title: ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

acronym: EASE LID 3

summary:
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

ReferenceCitation: Hauser RA, Mehta SH, Kremens D, Chernick D, Formella AE. Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Dec;10(2):739-751. doi: 10.1007/s40120-021-00256-1. Epub 2021 May 22.

family: Hauser

full_name: Robert A. Hauser

given: Robert A.

family: Mehta

full_name: Shyamal H. Mehta

given: Shyamal H.

family: Kremens

full_name: Daniel Kremens

given: Daniel

family: Chernick

full_name: Dustin Chernick

given: Dustin

family: Formella

full_name: Andrea E. Formella

given: Andrea E.

journal_name: Neurology and Therapy

oa_host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

title: Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson’s Disease and Dyskinesia

ReferenceCitation: Mehta SH, Pahwa R, Tanner CM, Hauser RA, Johnson R. Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Jun;10(1):307-320. doi: 10.1007/s40120-021-00246-3. Epub 2021 Apr 17.

family: Pahwa

full_name: Rajesh Pahwa

given: Rajesh

family: Tanner

full_name: Caroline M. Tanner

given: Caroline M.

family: Johnson

full_name: Reed Johnson

given: Reed

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson’s Disease and Dyskinesia

ReferenceCitation: Elmer LW, Juncos JL, Singer C, Truong DD, Criswell SR, Parashos S, Felt L, Johnson R, Patni R. Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease. CNS Drugs. 2018 Apr;32(4):387-398. doi: 10.1007/s40263-018-0498-4. Erratum in: CNS Drugs. 2018 Apr 10;:.

family: Elmer

full_name: Lawrence W. Elmer

given: Lawrence W.

family: Juncos

full_name: Jorge L. Juncos

given: Jorge L.

family: Singer

full_name: Carlos Singer

title: Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson’s Disease

location_country:
Austria
Germany
France
Spain
United States


ReferenceType: derived

ReferenceCitation: Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.

name: Eli Lilly and Company  Indianapolis Indiana USA

family: Wessels

full_name: Alette M. Wessels

given: Alette M.

sequence: first

name: Merck & Co., Inc.  Kenilworth New Jersey USA

family: Lines

full_name: Christopher Lines

given: Christopher

sequence: additional

name: Alzheimer's Disease Center Boston University School of Medicine  Boston Massachusetts USA

family: Stern

full_name: Robert A. Stern

family: Kost

full_name: James Kost

given: James

family: Voss

full_name: Tiffini Voss

given: Tiffini

family: Mozley

full_name: Lyn Harper Mozley

given: Lyn Harper

family: Furtek

full_name: Christine Furtek

given: Christine

family: Mukai

full_name: Yuki Mukai

given: Yuki

name: University of Southern California  San Diego California USA

family: Aisen

full_name: Paul S. Aisen

given: Paul S.

name: Department of Brain Health School of Integrated Health Sciences University of Nevada Las Vegas (UNLV) and Cleveland Clinic Lou Ruvo Center for Brain Health  Las Vegas Nevada USA

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

name: Banner Alzheimer's Institute  Phoenix Arizona USA

family: Tariot

full_name: Pierre N. Tariot

given: Pierre N.

name: Gerontopole INSERM U1027 Alzheimer's Disease Research and Clinical Center Toulouse University Hospital  Toulouse France

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Dupre

full_name: Nicole Dupre

given: Nicole

name: MedAvante‐ProPhase, Hamilton, NJ and Department of Neurology Loyola University Medical Center  Maywood Illinois USA

family: Randolph

full_name: Christopher Randolph

family: Michelson

full_name: David Michelson

given: David

family: Andersen

full_name: Scott W. Andersen

given: Scott W.

family: Shering

full_name: Craig Shering

given: Craig

family: Sims

full_name: John R. Sims

given: John R.

family: Egan

full_name: Michael F. Egan

given: Michael F.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Alzheimer's & Dementia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum in: JAMA Neurol. 2020 Sep 1;77(9):1179.

name: Eli Lilly and Company, Indianapolis, Indiana

name: Banner Alzheimer’s Institute, University of Arizona College of Medicine, Phoenix

family: Zimmer

full_name: Jennifer A. Zimmer

given: Jennifer A.

family: Selzler

name: AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland

name: Alzheimer’s Disease Center, Boston University School of Medicine, Boston, Massachusetts

name: Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Unités Mixtes de Recherche Institut National de la Santé et de la Recherche Médicale 1027, Université Toulouse III–Paul Sabatier, Toulouse, France

name: Toronto Memory Program, Toronto, Ontario, Canada

name: Re:Cognition Health, London, United Kingdom

name: Research Center and Memory Clinic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociències Aplicades, Barcelona–Universitat Internacional de Catalunya, Barcelona, Spain

name: Networking Research Center on Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain

repository_institution: The University of Arizona - UA Campus Repository

ReferenceCitation: Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjäll S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053.

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

location_country:
Italy
United States
Germany
France
Japan
Poland
Romania
Hungary
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Centro de Atencion Especializada (CAE) OROITU

location_facility: Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico

location_facility: Quillen College of Medicine, East TN State University

location_facility: CSSS-Institut Universitaire Gériatric de Sherbrooke

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Hospital Universitario La Fe de Valencia

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Alzheimer's Research and Treatment Center

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: IRCCS San Giovanni di Dio Fatebenefratelli

location_facility: PTE KK Pszichiatriai es Pszichoterapias Klinika

location_facility: Institute for Neurodegenerative Disorders

location_facility: Australian Alzheimer's Research Foundation

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet

location_facility: Nuovo Ospedale Civile Sant'Agostino Estense

location_facility: True North Clinical Research Halifax, LLC

location_facility: National Institute for Longevity Sciences NCGG

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: Fondazione San Raffaele Giglio di Cefalu

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Università Politecnica delle Marche Torrette

location_facility: Azienda Ospedaliera Citta della Salute della Scienza Torino

location_facility: Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles

location_facility: Kyoto Prefectural University of Medicine

location_facility: Memory Enhancement Center of America, Inc.

location_facility: The Florey Institute of Neuroscience and Mental Health

location_facility: Allied Biomedical Research Institute, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Territory Neurology & Research Institute

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Alzheimer's Disease and Memory Disorders Center

location_facility: University of Texas Health Services Center - Houston

location_facility: Neurology Specialists of Monmouth County

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

location_facility: Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: The Catholic University of Korea-Bucheon St. Mary's Hospital

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Collaborative Neuroscience Network - CNS

location_facility: Tokyo Women's Medical University Hospital

title: A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)

summary: The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.


ReferenceType: background

ReferenceCitation: Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. Review.

