title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

ReferenceCitation: Coates LC, Smolen JS, Mease PJ, Husni ME, Merola JF, Lespessailles E, Kishimoto M, Macpherson L, Bradley AJ, Bolce R, Helliwell PS. Comparative performance of composite measures from two phase III clinical trials of ixekizumab in psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002457. doi: 10.1136/rmdopen-2022-002457.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk

ReferenceCitation: Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

ReferenceCitation: Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
HAL
PubMed Central
Research Square
research-repository.griffith.edu.au

ReferenceCitation: Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.

ReferenceCitation: Chandran V, van der Heijde D, Fleischmann RM, Lespessailles E, Helliwell PS, Kameda H, Burgos-Vargas R, Erickson JS, Rathmann SS, Sprabery AT, Birt JA, Shuler CL, Gallo G. Ixekizumab treatment of biologic-naive patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020 Oct 1;59(10):2774-2784. doi: 10.1093/rheumatology/kez684.

ReferenceCitation: Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

ReferenceCitation: Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.

ReferenceCitation: Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.

ReferenceCitation: Gottlieb AB, Strand V, Kishimoto M, Mease P, Thaci D, Birt J, Lee CH, Shuler CL, Lin CY, Gladman DD. Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naive patients with active psoriatic arthritis (SPIRIT-P1). Rheumatology (Oxford). 2018 Oct 1;57(10):1777-1788. doi: 10.1093/rheumatology/key161.

ReferenceCitation: Coates LC, Kishimoto M, Gottlieb A, Shuler CL, Lin CY, Lee CH, Mease PJ. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naive patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567. eCollection 2017.

ReferenceCitation: van der Heijde D, Gladman DD, Kishimoto M, Okada M, Rathmann SS, Moriarty SR, Shuler CL, Carlier H, Benichou O, Mease PJ. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1). J Rheumatol. 2018 Mar;45(3):367-377. doi: 10.3899/jrheum.170429. Epub 2017 Dec 15. Erratum In: J Rheumatol. 2018 Nov;45(11):1608.

ReferenceCitation: Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

location_country:
Poland
United Kingdom
Estonia
Japan
Netherlands
Mexico
Belgium
United States
Spain
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France

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.


type: EudraCT Number

title: MEA115666: A Multi-centre, Open-label, Long Term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in the MEA112997 Trial

summary: This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, Barros M, Buhl R, Howarth P, Albers FC, Bradford ES, Gilson M, Price RG, Yancey SW, Ortega H. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019 May;143(5):1742-1751.e7. doi: 10.1016/j.jaci.2018.09.033. Epub 2018 Oct 23.

ReferenceType: derived

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United Kingdom
Argentina
Romania
Australia
United States
Korea, Republic of
Chile
Canada
Ukraine
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma

acronym: TAURUS

summary: Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

status: Terminated

design_allocation: Randomized

ipd_sharing: No

lead_sponsor: AVEO Pharmaceuticals, Inc.

sponsor_collaborators:
AVEO Pharmaceuticals, Inc.
Astellas Pharma Inc

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
France

status_simplified: Unknown


title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects With Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

acronym: NASH

summary:
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

Randomized Double-Blind Phase
Open-Label Phase (optional)

ReferenceType: result

ReferenceCitation: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.

ReferenceCitation: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.

ReferenceCitation: Bosch J, Harrison S, Ratziu V, Shiffman M, Diehl A, Caldwell S, et al. Impact of modest weight reduction on liver histology, portal pressure, and clinical events in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2017; 66 (1): S159-S160.

ReferenceCitation: Sanyal A, Goodman Z, Harrison S, Rockey DC, Diehl AM, Caldwell S, et al. Correlation between the hepatic venous pressure gradient and alpha-smooth muscle actin (SMA) expression in patients with compensated cirrhosis due to nonalcoholic steatohepatitis. J Hepatol 2016; 64 (2): S251.

ReferenceCitation: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.

ReferenceCitation: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.

ReferenceCitation: Bosch J, Ratziu V, Rockey DC, Ghalib RH, Thuluvath PJ, Shiefke I, et al. Correlation between noninvasive markers of fibrosis and the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 578A.

ReferenceCitation: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.

ReferenceCitation: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.

ReferenceCitation: Sanyal AJ, Goodman ZD, Abdelmalek MF, Harrison SA, Rockey DC, Diehl AM, et al. Clinical and histologic correlates of the hepatic venous pressure gradient (HVPG) in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 577A.

ReferenceCitation: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

oa_host_type: closed

ReferenceCitation: Harrison SA, Abdelmalek MF, Caldwell S, Shiffman ML, Diehl AM, Ghalib R, Lawitz EJ, Rockey DC, Schall RA, Jia C, McColgan BJ, McHutchison JG, Subramanian GM, Myers RP, Younossi Z, Ratziu V, Muir AJ, Afdhal NH, Goodman Z, Bosch J, Sanyal AJ; GS-US-321-0105 and GS-US-321-0106 Investigators. Simtuzumab Is Ineffective for Patients With Bridging Fibrosis or Compensated Cirrhosis Caused by Nonalcoholic Steatohepatitis. Gastroenterology. 2018 Oct;155(4):1140-1153. doi: 10.1053/j.gastro.2018.07.006. Epub 2018 Jul 7.

lead_sponsor: Gilead Sciences

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

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: University of California San Francisco (UCSF)

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

location_facility: Indiana University School of Medicine, Division of Gastroenterology/Hepatology

location_facility: Walter Reed National Military Medical Center

location_facility: University Hospitals Case Medical Center

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: University of Mississippi Medical Center

location_facility: University of California, San Diego (UCSD)

intervention_type: Biological


title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

summary:
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH.

