ReferenceCitation: Confavreux C, O'Connor P, Comi G, Freedman MS, Miller AE, Olsson TP, Wolinsky JS, Bagulho T, Delhay JL, Dukovic D, Truffinet P, Kappos L; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Mar;13(3):247-56. doi: 10.1016/S1474-4422(13)70308-9. Epub 2014 Jan 23.

family: Confavreux

full_name: Christian Confavreux

given: Christian

family: O'Connor

full_name: Paul O'Connor

given: Paul

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Freedman

full_name: Mark S Freedman

given: Mark S

family: Miller

full_name: Aaron E Miller

given: Aaron E

family: Olsson

full_name: Tomas P Olsson

given: Tomas P

family: Wolinsky

full_name: Jerry S Wolinsky

given: Jerry S

family: Bagulho

full_name: Teresa Bagulho

given: Teresa

family: Delhay

full_name: Jean-Luc Delhay

given: Jean-Luc

family: Dukovic

full_name: Deborah Dukovic

given: Deborah

family: Truffinet

full_name: Philippe Truffinet

given: Philippe

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: The Lancet Neurology

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

full_name: Mark S. Freedman

given: Mark S.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

given: Alexander

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Gold

full_name: Ralf Gold

given: Ralf

family: Korideck

full_name: Houari Korideck

given: Houari

family: Chavin

full_name: Jeffrey Chavin

given: Jeffrey

family: Poole

ReferenceCitation: Miller AE, Olsson TP, Wolinsky JS, Comi G, Kappos L, Hu X, Xu X, Lublin AL, Truffinet P, Chavin J, Delhay JL, Benamor M, Purvis A, Freedman MS; TOWER investigators. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study. Mult Scler Relat Disord. 2020 Nov;46:102438. doi: 10.1016/j.msard.2020.102438. Epub 2020 Aug 1.

journal_name: Multiple Sclerosis and Related Disorders

ReferenceCitation: Qiu W, Huang DH, Hou SF, Zhang MN, Jin T, Dong HQ, Peng H, Zhang CD, Zhao G, Huang YN, Zhou D, Wu WP, Wang BJ, Li JM, Zhang XH, Cheng Y, Li HF, Li L, Lu CZ, Zhang X, Bu BT, Dong WL, Fan DS, Hu XQ, Xu XH; TOWER Trial Chinese Group. Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study. Chin Med J (Engl). 2018 Dec 5;131(23):2776-2784. doi: 10.4103/0366-6999.246067.

ReferenceCitation: Freedman MS, Morawski J, Thangavelu K. Clinical efficacy of teriflunomide over a fixed 2-year duration in the TOWER study. Mult Scler J Exp Transl Clin. 2018 May 16;4(2):2055217318775236. doi: 10.1177/2055217318775236. eCollection 2018 Apr-Jun.

name: Multiple Sclerosis Research Clinic, University of Ottawa and the Ottawa Hospital Research Institute, Canada

name: MS Global Health Economics and Value Assessment, Sanofi, USA

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

name: University of Ottawa and The Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada

name: Multiple Sclerosis Research Group and MRI-Analysis Center, McGovern Medical School, UTHealth, Houston, TX, USA

name: Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

name: Neurology and Department of Biomedicine, University Hospital Basel, Basel, Switzerland

name: Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden

name: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA

name: University of Toronto, Toronto, ON, Canada

location_country:
Greece
Romania
Australia
Belgium
Czech Republic
Ukraine
France
Poland
Thailand
Slovakia
Canada
Turkey
Chile
Sweden
Netherlands
Philippines
China
Germany
United States
United Kingdom
Austria
Mexico
Tunisia
Belarus
Spain
Estonia