ReferenceCitation: Colosimo C, Martínez-Martín P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072. Review.

ReferenceCitation: da Silva-Júnior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. Epub 2005 Sep 9.

ReferenceCitation: Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6.

ReferenceCitation: Del Sorbo F, Albanese A. Levodopa-induced dyskinesias and their management. J Neurol. 2008 Aug;255 Suppl 4:32-41. doi: 10.1007/s00415-008-4006-5. Review.

ReferenceCitation: Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol. 2008;60(2):57-66. doi: 10.1159/000131893. Epub 2008 May 15. Review.

ReferenceCitation: Factor SA, Molho ES. Transient benefit of amantadine in Parkinson's disease: the facts about the myth. Mov Disord. 1999 May;14(3):515-7. Review.

ReferenceCitation: Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008 Dec 15;23(16):2398-403. doi: 10.1002/mds.22341.

ReferenceCitation: Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

ReferenceCitation: Goetz CG, Stebbins GT, Chung KA, Hauser RA, Miyasaki JM, Nicholas AP, Poewe W, Seppi K, Rascol O, Stacy MA, Nutt JG, Tanner CM, Urkowitz A, Jaglin JA, Ge S. Which dyskinesia scale best detects treatment response? Mov Disord. 2013 Mar;28(3):341-6. doi: 10.1002/mds.25321. Epub 2013 Feb 6.

ReferenceCitation: Hayden FG, Gwaltney JM Jr, Van de Castle RL, Adams KF, Giordani B. Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults. Antimicrob Agents Chemother. 1981 Feb;19(2):226-33.

ReferenceCitation: Jackson G, Stanley E, Lee Muldoon R. Chemoprophylaxis of viral respiratory diseases. Bulletin Pan Am Health Org. 1967; 147: 595-603.

ReferenceCitation: Luginger E, Wenning GK, Bösch S, Poewe W. Beneficial effects of amantadine on L-dopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2000 Sep;15(5):873-8.

ReferenceCitation: Ory-Magne F, Corvol JC, Azulay JP, Bonnet AM, Brefel-Courbon C, Damier P, Dellapina E, Destée A, Durif F, Galitzky M, Lebouvier T, Meissner W, Thalamas C, Tison F, Salis A, Sommet A, Viallet F, Vidailhet M, Rascol O; NS-Park CIC Network. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. Neurology. 2014 Jan 28;82(4):300-7. doi: 10.1212/WNL.0000000000000050. Epub 2013 Dec 26.

ReferenceCitation: Paci C, Thomas A, Onofrj M. Amantadine for dyskinesia in patients affected by severe Parkinson's disease. Neurol Sci. 2001 Feb;22(1):75-6.

ReferenceCitation: Parkes JD, Zilkha KJ, Marsden P, Baxter RC, Knill-Jones RP. Amantadine dosage in treatment of Parkinson's disease. Lancet. 1970 May 30;1(7657):1130-3.

ReferenceCitation: Sawada H, Oeda T, Kuno S, Nomoto M, Yamamoto K, Yamamoto M, Hisanaga K, Kawamura T; Amantadine Study Group. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial. PLoS One. 2010 Dec 31;5(12):e15298. doi: 10.1371/journal.pone.0015298.

ReferenceCitation: Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305.

ReferenceCitation: Schwab RS, Poskanzer DC, England AC Jr, Young RR. Amantadine in Parkinson's disease. Review of more than two years' experience. JAMA. 1972 Nov 13;222(7):792-5.

ReferenceCitation: Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5.

ReferenceCitation: Spencer TJ, Biederman J, Ciccone PE, Madras BK, Dougherty DD, Bonab AA, Livni E, Parasrampuria DA, Fischman AJ. PET study examining pharmacokinetics, detection and likeability, and dopamine transporter receptor occupancy of short- and long-acting oral methylphenidate. Am J Psychiatry. 2006 Mar;163(3):387-95.

ReferenceCitation: Swanson JM, Volkow ND. Pharmacokinetic and pharmacodynamic properties of stimulants: implications for the design of new treatments for ADHD. Behav Brain Res. 2002 Mar 10;130(1-2):73-8. Review.

ReferenceCitation: Thomas A, Iacono D, Luciano AL, Armellino K, Di Iorio A, Onofrj M. Duration of amantadine benefit on dyskinesia of severe Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):141-3.

ReferenceCitation: Tyrrell DA, Bynoe ML, Hoorn B. Studies on the antiviral activity of 1-adamantanamine. Br J Exp Pathol. 1965 Aug;46(4):370-5.

ReferenceCitation: Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6.

ReferenceCitation: Metman LV, Del Dotto P, LePoole K, Konitsiotis S, Fang J, Chase TN. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch Neurol. 1999 Nov;56(11):1383-6.

ReferenceCitation: Volkow ND, Wang GJ, Fowler JS, Gatley SJ, Logan J, Ding YS, Hitzemann R, Pappas N. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998 Oct;155(10):1325-31.

ReferenceCitation: Wolf E, Seppi K, Katzenschlager R, Hochschorner G, Ransmayr G, Schwingenschuh P, Ott E, Kloiber I, Haubenberger D, Auff E, Poewe W. Long-term antidyskinetic efficacy of amantadine in Parkinson's disease. Mov Disord. 2010 Jul 30;25(10):1357-63. doi: 10.1002/mds.23034.

ReferenceCitation: Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15.

ReferenceCitation: Hauser RA, Pahwa R, Tanner CM, Oertel W, Isaacson SH, Johnson R, Felt L, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study. J Parkinsons Dis. 2017;7(3):511-522. doi: 10.3233/JPD-171134.

name: University of South Florida, Tampa, FL, USA

family: Hauser

full_name: Robert A. Hauser

given: Robert A.

name: University of Kansas Medical Center, Kansas City, KS, USA

family: Pahwa

full_name: Rajesh Pahwa

given: Rajesh

name: University of California San Francisco and San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA

family: Tanner

full_name: Caroline M. Tanner

given: Caroline M.

family: Oertel

full_name: Wolfgang Oertel

given: Wolfgang

name: Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA

family: Isaacson

full_name: Stuart H. Isaacson

given: Stuart H.

name: Adamas Pharmaceuticals, Inc., Emeryville, CA, USA

family: Johnson

full_name: Reed Johnson

given: Reed

family: Felt

full_name: Larissa Felt

given: Larissa

family: Stempien

full_name: Mary Jean Stempien

given: Mary Jean

journal_name: Journal of Parkinson's Disease

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson’s Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study

intervention_type: Drug

status: Completed

study_type: Interventional

location_country:
Austria
Germany
France
Spain
United States
Canada

title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

summary: This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).


publications_result: Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.

