title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

lead_sponsor: Incyte Corporation

location_country:
Italy
France
Belgium
United States
United Kingdom

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: University of Pennsylvania Health System

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital


type: EudraCT Number

title: HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

summary: The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in patients with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran or the reference comparator patisiran during the Treatment Period. The Treatment Period is followed by a Treatment Extension Period during which all participants in the patisiran group will switch to vutrisiran. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Malaysia
Greece
Belgium
Australia
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Cyprus
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Efficacy and Safety of Fixed-Dose Combination (FDC) Products Containing Trazodone and Gabapentin in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose Finding Study.

summary: The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment period.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

location_country:
United Kingdom
France
Czechia
Poland

location_facility: Fondation Hôtel Dieu Groupe SOS Service de Diabétologie

location_facility: Lancashire Clinical Research Facility The Avondale Unit Royal Preston Hospital

location_facility: Diabetes Centre George Eliot Hospital NHS Trust

location_facility: Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET

location_facility: CHU de Nantes - Hôpital Guillaume-et-René-Laënnec Clinique d'Endocrinologie, maladies métaboliques et nutrition CIC Endocrino - Nutrition - UF 7015

location_facility: WroMedica I. Bielicka, A. Strzałkowska s.c.

location_facility: Pro Familia Altera Poradnia Wielospecjalistyczna

location_facility: Medical Innovation Development and Research Unit (MIDRU) Heartlands Hospital

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki Klinika Diabetologii

location_facility: Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy

location_facility: Nemocnice Pardubického kraje a.s. Pardubická nemocnice Neurologická klinika

location_facility: Manchester Clinical Research Facility Manchester Royal Infirmary

location_facility: GHR MSA - Hôpital Emile Muller Service de Diabétologie-Endocrinologie-Nutrition

location_facility: Clinical Research Facility Royal Hallamshire Hospital

location_facility: Diabetologická ambulance Milan Kvapil s.r.o.

location_facility: Centre de Recherche Clinique G.H.M les Portes du Sud Departement d'Endocrinologie

status_simplified: Completed


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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Netherlands
Germany
France
Japan
Poland
Romania
Argentina
Australia
Russian Federation
Spain
Canada
Korea, Republic of
Ukraine

ipd_sharing: Yes

source: euctr

title: A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)

summary:
Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram [mg] Subcutaneous [SC]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks.

Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).


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

lead_sponsor: AstraZeneca

location_country:
Italy
Peru
Serbia
Mexico
Spain
Germany
France
Poland
Hungary
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Korea, Republic of
Taiwan

title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with active proliferative lupus nephritis (LN).


title: A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With an Open-Label Safety Extension

summary: This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

lead_sponsor: Maruho Co., Ltd.

location_country:
United States
Sweden
Netherlands
Germany
France
Australia
New Zealand
Canada
United Kingdom


type: Other Identifier

title: A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

ReferenceType: derived

ReferenceCitation: Borthakur G, Martinelli G, Raffoux E, Chevallier P, Chromik J, Lithio A, Smith CL, Yuen E, Oakley GJ 3rd, Benhadji KA, DeAngelo DJ. Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T-cell acute lymphoblastic leukemia and lymphoma. Cancer. 2021 Feb 1;127(3):372-380. doi: 10.1002/cncr.33188. Epub 2020 Oct 27.

name: The University of Texas MD Anderson Cancer Center Houston Texas

family: Borthakur

full_name: Gautam Borthakur

given: Gautam

sequence: first

name: Department of Specialized, Diagnostic, and Experimental Medicine University of Bologna Bologna Italy

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

sequence: additional

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

name: Central University Research Hospital (CHRU) De Nantes, Hotel‐Dieu Nantes France

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: University Hospital Frankfurt Frankfurt am Main Germany

family: Chromik

full_name: Jörg Chromik

given: Jörg

name: Eli Lilly and Company Indianapolis Indiana

family: Lithio

full_name: Andrew Lithio

given: Andrew

name: Eli Lilly and Company Surrey United Kingdom

family: Smith

full_name: Claire L. Smith

given: Claire L.

family: Yuen

full_name: Eunice Yuen

given: Eunice

family: Oakley

full_name: Gerard Joseph Oakley

given: Gerard Joseph

suffix: III

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

name: Dana‐Farber Cancer Institute Boston Massachusetts

family: DeAngelo

full_name: Daniel J. DeAngelo

given: Daniel J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cancer

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Phase 1 study to evaluate Crenigacestat (LY3039478) in combination with dexamethasone in patients with T‐cell acute lymphoblastic leukemia and lymphoma

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.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
France
Israel
Germany

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

location_facility: Johann Wolfgang Goethe-Universität Frankfurt

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.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

summary: Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive [NR]).

ReferenceCitation: Munck A, Kerem E, Ellemunter H, Campbell D, Wang LT, Ahluwalia N, Owen CA, Wainwright C. Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations. J Cyst Fibros. 2020 Nov;19(6):962-968. doi: 10.1016/j.jcf.2020.04.015. Epub 2020 Jun 13.

family: Munck

full_name: Anne Munck

given: Anne

family: Kerem

full_name: Eitan Kerem

given: Eitan

family: Ellemunter

full_name: Helmut Ellemunter

given: Helmut

family: Campbell

full_name: Daniel Campbell

given: Daniel

family: Wang

full_name: Linda T. Wang

given: Linda T.

family: Ahluwalia

full_name: Neil Ahluwalia

given: Neil

family: Owen

full_name: Caroline A. Owen

given: Caroline A.

family: Wainwright

full_name: Claire Wainwright

given: Claire

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Austria
United States
France
Israel
Australia
Spain
Canada


title: A Phase III, Double-blind, Randomized, Placebo-controlled Multi-centre, Study to Assess the Efficacy and Safety of AZD9291 Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA).

acronym: ADAURA

summary: To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

ReferenceType: result

ReferenceCitation: Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. N Engl J Med. 2021 Feb 18;384(7):675-676. doi: 10.1056/NEJMc2033951.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Osimertinib in EGFR-Mutated Lung Cancer

ReferenceCitation: Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(35):4827-4835. doi: 10.2217/fon-2021-0752. Epub 2021 Nov 1.