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 764002

location_facility: Sanofi-Aventis Investigational Site Number 804119

location_facility: Sanofi-Aventis Investigational Site Number 826001

location_facility: Sanofi-Aventis Investigational Site Number 036005

location_facility: Sanofi-Aventis Investigational Site Number 156014

location_facility: Sanofi-Aventis Investigational Site Number 788003

location_facility: Sanofi-Aventis Investigational Site Number 152007

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 156009

location_facility: Sanofi-Aventis Investigational Site Number 276010

location_facility: Sanofi-Aventis Investigational Site Number 156008

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 112101

location_facility: Sanofi-Aventis Investigational Site Number 156011

location_facility: Sanofi-Aventis Investigational Site Number 804109

location_facility: Sanofi-Aventis Investigational Site Number 276003

location_facility: Sanofi-Aventis Investigational Site Number 752003

location_facility: Sanofi-Aventis Investigational Site Number 804118

location_facility: Sanofi-Aventis Investigational Site Number 804121

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 156006

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 840025

location_facility: Sanofi-Aventis Investigational Site Number 840084

location_facility: Sanofi-Aventis Investigational Site Number 156030

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 124008

location_facility: Sanofi-Aventis Investigational Site Number 792009

location_facility: Sanofi-Aventis Investigational Site Number 840060

location_facility: Sanofi-Aventis Investigational Site Number 840073

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 703005

location_facility: Sanofi-Aventis Investigational Site Number 792002

location_facility: Sanofi-Aventis Investigational Site Number 156022

location_facility: Sanofi-Aventis Investigational Site Number 608002

location_facility: Sanofi-Aventis Investigational Site Number 484005

location_facility: Sanofi-Aventis Investigational Site Number 840075

location_facility: Sanofi-Aventis Investigational Site Number 040001

location_facility: Sanofi-Aventis Investigational Site Number 642005

location_facility: Sanofi-Aventis Investigational Site Number 804104

location_facility: Sanofi-Aventis Investigational Site Number 703003

location_facility: Sanofi-Aventis Investigational Site Number 152006

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 156001

location_facility: Sanofi-Aventis Investigational Site Number 112103

location_facility: Sanofi-Aventis Investigational Site Number 788004

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 804107

location_facility: Sanofi-Aventis Investigational Site Number 156007

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 792005

location_facility: Sanofi-Aventis Investigational Site Number 276006

location_facility: Sanofi-Aventis Investigational Site Number 840022

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 156016

location_facility: Sanofi-Aventis Investigational Site Number 124004

location_facility: Sanofi-Aventis Investigational Site Number 152002

location_facility: Sanofi-Aventis Investigational Site Number 804101

location_facility: Sanofi-Aventis Investigational Site Number 642007

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 804124

location_facility: Sanofi-Aventis Investigational Site Number 804108

location_facility: Sanofi-Aventis Investigational Site Number 156017

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 840079

location_facility: Sanofi-Aventis Investigational Site Number 840063

location_facility: Sanofi-Aventis Investigational Site Number 840088

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 608001

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 203001

location_facility: Sanofi-Aventis Investigational Site Number 826002

location_facility: Sanofi-Aventis Investigational Site Number 840069

location_facility: Sanofi-Aventis Investigational Site Number 840068

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 616003

location_facility: Sanofi-Aventis Investigational Site Number 804117

location_facility: Sanofi-Aventis Investigational Site Number 804111

location_facility: Sanofi-Aventis Investigational Site Number 156027

location_facility: Sanofi-Aventis Investigational Site Number 276002

location_facility: Sanofi-Aventis Investigational Site Number 112104

location_facility: Sanofi-Aventis Investigational Site Number 233002

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 300006

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 804114

location_facility: Sanofi-Aventis Investigational Site Number 156033

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 156010

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 156002

location_facility: Sanofi-Aventis Investigational Site Number 804115

location_facility: Sanofi-Aventis Investigational Site Number 826005

location_facility: Sanofi-Aventis Investigational Site Number 608003

location_facility: Sanofi-Aventis Investigational Site Number 156023

location_facility: Sanofi-Aventis Investigational Site Number 276005

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 156025

location_facility: Sanofi-Aventis Investigational Site Number 764001

location_facility: Sanofi-Aventis Investigational Site Number 840089

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 203004