ReferenceType: result

ReferenceCitation: Mangia, A., Roberts, SK., Pianko, S., Thompson, A at al. Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study. Hepatology 2015; 62: 1 (SUPPL) 338A.

ReferenceCitation: Foster GR, Afdhal N, Roberts SK, Bräu N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourlière M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Afdhal

full_name: Nezam Afdhal

given: Nezam

family: Roberts

full_name: Stuart K. Roberts

given: Stuart K.

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Gane

full_name: Edward J. Gane

given: Edward J.

family: Pianko

full_name: Stephen Pianko

given: Stephen

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Thompson

full_name: Alex Thompson

given: Alex

family: Shiffman

full_name: Mitchell L. Shiffman

given: Mitchell L.

family: Cooper

full_name: Curtis Cooper

given: Curtis

family: Towner

full_name: William J. Towner

given: William J.

family: Conway

full_name: Brian Conway

given: Brian

family: Ruane

full_name: Peter Ruane

given: Peter

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Berg

full_name: Thomas Berg

given: Thomas

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Rosenberg

full_name: William Rosenberg

given: William

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Stedman

full_name: Catherine A.M. Stedman

given: Catherine A.M.

family: Mo

full_name: Hongmei Mo

given: Hongmei

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Han

full_name: Lingling Han

given: Lingling

family: Wang

full_name: Jing Wang

given: Jing

family: McNally

repository_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.

journal_name: Clinical Gastroenterology and Hepatology

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

location_country:
Italy
United States
Germany
France
Australia
Puerto Rico
New Zealand
Canada
United Kingdom

title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

summary: The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.


ReferenceCitation: Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.

ReferenceCitation: Feld JJ, Jacobson IM, Hézode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.

family: Feld

full_name: Jordan J. Feld

given: Jordan J.

family: Jacobson

full_name: Ira M. Jacobson

given: Ira M.

family: Hézode

full_name: Christophe Hézode

given: Christophe

full_name: Peter J. Ruane

given: Peter J.

family: Gruener

full_name: Norbert Gruener

given: Norbert

family: Abergel

full_name: Armand Abergel

given: Armand

family: Mangia

full_name: Alessandra Mangia

given: Alessandra

family: Lai

full_name: Ching-Lung Lai

given: Ching-Lung

family: Chan

full_name: Henry L.Y. Chan

given: Henry L.Y.

family: Mazzotta

full_name: Francesco Mazzotta

given: Francesco

family: Moreno

full_name: Christophe Moreno

family: Yoshida

full_name: Eric Yoshida

given: Eric

family: Shafran

full_name: Stephen D. Shafran

given: Stephen D.

family: Tran

full_name: Tram T. Tran

given: Tram T.

full_name: John McNally

given: John

family: Osinusi

full_name: Anu Osinusi

given: Anu

family: Svarovskaia

full_name: Evguenia Svarovskaia

given: Evguenia

family: Zhu

full_name: Yanni Zhu

given: Yanni

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: McHutchison

full_name: John G. McHutchison

given: John G.

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

repositories_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Feld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A.

title: Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis

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

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


type: Other Identifier

type: EudraCT Number

title: JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy

acronym: JUNIPER

summary: The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Göskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.

family: Goldman

full_name: Jonathan W. Goldman

given: Jonathan W.

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Dragnev

full_name: Konstantin H. Dragnev

given: Konstantin H.

family: Koczywas

full_name: Marianna Koczywas

given: Marianna

family: Göskel

full_name: Tuncay Göskel

given: Tuncay

family: Cortot

full_name: Alexis B. Cortot

given: Alexis B.

family: Girard

full_name: Nicolas Girard

given: Nicolas

family: Wesseler

full_name: Claas Wesseler

given: Claas

family: Bischoff

full_name: Helge Bischoff

given: Helge

family: Nadal

full_name: Ernest Nadal

given: Ernest

family: Park

full_name: Keunchil Park

given: Keunchil

family: Lu

full_name: Shun Lu

given: Shun

family: Taus

full_name: Alvaro Taus

given: Alvaro

family: Cobo

full_name: Manuel Cobo

given: Manuel

family: Estrem

full_name: Shawn T. Estrem

given: Shawn T.

family: Wijayawardana

full_name: Sameera R. Wijayawardana

given: Sameera R.

family: Turner

full_name: Kellie Turner

given: Kellie

family: Oakley

full_name: Gerard Joseph Oakley

given: Gerard Joseph

suffix: III

family: Hurt

full_name: Karla C. Hurt

given: Karla C.

family: Chiang

full_name: Alan Y. Chiang

given: Alan Y.

family: Hossain

full_name: Anwar M. Hossain

given: Anwar M.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

ReferenceCitation: Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.

title: Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non–Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy

location_country:
Greece
Romania
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Puerto Rico
China
United States
Germany
Italy
Austria
Brazil
Israel
Spain
Turkey

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

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

location_facility: Russian oncological scientific centre n.a. N.N. Blokhin of RAMS

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: Loma Linda University School of Medicine

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

location_facility: Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

location_facility: Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo

location_facility: Central Coast Medical Oncology Corporation

location_facility: Republic clinical oncology dispensary of MoH of Bashkortostan Republic

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

location_facility: Metro-West and Greater Boston CNS Research

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: Volgograd regional clinical oncology dispensary

location_facility: UCLA Department of Medicine-Hematology/Oncology

location_facility: Chattanooga Oncology Hematology Associates


lead_sponsor: Alexion Pharmaceuticals

primary_purpose: Prevention

location_country:
Italy
Brazil
United States
Germany
France
Czechia
Australia
Spain
Canada

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

study_completion_date_type: Actual

source: euctr

title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.

summary: The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.

lead_sponsor_type: industriel

status_simplified: Completed


title: Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

summary:
Primary Objective:

To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.