name: Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

name: Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan

family: Tsuboi

full_name: Masahiro Tsuboi

given: Masahiro

name: Department of Medical Oncology, Austin Health, Melbourne, Australia

family: John

full_name: Thomas John

given: Thomas

name: Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin, Germany; 5Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

family: Grohe

full_name: Christian Grohe

given: Christian

family: Majem

full_name: Margarita Majem

given: Margarita

name: David Geffen School of Medicine at University of California Los Angeles, CA, USA

family: Goldman

full_name: Jonathan W Goldman

given: Jonathan W

name: Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow, Russia

family: Laktionov

full_name: Konstantin Laktionov

given: Konstantin

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Kim

full_name: Sang-We Kim

given: Sang-We

name: Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan

family: Kato

full_name: Terufumi Kato

given: Terufumi

name: Department of Thoracic Surgery, Choray Hospital, Ho Chi Minh City, Vietnam

family: Vu

full_name: Huu-Vinh Vu

given: Huu-Vinh

name: Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China

family: Lu

full_name: Shun Lu

given: Shun

name: Precision Medicine, Lung Cancer Center, Konkuk University Medical Center, Seoul, South Korea

family: Lee

full_name: Kye-Young Lee

given: Kye-Young

name: Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand

family: Akewanlop

full_name: Charuwan Akewanlop

given: Charuwan

name: Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch and National Taiwan University College of Medicine, Taipei, Taiwan

family: Yu

full_name: Chong-Jen Yu

given: Chong-Jen

name: Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy

family: de Marinis

full_name: Filippo de Marinis

given: Filippo

name: Medical Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy

family: Bonanno

full_name: Laura Bonanno

given: Laura

name: Instituto de Investigacion Sanitaria-Fundacion de la Jimenez Diaz, Madrid, Spain

family: Domine

full_name: Manuel Domine

given: Manuel

name: Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Hospital and the University of Toronto, Toronto, Ontario, Canada

family: Shepherd

full_name: Frances A Shepherd

given: Frances A

name: Late Oncology Statistics, AstraZeneca, Gaithersburg, MD, USA;

family: Zeng

full_name: Lingmin Zeng

given: Lingmin

name: Late Oncology Statistics, AstraZeneca, Cambridge, UK

family: Hodge

full_name: Rachel Hodge

given: Rachel

name: Late Oncology Research & Development, AstraZeneca, Cambridge, UK

name: Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA

ReferenceCitation: Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19.

name: From the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center–National Clinical Research Center for Cancer–Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) — all in China; the Department of Thoracic Surgery and...

title: Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer

ReferenceCitation: Wu YL, Herbst RS, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clin Lung Cancer. 2018 Jul;19(4):e533-e536. doi: 10.1016/j.cllc.2018.04.004. Epub 2018 May 1.

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Vietnam
Hungary
China
United States
Germany
Italy
Brazil
Israel
Spain
Turkey


title: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis

acronym: Compare Absorb

summary:
The primary objectives of this trial are:

In patients at high-risk for restenosis,

To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
To assess superiority of the BRS to the EES in TLF between 3 and 7 years

ReferenceCitation: Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kočka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.

family: Chang

full_name: Chun Chin Chang

given: Chun Chin

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

family: Achenbach

full_name: Stephan Achenbach

given: Stephan

family: Barbato

full_name: Emanuele Barbato

given: Emanuele

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Cook

full_name: Stéphane Cook

given: Stéphane

family: Dudek

full_name: Dariusz Dudek

given: Dariusz

family: Escaned

full_name: Javier Escaned

given: Javier

family: Gori

full_name: Tommaso Gori

given: Tommaso

family: Kočka

full_name: Viktor Kočka

given: Viktor

family: Tarantini

full_name: Giuseppe Tarantini

given: Giuseppe

family: West

full_name: Nick E.J. West

given: Nick E.J.

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: Tijssen

full_name: Jan G.P. Tijssen

given: Jan G.P.

family: van Geuns

full_name: Robert-Jan van Geuns

given: Robert-Jan

family: Smits

full_name: Pieter C. Smits

given: Pieter C.

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: Jagiellonian University - Jagiellonian University Repository

repository_institution: Erasmus University, Rotterdam - RePub

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

repository_institution: reroDoc Digital Library

location_country:
Italy
Netherlands
France
Czechia
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Università degli Studi di Napoli Federico II

location_facility: Cardiocentre, University Hospital Kralovske


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention

acronym: ARISE

summary: To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

ReferenceType: background

ReferenceCitation: Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.

ReferenceCitation: Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.

ReferenceCitation: Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18. Erratum in: Neurology. 2020 Jun 9;94(23):1052.

family: Kudrow

full_name: David Kudrow

given: David

family: Pascual

full_name: Julio Pascual

given: Julio

family: Winner

full_name: Paul K. Winner

given: Paul K.

family: Dodick

full_name: David W. Dodick

given: David W.

family: Tepper

full_name: Stewart J. Tepper

given: Stewart J.

family: Reuter

full_name: Uwe Reuter

given: Uwe

family: Hong

full_name: Frank Hong

given: Frank

family: Klatt

full_name: Jan Klatt

given: Jan

family: Zhang

full_name: Feng Zhang

given: Feng

family: Cheng

full_name: Sunfa Cheng

given: Sunfa

family: Picard

full_name: Hernan Picard

given: Hernan

family: Eisele

full_name: Osa Eisele

given: Osa

family: Wang

full_name: Julie Wang

given: Julie

family: Latham

full_name: Jonathan N. Latham

given: Jonathan N.

family: Mikol

full_name: Daniel D. Mikol

given: Daniel D.

journal_name: Neurology

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.

name: Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark

name: California Medical Clinic for Headache, Santa Monica, CA, USA

name: Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany

name: Dado Medical sro, Prague Headache Center, Prague, Czech Republic

name: Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA

name: Geisel School of Medicine at Dartmouth, Hanover, NH, USA

location_country:
Switzerland
Spain
France
Greece
Russian Federation
Portugal
Denmark
United States


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma

summary: A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

ReferenceCitation: Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.

family: Ortega

full_name: Hector Ortega

given: Hector

family: Fitzgerald

full_name: Mary Fitzgerald

given: Mary

family: Raghupathi

full_name: Kartik Raghupathi

given: Kartik

family: Tompkins

full_name: Cindy‐ann Tompkins

given: Cindy‐ann

family: Shen

full_name: Jinshan Shen

given: Jinshan

family: Dittrich

full_name: Karen Dittrich

given: Karen

name: Medicines Evaluation Unit Manchester University Hospital Trust Manchester UK

family: Pattwell

full_name: Caroline Pattwell

given: Caroline

name: The University of Manchester Manchester UK

family: Singh

full_name: Dave Singh

given: Dave

journal_name: Clinical & Experimental Allergy

title: A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild‐to‐moderate asthma

lead_sponsor: GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.

location_country:
Austria
United States
Germany
France
Czechia
Poland
Belgium
Spain
Canada
United Kingdom
Ukraine

location_facility: St. Anne's University Hospital Brno, Institute of Clinical Immunology and Allergology

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital

location_facility: Allergiste & Immunologue - Clinic/Outpatient Facility

location_facility: Southern California Institute for Respiratory Diseases, Inc.