location_facility: Sanofi-Aventis Investigational Site Number 788002

location_facility: Sanofi-Aventis Investigational Site Number 156015

location_facility: Sanofi-Aventis Investigational Site Number 804122

location_facility: Sanofi-Aventis Investigational Site Number 792007

location_facility: Sanofi-Aventis Investigational Site Number 300001

location_facility: Sanofi-Aventis Investigational Site Number 804102

location_facility: Sanofi-Aventis Investigational Site Number 804120

location_facility: Sanofi-Aventis Investigational Site Number 840071

location_facility: Sanofi-Aventis Investigational Site Number 156018

location_facility: Sanofi-Aventis Investigational Site Number 792012

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 840016

location_facility: Sanofi-Aventis Investigational Site Number 276007

location_facility: Sanofi-Aventis Investigational Site Number 156034

location_facility: Sanofi-Aventis Investigational Site Number 826003

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 826004

location_facility: Sanofi-Aventis Investigational Site Number 156003

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 642001

location_facility: Sanofi-Aventis Investigational Site Number 840078

location_facility: Sanofi-Aventis Investigational Site Number 840083

location_facility: Sanofi-Aventis Investigational Site Number 840064

location_facility: Sanofi-Aventis Investigational Site Number 036008

location_facility: Sanofi-Aventis Investigational Site Number 156005

location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 804105

location_facility: Sanofi-Aventis Investigational Site Number 840007

location_facility: Sanofi-Aventis Investigational Site Number 792011

location_facility: Sanofi-Aventis Investigational Site Number 804116

location_facility: Sanofi-Aventis Investigational Site Number 840074

location_facility: Sanofi-Aventis Investigational Site Number 112105

location_facility: Sanofi-Aventis Investigational Site Number 233001

location_facility: Sanofi-Aventis Investigational Site Number 276009

location_facility: Sanofi-Aventis Investigational Site Number 156019

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 608004

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 642006

location_facility: Sanofi-Aventis Investigational Site Number 156028

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 156021

location_facility: Sanofi-Aventis Investigational Site Number 036006

location_facility: Sanofi-Aventis Investigational Site Number 156032

location_facility: Sanofi-Aventis Investigational Site Number 804103

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 156029

location_facility: Sanofi-Aventis Investigational Site Number 840090

location_facility: Sanofi-Aventis Investigational Site Number 788001

location_facility: Sanofi-Aventis Investigational Site Number 703006

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 156012

location_facility: Sanofi-Aventis Investigational Site Number 840076

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 840086

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 156024

location_facility: Sanofi-Aventis Investigational Site Number 276001

location_facility: Sanofi-Aventis Investigational Site Number 840066

location_facility: Sanofi-Aventis Investigational Site Number 156035

location_facility: Sanofi-Aventis Investigational Site Number 124002

location_facility: Sanofi-Aventis Investigational Site Number 156004

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 792010

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 112102

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 840034

location_facility: Sanofi-Aventis Investigational Site Number 276004

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 703001

location_facility: Sanofi-Aventis Investigational Site Number 528006

location_facility: Sanofi-Aventis Investigational Site Number 203002

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 156031

title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

summary:
The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

To assess the effect of the two doses of teriflunomide in comparison to placebo on:

Fatigue;
Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
To evaluate the safety and tolerability of teriflunomide.


title: Heart Failure Optimization Study

acronym: HF-Opt

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

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Zoll Medical Corporation

location_country:
Austria
United States
Germany
France

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

location_facility: Methodist South (MS) University Hospital

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

location_facility: CHU de Clermont-Ferrand- Hopital Albert Michallon

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Texas Health Research & Education Institute

location_facility: Amper Kliniken AG, Heliios Amper-Klinikum Dachau

location_facility: CHU de Grenoble site Nord- Hopital Albert Michallon

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

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

acronym: COMBO

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

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Netherlands
France
Hungary
Belgium
Spain
United States

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Centre Hospitalier de l'Ardenne - Pharmacie