It will consist of 2 phases:

Randomized Double-Blind Phase
Open-Label Phase (optional)

ReferenceCitation: Ratziu V, Sanyal A, Torres D, Hinrichsen H, Serfaty L, Bambha K, et al. Impact of weight reduction on serum markers and liver histology including progression to cirrhosis in patients with nonalcoholic steatohepatitis (NASH) and bridging fibrosis. J Hepatol 2017; 66 (1): S594.

publications_result: Sanyal A, Harrison S, Ratziu V, Abdelmalek M, Diehl A, Caldwell S, et al. Changes in fibrosis, but not the NAFLD Activity Score (NAS), are associated with disease progression in patients with nonalcoholic steatohepatitis (NASH) and advanced fibrosis. J Hepatol 2017; 66 (1): S2.

publications_result: Sanyal A, Abdelmalek M, Diehl A, Caldwell S, Shiffman M, Ghalib R, et al. Efficacy and safety of simtuzumab for the treatment of nonalcoholic steatohepatitis with bridging fibrosis or cirrhosis: results of two phase 2b, dose-ranging, randomized, placebo-controlled trials. J Hepatol 2017; 66 (1): S54.

publications_result: Shea PR, Sanyal A, Harrison S, Ratziu V, Loomba R, Caldwell S, et al. PNPLA3 variants confer an increased risk of advanced fibrosis due to non-alcoholic steatohepatitis. J Hepatol 2016; 64 (2): S493.

publications_result: Shea PR, Sanyal A, Rockey DC, Loomba R, Diehl AM, Kleinstein SE, et al. Genome-wide association study of clinically significant portal hypertension in patients with nonalcoholic steatohepatitis and advanced fibrosis. J Hepatol 2016; 64 (2): S280.

publications_result: Goodman ZD, Alaparthi L, Monge F, Patel K, Loomba R, Caldwell SH, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis staging, and serum markers in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 906A.

publications_result: Harrison SA, Goodman ZD, Ratziu V, Loomba R, Diehl AM, Lawitz E, et al. Serum lysyl oxidase-like-2 (sLOXL2) levels correlate with fibrosis stage in patients with nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 910A.

publications_result: Ratziu V, Sanyal AJ, Loomba R, Caldwell SH, Ghalib RH, Torres DM, et al. Characterization of insulin resistance in patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH). Hepatol 2015; 62 (1): 1298A-1299A.

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

location_facility: Miami Veterans Administration Healthcare System

location_facility: Virginia Commonwealth University Health System

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Nottingham University Hospitals Queens Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: King's College Hospital NHS Foundation Trust No. 1 Account


title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis

acronym: BREVAS

summary: The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.

ReferenceCitation: Jayne D, Blockmans D, Luqmani R, Moiseev S, Ji B, Green Y, Hall L, Roth D, Henderson RB, Merkel PA; BREVAS Study Collaborators. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. Arthritis Rheumatol. 2019 Jun;71(6):952-963. doi: 10.1002/art.40802. Epub 2019 Apr 16.

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by

license_normalized: cc-by

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

repository_institution: Aberdeen University - Aberdeen University Research Archive

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University of Cambridge - Apollo

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: LIRIAS (KU Leuven);PubMed Central;aura.abdn.ac.uk;tara.tcd.ie;www.repository.cam.ac.uk

publisher_dissemination: Wiley

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Germany
Ireland
Poland
Australia
Czechia
Canada
France
Hungary
Switzerland
United States
Romania
Belgium
Peru
Italy
Norway
United Kingdom
Mexico
Spain
Russian Federation
Sweden


lead_sponsor: Tetec AG

summary: In this phase 3 clinical trial, a second generation ACI (autologous chondrocyte implantation technique) is compared to standard of care therapy (microfracture) to treat traumatic cartilage defects of the knee for efficacy and safety. The investigated study treatment NOVOCART 3D plus is a biphasic biological scaffold which contains cultivated chondrocytes derived from the patient in a previous tissue harvest procedure. Allocation to the study treatment is done by randomization in a ration of 2:1 in favor to ACI (investigational product). Follow-up data for efficacy is collected for 2 years: follow-up visits are performed 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months after treatment; additional data for safety will be collected for up to 5 years: 36, 48, and 60 months after treatment. The study involves knee surgery (by arthroscopy, or mini-arthrotomically for implantation surgery), and blood withdrawal for safety within the first year after treatment. Initial imaging is required at baseline. Optional MRI imaging and biomarker collection is done as substudy at specific sites only.

location_facility: Szpital sw. Lukasza BGL Sp z o.o. S.K.A.

location_facility: Samozdzielny Publiczny Zaklad Opieki Zdrowotnej Miejskiego Szpitala Zespolonego

location_facility: Orthopädische Klinik und Poliklinik der LMU München

location_facility: Urazova nemocnice v Brne - Traumatologie

location_facility: Hospital of Traumatology and Orthopaedics, Trauma Department

location_facility: Fakultni nemocnice Hradec Kralove - Ortopedicka klinika

location_facility: NH Hospital, a.s., Ortopedicke oddeleni nemocnice Horovice

location_facility: B-A-Z Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Hôpital Ambroise Paré - Service de Chirurgie Orthopedique et Traumatologie

location_facility: JSC "SK Impeks Medicinos Diagnostikos Centras"

location_facility: Fakultni nemocnice Brno - Ortopedicka klinika

location_facility: CHU de Saint-Etienne Hôpital Nord - Service orthopedie et traumatologie

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Orthopaedie

location_facility: Samozdzielny Publiczny Wojewodzki Szpital Chirurgii Urazowej

title: A Prospective Randomized Controlled Multicenter Phase-III Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D Plus Compared to the Standard Procedure Microfracture in the Treatment of Articular Cartilage Defects of the Knee

source: euctr

location_country:
Germany
Lithuania
Poland
Hungary
United Kingdom
Switzerland
Austria
Latvia
Czechia
France


title: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer

summary: This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Hill AG, Findlay MP, Burge ME, Jackson C, Alfonso PG, Samuel L, Ganju V, Karthaus M, Amatu A, Jeffery M, Bartolomeo MD, Bridgewater J, Coveler AL, Hidalgo M, Kapp AV, Sufan RI, McCall BB, Hanley WD, Penuel EM, Pirzkall A, Tabernero J. Phase II Study of the Dual EGFR/HER3 Inhibitor Duligotuzumab (MEHD7945A) versus Cetuximab in Combination with FOLFIRI in Second-Line RAS Wild-Type Metastatic Colorectal Cancer. Clin Cancer Res. 2018 May 15;24(10):2276-2284. doi: 10.1158/1078-0432.CCR-17-0646. Epub 2018 Mar 5.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

version: submittedVersion

repositories_institution: Aberdeen University - Aberdeen University Research Archive

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Genentech, Inc.

location_country:
Germany
Italy
New Zealand
United Kingdom
Romania
Australia
Belgium
United States
Spain
France


type: Other Identifier

title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
To evaluate the effect of alirocumab on other lipid parameters
To evaluate the safety and tolerability of alirocumab

ReferenceCitation: Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.