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Allergy and Asthma Diagnostic Treatment Center

location_facility: Allergy, Asthma & Sinus Consultants, Inc

location_facility: University Hospital Hradec Kralove, Institute of Clinical Immunology and Allergollogy

location_facility: Public Institution "City Clinical Hospital #4" under Dnipro City Council

location_facility: University Hospital Olomouc, Department of Allergology and Clinical Immunology

location_facility: Allergy and Clinical Immunology Associates

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ)

location_facility: California Allergy and Asthma Medical Group

location_facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy Marek Jutel

location_facility: Berks Schuylkill Respiratory Specialists, Ltd.

location_facility: State Organization "National Institute of Phthisiology and Pulmonolgy named after F.G. Yanovsky NAMSU"

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Outpatient Allergology and Neurology Clinic Kasmed Ltd.

location_facility: Allergy & Asthma Medical Group and Research Center, A P.C.

location_facility: University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

location_facility: UZ Gent - Department of Respiratory Medicine

location_facility: Banner University of Arizona Medical Center

location_facility: Washington University School of Medicine

location_facility: SALK University Hospital Salzburg, State Hospital Salzburg

location_facility: Public Non-Profit Enterprise City Hospital #1 under Zaporizhia City Council

location_facility: NOUVEL HOPITAL CIVIL - New Civil Hospital

location_facility: Public Enterprise "Hospital #1" under Zhytomyr City Council

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Pulmonary Outpatient Clinic - Dr. Otakar Hokynar

location_facility: Medical University of Vienna, Department of Internal Medicine II, Clinical Division of Pulmonolog

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1

location_facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

location_facility: Allergy and Asthma Associates of Santa Clara Valley Research Center

location_facility: Glasgow Clinical Research Facility, Glasgow Royal Infirmary

location_facility: Centre integre universitaire de sante et de services sociaux du Nord-de-I'lle-de-Montreal - Hopital du Sacre-Coeur de Montreal

location_facility: MultiCare Institute for Research & Innovation

location_facility: The Lung Centre, Vancouver General Hospital

location_facility: Pulmonary Outpatient Clinic Rokycany s.r.o.

location_facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin V

location_facility: Public Non-Profit Enterprise: City Clinical Hospital #13 under Kharkiv City Council

location_facility: Institut fuer Allergie - und Asthmaforschung

location_facility: Public Institution: City Clinical Hospital #6

location_facility: Public Institution: Dnipro Clinical Association of Urgent Medical Care under Dnipro City Council


title: Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers

acronym: AURA

summary:
Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC).

Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Martinez Chanza N, Soukane L, Barthelemy P, Carnot A, Gil T, Casert V, Vanhaudenarde V, Sautois B, Staudacher L, Van den Brande J, Culine S, Seront E, Gizzi M, Albisinni S, Tricard T, Fantoni JC, Paesmans M, Caparica R, Roumeguere T, Awada A. Avelumab as neoadjuvant therapy in patients with urothelial non-metastatic muscle invasive bladder cancer: a multicenter, randomized, non-comparative, phase II study (Oncodistinct 004 - AURA trial). BMC Cancer. 2021 Dec 2;21(1):1292. doi: 10.1186/s12885-021-08990-3.

lead_sponsor: Jules Bordet Institute

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage

intervention_type: Combination Product


title: An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

summary: Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

lead_sponsor: Albireo

location_country:
Italy
United States
Sweden
Saudi Arabia
Netherlands
Germany
France
Poland
Israel
Belgium
Australia
Spain
Turkey
Canada
United Kingdom

location_facility: Institute of Liver Studies - Kings College Hospital

location_facility: Kinderklinik Tubingen, Universitatsklinikum Tubingen

location_facility: Riley Hospital for Children - Riley Children's Specialists

location_facility: Instytut Pomnik - Centrum Zarowia Dziecka

location_facility: Washington University School of Medicine

location_facility: Schneider Children's Medical Center Of Israel

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Universite Paris SUD - Hpitaux Universitaires Paris-Sud - Hopital Bicetre

location_facility: Baylor College of Medicine - Texas Children's Liver Center

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Hacettepe University Faculty of Medicine

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: University and Pediatric Hospital of Lyon

location_facility: Univesitatsklinikum Tubingen Klinik fur Kinder und Jugendmedizin

location_facility: Columbia University Medical Center - Presbyterian Hospital Building

location_facility: Universitair Medisch Centrum (UMC) Utrecht


design_allocation: Non-Randomized

status: Terminated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Netherlands
France
Japan
Singapore
Belgium
Spain
Germany
Korea, Republic of

acronym: Study of INC280 alone and in combination with erlotinib vs. chemotherapy in EGFR+/cMET amp NSCLC

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: University of California Irvine Medical Center Chao Family SC

location_facility: Los Angeles Hematology/Oncology Medical Group

title: A Phase Ib/II, Open-label, Multicenter Trial With Oral cMET Inhibitor INC280 Alone and in Combination With Erlotinib Versus Platinum With Pemetrexed in Adult Patients With EGFR Mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) With Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (EGFR TKI)

summary: The purpose of this study was to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of INC280 in combination with erlotinib in the Phase Ib of this study, and to assess the anti-tumor activity and safety of INC280 alone, and in combination with erlotinib, versus platinum with pemetrexed in the Phase II of this study, in adult patients with EGFR mutated, cMET amplified, advanced/metastatic non-small cell lung cancer with acquired resistance to prior EGFR TKI.

status_simplified: Unknown


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

location_country:
Peru
Greece
Belgium
Russian Federation
France
Thailand
Slovakia
Argentina
Colombia
South Africa
Chile
Vietnam
Philippines
Bulgaria
Hungary
Germany
United States
United Kingdom
Czechia
Spain
Turkey

acronym:
Systemic Corticosteroids Avoidance Study in Severe Asthma Patients.