location_facility: Yale University Institutional Review Board

location_facility: Hematology - Oncology Associates of the Treasure Coast

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

location_facility: University of Oklahoma Health Sciences Center

intervention_type: Drug

status_simplified: Unknown


ReferenceType: derived

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

family: Höglinger

full_name: Günter U Höglinger

given: Günter U

sequence: first

family: Litvan

full_name: Irene Litvan

given: Irene

sequence: additional

family: Mendonca

full_name: Nuno Mendonca

given: Nuno

family: Wang

full_name: Deli Wang

given: Deli

family: Zheng

full_name: Hui Zheng

given: Hui

family: Rendenbach-Mueller

full_name: Beatrice Rendenbach-Mueller

given: Beatrice

family: Lon

full_name: Hoi-Kei Lon

given: Hoi-Kei

family: Jin

full_name: Ziyi Jin

given: Ziyi

family: Fisseha

full_name: Nahome Fisseha

given: Nahome

family: Budur

full_name: Kumar Budur

given: Kumar

full_name: Michael Gold

given: Michael

family: Ryman

full_name: Davis Ryman

given: Davis

family: Florian

full_name: Hana Florian

given: Hana

family: Ahmed

full_name: Anwar Ahmed

given: Anwar

family: Aiba

full_name: Ikuko Aiba

given: Ikuko

family: Albanese

full_name: Alberto Albanese

given: Alberto

family: Bertram

full_name: Kelly Bertram

given: Kelly

family: Bordelon

full_name: Yvette Bordelon

given: Yvette

family: Bower

full_name: James Bower

given: James

family: Brosch

full_name: Jared Brosch

given: Jared

family: Claassen

full_name: Daniel Claassen

given: Daniel

family: Colosimo

full_name: Carlo Colosimo

given: Carlo

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

family: Cudia

full_name: Paola Cudia

given: Paola

family: Daniele

full_name: Antonio Daniele

given: Antonio

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

location_country:
Italy
United States
Germany
France
Japan
Australia
Spain
Canada

location_facility: Rush University Medical Center /ID# 144894

location_facility: Istituto Neuro Mediterraneo IR /ID# 153106

location_facility: Central Texas Neurology Consul /ID# 167417

location_facility: NHO Sendai Nishitaga National Hospital /ID# 202132

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

location_facility: Cleveland Clinic Lou Ruvo Cent /ID# 148919

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

location_facility: Cleveland Clinic Main Campus /ID# 144885

location_facility: CHU Strasbourg Hautepierre Hos /ID# 206942

location_facility: Universitaetsklinikum Leipzig /ID# 201761

location_facility: Policlinico Agostino Gemelli /ID# 153104

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

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

location_facility: Juntendo University Hospital /ID# 200870

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

location_facility: Neurodegenerative Disorders Re /ID# 153770

location_facility: Montreal Neurological Institut /ID# 156413

location_facility: Hopital Universitaire Purpan /ID# 153152

location_facility: Oregon Health and Science University /ID# 149774

location_facility: COLUMBIA University Medical Center /ID# 149037

location_facility: Univ California, San Francisco /ID# 144897

location_facility: Universita di Catanzaro Magna Graecia /ID# 166322

location_facility: University of Florida - Archer /ID# 144906

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

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

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

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

location_facility: Rocky Mountain Movement Disorders Center /ID# 153397

location_facility: Hospital General Universitario Gregorio Maranon /ID# 200876

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

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

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

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


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

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

status: Recruiting

design_allocation: Randomized

ReferenceType: background

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

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

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

family: Stupp

full_name: Roger Stupp

given: Roger

family: Wong

full_name: Eric T. Wong

given: Eric T.

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

family: Steinberg

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

given: Uri

family: Schiff

full_name: David Schiff

family: Kunschner

full_name: Lara Kunschner

given: Lara

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Honnorat

full_name: Jerome Honnorat

given: Jerome

family: Sloan

full_name: Andrew Sloan

given: Andrew

family: Malkin

full_name: Mark Malkin

given: Mark

family: Landolfi

full_name: Joseph C. Landolfi

given: Joseph C.

family: Payer

full_name: Franz Payer

given: Franz

family: Mehdorn

full_name: Maximilian Mehdorn

given: Maximilian

title: NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality

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

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

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

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

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

name: University Hospital Zurich and University of Zurich, Zurich, Switzerland2Lausanne University Hospital (CHUV), Lausanne, Switzerland

name: Assistance Publique des Hôpitaux de Paris, La Pitié-Salpétrière-University Hospital, Pierre and Marie Curie University, Paris, France

name: Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

name: Geisinger Health System, Danville, Pennsylvania

name: Tufts Medical Center, Boston, Massachusetts

name: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: Istituto Nazionale Neurologico Carlo Besta, Milan, Italy

