saußele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013 Aug 8;122(6):872-84. doi: 10.1182/blood-2013-05-501569. Epub 2013 Jun 26. Review.

ReferenceCitation: Cross NC, White HE, Müller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012 Oct;26(10):2172-5. doi: 10.1038/leu.2012.104. Epub 2012 Apr 16. Review.

ReferenceCitation: Müller MC, Cross NC, Erben P, Schenk T, Hanfstein B, Ernst T, Hehlmann R, Branford S, Saglio G, Hochhaus A. Harmonization of molecular monitoring of CML therapy in Europe. Leukemia. 2009 Nov;23(11):1957-63. doi: 10.1038/leu.2009.168. Epub 2009 Aug 27. Review.

ReferenceCitation: Hehlmann R, Müller MC, Lauseker M, Hanfstein B, Fabarius A, Schreiber A, Proetel U, Pletsch N, Pfirrmann M, Haferlach C, Schnittger S, Einsele H, Dengler J, Falge C, Kanz L, Neubauer A, Kneba M, Stegelmann F, Pfreundschuh M, Waller CF, Spiekermann K, Baerlocher GM, Ehninger G, Heim D, Heimpel H, Nerl C, Krause SW, Hossfeld DK, Kolb HJ, Hasford J, Saußele S, Hochhaus A. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. J Clin Oncol. 2014 Feb 10;32(5):415-23. doi: 10.1200/JCO.2013.49.9020. Epub 2013 Dec 2.

ReferenceCitation: Graham SM, Jørgensen HG, Allan E, Pearson C, Alcorn MJ, Richmond L, Holyoake TL. Primitive, quiescent, Philadelphia-positive stem cells from patients with chronic myeloid leukemia are insensitive to STI571 in vitro. Blood. 2002 Jan 1;99(1):319-25.

ReferenceCitation: Corbin AS, Agarwal A, Loriaux M, Cortes J, Deininger MW, Druker BJ. Human chronic myeloid leukemia stem cells are insensitive to imatinib despite inhibition of BCR-ABL activity. J Clin Invest. 2011 Jan;121(1):396-409. doi: 10.1172/JCI35721. Epub 2010 Dec 13. Erratum in: J Clin Invest. 2011 Mar 1;121(3):1222.

ReferenceCitation: Cortes J, O'Brien S, Kantarjian H. Discontinuation of imatinib therapy after achieving a molecular response. Blood. 2004 Oct 1;104(7):2204-5.

ReferenceCitation: Rousselot P, Huguet F, Rea D, Legros L, Cayuela JM, Maarek O, Blanchet O, Marit G, Gluckman E, Reiffers J, Gardembas M, Mahon FX. Imatinib mesylate discontinuation in patients with chronic myelogenous leukemia in complete molecular remission for more than 2 years. Blood. 2007 Jan 1;109(1):58-60. Epub 2006 Sep 14.

ReferenceCitation: Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

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ReferenceCitation: Kreutzman A, Rohon P, Faber E, Indrak K, Juvonen V, Kairisto V, Voglová J, Sinisalo M, Flochová E, Vakkila J, Arstila P, Porkka K, Mustjoki S. Chronic myeloid leukemia patients in prolonged remission following interferon-α monotherapy have distinct cytokine and oligoclonal lymphocyte profile. PLoS One. 2011;6(8):e23022. doi: 10.1371/journal.pone.0023022. Epub 2011 Aug 9.

ReferenceCitation: Baccarani M, Martinelli G, Rosti G, Trabacchi E, Testoni N, Bassi S, Amabile M, Soverini S, Castagnetti F, Cilloni D, Izzo B, de Vivo A, Messa E, Bonifazi F, Poerio A, Luatti S, Giugliano E, Alberti D, Fincato G, Russo D, Pane F, Saglio G; GIMEMA Working Party on Chronic Myeloid Leukemia. Imatinib and pegylated human recombinant interferon-alpha2b in early chronic-phase chronic myeloid leukemia. Blood. 2004 Dec 15;104(13):4245-51. Epub 2004 Aug 19.