 Étude de réduction des corticoïdes systémiques chez des patients souffrant d'asthme sévère.

title: A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma

summary: The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.


title: A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-OLS)

acronym: ASPEN-OLS

summary: Phase 3, open-label, multi-center trial to evaluate the long-term safety, efficacy, and immunogenicity of up to four continuous treatment cycles of daxibotulinumtoxinA (DAXI) for injection.

lead_sponsor: Revance Therapeutics, Inc.

location_country:
Austria
Germany
France
Czechia
Poland
Spain
United States
United Kingdom
Canada

location_facility: Nemocnice Pardubickeho kraje, a.s.; Pardubicka nemocnice

location_facility: The Walton Centre NHS Foundation Trust, Neuroscience Research Centre

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: University Health Network, Toronto Western Hospital

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: The University of Vermont Medical Center

location_facility: Houston Methodist Neurological Institute

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

location_facility: Ki Health Partners LLC DBA New England Institute for Clinical Research

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

location_facility: Neurologisches Studienzentrum Universitätsklinik für Neurologie Innsbruck

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: Intrafusion Research Network - Wesley Neurology Clinic

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

intervention_type: Biological


intervention_type: Other

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Sweden
Germany
Finland
France
Czechia
Poland
Israel
Hungary
Australia
Puerto Rico
New Zealand
Spain
Canada
United Kingdom

location_facility: Dermatology and Skin Surgery Center - Exton

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Synexus Clinical Research - Saint Petersburg

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Marietta Dermatology & The Skin Cancer Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan

location_facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck

location_facility: Progressive Clinical Research - San Antonio

location_facility: St. George Dermatology & Skin Care Centre

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Synexus - Lancashire Clinical Research Centre

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: University Hospitals Case Medical Center

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: DelRicht Research - New Orleans - Prytania Street

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: York Dermatology Clinic and Research Centre

location_facility: University of California San Diego Health Systems

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

location_facility: Center for Dermatology Clinical Research

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: Southern Illinois University School of Medicine

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Larrey

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi

location_facility: Artemis Institute for Clinical Research - San Diego

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: ActivMed Practices and Research - Portsmouth

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Artemis Institute for Clinical Research - San Marcos

location_facility: Precision Clinical Research - Corporate Office

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

summary: The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

summary: This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

location_facility: Royal Devon and Exeter Foundation Trust Hospital

location_facility: Marta Dagmara BANACH Marta Banach Specjalistyczny Gabinet Neurologiczny

location_facility: Mazowiecki Szpital Brodnowski Sp. z o.o.

location_facility: University of Pennsylvania, Department of Neurology

location_facility: University Health Network, Toronto Western Hospital

location_facility: New England Institute for Clinical Research

location_facility: University of Florida Center for Movement Disorders and Neurorestoration

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Houston Methodist Neurological Institute

location_facility: Fakultní nemocnice Ostrava, Neurologicka klinika

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Neurologicka klinika 1. LF UK a VFN v Praze

location_facility: Szpital sw. Wojciecha Podmiot Leczniczy Copernicus Sp. Z o.o.

location_facility: GFO Kliniken Troisdorf, Betriebsstätte St. Johannes Sieglar

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

location_facility: Praxis fuer Neurologie im Bismark Karrée

location_facility: University of Florida Health Science Center Jacksonville

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Fakultni nemocnice Olomouc, Neurologicka klinika

location_facility: The Parkinsons and Movement Disorder Institute


title: An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety in Patients With Endogenous Cushing's Syndrome Who Have Completed a Prior Novartis-sponsored Osilodrostat (LCI699) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat

summary: The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.

ipd_sharing: Undecided

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Austria
Brazil
India
Costa Rica
Spain
Germany
France
Bulgaria
Japan
Korea, Republic of
Poland
Thailand
Argentina
Belgium
Russian Federation
China
Turkey
United States
Canada

location_facility: University of Pennsylvania Medical Center Univ Penn

location_facility: Northwestern University SC - LCI699C2301

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Columbia University Medical Center New York Presbyterian Neuroendocrine Unit


lead_sponsor: Bayer

location_country:
United States
Netherlands
France
Bulgaria
Spain
Germany
United Kingdom

location_facility: SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hopital Necker les enfants malades - Paris

title: A Phase 1/2 Open-label Safety and Dose-finding Study of BAY2599023 (DTX201), an Adeno-associated Virus (AAV) hu37-mediated Gene Transfer of B-domain Deleted Human Factor VIII, in Adults With Severe Hemophilia A

summary: In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the disease. By replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. Hemophilia A is a bleeding disorder in which the human body does not have enough clotting factor VIII, a protein that controls bleeding. Researcher want to find the optimal dose of BAY 2599023 (DTX201) so that the body may produce enough clotting factor on its own.


title: Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma.

summary: The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

ReferenceCitation: Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.

name: From the Institute for Lung Health, Leicester NIHR Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B., D.J.C.), and the University of Manchester, Manchester University NHS Foundation Trust, Manchester (D.S.) — both in the United Kingdom; the Firestone Institute for Respiratory Health, McMaster University and St. Joseph’s Healthcare, Hamilton, ON, Canada (P.N.); and the GIGA-I3 Research Unit, University of Liege, Department of Pneumology, Centre...

family: Brightling

full_name: Christopher E. Brightling

given: Christopher E.

family: Nair

full_name: Parameswaran Nair

given: Parameswaran

family: Cousins

full_name: David J. Cousins

given: David J.

family: Louis

full_name: Renaud Louis

given: Renaud

title: Risankizumab in Severe Asthma — A Phase 2a, Placebo-Controlled Trial

lead_sponsor: AbbVie

location_country:
United States
Netherlands
Germany
France
Poland
Belgium
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat

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

location_facility: Respiratory and Sleep Disorders Specialists

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hamburger Institut für Therapieforschung GmbH (HIT)

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel


title: Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

acronym: FORMULA-OLS

summary: A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

lead_sponsor: F2G Biotech GmbH

location_country:
Brazil
Netherlands
Spain
Germany
Vietnam
France
Poland
Thailand
Israel
Belgium
Australia
Egypt
Russian Federation
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Valley Fever Institute at Kern Medical Center

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: University of California San Diego Medical Center

location_facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná

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

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: SBEIHPE "NWSMU n. a. I.I Mechnikov" of MoH and SD of RH

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital da Universidade Federal de Santa Maria CEP/UFSM

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"


type: Registry Identifier

title: A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).

acronym: TRANSFORM

summary:
The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm A) or to receive JCAR017 (Arm B).