To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

Systemic exposure
Anti-drug antibodies
Biomarkers

ReferenceCitation: Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2021 Sep 28. pii: S2213-2600(21)00322-2. doi: 10.1016/S2213-2600(21)00322-2. [Epub ahead of print]

family: Wechsler

full_name: Michael E Wechsler

given: Michael E

family: Ford

full_name: Linda B Ford

given: Linda B

family: Maspero

full_name: Jorge F Maspero

given: Jorge F

family: Pavord

full_name: Ian D Pavord

given: Ian D

family: Papi

full_name: Alberto Papi

given: Alberto

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Watz

full_name: Henrik Watz

given: Henrik

family: Castro

full_name: Mario Castro

given: Mario

family: Nenasheva

full_name: Natalia M Nenasheva

given: Natalia M

family: Tohda

full_name: Yuji Tohda

given: Yuji

family: Langton

full_name: David Langton

given: David

family: Cardona

full_name: Guido Cardona

given: Guido

family: Domingo

full_name: Christian Domingo

given: Christian

full_name: Hae Sim Park

given: Hae Sim

family: Chapman

full_name: Kenneth R Chapman

given: Kenneth R

family: Mao

full_name: Xuezhou Mao

given: Xuezhou

family: Zhang

full_name: Yi Zhang

given: Yi

family: Khan

full_name: Asif H Khan

given: Asif H

family: Deniz

full_name: Yamo Deniz

given: Yamo

family: Rowe

full_name: Paul J Rowe

given: Paul J

family: Kapoor

full_name: Upender Kapoor

given: Upender

family: Khokhar

full_name: Faisal A Khokhar

given: Faisal A

family: Mannent

full_name: Leda P Mannent

given: Leda P

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

ipd_sharing_description: Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey

location_facility:
Investigational Site Number 376003
Investigational Site Number 124015
Investigational Site Number 124007
Investigational Site Number 152018
Investigational Site Number 616009
Investigational Site Number 710002
Investigational Site Number 804003
Investigational Site Number 392137
Investigational Site Number 076003
Investigational Site Number 792002
Investigational Site Number 392187
Investigational Site Number 124012
Investigational Site Number 840057
Investigational Site Number 392013
Investigational Site Number 124003
Investigational Site Number 056001
Investigational Site Number 392155
Investigational Site Number 124013
Investigational Site Number 840112
Investigational Site Number 392040
Investigational Site Number 643007
Investigational Site Number 276010
Investigational Site Number 036009
Investigational Site Number 250013
Investigational Site Number 804015
Investigational Site Number 643002
Investigational Site Number 840942
Investigational Site Number 392169
Investigational Site Number 410003
Investigational Site Number 642105
Investigational Site Number 076002
Investigational Site Number 840071
Investigational Site Number 152007
Investigational Site Number 643009
Investigational Site Number 032091
Investigational Site Number 840041
Investigational Site Number 840037
Investigational Site Number 840099
Investigational Site Number 036006
Investigational Site Number 840015
Investigational Site Number 392112
Investigational Site Number 032007
Investigational Site Number 840070
Investigational Site Number 380010
Investigational Site Number 840130
Investigational Site Number 076012
Investigational Site Number 792004
Investigational Site Number 276011
Investigational Site Number 380002
Investigational Site Number 840024
Investigational Site Number 392165
Investigational Site Number 152010
Investigational Site Number 392177
Investigational Site Number 826006
Investigational Site Number 348301
Investigational Site Number 840027
Investigational Site Number 840073
Investigational Site Number 826001
Investigational Site Number 484012
Investigational Site Number 392029
Investigational Site Number 484007
Investigational Site Number 840004
Investigational Site Number 724096
Investigational Site Number 392162
Investigational Site Number 840078
Investigational Site Number 124019
Investigational Site Number 616005
Investigational Site Number 840087
Investigational Site Number 840107
Investigational Site Number 616003
Investigational Site Number 642103
Investigational Site Number 804007
Investigational Site Number 826009
Investigational Site Number 392173
Investigational Site Number 643091
Investigational Site Number 840029
Investigational Site Number 840401
Investigational Site Number 840104
Investigational Site Number 528002
Investigational Site Number 032096
Investigational Site Number 643099
Investigational Site Number 616007
Investigational Site Number 528001
Investigational Site Number 792006
Investigational Site Number 792098
Investigational Site Number 410006
Investigational Site Number 840109
Investigational Site Number 392119
Investigational Site Number 036008
Investigational Site Number 643010
Investigational Site Number 724001
Investigational Site Number 804002
Investigational Site Number 392108
Investigational Site Number 392152
Investigational Site Number 392170
Investigational Site Number 250010
Investigational Site Number 152011
Investigational Site Number 392122
Investigational Site Number 410008
Investigational Site Number 076013
Investigational Site Number 410012
Investigational Site Number 840923
Investigational Site Number 392133
Investigational Site Number 276003
Investigational Site Number 710092
Investigational Site Number 840093
Investigational Site Number 840121
Investigational Site Number 724002
Investigational Site Number 032012
Investigational Site Number 380008
Investigational Site Number 840045
Investigational Site Number 840080
Investigational Site Number 124014
Investigational Site Number 250002
Investigational Site Number 804021
Investigational Site Number 392153
Investigational Site Number 484010
Investigational Site Number 840083
Investigational Site Number 124016
Investigational Site Number 032009
Investigational Site Number 642102
Investigational Site Number 152024
Investigational Site Number 804004
Investigational Site Number 036004
Investigational Site Number 158008
Investigational Site Number 840035
Investigational Site Number 348303
Investigational Site Number 392167
Investigational Site Number 380001
Investigational Site Number 840091
Investigational Site Number 804018
Investigational Site Number 643001
Investigational Site Number 792096
Investigational Site Number 032095
Investigational Site Number 710009
Investigational Site Number 380007
Investigational Site Number 392132
Investigational Site Number 804017
Investigational Site Number 484008
Investigational Site Number 840146
Investigational Site Number 840002
Investigational Site Number 484006
Investigational Site Number 840402
Investigational Site Number 724014
Investigational Site Number 804006
Investigational Site Number 124006
Investigational Site Number 642104
Investigational Site Number 158009
Investigational Site Number 076009
Investigational Site Number 804014
Investigational Site Number 616097
Investigational Site Number 392158
Investigational Site Number 392186
Investigational Site Number 124017
Investigational Site Number 642107
Investigational Site Number 250006
Investigational Site Number 152005