ReferenceCitation: Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucémies Myéloïdes Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.

title: Imatinib plus Peginterferon Alfa-2a in Chronic Myeloid Leukemia

ReferenceCitation: Simonsson B, Gedde-Dahl T, Markevärn B, Remes K, Stentoft J, Almqvist A, Björeman M, Flogegård M, Koskenvesa P, Lindblom A, Malm C, Mustjoki S, Myhr-Eriksson K, Ohm L, Räsänen A, Sinisalo M, Själander A, Strömberg U, Bjerrum OW, Ehrencrona H, Gruber F, Kairisto V, Olsson K, Sandin F, Nagler A, Nielsen JL, Hjorth-Hansen H, Porkka K; Nordic CML Study Group. Combination of pegylated IFN-α2b with imatinib increases molecular response rates in patients with low- or intermediate-risk chronic myeloid leukemia. Blood. 2011 Sep 22;118(12):3228-35. doi: 10.1182/blood-2011-02-336685. Epub 2011 Jun 17.

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ReferenceCitation: Nicolini FE, Etienne G, Dubruille V, Roy L, Huguet F, Legros L, Giraudier S, Coiteux V, Guerci-Bresler A, Lenain P, Cony-Makhoul P, Gardembas M, Hermet E, Rousselot P, Amé S, Gagnieu MC, Pivot C, Hayette S, Maguer-Satta V, Etienne M, Dulucq S, Rea D, Mahon FX. Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study. Lancet Haematol. 2015 Jan;2(1):e37-46. doi: 10.1016/S2352-3026(14)00027-1. Epub 2015 Jan 7.

ReferenceCitation: Burchert A, Müller MC, Kostrewa P, Erben P, Bostel T, Liebler S, Hehlmann R, Neubauer A, Hochhaus A. Sustained molecular response with interferon alfa maintenance after induction therapy with imatinib plus interferon alfa in patients with chronic myeloid leukemia. J Clin Oncol. 2010 Mar 10;28(8):1429-35. doi: 10.1200/JCO.2009.25.5075. Epub 2010 Feb 8.

ReferenceCitation: Burchert A, Saussele S, Eigendorff E, Müller MC, Sohlbach K, Inselmann S, Schütz C, Metzelder SK, Ziermann J, Kostrewa P, Hoffmann J, Hehlmann R, Neubauer A, Hochhaus A. Interferon alpha 2 maintenance therapy may enable high rates of treatment discontinuation in chronic myeloid leukemia. Leukemia. 2015 Jun;29(6):1331-5. doi: 10.1038/leu.2015.45. Epub 2015 Feb 25.

ReferenceCitation: Baccarani M, Rosti G, de Vivo A, Bonifazi F, Russo D, Martinelli G, Testoni N, Amabile M, Fiacchini M, Montefusco E, Saglio G, Tura S; Italian Cooperative Study Group on Myeloid Leukemia. A randomized study of interferon-alpha versus interferon-alpha and low-dose arabinosyl cytosine in chronic myeloid leukemia. Blood. 2002 Mar 1;99(5):1527-35.

ReferenceCitation: Lipton JH, Khoroshko N, Golenkov A, Abdulkadyrov K, Nair K, Raghunadharao D, Brummendorf T, Yoo K, Bergstrom B; Pegasys CML Study Group. Phase II, randomized, multicenter, comparative study of peginterferon-alpha-2a (40 kD) (Pegasys) versus interferon alpha-2a (Roferon-A) in patients with treatment-naïve, chronic-phase chronic myelogenous leukemia. Leuk Lymphoma. 2007 Mar;48(3):497-505.

ReferenceCitation: Koskenvesa P, Kreutzman A, Rohon P, Pihlman M, Vakkila E, Räsänen A, Vapaatalo M, Remes K, Lundán T, Hjorth-Hansen H, Vakkila J, Simonsson B, Mustjoki S, Porkka K. Imatinib and pegylated IFN-α2b discontinuation in first-line chronic myeloid leukemia patients following a major molecular response. Eur J Haematol. 2014;92(5):413-20. doi: 10.1111/ejh.12258. Epub 2014 Jan 28.

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ReferenceCitation: Saußele S, Richter J, Hochhaus A, Mahon FX. The concept of treatment-free remission in chronic myeloid leukemia. Leukemia. 2016 Aug;30(8):1638-47. doi: 10.1038/leu.2016.115. Epub 2016 May 2. Review.