All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP, RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT) and Hematopoietic stem cell transplant (HSCT).

Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an EFS event.

Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by JCAR017 infusion.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Ernst

full_name: Moritz Ernst

given: Moritz

family: Oeser

full_name: Annika Oeser

given: Annika

family: Besiroglu

full_name: Burcu Besiroglu

given: Burcu

family: Caro-Valenzuela

full_name: Julia Caro-Valenzuela

given: Julia

name: Department of Surgery; Mayo Clinic; Rochester Minnesota USA

family: Abd El Aziz

full_name: Mohamed Abd El Aziz

given: Mohamed

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department I of Internal Medicine; University Hospital of Cologne; Cologne Germany

family: Borchmann

full_name: Peter Borchmann

given: Peter

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

family: Goldkuhle

full_name: Marius Goldkuhle

given: Marius

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Kambhampati S, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.

family: Kambhampati

full_name: Swetha Kambhampati

given: Swetha

family: Hunter

full_name: Bradley Hunter

given: Bradley

family: Varnavski

full_name: Andrei Varnavski

given: Andrei

family: Fakhri

full_name: Bita Fakhri

given: Bita

family: Kaplan

full_name: Lawrence Kaplan

given: Lawrence

family: Ai

full_name: Weiyun Z. Ai

given: Weiyun Z.

family: Pampaloni

full_name: Miguel Pampaloni

given: Miguel

family: Huang

full_name: Chiung-Yu Huang

given: Chiung-Yu

family: Martin

full_name: Thomas Martin

given: Thomas

family: Damon

full_name: Lloyd Damon

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Japan
Belgium
Spain
Germany
United Kingdom

location_facility: Hospital Clinic i Provincial de Barcelona - ICMHO

location_facility: Northwestern University-Feinberg School of Medicine

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: H. Lee Moffitt Cancer Center and Research Institute

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

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

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

location_facility: Loyola University Medical Center Cardinal Bernardin Cancer Center

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Karolinska Universitetssjukhuset - Huddinge

location_facility: Blood and Marrow Transplant Group of Georgia


ReferenceCitation: Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdová EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405.

name: Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering University Hospital and University of Basel, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Fox

full_name: Robert J. Fox

given: Robert J.

name: Actelion Pharmaceuticals, Part of Janssen Pharmaceutical Companies, Allschwil, Switzerland

family: Burcklen

full_name: Michel Burcklen

given: Michel

name: Department of Medicine, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

name: Department of Neurology, First Medical Faculty, Charles University, Prague, Czech Republic

family: Havrdová

full_name: Eva K. Havrdová

given: Eva K.

family: Hennessy

full_name: Brian Hennessy

given: Brian

name: Institute of Clinical Neuroimmunology, Ludwig Maximilians University Munich, Munich, Germany

name: Munich Cluster of Systems Neurology (SyNergy), Ludwig Maximilians University Munich, Munich, Germany

family: Hohlfeld

full_name: Reinhard Hohlfeld

given: Reinhard

name: Icahn School of Medicine at Mount Sinai, New York, New York

family: Lublin

full_name: Fred Lublin

given: Fred

name: Department of Neurology-Neuroimmunology, Multiple Sclerosis Center of Catalonia, Vall d’Hebron University Hospital, Barcelona, Spain

family: Montalban

full_name: Xavier Montalban

given: Xavier

name: Sant’Andrea Multiple Sclerosis Centre, Sapienza University of Rome, Rome, Italy

family: Pozzilli

full_name: Carlo Pozzilli

given: Carlo

family: Scherz

full_name: Tatiana Scherz

given: Tatiana

name: Now with Clinical Research Department, Galapagos GmbH, Basel, Switzerland

family: D'Ambrosio

full_name: Daniele D'Ambrosio

given: Daniele

family: Linscheid

full_name: Philippe Linscheid

given: Philippe

family: Vaclavkova

full_name: Andrea Vaclavkova

given: Andrea

family: Pirozek-Lawniczek

full_name: Magdalena Pirozek-Lawniczek

given: Magdalena

family: Kracker

full_name: Hilke Kracker

given: Hilke

name: DKD Helios Klinik Wiesbaden, Wiesbaden, Germany

family: Sprenger

full_name: Till Sprenger

given: Till

journal_name: JAMA Neurology

oa_colors: green other

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Actelion

location_country:
Finland
Greece
Romania
Russian Federation
Ukraine
Spain
Croatia
France
Lithuania
Poland
Canada
Sweden
Bulgaria
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Mexico
Czechia
Israel
Georgia
Belarus
Turkey
Latvia