ReferenceCitation: Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

evidence: oa repository (semantic scholar lookup)

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

publisher_dissemination: Oxford University Press

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

evidence: open (via free article)

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

location_country:
Hungary
Israel
Denmark
United States
Korea, Republic of
South Africa
Canada
Ukraine
Russian Federation
France

location_facility:
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Investigational Site Number 840928


title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
Poland
Hungary
Argentina
Brazil
Mexico
Belgium
United States
Spain
Czechia
Ukraine
Russian Federation
France


title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

acronym: PRINCIPAL

summary: The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
New Zealand
Argentina
Australia
Japan
Chile
France
Hong Kong
United States
Belgium
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Greece
Taiwan
Russian Federation

location_facility: University Of Pittsburgh Medical Center, Ctr For Liver Diseases

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: University Of California, San Francisco/Sf General Hospital


title: A 12-week Treatment, Randomized, Blinded, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of NVA237 (50 µg o.d.) Compared to Tiotropium (18 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

ReferenceCitation: Chapman KR, Beeh KM, Beier J, Bateman ED, D'Urzo A, Nutbrown R, Henley M, Chen H, Overend T, D'Andrea P. A blinded evaluation of the efficacy and safety of glycopyrronium, a once-daily long-acting muscarinic antagonist, versus tiotropium, in patients with COPD: the GLOW5 study. BMC Pulm Med. 2014 Jan 17;14:4. doi: 10.1186/1471-2466-14-4.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Cape Town - Open University of Cape Town

repository_normalized: localhost

repository_institution: University of Toronto - TSpace

repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Lithuania
Poland
Guatemala
India
Korea, Republic of
Latvia
South Africa
Croatia
Taiwan
Canada
Estonia
Czech Republic
Philippines
France


title: Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group

summary:
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.

The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.

enrollment_type: Anticipated

ReferenceCitation: Wildiers H, Tryfonidis K, Dal Lago L, Vuylsteke P, Curigliano G, Waters S, Brouwers B, Altintas S, Touati N, Cardoso F, Brain E. Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer (EORTC 75111-10114): an open-label, randomised, phase 2 trial from the Elderly Task Force/Breast Cancer Group. Lancet Oncol. 2018 Mar;19(3):323-336. doi: 10.1016/S1470-2045(18)30083-4. Epub 2018 Feb 9.

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

location_country:
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
Belgium
France

location_facility: Uppsala University Hospital - Akademiska Sjukhuset

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Velindre NHS Trust - Velindre Cancer Centre

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Peterborough and Stamford Hospitals NHS Foundation Trust - Peterborough City Hospita

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo


title: International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

acronym: IGOS

summary:
International GBS Outcome Study (IGOS) is a study conducted by the members of the Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease course and outcome in individual patients with Guillain-Barré syndrome, as early as possible after onset of disease.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Pereon Y, Burmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutierrez-Gutierrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barre Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.

oa_host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barre Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barre syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: University of Melbourne - Minerva Access;eprints.gla.ac.uk;ora.ox.ac.uk

ipd_sharing: Undecided

lead_sponsor: Erasmus Medical Center

location_country:
Germany
Argentina
Australia
Japan
Canada
France
Denmark
Switzerland
United States
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Netherlands
Spain
Bangladesh
Greece
South Africa
Taiwan

location_facility: Southern Illinois University School of Medicine

location_facility: The affiliated Hospital of Xuzhou Medical University

location_facility: Concord Repatriation General Hospital Sydney

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Maryland School of Medicine

location_facility: University of Vermont College of Medicine

location_facility: Wexner Medical Center at The Ohio State University

location_facility: National Hospital of Neurology and Neurosurgery

location_facility: The university of Texas Health Science Center

location_facility: Affiliated Hospital of Jining Medical University

status_simplified: Ongoing


acronym: PROTECT-VIII

lead_sponsor: Bayer

summary:
Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.

The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.

In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.

120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.

Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

ReferenceCitation: Baumann A, Piel I, Hucke F, Sandmann S, Hetzel T, Schwarz T. Pharmacokinetics, excretion, distribution, and metabolism of 60-kDa polyethylene glycol used in BAY 94-9027 in rats and its value for human prediction. Eur J Pharm Sci. 2019 Mar 15;130:11-20. doi: 10.1016/j.ejps.2019.01.015. Epub 2019 Jan 14.

ReferenceCitation: Lalezari S, Reding MT, Pabinger I, Holme PA, Negrier C, Chalasani P, Shin HJ, Wang M, Tseneklidou-Stoeter D, Maas Enriquez M. BAY 94-9027 prophylaxis is efficacious and well tolerated for up to >5 years with extended dosing intervals: PROTECT VIII extension interim results. Haemophilia. 2019 Nov;25(6):1011-1019. doi: 10.1111/hae.13853. Epub 2019 Oct 17.

ReferenceCitation: Reding MT, Ng HJ, Poulsen LH, Eyster ME, Pabinger I, Shin HJ, Walsch R, Lederman M, Wang M, Hardtke M, Michaels LA. Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII. J Thromb Haemost. 2017 Mar;15(3):411-419. doi: 10.1111/jth.13597. Epub 2017 Feb 22.