ReferenceCitation: Rea D, Nicolini FE, Tulliez M, Guilhot F, Guilhot J, Guerci-Bresler A, Gardembas M, Coiteux V, Guillerm G, Legros L, Etienne G, Pignon JM, Villemagne B, Escoffre-Barbe M, Ianotto JC, Charbonnier A, Johnson-Ansah H, Noel MP, Rousselot P, Mahon FX; France Intergroupe des Leucémies Myéloïdes Chroniques. Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI study. Blood. 2017 Feb 16;129(7):846-854. doi: 10.1182/blood-2016-09-742205. Epub 2016 Dec 8.

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ReferenceCitation: Putter H, Fiocco M, Geskus RB. Tutorial in biostatistics: competing risks and multi-state models. Stat Med. 2007 May 20;26(11):2389-430.

lead_sponsor: Philipps University Marburg Medical Center

location_facility: 02 Universitätsklinikum Jena, linik für Innere Medizin II Abt. für Hämatologie und Internistische Onkologie

location_facility: 15 Universitätsklinikum Würzburg, Zentrum für Innere Medizin

location_facility: 24 Institut für Versorgungsforschung in der Onkologie GbR

location_facility: 04 Universitätsmedizin Mannheim, III. Medizinische Klinik

location_facility: 06 Universitätsmedizin Berlin Charite- Campus Virchow Klinikum, Klinik für Hämatologie und Onkologie

location_facility: 14 Johannes-Gutenberg-Universität III. Medizinische Klinik

location_facility: 19 Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

location_facility: 05 Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: 20 Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: 12 Universitätsklinikum Ulm, Klinik für Innere Medizin III

location_facility: 07 Universitätsklinikum Erlangen, Medizinische Klinik 5

location_facility: 09 Universitätsklinikum Tübingen, Medizinische Klinik

location_facility: 01 Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Klinik für Hämatologie, Onkologie und Immunologie

location_facility: 16 Klinikum Bremen Mitte, Medizinische Klinik I

location_facility: 10 Technische Universität München (TUM) Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik

location_facility: 22 BAG / Onkologische Gemeinschaftspraxis

location_facility: 23 Evangelische Krankenhaus Hamm gGmbH, Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: 13 Universitätsklinikum Leipzig, Abteilung für Hämatologie u. Internistische Onkologie

location_facility: 08 Universitätsklinikum Münster, Medizinische Klinik, Innere Medizin A

location_facility: 17 Klinikum der Goethe Universität, Medizinische Klinik II

location_facility: 21 Universitätsklinikum Hamburg Eppendorf, Klinik für Onkologie, Hämatologie und KMT

location_facility: 03 Universitätsklinikum Aachen, Hämatologie/Onkologie

title: Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

summary: A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).


title: A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of CC-90011 in Subjects With Advanced Solid Tumors and Non-Hodgkin Lymphomas

summary: Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

ReferenceCitation: Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sánchez-Pérez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Phase I Study of Lysine-Specific Demethylase 1 Inhibitor, CC-90011, in Patients with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jan 15;27(2):438-446. doi: 10.1158/1078-0432.CCR-20-2380. Epub 2020 Oct 12.

lead_sponsor: Celgene

location_country:
Italy
France
Japan
Spain
United Kingdom

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Hospital Universitario Marques de Valdecilla


title: Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study

summary:
This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study.

The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.

lead_sponsor: Hairstetics

location_country:
Romania
United Kingdom
India
France

location_facility:
Metropolitan hospital
Revere clinic
Georges Mandel Office Surgery Clinic
Egoclinic
Fortis Hospital
Paras hospital
Cabinet médical du Dr Jack Smadja
Cabinet du Dr G. Beilin


title: A Phase 1/2, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered ALN-GO1 in Healthy Adult Subjects, and Patients With Primary Hyperoxaluria Type 1

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.