acronym: OPTIMUM

location_facility:
Investigator Site 3803
Investigator Site 8101
Investigator Site 1605
Investigator Site 3717
Investigator Site 2212
Investigator Site 3002
Investigator Site 2811
Investigator Site 3217
Investigator Site 1104
Investigator Site 3814
Investigator Site 2702
Investigator Site 3722
Investigator Site 3716
Investigator Site 3718
Investigator Site 2602
Investigator Site 4010
Investigator Site 1405
Investigator Site 1102
Investigator Site 1303
Investigator Site 3713
Investigator Site 1107
Investigator Site 7410
Investigator Site 3801
Investigator Site 3831
Investigator Site 3842
Investigator Site 3220
Investigator Site 1705
Investigator Site 3723
Investigator Site 8006
Investigator Site 3903
Investigator Site 3829
Investigator Site 1409
Investigator Site 3602
Investigator Site 3214
Investigator Site 3904
Investigator Site 3810
Investigator Site 2015
Investigator Site 3219
Investigator Site 3825
Investigator Site 2709
Investigator Site 3840
Investigator Site 3711
Investigator Site 2902
Investigator Site 8013
Investigator Site 3009
Investigator Site 1504
Investigator Site 3823
Investigator Site 3007
Investigator Site 2903
Investigator Site 3835
Investigator Site 3403
Investigator Site 3837
Investigator Site 3805
Investigator Site 1706
Investigator Site 2905
Investigator Site 3216
Investigator Site 3701
Investigator Site 1715
Investigator Site 3902
Investigator Site 3724
Investigator Site 2601
Investigator Site 3603
Investigator Site 3401
Investigator Site 1502
Investigator Site 3906
Investigator Site 2701
Investigator Site 2807
Investigator Site 3006
Investigator Site 2711
Investigator Site 3503
Investigator Site 4006
Investigator Site 3203
Investigator Site 3703
Investigator Site 2509
Investigator Site 2003
Investigator Site 3808
Investigator Site 3714
Investigator Site 4004
Investigator Site 1307
Investigator Site 1403
Investigator Site 3819
Investigator Site 2021
Investigator Site 8113
Investigator Site 2909
Investigator Site 1301
Investigator Site 3004
Investigator Site 1506
Investigator Site 1604
Investigator Site 3001
Investigator Site 7409
Investigator Site 3813
Investigator Site 8036
Investigator Site 3202
Investigator Site 2707
Investigator Site 8045
Investigator Site 2502
Investigator Site 2508
Investigator Site 4005
Investigator Site 3721
Investigator Site 3905
Investigator Site 3207
Investigator Site 2910
Investigator Site 3821
Investigator Site 3605
Investigator Site 8040
Investigator Site 3010
Investigator Site 1603
Investigator Site 2606
Investigator Site 3730
Investigator Site 2101
Investigator Site 3215
Investigator Site 1501
Investigator Site 1505
Investigator Site 9004
Investigator Site 8018
Investigator Site 3811
Investigator Site 2802
Investigator Site 3003
Investigator Site 2703
Investigator Site 3504
Investigator Site 8311
Investigator Site 8065
Investigator Site 8042
Investigator Site 3606
Investigator Site 3008
Investigator Site 8102
Investigator Site 3807
Investigator Site 2103
Investigator Site 2506
Investigator Site 3802
Investigator Site 8015
Investigator Site 2708
Investigator Site 8120
Investigator Site 3208
Investigator Site 3715
Investigator Site 1109
Investigator Site 2804
Investigator Site 1713
Investigator Site 3213
Investigator Site 3812
Investigator Site 2202
Investigator Site 1113
Investigator Site 3205
Investigator Site 1413
Investigator Site 3402
Investigator Site 3502
Investigator Site 3818
Investigator Site 3833
Investigator Site 2603
Investigator Site 1509
Investigator Site 3839
Investigator Site 1602
Investigator Site 3822
Investigator Site 3836
Investigator Site 3604
Investigator Site 3725
Investigator Site 9104
Investigator Site 2607
Investigator Site 3815
Investigator Site 3834
Investigator Site 2110
Investigator Site 1703

title: Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

summary: International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

summary: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

ReferenceCitation: Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

family: Peters

full_name: Anne L. Peters

given: Anne L.

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

family: Danne

full_name: Thomas Danne

given: Thomas

family: Kushner

full_name: Jake A. Kushner

given: Jake A.

family: Rodbard

full_name: Helena W. Rodbard

given: Helena W.

family: Dhatariya

full_name: Ketan Dhatariya

given: Ketan

family: Sawhney

full_name: Sangeeta Sawhney

given: Sangeeta

family: Banks

full_name: Phillip Banks

given: Phillip

family: Jiang

full_name: Wenjun Jiang

given: Wenjun

family: Davies

full_name: Michael J. Davies

given: Michael J.

family: Lapuerta

full_name: Pablo Lapuerta

given: Pablo

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

name: Department for General Pediatrics, Diabetes, Endocrinology, and Clinical Research, Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.

name: Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.

family: Joish

full_name: Vijay N. Joish

given: Vijay N.

family: Afonso

full_name: Marion Afonso

given: Marion

name: Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.

name: Sanofi US, Inc., Bridgewater, New Jersey, USA.

name: Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

name: AMCR Institute, Escondido, California, USA.

name: Behavioral Diabetes Institute, San Diego, California, USA.

ReferenceCitation: Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

ReferenceCitation: Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA(1c) and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.

title: HbA1cand Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
France
Bulgaria
Lithuania
Israel
Poland
Romania
Hungary
Belgium
Slovakia
Spain
Germany
United Kingdom


ReferenceCitation: Cudkowicz M, Genge A, Maragakis N, Petri S, van den Berg L, Aho VV, Sarapohja T, Kuoppamäki M, Garratt C, Al-Chalabi A; REFALS investigators. Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2021 Oct;20(10):821-831. doi: 10.1016/S1474-4422(21)00242-8.

family: Cudkowicz

full_name: Merit Cudkowicz

given: Merit

family: Genge

full_name: Angela Genge

given: Angela

family: Maragakis

full_name: Nicholas Maragakis

given: Nicholas

family: Petri

full_name: Susanne Petri

given: Susanne

family: van den Berg

full_name: Leonard van den Berg

given: Leonard

family: Aho

full_name: Valtteri V Aho

given: Valtteri V

family: Sarapohja

full_name: Toni Sarapohja

given: Toni

family: Kuoppamäki

full_name: Mikko Kuoppamäki

given: Mikko

family: Garratt

full_name: Chris Garratt

given: Chris

family: Al-Chalabi

full_name: Ammar Al-Chalabi

given: Ammar

family: Kiernan

full_name: Matthew Kiernan

given: Matthew

family: Mathers

full_name: Susan Mathers

given: Susan

family: Henderson

full_name: Robert Henderson

given: Robert

family: Needham

full_name: Merrilee Needham

given: Merrilee

family: Schultz

full_name: David Schultz

given: David

family: Löscher

full_name: Wolfgang Löscher

given: Wolfgang

family: Mitrovic

full_name: Nenad Mitrovic

given: Nenad

family: Rath

full_name: Jakob Rath

given: Jakob

family: Damme

full_name: Philip Van Damme

given: Philip Van

family: De Bleecker

full_name: Jan L. De Bleecker

given: Jan L.