ReferenceCitation: Reding MT, Pabinger I, Holme PA, Maas Enriquez M, Mancuso ME, Lalezari S, Miesbach W, Di Minno G, Klamroth R, Hermans C. Efficacy and safety of damoctocog alfa pegol prophylaxis in patients ⩾40 years with severe haemophilia A and comorbidities: post hoc analysis from the PROTECT VIII study. Ther Adv Hematol. 2023 Apr 22;14:20406207231166779. doi: 10.1177/20406207231166779. eCollection 2023.

repositories_concat: PubMed Central

publisher_dissemination: SAGE Publications

title: A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

location_country:
Germany
Poland
Japan
Turkey
Canada
France
Colombia
Denmark
United States
Romania
Belgium
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Taiwan
Israel


title: Clinical Investigation of the Nucleus® CI532 Cochlear Implant

summary:
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.

ReferenceCitation: Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.

publisher_dissemination: Informa

lead_sponsor: Cochlear

location_country: Germany Spain Australia France

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Ear, Nose and Throat Department, Medizinische Hochschule

location_facility: Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: Ear, Nose and Throat Department, Universitätsklinikum Erlangen

location_facility: Ear, Nose and Throat Department, University of Freiburg

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil

intervention_type: Device


title: A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study

summary:
The primary objectives of the study are:

-To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn's Disease（CD）

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Germany France Italy Poland Slovakia Hungary Japan Netherlands Czechia Ukraine Israel


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.

ReferenceCitation: Padidela R, Yates R, Benscoter D, McPhail G, Chan E, Nichani J, Mughal MZ, Myer C 4th, Narayan O, Nissenbaum C, Wilkinson S, Zhou S, Saal HM. Characterization of tracheobronchomalacia in infants with hypophosphatasia. Orphanet J Rare Dis. 2020 Aug 6;15(1):204. doi: 10.1186/s13023-020-01483-9.

publisher_dissemination: Springer-Nature

ReferenceCitation: Hofmann CE, Harmatz P, Vockley J, Hogler W, Nakayama H, Bishop N, Martos-Moreno GA, Moseley S, Fujita KP, Liese J, Rockman-Greenberg C; ENB-010-10 Study Group. Efficacy and Safety of Asfotase Alfa in Infants and Young Children With Hypophosphatasia: A Phase 2 Open-Label Study. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2735-2747. doi: 10.1210/jc.2018-02335.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories:
PubMed Central
Pure (Denmark)
dnet
eprints.whiterose.ac.uk

publisher_dissemination: The Endocrine Society

ReferenceCitation: Whyte MP, Rockman-Greenberg C, Ozono K, Riese R, Moseley S, Melian A, Thompson DD, Bishop N, Hofmann C. Asfotase Alfa Treatment Improves Survival for Perinatal and Infantile Hypophosphatasia. J Clin Endocrinol Metab. 2016 Jan;101(1):334-42. doi: 10.1210/jc.2015-3462. Epub 2015 Nov 3.

location_facility: Health Sciences Centre Winnipeg, University of Manitoba

location_facility: Children's Hospital & Research Center Oakland

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: King Faisal Specialist Hospital and Research Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: St. Marianna University School of Medicine, Yokohayama City Seibu Hospital

title: An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)

location_country:
Germany
Italy
United Kingdom
Australia
Japan
United States
Saudi Arabia
Spain
Turkey
Canada
Russian Federation
France


title: Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR

summary: In case of PET or CT based cN1 (suspected) NSCLC, ESTS guidelines propose mediastinal staging by echo-endoscopy OR mediastinoscopy. Recent data show a sensitivity of less than 50% for echo-endoscopy to detect N2 disease in cN1 NSCLC patients, while prevalence of mediastinal nodal disease was 24% (unpublished data Aster II).2 The investigators plan to perform a prospective multicentric observational study to measure the sensitivity of mediastinal staging by video-assisted mediastinoscopy (VAM) in cN1 operable and resectable (suspected) NSCLC patients.

ReferenceCitation: Decaluwe H, Dooms C, D'Journo XB, Call S, Sanchez D, Haager B, Beelen R, Kara V, Klikovits T, Aigner C, Tournoy K, Zahin M, Moons J, Brioude G, Trujillo JC, Klepetko W, Turna A, Passlick B, Molins L, Rami-Porta R, Thomas P, Leyn P. Mediastinal staging by videomediastinoscopy in clinical N1 non-small cell lung cancer: a prospective multicentre study. Eur Respir J. 2017 Dec 21;50(6):1701493. doi: 10.1183/13993003.01493-2017. Print 2017 Dec.

publisher_dissemination: European Respiratory Society

lead_sponsor: Johnny Moons

location_country: Germany Switzerland Belgium Spain Turkey France

location_facility: Istanbul University, Cerrahpasa Medical Faculty

location_facility: University Hospital, Division of Thoracic Surgery

location_facility: Aix-Marseille University & Hospitals System of Marseille (AP-HM)


title: Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

acronym: STAR

summary: The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.

ReferenceCitation: Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-based analysis of implanted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Sleep. 2021 Apr 27;44(44 Suppl 1):S11-S19. doi: 10.1093/sleep/zsaa269.

ReferenceCitation: Yu JL, Younes M. Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial. J Clin Sleep Med. 2021 Apr 1;17(4):797-801. doi: 10.5664/jcsm.9050.

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Op de Beeck S, Wellman A, Dieltjens M, Strohl KP, Willemen M, Van de Heyning PH, Verbraecken JA, Vanderveken OM, Sands SA; STAR Trial Investigators. Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021 Mar 15;203(6):746-755. doi: 10.1164/rccm.202006-2176OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Inspire Medical Systems, Inc.

location_country:
Germany
Netherlands
Belgium
United States
France

location_facility: University Hospitals / Case Western Reserve

location_facility: Wayne State University / Detroit Medical Center

location_facility: Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen

location_facility: University of Pittsburgh Medical Center; Montefiore

location_facility: Clinical Research Group of St. Petersburg, Inc.


summary: This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

location_facility:
Novartis Investigative Site
Novartis Investigator Site

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma

location_country:
Germany
United Kingdom
Netherlands
United States
Jordan
France


title: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years

summary: The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Grünenthal GmbH

location_country:
United States
Spain
Canada
France


title: A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

summary:
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.