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: Baylor University Medical Center, Dallas, Texas13University of Texas Health Science Center, Houston

name: Swedish Neuroscience Institute, Seattle, Washington

name: University of Southern California, Los Angeles

name: Washington University Barnes-Jewish Hospital, St Louis, Missouri

name: Na Homolce Hospital, Prague, Czech Republic

name: New Jersey Neuroscience Institute, Edison

name: Fondazione Ospedale Maggiore Policlinico, Milan, Italy

name: Houston Methodist Hospital, Houston, Texas

name: Hospices Civils de Lyon, University Claude Bernard Lyon 1, Lyon, France

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

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

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

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

location_facility: Huntsman Cancer Institute/University of Utah

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

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

location_facility: Thomayerova Nemocnice Dept. of Pneumology

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

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

location_facility: The University of Texas Southwestern Medical Center

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center

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

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

location_facility: Hospital Universitari i Politécnic La Fe

location_facility: Baylor Scott & White Health/McClinton Cancer Center

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

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

location_facility: INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer

location_facility: Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

location_facility: University of Maryland School of Medicine

location_facility: Kantonsspital Winterthur Tumorzentrum Winterthur

location_facility: Renown Regional Medical Center Institute for Cancer

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

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

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Arnau de Vilanova

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

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

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

location_facility: HealthPartners Institute, Regions Cancer Care Center

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

location_facility: Centre Hospitalier de Saint-Quentin Service de pneumologie

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

location_facility: Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell

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

location_facility: Affiliated Cancer Hospital of Guangzhou Medical University

location_facility: Bezanijska kosa Clinical Hospital Center

location_facility: Hospital Regional Universitario Carlos Haya Medical Oncology Department

location_facility: Tufts Medical Center, Division of Hematology and Oncology

location_facility: Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

location_facility: New York-Presbyterian/Queens Radiation Oncology


title: A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

summary: This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

status: Completed

ReferenceType: result

ReferenceCitation: Nauck MA, Del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care. 2011 Sep;34(9):2015-22. doi: 10.2337/dc11-0606. Epub 2011 Aug 4.

family: Nauck

full_name: Michael A. Nauck

given: Michael A.

family: Del Prato

full_name: Stefano Del Prato

given: Stefano

family: Meier

full_name: Juris J. Meier

given: Juris J.

family: Durán-García

full_name: Santiago Durán-García

given: Santiago

family: Rohwedder

full_name: Katja Rohwedder

given: Katja

family: Elze

full_name: Martina Elze

given: Martina

family: Parikh

full_name: Shamik J. Parikh

given: Shamik J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Dapagliflozin Versus Glipizide as Add-on Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin

ReferenceCitation: Nauck M, del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. [Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S6-15. doi: 10.1055/s-0032-1305283. Epub 2013 Mar 25. German.

name: Diabeteszentrum, Bad Lauterberg, Deutschland

full_name: M. Nauck

given: M.

name: Abteilung Diabetes und Metabolische Störungen, Institut für Endokrinologie und Stoffwechsel, Universität Pisa, Italien

family: del Prato

full_name: S. del Prato

given: S.

name: Medizinische Universitätsklinik, Ruhr-Universität Bochum, Deutschland

full_name: J. Meier

given: J.

name: Hospital Universitario de Valme, Sevilla, Spanien

full_name: S. Durán-García

full_name: K. Rohwedder

given: K.

full_name: M. Elze

full_name: S. Parikh

journal_name: DMW - Deutsche Medizinische Wochenschrift

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

title: Vergleich von Dapagliflozin und Glipizid als Add-on-Therapie bei Typ-2-Diabetikern mit unzureichender Blutzuckerkontrolle unter Metformin

location_country:
Italy
South Africa
Sweden
Mexico
Netherlands
France
Argentina
Spain
Germany
United Kingdom


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

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

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

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

family: Schwartz

full_name: Carolyn E. Schwartz

given: Carolyn E.

family: Stark

full_name: Roland B. Stark

given: Roland B.

family: Borowiec

full_name: Katrina Borowiec

given: Katrina

family: Nolte

full_name: Sandra Nolte

given: Sandra

family: Myren

full_name: Karl-Johan Myren

given: Karl-Johan

currency_apc_doaj: GBP

journal_name: Orphanet Journal of Rare Diseases

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

name: Institute of Transfusion Medicine, University of Ulm and Institute for Clinical Transfusion Medicine and Immunogenetics Ulm, German Red Cross Blood Transfusion Service and University Hospital Ulm, Ulm, Germany

family: Schrezenmeier

full_name: Hubert Schrezenmeier

given: Hubert

name: Department of Haematological Medicine, King’s College Hospital, NIHR/Wellcome King’s Clinical Research Facility, London, UK