Investigational Site Number 643008
Investigational Site Number 724097
Investigational Site Number 392030
Investigational Site Number 410002
Investigational Site Number 804020
Investigational Site Number 152003
Investigational Site Number 152004
Investigational Site Number 036005
Investigational Site Number 276005
Investigational Site Number 804016
Investigational Site Number 643005
Investigational Site Number 840065
Investigational Site Number 840062
Investigational Site Number 840044
Investigational Site Number 208001
Investigational Site Number 616098
Investigational Site Number 840077
Investigational Site Number 410004
Investigational Site Number 032006
Investigational Site Number 616008
Investigational Site Number 792008
Investigational Site Number 276006
Investigational Site Number 710003
Investigational Site Number 840117
Investigational Site Number 152008
Investigational Site Number 392142
Investigational Site Number 392045
Investigational Site Number 840047
Investigational Site Number 032002
Investigational Site Number 208002
Investigational Site Number 410007
Investigational Site Number 840082
Investigational Site Number 392032
Investigational Site Number 392025
Investigational Site Number 124018
Investigational Site Number 392044
Investigational Site Number 643013
Investigational Site Number 032004
Investigational Site Number 840014
Investigational Site Number 840111
Investigational Site Number 250009
Investigational Site Number 124009
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 392036
Investigational Site Number 392042
Investigational Site Number 276009
Investigational Site Number 392037
Investigational Site Number 840059
Investigational Site Number 032011
Investigational Site Number 792013
Investigational Site Number 124001
Investigational Site Number 840052
Investigational Site Number 804008
Investigational Site Number 392006
Investigational Site Number 410010
Investigational Site Number 804019
Investigational Site Number 410005
Investigational Site Number 616096
Investigational Site Number 792001
Investigational Site Number 804022
Investigational Site Number 840046
Investigational Site Number 158007
Investigational Site Number 392131
Investigational Site Number 392144
Investigational Site Number 380004
Investigational Site Number 152014
Investigational Site Number 392164
Investigational Site Number 840064
Investigational Site Number 840115
Investigational Site Number 616011
Investigational Site Number 724006
Investigational Site Number 840137
Investigational Site Number 032005
Investigational Site Number 076001
Investigational Site Number 392168
Investigational Site Number 484005
Investigational Site Number 642106
Investigational Site Number 840022
Investigational Site Number 840055
Investigational Site Number 392043
Investigational Site Number 392011
Investigational Site Number 376001
Investigational Site Number 250014
Investigational Site Number 376005
Investigational Site Number 840403
Investigational Site Number 840132
Investigational Site Number 036001
Investigational Site Number 840404
Investigational Site Number 392020
Investigational Site Number 484011
Investigational Site Number 380099
Investigational Site Number 840017
Investigational Site Number 392002
Investigational Site Number 840006
Investigational Site Number 616001
Investigational Site Number 840101
Investigational Site Number 380009
Investigational Site Number 840907
Investigational Site Number 484014
Investigational Site Number 392135
Investigational Site Number 840951
Investigational Site Number 170001
Investigational Site Number 804012
Investigational Site Number 124010
Investigational Site Number 392127
Investigational Site Number 840102
Investigational Site Number 616004
Investigational Site Number 392010
Investigational Site Number 826007
Investigational Site Number 032097
Investigational Site Number 250005
Investigational Site Number 392021
Investigational Site Number 392146
Investigational Site Number 792005
Investigational Site Number 710006
Investigational Site Number 710011
Investigational Site Number 840031
Investigational Site Number 804094
Investigational Site Number 840085
Investigational Site Number 840038
Investigational Site Number 724010
Investigational Site Number 410011
Investigational Site Number 804005
Investigational Site Number 840011
Investigational Site Number 392007
Investigational Site Number 840008
Investigational Site Number 056002
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 392012
Investigational Site Number 840068
Investigational Site Number 643006
Investigational Site Number 392004
Investigational Site Number 792090
Investigational Site Number 392034
Investigational Site Number 710091
Investigational Site Number 840922
Investigational Site Number 792003
Investigational Site Number 724007
Investigational Site Number 792007
Investigational Site Number 840126
Investigational Site Number 152002
Investigational Site Number 840049
Investigational Site Number 124008
Investigational Site Number 392185
Investigational Site Number 804009
Investigational Site Number 152023
Investigational Site Number 840023
Investigational Site Number 643012
Investigational Site Number 484013
Investigational Site Number 840040
Investigational Site Number 170002
Investigational Site Number 036094
Investigational Site Number 392008
Investigational Site Number 124002
Investigational Site Number 840018
Investigational Site Number 724003
Investigational Site Number 710001
Investigational Site Number 643011
Investigational Site Number 392163
Investigational Site Number 840034
Investigational Site Number 348003
Investigational Site Number 410013
Investigational Site Number 392106
Investigational Site Number 840019
Investigational Site Number 484001
Investigational Site Number 724008
Investigational Site Number 804023
Investigational Site Number 616010
Investigational Site Number 643096
Investigational Site Number 032001
Investigational Site Number 036093
Investigational Site Number 840021
Investigational Site Number 392005
Investigational Site Number 826010
Investigational Site Number 840902
Investigational Site Number 392014
Investigational Site Number 036003
Investigational Site Number 804001
Investigational Site Number 840032
Investigational Site Number 250008
Investigational Site Number 076006
Investigational Site Number 392023
Investigational Site Number 032003
Investigational Site Number 032010
Investigational Site Number 392038
Investigational Site Number 152013
Investigational Site Number 840118
Investigational Site Number 250004
Investigational Site Number 840030
Investigational Site Number 840124
Investigational Site Number 392009
Investigational Site Number 392179
Investigational Site Number 840928
Investigational Site Number 616006
Investigational Site Number 376002
Investigational Site Number 840067
Investigational Site Number 484004
Investigational Site Number 710007
Investigational Site Number 392130
Investigational Site Number 840079
Investigational Site Number 152021
Investigational Site Number 392024
Investigational Site Number 056003
Investigational Site Number 840108
Investigational Site Number 076007
Investigational Site Number 250007