The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

design_allocation: Non-Randomized

location_country:
Italy
United Kingdom
Belgium
United States
Spain
France

location_facility: Sarah Cannon Research Institute Sarah Cannon Cancer Center SC

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp


summary: The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

location_country:
Germany
France
Norway
Japan
United States
Iceland
Israel


title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

summary: This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

ReferenceCitation: Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.

repository_institution: Hindawi - Hindawi

repositories_concat: PubMed Central;hindawi.com

repositories_institution:
Hindawi - Hindawi
PubMed Central - Europe PMC

publisher_dissemination: Hindawi

lead_sponsor: Impax Laboratories, LLC

location_country:
United States
Italy
Germany
France

location_facility: Hôpital Gabriel Montpied-Service de Neurologie A-

location_facility: Parkinson's Disease and Movement Disorders Center of Long Island

location_facility: Praxis für Neurologie, Psychiatrie und Psychotherapie Achim

location_facility: USF Parkinson's and Movement Disorders Center

location_facility: RKU, Neurologische Klinik der Universität Ulm

location_facility: Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio

location_facility: Service de neurologie-Hôpital de la Timone-

location_facility: San Raffaele Cassino, San Raffaele Cassino,

location_facility: Klinikum rechts der Isar der Technischen Universität München


summary:
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway.

Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.

location_facility: Children's Healthcare of Atlanta Childern Hosp - ATL

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. John Hopkins

location_facility: Seattle Children's Hospital CPKC412A2114

title: A Phase I/II Study of LDE225 in Pediatric Patients With Recurrent or Refractory Medulloblastoma or Other Tumors Potentially Dependent on the Hedgehog-signaling Pathway and Adult Patients With Recurrent or Refractory Medulloblastoma

location_country:
Italy
United Kingdom
Australia
United States
Canada
France


lead_sponsor: Cephalon

summary: The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

location_facility:
Teva Investigational Site 119
Teva Investigational Site 450
Teva Investigational Site 107
Teva Investigational Site 692
Teva Investigational Site 217
Teva Investigational Site 136
Teva Investigational Site 113
Teva Investigational Site 651
Teva Investigational Site 834
Teva Investigational Site 148
Teva Investigational Site 229
Teva Investigational Site 854
Teva Investigational Site 115
Teva Investigational Site 190
Teva Investigational Site 103
Teva Investigational Site 147
Teva Investigational Site 409
Teva Investigational Site 192
Teva Investigational Site 182
Teva Investigational Site 296
Teva Investigational Site 110
Teva Investigational Site 433
Teva Investigational Site 336
Teva Investigational Site 245
Teva Investigational Site 235
Teva Investigational Site 706
Teva Investigational Site 118
Teva Investigational Site 138
Teva Investigational Site 183
Teva Investigational Site 831
Teva Investigational Site 301
Teva Investigational Site 688
Teva Investigational Site 257
Teva Investigational Site 131
Teva Investigational Site 156
Teva Investigational Site 689
Teva Investigational Site 111
Teva Investigational Site 434
Teva Investigational Site 837
Teva Investigational Site 634
Teva Investigational Site 258
Teva Investigational Site 400
Teva Investigational Site 712
Teva Investigational Site 236
Teva Investigational Site 855
Teva Investigational Site 370
Teva Investigational Site 698
Teva Investigational Site 606
Teva Investigational Site 256
Teva Investigational Site 286
Teva Investigational Site 121
Teva Investigational Site 411
Teva Investigational Site 155
Teva Investigational Site 873
Teva Investigational Site 228
Teva Investigational Site 664
Teva Investigational Site 633
Teva Investigational Site 184
Teva Investigational Site 175
Teva Investigational Site 406
Teva Investigational Site 207
Teva Investigational Site 299
Teva Investigational Site 861
Teva Investigational Site 219
Teva Investigational Site 281
Teva Investigational Site 135
Teva Investigational Site 225
Teva Investigational Site 127
Teva Investigational Site 371
Teva Investigational Site 605
Teva Investigational Site 198
Teva Investigational Site 709
Teva Investigational Site 832
Teva Investigational Site 247
Teva Investigational Site 462
Teva Investigational Site 157
Teva Investigational Site 201
Teva Investigational Site 153
Teva Investigational Site 177
Teva Investigational Site 132
Teva Investigational Site 116
Teva Investigational Site 710
Teva Investigational Site 196
Teva Investigational Site 105
Teva Investigational Site 666
Teva Investigational Site 853
Teva Investigational Site 102
Teva Investigational Site 100
Teva Investigational Site 303
Teva Investigational Site 403
Teva Investigational Site 612
Teva Investigational Site 238
Teva Investigational Site 176
Teva Investigational Site 404
Teva Investigational Site 875
Teva Investigational Site 145
Teva Investigational Site 128
Teva Investigational Site 134
Teva Investigational Site 104
Teva Investigational Site 282
Teva Investigational Site 133
Teva Investigational Site 200
Teva Investigational Site 881
Teva Investigational Site 255
Teva Investigational Site 884
Teva Investigational Site 613
Teva Investigational Site 205
Teva Investigational Site 117
Teva Investigational Site 696
Teva Investigational Site 687
Teva Investigational Site 609
Teva Investigational Site 213
Teva Investigational Site 224
Teva Investigational Site 181
Teva Investigational Site 699
Teva Investigational Site 202
Teva Investigational Site 711
Teva Investigational Site 600
Teva Investigational Site 237
Teva Investigational Site 610
Teva Investigational Site 635
Teva Investigational Site 616
Teva Investigational Site 662
Teva Investigational Site 290
Teva Investigational Site 430
Teva Investigational Site 204
Teva Investigational Site 603
Teva Investigational Site 292
Teva Investigational Site 833
Teva Investigational Site 401
Teva Investigational Site 300
Teva Investigational Site 122
Teva Investigational Site 259
Teva Investigational Site 195
Teva Investigational Site 193
Teva Investigational Site 408
Teva Investigational Site 240
Teva Investigational Site 106
Teva Investigational Site 851
Teva Investigational Site 180
Teva Investigational Site 697
Teva Investigational Site 608
Teva Investigational Site 852
Teva Investigational Site 212
Teva Investigational Site 141
Teva Investigational Site 223
Teva Investigational Site 872
Teva Investigational Site 655
Teva Investigational Site 708
Teva Investigational Site 146
Teva Investigational Site 295
Teva Investigational Site 249
Teva Investigational Site 280
Teva Investigational Site 129
Teva Investigational Site 871
Teva Investigational Site 248
Teva Investigational Site 661
Teva Investigational Site 624