family: Delstanche

full_name: Stéphanie Delstanche

given: Stéphanie

family: Johnston

full_name: Wendy Johnston

given: Wendy

family: Zinman

full_name: Lorne Zinman

given: Lorne

family: O'Connell

full_name: Colleen O'Connell

given: Colleen

family: Matte

full_name: Genevieve Matte

given: Genevieve

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

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau

location_facility: Universitair Medisch Centrum Utrecht - Rudolf Magnus Instituut voor Neurowetenschappen

location_facility: Hospital of the University of Pennsylvania

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Neurologian Poliklinikka - Meilahden Tornisairaala 3

location_facility: Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Wake Forest University Baptist Medical Center

location_facility: Washington University School of Medicine

location_facility: Northwestern University Feinberg School of Medicine

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Montreal Neurological Institute and Hospital

location_facility: Neurosciences Institute - Neurology Charlotte

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

location_facility: Colorado Springs Neurological Associates

location_facility: University of Florida Health - Jacksonville

location_facility: Neuromuscular Research Center and Neuromuscular Clinic of Arizona

location_facility: Centre Hospitalier Affilie Universitaire de Quebec

location_facility: Moncton Hospital, Southeast Regional Health Authority

location_facility: Alberta Health Services - Neuromuscular Clinic

location_facility: Centre De Recherche Du Centre Hospitalier de l'Universite de Montreal - Hopital Notre-Dame

location_facility: University of Kentucky Chandler Medical Center

location_facility: University of Utah - Imaging & Neurosciences Center

location_facility: The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara

title: Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

summary: This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.


title: Prospective, Single-arm, Multi-center, Observational Study to Further Confirm Safety and Efficacy of the Dual-layer Micromesh Roadsaver Stent for the Treatment of Carotid Artery Stenosis in Patients Eligible for Elective Stenting Procedure

acronym: ROADSAVER

summary: Approximately 2000 patients eligible for elective treatment with a Carotid Stent according to hospital routine practice in centers across Europe will be enrolled in the study. The maximum number of patients enrolled at each site will be not limited. Follow-ups are scheduled at discharge, 30 days, and 1 year, as per local practice. Each patient will have follow-up contacts via hospital visit and/or telephone.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Terumo Europe N.V.

location_country:
Serbia
Netherlands
North Macedonia
Spain
France
Czechia
Poland
Slovakia
Hungary
Belgium
Portugal
Germany
Latvia

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hospital Universitario Girona Josep Trueta

location_facility: GCS Centre de Cardiologie du Pays Basque

location_facility: Polyclinique Louis Pasteur Essey Les Nancy

location_facility: Hospital Universitario Clínico de Valladolid

location_facility: Diakonissenkrankenhaus Flensburg Ev.-Luth. Diakonissenanstalt zu Flensburg

location_facility: Semmelweis University Heart and Vascular Center

location_facility: City General Hospital 8th September Skopje

location_facility: Universitäts und Rehabilitationskliniken Ulm

location_facility: Szpital Uniwersytecki nr.2 im. Dr J. Biziela w Bydgoszczy

location_facility: Paul Stradins Clinical University Hospital

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Szent György Fejér County - University Teaching Hospital

intervention_type: Device


title: A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

acronym: PULSAR

summary: Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 6 months in the Placebo-Controlled Treatment Period, and then will be eligible to enroll into an 18- month Extension Period during which all participants will receive sotatercept. All treated patients will be also undergo follow-up period after last study drug treatment.

ReferenceCitation: Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.

name: From the Department of Respiratory and Intensive Care Medicine, Hôpital Bicêtre, Assistance Publique–Hôpitaux de Paris, INSERM Unité Mixte de Recherche 999, Université Paris-Saclay, Le Kremlin-Bicêtre, France (M.H., D.M.); the Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor (V.M.); the National Heart and Lung Institute, Imperial College London, and the National Pulmonary Hypertension Service, Hammersmith Hospital, Imperial College...

family: Humbert

full_name: Marc Humbert

given: Marc

family: McLaughlin

full_name: Vallerie McLaughlin

given: Vallerie

family: Gibbs

full_name: J. Simon R. Gibbs

given: J. Simon R.

family: Gomberg-Maitland

full_name: Mardi Gomberg-Maitland

given: Mardi

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Preston

full_name: Ioana R. Preston

given: Ioana R.

family: Souza

full_name: Rogerio Souza

given: Rogerio

family: Waxman

full_name: Aaron Waxman

given: Aaron

family: Escribano Subias

full_name: Pilar Escribano Subias

given: Pilar

family: Feldman

full_name: Jeremy Feldman

given: Jeremy

family: Meyer

full_name: Gisela Meyer

given: Gisela

family: Montani

full_name: David Montani

family: Olsson

full_name: Karen M. Olsson

given: Karen M.

family: Manimaran

full_name: Solaiappan Manimaran

given: Solaiappan

family: Barnes

full_name: Jennifer Barnes

given: Jennifer

family: Linde

full_name: Peter G. Linde

given: Peter G.

family: de Oliveira Pena

full_name: Janethe de Oliveira Pena

given: Janethe

family: Badesch

full_name: David B. Badesch

given: David B.

lead_sponsor: Acceleron Pharma Inc.

location_country:
Brazil
Germany
France
Israel
Australia
Spain
United States
United Kingdom

location_facility: University of California, San Francisco Medical Center

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Banner-University Medical Center Phoenix

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre


title: ThRombosis ExclUsion STudy

acronym: TRUST

summary: The purpose of this study is to demonstrate the ability of new D-Dimer assay combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.

lead_sponsor: Diagnostica Stago

location_country:
Italy
France
Belgium
Spain
United States

location_facility: Duke Hemostasis and Thrombosis Research Center


ReferenceCitation: Burstein Waldman C, Owens A. A plain language summary of the EXPLORER-HCM study: mavacamten for obstructive hypertrophic cardiomyopathy. Future Cardiol. 2021 Oct;17(7):1269-1275. doi: 10.2217/fca-2021-0044. Epub 2021 May 21.

family: Burstein Waldman

full_name: Cynthia Burstein Waldman

given: Cynthia

name: University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA

family: Owens

full_name: Anjali Owens

given: Anjali

journal_name: Future Cardiology

license: cc-by-nd

license_normalized: cc-by-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Spertus JA, Fine JT, Elliott P, Ho CY, Olivotto I, Saberi S, Li W, Dolan C, Reaney M, Sehnert AJ, Jacoby D. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 26;397(10293):2467-2475. doi: 10.1016/S0140-6736(21)00763-7. Epub 2021 May 15.