family: Kulasekararaj

full_name: Austin Kulasekararaj

given: Austin

name: Department of Haematology, University Hospital Monklands, Lanarkshire, UK

family: Mitchell

full_name: Lindsay Mitchell

given: Lindsay

name: Service d’Hématologie Greffe, Centre de Référence Aplasie Médullaire, Assistance Publique des Hôpitaux de Paris, Hôpital Saint-Louis, Paris, France

family: Sicre de Fontbrune

full_name: Flore Sicre de Fontbrune

given: Flore

name: Department of Hematology, University Hospitals Leuven and Department of Microbiology and Immunology, Laboratory of Molecular Immunology (Rega Institute), KU Leuven, Leuven, Belgium

family: Devos

full_name: Timothy Devos

given: Timothy

name: Division of Hematology, Keio University School of Medicine, Tokyo, Japan

family: Okamoto

full_name: Shinichiro Okamoto

given: Shinichiro

name: Division of Medical Oncology and Hematology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

family: Wells

full_name: Richard Wells

given: Richard

name: Global Medicine, Alexion Pharmaceuticals, Inc., Boston, MA, USA

family: Rottinghaus

full_name: Scott T. Rottinghaus

given: Scott T.

name: Biostatistics, Alexion Pharmaceuticals, Inc., Boston, MA, USA

family: Liu

full_name: Peng Liu

given: Peng

name: Clinical Pharmacology, Alexion Pharmaceuticals, Inc., Boston, MA, USA

family: Ortiz

full_name: Stephan Ortiz

given: Stephan

name: Department of Hematology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea

family: Lee

full_name: Jong Wook Lee

given: Jong Wook

name: Hematology Transplantation, Hôpital Saint-Louis, Paris, France

name: Institut National de la Santé et de la Recherche Médicale, Université de Paris, Paris, France

family: Socié

full_name: Gérard Socié

given: Gérard

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

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

repository_institution: University of Melbourne - Minerva Access

publisher: Ferrata Storti Foundation (Haematologica)

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


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

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

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

family: Abou-Alfa

full_name: Ghassan K Abou-Alfa

given: Ghassan K

family: Sahai

full_name: Vaibhav Sahai

given: Vaibhav

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Vaccaro

full_name: Gina Vaccaro

given: Gina

family: Melisi

full_name: Davide Melisi

given: Davide

family: Al-Rajabi

full_name: Raed Al-Rajabi

given: Raed

family: Paulson

full_name: Andrew S Paulson

given: Andrew S

family: Borad

full_name: Mitesh J Borad

given: Mitesh J

family: Gallinson

full_name: David Gallinson

given: David

family: Murphy

full_name: Adrian G Murphy

given: Adrian G

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Dotan

full_name: Efrat Dotan

given: Efrat

family: Catenacci

full_name: Daniel V Catenacci

given: Daniel V

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Ji

full_name: Tao Ji

given: Tao

family: Lihou

full_name: Christine F Lihou

given: Christine F

family: Zhen

full_name: Huiling Zhen

given: Huiling

family: Féliz

full_name: Luis Féliz

given: Luis

family: Vogel

full_name: Arndt Vogel

given: Arndt

journal_name: The Lancet Oncology

oa_host_type: repository

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: Yes

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

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


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

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

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
Austria
Netherlands
Germany
France
Belgium
Spain
United States

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

location_facility: Klinikum rechts der Isar, Technische Universität München

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

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

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

location_facility: CHU de Brest - Hopital de la Cavale Blanche

status_simplified: Completed


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

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

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

lead_sponsor: Molnlycke Health Care AB

location_country: Sweden France Czechia Poland Denmark Germany

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

location_facility: Regional hospital Pardubice Dermatology Department

location_facility: St. Ann University Hospital Dep of Dermatovenereology

location_facility: Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro

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

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


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

name: The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology, Houston, TX 77030, USA

family: Tripathy

full_name: Debu Tripathy

given: Debu

name: Dana-Farber Cancer Institute, Center for Women's Cancers, Boston, MA 02215, USA

family: Tolaney

full_name: Sara M Tolaney

given: Sara M

name: Memorial Sloan-Kettering Cancer Center, Bobst International Center, New York, NY 10065, USA

family: Seidman

full_name: Andrew D Seidman

given: Andrew D

name: University of North Carolina School of Medicine, Duke Cancer Center, Chapel Hill, NC 27710, USA