title: A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Argentina
Australia
Brazil
United States
Spain
South Africa
Croatia
Ukraine
Bulgaria
Canada
Serbia
France


type: Other Grant/Funding Number

title: European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

acronym: ESPOIR

summary:
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
No additional diagnostic or monitoring procedures shall be applied to the patients
and epidemiological methods shall be used for the analysis of collected data.

Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

ReferenceCitation: Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hubler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.

repository_institution: KU Leuven - Lirias

endpoint_id: ebkqzhfrceygztdsjokh

repository_institution: University of Padua - Padua Research Archive

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org;www.research.unipd.it

ReferenceCitation: Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac219. doi: 10.1093/ejcts/ezac219.

repository_institution: Leiden University - Leiden Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;scholarlypublications.universiteitleiden.nl

repositories_institution:
KU Leuven - Lirias
Leiden University - Leiden Repository

lead_sponsor: corlife

collaborators: State University of Medicine and Pharmaceutics, Chisinau, Moldavia

collaborators: Great Ormond Street Hospital for Children NHS Foundation Trust

collaborators: German Society for Tissue Transplantation

collaborators: Gottfried Wilhelm Leibniz Universität Hannover

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
Belgium
Moldova, Republic of
France

location_facility: Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU

location_facility: Great Ormond Street Hospital for Children NHS Trust, GOSH

location_facility: Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP

location_facility: Leids Universitair Medisch Centrum, LUMC

intervention_type: Other


title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study

summary: The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

lead_sponsor: Medtronic

location_country:
Germany
Italy
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Canada
Serbia
France


title: A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once Daily Versus Twice Daily Dosing of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638

summary: The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).

ReferenceCitation: McEachern KA, Fung J, Komarnitsky S, Siegel CS, Chuang WL, Hutto E, Shayman JA, Grabowski GA, Aerts JM, Cheng SH, Copeland DP, Marshall J. A specific and potent inhibitor of glucosylceramide synthase for substrate inhibition therapy of Gaucher disease. Mol Genet Metab. 2007 Jul;91(3):259-67. doi: 10.1016/j.ymgme.2007.04.001. Epub 2007 May 16.

ReferenceCitation: Lukina E, Watman N, Arreguin EA, Banikazemi M, Dragosky M, Iastrebner M, Rosenbaum H, Phillips M, Pastores GM, Rosenthal DI, Kaper M, Singh T, Puga AC, Bonate PL, Peterschmitt MJ. A phase 2 study of eliglustat tartrate (Genz-112638), an oral substrate reduction therapy for Gaucher disease type 1. Blood. 2010 Aug 12;116(6):893-9. doi: 10.1182/blood-2010-03-273151. Epub 2010 May 3.

ReferenceCitation: Lukina E, Watman N, Arreguin EA, Dragosky M, Iastrebner M, Rosenbaum H, Phillips M, Pastores GM, Kamath RS, Rosenthal DI, Kaper M, Singh T, Puga AC, Peterschmitt MJ. Improvement in hematological, visceral, and skeletal manifestations of Gaucher disease type 1 with oral eliglustat tartrate (Genz-112638) treatment: 2-year results of a phase 2 study. Blood. 2010 Nov 18;116(20):4095-8. doi: 10.1182/blood-2010-06-293902. Epub 2010 Aug 16. Erratum In: Blood. 2011 May 19;117(20):5551.

ReferenceCitation: Charrow J, Fraga C, Gu X, Ida H, Longo N, Lukina E, Nonino A, Gaemers SJM, Jouvin MH, Li J, Wu Y, Xue Y, Peterschmitt MJ. Once- versus twice-daily dosing of eliglustat in adults with Gaucher disease type 1: The Phase 3, randomized, double-blind EDGE trial. Mol Genet Metab. 2018 Mar;123(3):347-356. doi: 10.1016/j.ymgme.2017.12.001. Epub 2018 Jan 4.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
India
Portugal
Romania
Australia
Brazil
Japan
Austria
Netherlands
Sweden
United States
China
Greece
Croatia
Canada
Serbia
Russian Federation
France

location_facility: Hospital de Clínicas da Universidade Federal do Parana

location_facility: St. Petersburg State Medical Pavlov University

location_facility: IGEIM - Institute of Genetic and Inborn Erros of Metabolism

location_facility: Cettro - Centro de Tratamento de Oncologia e Hematologia

location_facility: Hospital Universitario Walter Cantidio - HUWC

location_facility: Hemocentro de Ribeirão Preto Núcleo de Hemoterapia de Franca

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Shanghai Xinhua Hospital Shanghai Xinhua Hospital

location_facility: University of California, San Diego Medical Center

location_facility: State Medical and Prophylactic Healthcare Institution; Chelyabinsk Regional Clinical Hospital

location_facility: Hematology Research Center of Russian Academy of Medical Sciences

location_facility: Instituto Tropical de Medicina Reprodutiva e Menopausa - INTRO

location_facility: Hôpital Femme Mère Enfant Centre de référence des maladies Héréditaires du métabolisme


title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

summary: To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Australia
Austria
United States
Canada
France


title: A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

summary:
The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer.

EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).

EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies have been conducted in healthy volunteers. In the other five studies, subjects with advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and neck (SCCHN).

In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The study will be conducted as a multicenter study in several European Union (EU) member states and the Unites States.

EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in subjects by examining its effects on accepted clinical endpoints. Progression-free survival (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic therapy.

Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as investigational medicinal product (IMP) in this study. Commercially available Cetuximab will be provided in the United States.

ReferenceCitation: Ruzsa A, Sen M, Evans M, Lee LW, Hideghety K, Rottey S, Klimak P, Holeckova P, Fayette J, Csoszi T, Erfan J, Forssmann U, Goddemeier T, Bexon A, Nutting C; NA EMD 1201081 Study Group. Phase 2, open-label, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in second-line cetuximab-naive patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Invest New Drugs. 2014 Dec;32(6):1278-84. doi: 10.1007/s10637-014-0117-2. Epub 2014 Jun 4.

lead_sponsor: EMD Serono

location_country:
Poland
Slovakia
Hungary
United Kingdom
Belgium
United States
Czech Republic
France

location_facility: Southampton University Hospitals NHS Trust

location_facility: SPZOZ Centrum Onkologi Liemi Lubelskiej, II Odzial Radioterapiii z pododdzialem Chemioterpii

location_facility: Zala Megyei Kohaz Kulsokorhaz Onkologia Osztaly

location_facility: Zaklad Opleki Zdrowotnej MSWIA z Warminsko-Mazurskim Centrum Onkologil, Oddziat Chemioterapli

location_facility: University of Kentucky, Markey Cancer Center

location_facility: Szegedi Tudomayegyetem Altalanos Orvostudomanyi Kar Onkoterapias Klinika

location_facility: Ustav radiacni onkologie Fakultni nemacnice Na Bulovce

location_facility: Centrum Onkologi - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Glowy i Szyi (NCI)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet


title: Women's INternational Transcatheter Aortic Valve Implantation Registry

acronym: WINTAVI

summary: The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

ReferenceCitation: Buchanan GL, Chieffo A, Montorfano M, Maisano F, Latib A, Godino C, Cioni M, Gullace MA, Franco A, Gerli C, Alfieri O, Colombo A. The role of sex on VARC outcomes following transcatheter aortic valve implantation with both Edwards SAPIEN and Medtronic CoreValve ReValving System(R) devices: the Milan registry. EuroIntervention. 2011 Sep;7(5):556-63. doi: 10.4244/EIJV7I5A91.

ReferenceCitation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

ReferenceCitation: Hayashida K, Morice MC, Chevalier B, Hovasse T, Romano M, Garot P, Farge A, Donzeau-Gouge P, Bouvier E, Cormier B, Lefevre T. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012 Feb 7;59(6):566-71. doi: 10.1016/j.jacc.2011.10.877.

lead_sponsor: Icahn School of Medicine at Mount Sinai

collaborators: Society for Cardiovascular Angiography and Interventions

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
France

location_facility: Department cardiovascular Sciences Policlinico Umberto I

location_facility: Radboud University Nijmegen Medical Center


title: Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

summary:
This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

ReferenceCitation: Mariani G, Dolce A, Batorova A, Auerswald G, Schved JF, Siragusa S, Napolitano M, Knudsen JB, Ingerslev J; STER and the International Factor VII Deficiency Study Groups. Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER. Br J Haematol. 2011 Feb;152(3):340-6. doi: 10.1111/j.1365-2141.2010.08287.x. Epub 2010 Dec 16.

ReferenceCitation: Mariani G, Dolce A, Napolitano M, Ingerslev J, Giansily-Blaizot M, Di Minno MD, Auerswald G, De Saez AR, Tagliaferri A, Batorova A; STER (Seven Treatment Evaluation Registry). Invasive procedures and minor surgery in factor VII deficiency. Haemophilia. 2012 May;18(3):e63-5. doi: 10.1111/j.1365-2516.2012.02751.x. Epub 2012 Feb 22. No abstract available.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
India
Slovakia
Israel
Hong Kong
Venezuela
Iran, Islamic Republic of
United States
Spain
Thailand
Greece
Pakistan
Turkey
Serbia
France


title: Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

summary: PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

ReferenceCitation: De Greef Y, Dekker L, Boersma L, Murray S, Wieczorek M, Spitzer SG, Davidson N, Furniss S, Hocini M, Geller JC, Csanadi Z; PRECISION GOLD investigators. Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial. Europace. 2016 May;18(5):687-95. doi: 10.1093/europace/euv385. Epub 2016 Jan 29.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
Hungary
United Kingdom
Netherlands
Belgium
France

location_facility: Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR


acronym: Neo-AEGIS

lead_sponsor: Cancer Trials Ireland

summary:
This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy (Investigator's choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol).

Primary Objective:

To evaluate one, two and three year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy versus resection plus neoadjuvant chemo radiotherapy.

Secondary Objective(s):

To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate (in particular relief of dysphagia, improvement in health related quality of life (HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression grade, node-positivity, post-operative pathology, disease-free survival, time to treatment failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL).

Exploratory Objective(s):

Translational Research: The collection of blood and tissue samples for storage in the bio bank for future research.

ReferenceCitation: Reynolds JV, Preston SR, O'Neill B, Baeksgaard L, Griffin SM, Mariette C, Cuffe S, Cunningham M, Crosby T, Parker I, Hofland K, Hanna G, Svendsen LB, Donohoe CL, Muldoon C, O'Toole D, Johnson C, Ravi N, Jones G, Corkhill AK, Illsley M, Mellor J, Lee K, Dib M, Marchesin V, Cunnane M, Scott K, Lawner P, Warren S, O'Reilly S, O'Dowd G, Leonard G, Hennessy B, Dermott RM. ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS). BMC Cancer. 2017 Jun 3;17(1):401. doi: 10.1186/s12885-017-3386-2.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Southampton - ePrints Soton

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: The Newcastle upon Tyne Hospital NHS Foundation TrustFreeman Hospital, Freeman Road, High Heaton

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Oxford University Hospital NHS Trust Churchill Hospital

location_facility: Imperial College Healthcare NHS Trust St Mary's Hospital

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Karolinska Institutet and Karolinska University Hospital

location_facility: SLRON- St Luke's Radiation Oncology Network

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Régional, Universitaire de Lille 2 Avenue Oscar Lambret, 59000

location_facility: Belfast Health and Social Care Trust, Northern Ireland Cancer Centre, Belfast CityHospital

location_facility: Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital,

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

title: Neo-AEGIS (NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (Modified MAGIC or FLOT Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction

location_country:
Ireland
France
United Kingdom
Denmark
Sweden


title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy

acronym: EUROCONDOR

summary: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

primary_purpose: Prevention

ReferenceCitation: Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

ReferenceCitation: Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.