family: Spertus

full_name: John A Spertus

given: John A

family: Fine

full_name: Jennifer T Fine

given: Jennifer T

family: Elliott

full_name: Perry Elliott

given: Perry

family: Ho

full_name: Carolyn Y Ho

given: Carolyn Y

family: Olivotto

full_name: Iacopo Olivotto

given: Iacopo

family: Saberi

full_name: Sara Saberi

given: Sara

family: Li

full_name: Wanying Li

given: Wanying

family: Dolan

full_name: Chantal Dolan

given: Chantal

family: Reaney

full_name: Matthew Reaney

given: Matthew

family: Sehnert

full_name: Amy J Sehnert

given: Amy J

family: Jacoby

full_name: Daniel Jacoby

given: Daniel

journal_name: The Lancet

oa_host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

ReferenceCitation: Olivotto I, Oreziak A, Barriales-Villa R, Abraham TP, Masri A, Garcia-Pavia P, Saberi S, Lakdawala NK, Wheeler MT, Owens A, Kubanek M, Wojakowski W, Jensen MK, Gimeno-Blanes J, Afshar K, Myers J, Hegde SM, Solomon SD, Sehnert AJ, Zhang D, Li W, Bhattacharya M, Edelberg JM, Waldman CB, Lester SJ, Wang A, Ho CY, Jacoby D; EXPLORER-HCM study investigators. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Epub 2020 Aug 29. Erratum in: Lancet. 2020 Sep 12;396(10253):758.

family: Oreziak

full_name: Artur Oreziak

given: Artur

family: Barriales-Villa

full_name: Roberto Barriales-Villa

given: Roberto

family: Abraham

full_name: Theodore P Abraham

given: Theodore P

repository_institution: University of Florence - Florence Research

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

ReferenceCitation: Ho CY, Olivotto I, Jacoby D, Lester SJ, Roe M, Wang A, Waldman CB, Zhang D, Sehnert AJ, Heitner SB. Study Design and Rationale of EXPLORER-HCM: Evaluation of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy. Circ Heart Fail. 2020 Jun;13(6):e006853. doi: 10.1161/CIRCHEARTFAILURE.120.006853. Epub 2020 Jun 5.

name: Brigham and Women’s Hospital, Boston, MA (C.Y.H.).

name: Careggi University Hospital, Florence, Italy (I.O.).

name: Duke Clinical Research Institute, Durham, NC (M.R.).

name: Duke University School of Medicine, Durham, NC (A.W.).

name: MyoKardia, Inc, Brisbane, CA (D.Z., A.J.S.).

name: Knight Cardiovascular Institute, Oregon Health and Sciences University, Portland (S.B.H.).

location_country:
Italy
Netherlands
Spain
Germany
France
Czechia
Poland
Israel
Belgium
Portugal
Denmark
United States
United Kingdom

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of Pennsylvania (Penn Heart and Vascular Center)

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Washington University School of Medicine

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Charité Campus Buch - Experimental and Clinical Research Center

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

location_facility: University of Pittsburgh Medical Center Presbyterian

location_facility: University of Texas Houston Medical School

location_facility: University of Texas Southwestern Medical Center

location_facility: University Of Iowa Hospitals And Clinics

location_facility: Cedars-Sinai Medical Center (Smidt Heart Institute)

title: A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

summary: This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.


title: ABLATOR Ablation Observational Registry

acronym: ABLATOR

summary: The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Austria
India
Saudi Arabia
Netherlands
Spain
Germany
France
Czechia
Belgium
China
Canada
United Kingdom
Korea, Republic of
Portugal

location_facility: Hospital general Universitario de Alicante

location_facility: Escorts Heart Institute and Research Centre

location_facility: Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: Third Xiangya Hospital of Central South University

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Ospedale San Giovanni di Dio - Torregalli

location_facility: Fuwai Heart Hospital & Cardiovascular Institute

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

summary: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Switzerland
Netherlands
Germany
Finland
France
Czechia
Poland
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: University Medical Center Groningen; Department of Dermatology

location_facility: Hospital Ramon y Cajal; servicio dermatologia

location_facility: Dr. Melinda Gooderham Medicine Professional Corporation

location_facility: National Taiwan University Hospital; Department of Dermatology

location_facility: Turku Central University Hospital; Dermatology and allergology

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

location_facility: Faculty Hospital; Department of Dermatology

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Cheng-Kung University Hospital; Department of Dermatology

location_facility: University of Iowa Healthcare; Dermatology

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Oregon Health & Science University; Department of Dermatology

location_facility: St George Dermatology and Skin Cancer Centre

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center

location_facility: Tampere University Hospital; Dermatology and allergology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Masarykova nemocnice o.z; kozni oddeleni

location_facility: Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology

location_facility: University of Texas Medical School-Houston

location_facility: Hospital Universitario La Paz; Servicio de dermatologia

location_facility: Charles University School of Medicine; Deptartment of Dermatology

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit

location_facility: Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii

location_facility: SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie

location_facility: HUGregorio Marañón, Servicio de dermatología

location_facility: Hospital General Universitario de Valencia; servicio de dermatología

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Hospital Universitario La Princesa, Servicio dermatologia

location_facility: Royal Melbourne Hospital; Dermatology Department

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique


title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

summary: A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

primary_purpose: Prevention

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France

location_facility: Wake Forest University School of Medicine


title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

summary: The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

ReferenceCitation: Berke JM, Dehertogh P, Vergauwen K, Mostmans W, Vandyck K, Raboisson P, Pauwels F. Antiviral Properties and Mechanism of Action Studies of the Hepatitis B Virus Capsid Assembly Modulator JNJ-56136379. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02439-19. doi: 10.1128/AAC.02439-19. Print 2020 Apr 21.

name: Janssen Research and Development, Beerse, Belgium

family: Berke

full_name: Jan Martin Berke

given: Jan Martin

family: Dehertogh

full_name: Pascale Dehertogh

given: Pascale

family: Vergauwen

full_name: Karen Vergauwen

given: Karen

family: Mostmans

full_name: Wendy Mostmans

given: Wendy

family: Vandyck

full_name: Koen Vandyck

given: Koen

family: Raboisson

full_name: Pierre Raboisson

given: Pierre

family: Pauwels

full_name: Frederik Pauwels

given: Frederik

journal_name: Antimicrobial Agents and Chemotherapy

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Italy
United States
Hong Kong
Spain
Germany
France
Japan
Malaysia
Poland
Thailand
Belgium
Russian Federation
China
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Queen Mary Hospital, University of Hong Kong

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Saglık Bilimleri University Şişli Trainig and Research Hospital,Department of Gastroenterology

location_facility: Kharkiv National Medical University, Regional Clinical Infectious Hospital

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Vinnytsia City Clinical Hospital #1, Department of Infectious Diseases #1

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: SE 'National institute therapy named L.T. Maloi NAMS of Ukraine'

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Beiijing Friendship Hospital, Capital Medical University