ReferenceCitation: Frishberg Y, Deschênes G, Groothoff JW, Hulton SA, Magen D, Harambat J, Van't Hoff WG, Lorch U, Milliner DS, Lieske JC, Haslett P, Garg PP, Vaishnaw AK, Talamudupula S, Lu J, Habtemariam BA, Erbe DV, McGregor TL, Cochat P; study collaborators. Phase 1/2 Study of Lumasiran for Treatment of Primary Hyperoxaluria Type 1: A Placebo-Controlled Randomized Clinical Trial. Clin J Am Soc Nephrol. 2021 Jul;16(7):1025-1036. doi: 10.2215/CJN.14730920. Epub 2021 May 13.

family: Frishberg

full_name: Yaacov Frishberg

given: Yaacov

family: Deschênes

full_name: Georges Deschênes

given: Georges

family: Groothoff

full_name: Jaap W. Groothoff

given: Jaap W.

family: Hulton

full_name: Sally-Anne Hulton

given: Sally-Anne

family: Magen

full_name: Daniella Magen

given: Daniella

family: Harambat

full_name: Jérôme Harambat

given: Jérôme

family: van’t Hoff

full_name: William G. van’t Hoff

given: William G.

family: Lorch

full_name: Ulrike Lorch

given: Ulrike

family: Milliner

full_name: Dawn S. Milliner

given: Dawn S.

family: Lieske

full_name: John C. Lieske

given: John C.

family: Haslett

full_name: Patrick Haslett

given: Patrick

family: Garg

full_name: Pushkal P. Garg

given: Pushkal P.

family: Vaishnaw

full_name: Akshay K. Vaishnaw

given: Akshay K.

family: Talamudupula

full_name: Sandeep Talamudupula

given: Sandeep

family: Lu

full_name: Jiandong Lu

given: Jiandong

family: Habtemariam

full_name: Bahru A. Habtemariam

given: Bahru A.

family: Erbe

full_name: David V. Erbe

given: David V.

family: McGregor

full_name: Tracy L. McGregor

given: Tracy L.

family: Cochat

full_name: Pierre Cochat

given: Pierre

journal_name: Clinical Journal of the American Society of Nephrology

evidence: open (via free pdf)

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

ipd_sharing: Undecided


title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease

summary: This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.

lead_sponsor: Amicus Therapeutics

location_country:
Greece
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Slovenia
Korea, Republic of
Sweden
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
New Zealand
Spain

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: UPMC Montefiore Clinical and Translational Research Center

location_facility: University of Cincinnati Gardner Neuroscience Institute

location_facility: University of Florida Clinical Research Center

location_facility: UOC di Neurologia e Malattie Neuromuscolari

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: Royal Free Hospital NHS Foundation Trust

location_facility: The Ohio State University Wexner Medical Center

location_facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc.


title: A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

summary:
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

ReferenceCitation: Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028.

family: Capodanno

full_name: Davide Capodanno

given: Davide

journal_name: JACC: Cardiovascular Interventions

lead_sponsor: Biotronik AG

location_country:
Italy
Austria
Switzerland
France
Poland
Hungary
Australia
Belgium
New Zealand
Spain
Denmark
Germany
Latvia

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaires Vaudoise

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH


title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in COPD participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 57 weeks, consisting of 2 screening visits, run-in period, and a 52-week intervention period. 800-1000 participants will be randomized in 1:1 ratio to receive mepolizumab 100 milligram (mg) or placebo every 4 weeks for a total of 13 doses.

lead_sponsor: GlaxoSmithKline

location_country:
Belgium
Australia
Denmark
France
Poland
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Ireland
China
Germany
United Kingdom
United States
Brazil
Mexico
Israel
New Zealand
Spain


location_country:
Peru
Guatemala
Romania
Australia
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Puerto Rico
United States
Germany
Italy
Mexico
Israel
Spain
Turkey
Latvia

acronym: Olaparib in combination with pembrolizumab in HRRm and HRD positive cancer

location_facility: City Clinical Hosp.4 of DCC ( Site 1700)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)

location_facility: Universitas Annex National Hospital ( Site 1902)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1300)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 1505)

location_facility: Okayama University Hospital ( Site 2505)

location_facility: Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)

location_facility: Pan American Center for Oncology Trials LLC ( Site 0501)

location_facility: Tasman Oncology Research Pty Ltd ( Site 2203)

location_facility: Daugavpils Regional Hospital ( Site 2104)

location_facility: Hokkaido University Hospital ( Site 2502)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)

location_facility: Winship Cancer Institute of Emory University ( Site 0057)

location_facility: Zhytomyr Regional Oncology Center ( Site 1710)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0802)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 3208)

location_facility: Northeast Georgia Medical Center ( Site 0026)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)

location_facility: The University of Oklahoma Health Sciences Center ( Site 0050)

location_facility: Hematology and Oncology Institute ( Site 0504)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1702)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0206)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2000)