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

repository_institution: University of Gloucestershire - Research Repository

repository_institution: Aston University - Aston Publications Explorer

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

publisher_dissemination: American Diabetes Association

lead_sponsor: BCN Peptides

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Spain
France

location_facility: Moorfields Eye Hospital NHS Foundation Trust (MEH)

location_facility: Aston University (UAston)Heart of England NHS Foundation Trust

location_facility: Gloucestershire Hospitals NHS Foundation Trust (CHGH)

location_facility: Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)

location_facility: Universita Vita-Salute San Raffaele (USR)

location_facility: Universita degli Study di Padova(UPadova)


title: CoreValve® ADVANCE Direct Aortic Study

summary: This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

lead_sponsor: Medtronic Bakken Research Center

location_country:
Germany
Italy
United Kingdom
Netherlands
Czechia
France

location_facility: Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital

location_facility: Azienda spedaliera Niguarda Ca' Granda Milano

location_facility: Azienda spedaliera Spedali Civili Di Brescia


acronym: INSPIRE

lead_sponsor: Eli Lilly and Company

summary: The research study is testing the investigational drug necitumumab in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and pemetrexed will be more effective in improving participant disease than the standard chemotherapy combination alone.

ReferenceCitation: Paz-Ares L, Mezger J, Ciuleanu TE, Fischer JR, von Pawel J, Provencio M, Kazarnowicz A, Losonczy G, de Castro G Jr, Szczesna A, Crino L, Reck M, Ramlau R, Ulsperger E, Schumann C, Miziara JE, Lessa AE, Dediu M, Balint B, Depenbrock H, Soldatenkova V, Kurek R, Hirsch FR, Thatcher N, Socinski MA; INSPIRE investigators. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study. Lancet Oncol. 2015 Mar;16(3):328-37. doi: 10.1016/S1470-2045(15)70046-X. Epub 2015 Feb 18.

repository_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: Elsevier

sponsor_collaborators:
Eli Lilly and Company
Quintiles, Inc.
Parexel
PPD
Medidata Solutions
Laboratory Corporation of America
University of Colorado, Denver
Thermo Fisher Scientific, Inc
Pacific Biomarkers
Intertek
Sysmex Inostics GmbH

location_facility:
ImClone Investigational Site
Imclone Investigational Site

title: A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

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

location_country:
Germany
Poland
Australia
Brazil
Croatia
Canada
France
Portugal
Slovakia
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
South Africa
Russian Federation


lead_sponsor: Janssen Sciences Ireland UC

summary: The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source [example, access program or government program]), or local standard of care, as appropriate.

title: Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

location_country:
Argentina
Romania
Brazil
United States
Spain
Thailand
Panama
South Africa
Canada
Puerto Rico
France


title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

summary: This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Spain
France


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

summary: To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

ReferenceCitation: Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8.

location_facility:
Teva Investigational Site 8002
Teva Investigational Site 3304
Teva Investigational Site 3402
Teva Investigational Site 3204
Teva Investigational Site 1109
Teva Investigational Site 1009
Teva Investigational Site 3401
Teva Investigational Site 1004
Teva Investigational Site 1002
Teva Investigational Site 1111
Teva Investigational Site 5101
Teva Investigational Site 1003
Teva Investigational Site 1108
Teva Investigational Site 3205
Teva Investigational Site 3004
Teva Investigational Site 1006
Teva Investigational Site 1061
Teva Investigational Site 1110
Teva Investigational Site 5103
Teva Investigational Site 1011
Teva Investigational Site 3502
Teva Investigational Site 3305
Teva Investigational Site 1010
Teva Investigational Site 3802
Teva Investigational Site 8003
Teva Investigational Site 3101
Teva Investigational Site 3203
Teva Investigational Site 1014
Teva Investigational Site 1001
Teva Investigational Site 3005
Teva Investigational Site 3206
Teva Investigational Site 1007
Teva Investigational Site 1012
Teva Investigational Site 8004
Teva Investigational Site 3202
Teva Investigational Site 3801
Teva Investigational Site 3403
Teva Investigational Site 1005
Teva Investigational Site 3103
Teva Investigational Site 3006
Teva Investigational Site 3603
Teva Investigational Site 1008
Teva Investigational Site 3201
Teva Investigational Site 3503
Teva Investigational Site 1013
Teva Investigational Site 5102
Teva Investigational Site 3102

title: A Multi-centered, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

location_country:
Germany
Italy
Portugal
Hungary
Israel
United Kingdom
Netherlands
Austria
United States
Spain
Canada
France


title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

summary: This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

ReferenceCitation: Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
India
United Kingdom
Hong Kong
Brazil
Mexico
United States
Korea, Republic of
Spain
South Africa
Taiwan
Peru
Philippines
France


lead_sponsor: UCB Pharma

summary: To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

title: An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

location_country:
Finland
Italy
Denmark
Romania
Switzerland
Austria
Mexico
United States
Spain
Greece
Turkey
Czechia
Bulgaria
Russian Federation
France


summary: This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.

ReferenceCitation: Ljung R, Karim FA, Saxena K, Suzuki T, Arkhammar P, Rosholm A, Giangrande P; Pioneer1 Investigators. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors. J Thromb Haemost. 2013 Jul;11(7):1260-8. doi: 10.1111/jth.12237.

title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of Prophylactic Administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients With Inhibitors

type: Registry Identifier

location_country:
United Kingdom
Japan
Brazil
Sweden
United States
Malaysia
South Africa
Turkey
Former Serbia and Montenegro
Serbia
France