ReferenceCitation: Eikelboom JW, van Ryn J, Reilly P, Hylek EM, Elsaesser A, Glund S, Pollack CV, Weitz JI. Dabigatran Reversal With Idarucizumab in Patients With Renal Impairment. J Am Coll Cardiol. 2019 Oct 8;74(14):1760-1768. doi: 10.1016/j.jacc.2019.07.070.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

family: van Ryn

full_name: Joanne van Ryn

given: Joanne

family: Reilly

full_name: Paul Reilly

given: Paul

family: Hylek

full_name: Elaine M. Hylek

given: Elaine M.

family: Elsaesser

full_name: Amelie Elsaesser

given: Amelie

family: Glund

full_name: Stephan Glund

given: Stephan

family: Pollack

full_name: Charles V. Pollack

given: Charles V.

family: Weitz

full_name: Jeffrey I. Weitz

given: Jeffrey I.

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Glund S, Coble K, Gansser D, Stangier J, Hoermann K, Pollack CV, Reilly P. Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran. J Thromb Haemost. 2019 Aug;17(8):1319-1328. doi: 10.1111/jth.14476. Epub 2019 Jun 18.

name: Boehringer Ingelheim Pharma GmbH and Co. KG Biberach an der Riss Germany

name: Boehringer Ingelheim Pharmaceuticals, Inc Ridgefield Connecticut

family: Coble

full_name: Kelly Coble

given: Kelly

family: Gansser

full_name: Dietmar Gansser

given: Dietmar

family: Stangier

full_name: Joachim Stangier

given: Joachim

family: Hoermann

full_name: Karin Hoermann

given: Karin

name: Thomas Jefferson University Philadelphia Pennsylvania

journal_name: Journal of Thrombosis and Haemostasis

oa_colors: green hybrid

ReferenceCitation: Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV Jr, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748-756. doi: 10.1161/CIRCULATIONAHA.118.036710. Erratum in: Circulation. 2019 Feb 5;139(6):e36.

name: Department of Thrombosis and Hemostasis, Leiden University Medical Center, the Netherlands (S.J.V.d.W., F.A.K., M.V.H.).

name: Division Cardiology, Duke University Medical Center, Durham, NC (R.D.L.).

name: Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY (J.A.).

name: Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (P.R.).

name: Boehringer Ingelheim International GmbH, Ingelheim and Biberach, Germany (J.v.R., S.G., A.E.).

name: Emergency Medicine, Thomas Jefferson University and Sidney Kimmel Medical College, Philadelphia, PA (C.V.P.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11.

title: Idarucizumab for Dabigatran Reversal — Full Cohort Analysis

ReferenceCitation: Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000. Epub 2015 Jun 22.

title: Idarucizumab for Dabigatran Reversal

ReferenceCitation: Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S, Huisman MV, Hylek E, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Sellke F, Stangier J, Steiner T, Wang B, Weitz JI. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015 Jul;114(1):198-205. doi: 10.1160/TH15-03-0192. Epub 2015 May 28.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Singapore
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Westmead Hospital-Clinical Haematology Dept

location_facility: Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: University of Florida College of Medicine

location_facility: Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin

location_facility: TYKS, Akuutti sisätautihoito ASIS, Turku

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: National Cerebral and Cardiovascular Center

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: CHLO, EPE - Hospital S. Francisco Xavier

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Prince of Wales Hosp, Dept of Med & Therapeutics

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Military Medical Academy n.a. S. M. Kirov, St. Petersburg

location_facility: Seoul National University Bundang Hospital

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: Emergency Department, John Radcliffe Hospital, Oxford

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

location_facility: Hospital General Universitario de Alicante

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

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

location_facility: Memorial Hermann Hospital - Texas Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Hospital Regional Universitario de Málaga

location_facility: HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: Baptist Health Center for Clinical Research

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Texas Health Research and Education Institute

title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

summary: Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.


title: Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.

acronym: SENIOR

summary: The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.

status: Unknown status

ReferenceCitation: Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrié D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.

family: Varenne

full_name: Olivier Varenne

given: Olivier

family: Cook

full_name: Stéphane Cook

given: Stéphane

family: Sideris

full_name: Georgios Sideris

given: Georgios

family: Kedev

full_name: Sasko Kedev

given: Sasko

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Carrié

full_name: Didier Carrié

given: Didier

family: Hovasse

full_name: Thomas Hovasse

family: Garot

full_name: Philippe Garot

given: Philippe

family: El Mahmoud

full_name: Rami El Mahmoud

given: Rami

family: Spaulding

full_name: Christian Spaulding

given: Christian

family: Helft

full_name: Gérard Helft

given: Gérard

family: Diaz Fernandez

full_name: José F Diaz Fernandez

given: José F

family: Brugaletta

full_name: Salvatore Brugaletta

given: Salvatore

family: Pinar-Bermudez

full_name: Eduardo Pinar-Bermudez

given: Eduardo

family: Mauri Ferre

full_name: Josepa Mauri Ferre

given: Josepa

family: Commeau

full_name: Philippe Commeau

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Bogaerts

full_name: Kris Bogaerts

given: Kris

family: Sabate

full_name: Manel Sabate

given: Manel

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: Sinnaeve

full_name: Peter R Sinnaeve

given: Peter R

journal_name: The Lancet

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Hospital Universitario virgen de la arrixaca

location_facility: University Clinic of Cardiology - Medical Faculty

location_facility: Heary Center - Satakunta Centyral Hospital

location_facility: Hospital Universati Germans Trias i Pujol

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital universitario Marquès de Valdecilla

location_facility: Centre hospitalier universitaire vaudois


title: Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4

summary:
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.

It is a prospective, non-randomized, observational multicenter study evaluating standard of care.

For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.

Study endpoints:

Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
Hong Kong
Netherlands
Spain
Switzerland
Finland
France
Japan
Israel
Singapore
Ireland
Belgium
Portugal
Denmark
Germany
United Kingdom
Colombia

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Guidant Europe SA / NV a Boston Scientific Company

location_facility: Azienda Ospedaliera Spedale Sant'Anna di Como

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Device


ReferenceCitation: Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.

name: Memorial Sloan Kettering Cancer Center, New York, NY;

family: Zelenetz

full_name: Andrew D. Zelenetz

given: Andrew D.

name: Faculté de Médecine et de Maïeutique Lyon Sud, Université de Lyon, Lyon, France;

family: Salles

full_name: Gilles Salles

given: Gilles

name: Royal Melbourne Hospital, Melbourne, VIC, Australia;

family: Mason

full_name: Kylie D. Mason

given: Kylie D.

name: Wilmot Cancer Institute, University of Rochester, Rochester, NY;

family: Casulo

full_name: Carla Casulo

given: Carla

name: Service d’Hématologie, CHU de Nantes, Nantes, France;

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

name: Centre for Lymphoid Cancer, BC Cancer Agency, Vancouver, BC, Canada;

family: Sehn

full_name: Laurie H. Sehn

given: Laurie H.

family: Tilly

full_name: Herve Tilly

given: Herve

name: Department of Hematology, University of Montpellier, Montpellier, France;

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

name: HOVON Lunenburg Lymphoma Phase I-II Consortium, VU University Medical Center, Amsterdam, The Netherlands;

family: Chamuleau

full_name: Martine E. D. Chamuleau

given: Martine E. D.

name: Hackensack University Medical Center, Hackensack, NJ;

family: Goy

full_name: Andre Goy

given: Andre

name: Peter MacCallum Cancer Centre, Melbourne, VIC, Australia;

name: University of Melbourne, Melbourne, VIC, Australia;

family: Tam

full_name: Constantine S. Tam

given: Constantine S.

name: HOVON Lunenburg Lymphoma Phase I-II Consortium, Erasmus MC Cancer Institute, Rotterdam, The Netherlands;

family: Lugtenburg

full_name: Pieternella J. Lugtenburg

given: Pieternella J.

family: Petrich

full_name: Adam M. Petrich

given: Adam M.