location_facility: National Cancer Center Hospital ( Site 2501)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 2902)

location_facility: Japanese Foundation for Cancer Research ( Site 2503)

location_facility: Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)

location_facility: Fundacion de Investigacion de Diego ( Site 0500)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0047)

location_facility: Akdeniz Universitesi Tıp Fakultesi ( Site 1503)

location_facility: Centro Medico Zambrano Hellion ( Site 3105)

location_facility: Banner MD Anderson Cancer Center ( Site 0049)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)

location_facility: National Cancer Center Hospital East ( Site 2500)

location_facility: Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)

location_facility: Hospital Nacional Adolfo Guevara Velasco ( Site 3205)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)

location_facility: Hospital Nacional Cayetano Heredia ( Site 3203)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)

location_facility: Cancercare Rondebosch Oncology ( Site 1901)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 3207)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0704)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)

location_facility: New York Cancer and Blood Specialists-Research Department ( Site 0080)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 3006)

location_facility: University of Texas, Southwestern Medical Center ( Site 0004)

location_facility: Baskent University Adana Training Hospital ( Site 1509)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1506)

location_facility: Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)

location_facility: Northwest Medical Specialties, PLLC ( Site 0007)

location_facility: Severance Hospital Yonsei University Health System ( Site 2400)

location_facility: Centro Oncologico Riojano Integral ( Site 2703)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)

location_facility: Seoul National University Hospital ( Site 2402)

location_facility: Inova Schar Cancer Institute ( Site 0008)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0039)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)

location_facility: Fundacion Rodolfo Padilla Padilla A.C. ( Site 3102)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)

location_facility: P. Stradina Clinical University Hospital ( Site 2102)

location_facility: Hospital Britanico de Buenos Aires ( Site 2705)

location_facility: Fundacion Cardiovascular de Colombia ( Site 2907)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 1809)

location_facility: Parkland Health & Hospital System ( Site 0091)

location_facility: Kirovograd Regional oncology Dispensary ( Site 1716)

location_facility: Medical Centre Consilium Medical ( Site 1712)

location_facility: Podillya Regional Center of Oncology ( Site 1708)

location_facility: Linear Clinical Research Ltd ( Site 2206)

location_facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)

location_facility: San Francisco Oncology Associates ( Site 0085)

location_facility: University Hospitals Cleveland Medical Center ( Site 0016)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Institut du Cancer de Montpellier ( Site 0610)

location_facility: Aichi Cancer Center Hospital ( Site 2504)

location_facility: Riga East Clinical University Hospital ( Site 2103)

location_facility: Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)

location_facility: Seoul National University Bundang Hospital ( Site 2403)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)

location_facility: Hospital Clinic i Provincial ( Site 1302)

location_facility: University of California San Francisco ( Site 0015)

location_facility: Vaal Triangle Oncology Centre ( Site 1905)

location_facility: Monash Health-Monash Medical Centre ( Site 2205)

location_facility: Banner MD Anderson Cancer Center ( Site 0092)

location_facility: Skanes Universitetssjukhus Lund. ( Site 2001)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 1705)

location_facility: Ad-Vance Medical Research LLC ( Site 0505)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0024)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1714)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0087)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1507)

title: A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

summary: The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.


title: A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation

summary:
Primary Objectives:

VCDI cohort:

To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation
To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.

VRDI Part A cohort and Part B cohort:

To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation.

Secondary Objectives:

VCDI cohort:

To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.
To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.
To evaluate the immunogenicity of SAR650984 in combination treatments.
To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.
To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density.

VRDI Part A cohort and Part B cohort:

To characterize the overall safety profile of isatuximab in combination with VRD regimen.
To evaluate the infusion duration (only applicable for VRDI Part B cohort)
To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.
To evaluate the immunogenicity of isatuximab in combination treatments.
To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.
To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.
To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).
To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country: Italy Germany France Spain

location_facility:
Investigational Site Number 250003
Investigational Site Number 380002
Investigational Site Number 380001
Investigational Site Number 724001
Investigational Site Number 250002
Investigational Site Number 724004
Investigational Site Number 380003
Investigational Site Number 276003
Investigational Site Number 276002
Investigational Site Number 724003
Investigational Site Number 250001
Investigational Site Number 724002