name: Roche Products Ltd, Welwyn Garden City, United Kingdom;

family: Sinha

full_name: Arijit Sinha

given: Arijit

family: Samineni

full_name: Divya Samineni

given: Divya

name: Roche Pharmaceutical Research and Early Development, Roche Innovation Center Zurich, Schlieren, Switzerland;

family: Herter

full_name: Sylvia Herter

given: Sylvia

family: Ingalla

full_name: Ellen Ingalla

given: Ellen

family: Szafer-Glusman

full_name: Edith Szafer-Glusman

given: Edith

family: Klein

full_name: Christian Klein

family: Sampath

full_name: Deepak Sampath

given: Deepak

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland; and

family: Kornacker

full_name: Martin Kornacker

given: Martin

family: Mobasher

full_name: Mehrdad Mobasher

given: Mehrdad

name: Université de Lille, CHU Lille, Groupe de Recherche sur les Formes Injectables et les Technologies Associées, Lille, France

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

journal_name: Blood

ReferenceCitation: Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2021 Nov 25. doi: 10.1007/s12325-021-01919-z. [Epub ahead of print]

title: Population Pharmacokinetics and Exposure–Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma

ReferenceCitation: Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illés Á, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trněný M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578. Erratum in: Blood. 2021 Apr 1;137(13):1844.

name: Université de Lille, Centre Hospitalier Universitaire (CHU) Lille, Groupe de Recherche sur les Formes Injectables et les Technologies Associées (ULR 7365–GRITA), Lille, France;

name: CHU de Nancy, Université de Lorraine, Vandoeuvre lès Nancy, France;

name: Sarah Cannon Research Institute-Tennessee Oncology, Nashville, TN;

name: Concord Hospital, University of Sydney, Sydney, NSW, Australia;

name: Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute–Center for Clinical Cancer and Immunology Trials, Salzburg, Austria;

name: Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary;

name: Jewish General Hospital, Montreal, QC, Canada;

name: CHU de Québec, Hôpital de l'Enfant-Jésus, Quebec City, QC, Canada;

name: Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy;

name: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, University of Lyon, Pierre-Bénite, France;

name: First Department of Medicine, Charles University General Hospital, Prague, Czech Republic;

name: David Geffen School of Medicine, University of California (UCLA), Los Angeles, CA;

name: Royal Marsden Hospital, Sutton, Surrey, United Kingdom;

name: Genentech, Inc., South San Francisco, CA;

name: Roche Products Limited, Welwyn Garden City, United Kingdom;

name: F. Hoffmann-La Roche Ltd., Basel, Switzerland; and

location_country:
Italy
Austria
United States
Netherlands
France
Czechia
Hungary
Australia
Spain
Canada

location_facility: Hopital Henri Mondor, Unite Hemopathies lymphoides

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals; Hematology

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

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

location_facility: Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hackensack University Medical Center; WFAN - Imus Pediatric Center

location_facility: CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek

title: A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

summary: This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.


title: BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

summary: This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

design_allocation: Non-Randomized

ReferenceCitation: Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

family: Syeda

full_name: Mahrukh M Syeda

given: Mahrukh M

family: Wiggins

full_name: Jennifer M Wiggins

given: Jennifer M

family: Corless

full_name: Broderick C Corless

given: Broderick C

family: Long

full_name: Georgina V Long

given: Georgina V

family: Flaherty

full_name: Keith T Flaherty

given: Keith T

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Nathan

full_name: Paul D Nathan

given: Paul D

family: Robert

full_name: Caroline Robert

given: Caroline

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Davies

full_name: Michael A Davies

given: Michael A

family: Grob

full_name: Jean Jacques Grob

given: Jean Jacques

family: Gasal

full_name: Eduard Gasal

given: Eduard

family: Squires

full_name: Matthew Squires

given: Matthew

family: Marker

full_name: Mahtab Marker

given: Mahtab

family: Garrett

full_name: James Garrett

given: James

family: Brase

full_name: Jan C Brase

given: Jan C

family: Polsky

full_name: David Polsky

given: David

journal_name: The Lancet Oncology

ReferenceCitation: Davies MA, Saiag P, Robert C, Grob JJ, Flaherty KT, Arance A, Chiarion-Sileni V, Thomas L, Lesimple T, Mortier L, Moschos SJ, Hogg D, Márquez-Rodas I, Del Vecchio M, Lebbé C, Meyer N, Zhang Y, Huang Y, Mookerjee B, Long GV. Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):863-873. doi: 10.1016/S1470-2045(17)30429-1. Epub 2017 Jun 4.

family: Saiag

full_name: Philippe Saiag

given: Philippe

full_name: Jean-Jacques Grob

title: Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial

location_country:
Italy
United States
Germany
France
Australia
Spain
Canada


ReferenceCitation: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Gonçalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. doi: 10.1093/annonc/mdy257.

family: Ettl

full_name: J. Ettl

given: J.

family: Quek

full_name: R.G.W. Quek

family: Lee

full_name: K.-H. Lee

family: Rugo

full_name: H.S. Rugo

family: Hurvitz

full_name: S. Hurvitz

given: S.

family: Gonçalves

full_name: A. Gonçalves

given: A.

family: Fehrenbacher

full_name: L. Fehrenbacher

given: L.

family: Yerushalmi

full_name: R. Yerushalmi

given: R.

family: Mina

full_name: L.A. Mina

family: Martin

full_name: M. Martin

given: M.

family: Roché

full_name: H. Roché

given: H.

family: Im

full_name: Y.-H. Im

family: Markova

full_name: D. Markova

given: D.

family: Bhattacharyya

full_name: H. Bhattacharyya

family: Hannah

full_name: A.L. Hannah

family: Eiermann

full_name: W. Eiermann

given: W.

family: Blum

full_name: J.L. Blum

family: Litton

full_name: J.K. Litton

journal_name: Annals of Oncology

evidence: open (via page says license)

title: Quality of life with talazoparib versus physician’s choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial

ReferenceCitation: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. doi: 10.1056/NEJMoa1802905. Epub 2018 Aug 15.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology–Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) — both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) — all in California; the Department...

full_name: Jennifer K. Litton

given: Jennifer K.

full_name: Hope S. Rugo

given: Hope S.

full_name: Johannes Ettl

given: Johannes

full_name: Sara A. Hurvitz

given: Sara A.

full_name: Anthony Gonçalves

given: Anthony

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

location_country:
Italy
Brazil
Germany
France
Poland
Israel
Ireland
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Sylvester Comprehensive Cancer Center Kendall

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.

location_facility: Sylvester Comprehensive Cancer Center Plantation

location_facility: Oncology Institute, Assuta Medical Center

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: Nottingham University Hospital NHS Trust

location_facility: Sir Charles Gairdner Hospital Lung Institute Of Western Australia

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Texas Oncology - El Paso Cancer Treatment Center Joe Battle

location_facility: Institut de Cancerologie de l'Ouest - Site Rene Gauducheau

location_facility: US Oncology Investigational Product Center (IPC)

location_facility: University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center

location_facility: Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina

location_facility: Sylvester Comprehensive Cancer Center Deerfield Beach

location_facility: Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum

location_facility: New York University Langone Medical Center

location_facility: A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo

location_facility: Uniao Brasileira de Educacao E Assistencia

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

location_facility: Central de Quimioterapia Hospital do Cancer-INCA-HCIII

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates

location_facility: Ballarat Oncology & Haematology Services Clinical Trials Unit

location_facility: Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach

location_facility: UCSF - Helen Diller Family Comprehensive Cancer Center

location_facility: State Budgetary Institution of Healthcare "Republican Oncology dispensary"'

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: Division of Oncology Tel Aviv Sourasky Medical Center

location_facility: Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

location_facility: S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi

location_facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice

location_facility: Oncology Institute, Rambam Health Care Campus

location_facility: Drug Management only: UCLA West Medical Pharmacy

location_facility: Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i

location_facility: Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum

location_facility: The Center for Cancer and Blood Disorders (Huguley)

location_facility: Arizona Oncology Associates P.C. - NAHOA

location_facility: UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building

location_facility: "University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"

location_facility: Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Nacional do Cancer Jose de Alencar Gomes da Silva

location_facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital

location_facility: The University of Kansas Cancer Center (Regulatory Office)

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

location_facility: Klinika Onkologii, Wojskowy lnstytut Medyczny

location_facility: Kaiser Permanente Medical Center Lab Drawing Station

location_facility: Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde

location_facility: Centro de Referencia da Saude da Mulher - Hospital Perola Byington

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Novant Health Presbyterian Medical Center

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: Kaiser Permanente Medical Center (clinic+DSL)

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Texas Oncology-El Paso Cancer Treatment Center Gateway

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu

location_facility: Los Angeles Hematology Oncolgy Medical Group

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Cancer Care SA trading as Icon Pharmacy Adelaide

location_facility: Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Hospital da Cidade de Passo Fundo - HCPF

location_facility: Kaiser Permanente Mission Bay Medical Center Lab Drawing Station

location_facility: The West Clinic, P.C. d/b/a West Cancer Center

location_facility: Novant Health Huntersville Medical Center

location_facility: Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ

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

location_facility: University of Munich (LMU), Grosshadern Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: The University of Kansas Cancer Center - Investigational Drug Services

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)

location_facility: Southern California Permanente Medical Group

location_facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Ballarat Oncology & Haematology Services

location_facility: Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus

location_facility: Lake Norman Hematology Oncology Specialists

location_facility: Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)

location_facility: Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: The Center for Cancer and Blood Disorders

location_facility: Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.

location_facility: Regulatory Managment Only: TRIO-US Central Administration

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton

location_facility: Northwest Cancer Specialists, P.C.(Admin Only)

location_facility: Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)

location_facility: Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)

location_facility: Central Coast Medical Oncology Corporation

location_facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)

location_facility: US Oncology Investigational Products Center(IPC)

location_facility: Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust

location_facility: Cancer And Hematology Centers Of Western Michigan

location_facility: Barwon Health, University Hospital Geelong

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

location_facility: Instituto de Oncologia de Piracicaba S/S Ltda.

location_facility: University Of Texas, Md Anderson Cancer Center

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Kaiser Permanente Medical Center (Radiology)

location_facility: La Maddalena Clinic For Cancer University Of Palermo

location_facility: Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

location_facility: Hospital do Cancer de Barretos - Fundacao Pio XII

title: A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE

summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.


title: A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

summary: The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

status: Terminated

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

name: College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea

name: D&D Pharmatech, Seongnam, Republic of Korea

family: Park

full_name: Eun Ji Park

given: Eun Ji

family: Choi

full_name: Jiyoung Choi

given: Jiyoung

name: College of Pharmacy, SungKyunKwan University, Suwon, Republic of Korea

full_name: Kang Choon Lee

given: Kang Choon

full_name: Dong Hee Na

given: Dong Hee

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Emerging PEGylated non-biologic drugs

ipd_sharing: No

ipd_sharing_description: There is no plan to share individual participant data at this time

lead_sponsor: Ophthotech Corporation

location_country:
Germany
France
Israel
Hungary
Argentina
Australia
Spain
Turkey
Denmark
United States
Colombia

status_simplified: Unknown


title: A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

summary: The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

family: Lee

title: Emerging PEGylated non-biologic drugs

ipd_sharing_description: There is no plan to share individual participant data at this time.

location_country:
Finland
Australia
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
Colombia
Hungary
Portugal
Germany
United States
Italy
Austria
Brazil
Czechia
Israel
Spain
Estonia
Latvia


title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Konstan MW, McKone EF, Moss RB, Marigowda G, Tian S, Waltz D, Huang X, Lubarsky B, Rubin J, Millar SJ, Pasta DJ, Mayer-Hamblett N, Goss CH, Morgan W, Sawicki GS. Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study. Lancet Respir Med. 2017 Feb;5(2):107-118. doi: 10.1016/S2213-2600(16)30427-1. Epub 2016 Dec 21.

family: Konstan

full_name: Michael W Konstan

given: Michael W

family: McKone

full_name: Edward F McKone

given: Edward F

family: Moss

full_name: Richard B Moss

given: Richard B

family: Marigowda

full_name: Gautham Marigowda

given: Gautham

family: Tian

full_name: Simon Tian

given: Simon

family: Waltz

full_name: David Waltz

given: David

family: Huang

full_name: Xiaohong Huang

given: Xiaohong

family: Lubarsky

full_name: Barry Lubarsky

given: Barry

family: Rubin

full_name: Jaime Rubin

given: Jaime

family: Millar

full_name: Stefanie J Millar

given: Stefanie J

family: Pasta

full_name: David J Pasta

given: David J

family: Mayer-Hamblett

full_name: Nicole Mayer-Hamblett

given: Nicole

family: Goss

full_name: Christopher H Goss

given: Christopher H

family: Morgan

full_name: Wayne Morgan

given: Wayne

family: Sawicki

full_name: Gregory S Sawicki

given: Gregory S

journal_name: The Lancet Respiratory Medicine

location_country:
Italy
Austria
United States
Sweden
United Kingdom
Netherlands
Germany
France
Ireland
Australia
Belgium
Spain
Denmark
Canada
Czech Republic