family: Anders

full_name: Carey K Anders

given: Carey K

family: Ibrahim

full_name: Nuhad Ibrahim

given: Nuhad

name: University of California San Francisco, Department of Medicine (Hematology/Oncology), San Francisco, CA 94115, USA

family: Rugo

full_name: Hope S Rugo

given: Hope S

name: University of Leeds, Leeds Institute of Cancer and Pathology (LICAP), Leeds, LS2 9JT, UK

name: St James' University Hospital, Institute of Oncology, Leeds, LS9 7BE, UK

family: Twelves

full_name: Chris Twelves

given: Chris

name: Institut Curie, Oncological Medicine Department, 75248, Paris, France

family: Dieras

full_name: Veronique Dieras

given: Veronique

name: University Medical Center Hamburg-Eppendorf, Department of Obstetrics and Gynecology, 20246 Hamburg, Germany

family: Müller

full_name: Volkmar Müller

given: Volkmar

name: Nektar Therapeutics, San Francisco, CA 94158, USA

family: Tagliaferri

full_name: Mary Tagliaferri

given: Mary

family: Hannah

full_name: Alison L Hannah

given: Alison L

name: IOB Institute of Oncology, Quironsalud Group, 28034 Madrid & 08023 Barcelona, Spain

name: Vall d'Hebron Institute of Oncology (VHIO), Breast Cancer and Melanoma Group, 08035 Barcelona, Spain

family: Cortés

full_name: Javier Cortés

given: Javier

journal_name: Future Oncology

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

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

version: submittedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Nektar Therapeutics

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

acronym: ATTAIN

location_facility: Investigator Site - Santa Cruz de Tenerife

location_facility: Investigator Site - Woluwe- Saint-Lambert

source: euctr

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

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


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

name: From the Department of Nephrology and Medical Intensive Care, Charité–Universitätsmedizin Berlin, Berlin (K.-U.E.); the Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis (R.A.); Gonzalez M.D. and Aswad M.D. Health Care Services, Miami (A. Aswad); Clinical Research Consultants, Kansas City, MO (A. Awad); U.S. Renal Care, Plano (G.A.B.), Baylor University Medical Center, Baylor Heart and Vascular Hospital, Baylor Heart and Vascular Institute, Dallas (P.A.M....

family: Eckardt

full_name: Kai-Uwe Eckardt

given: Kai-Uwe

family: Agarwal

full_name: Rajiv Agarwal

given: Rajiv

family: Aswad

full_name: Ahmad Aswad

given: Ahmad

family: Awad

full_name: Ahmed Awad

given: Ahmed

family: Block

full_name: Geoffrey A. Block

given: Geoffrey A.

family: Bacci

full_name: Marcelo R. Bacci

given: Marcelo R.

family: Farag

full_name: Youssef M.K. Farag

given: Youssef M.K.

family: Fishbane

full_name: Steven Fishbane

given: Steven

family: Hubert

full_name: Harold Hubert

given: Harold

family: Jardine

full_name: Alan Jardine

given: Alan

family: Khawaja

full_name: Zeeshan Khawaja

given: Zeeshan

family: Koury

full_name: Mark J. Koury

given: Mark J.

family: Maroni

full_name: Bradley J. Maroni

given: Bradley J.

family: Matsushita

full_name: Kunihiro Matsushita

given: Kunihiro

family: McCullough

full_name: Peter A. McCullough

given: Peter A.

family: Lewis

full_name: Eldrin F. Lewis

given: Eldrin F.

family: Luo

full_name: Wenli Luo

given: Wenli

family: Parfrey

full_name: Patrick S. Parfrey

given: Patrick S.

family: Pergola

full_name: Pablo Pergola

given: Pablo

family: Sarnak

full_name: Mark J. Sarnak

family: Spinowitz

full_name: Bruce Spinowitz

given: Bruce

family: Tumlin

full_name: James Tumlin

given: James

family: Vargo

full_name: Dennis L. Vargo

given: Dennis L.

family: Walters

full_name: Kimberly A. Walters

given: Kimberly A.

family: Winkelmayer

full_name: Wolfgang C. Winkelmayer

given: Wolfgang C.

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

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

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

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with DD-CKD


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

name: From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo...

family: Griffin

full_name: M. Pamela Griffin

given: M. Pamela

family: Yuan

full_name: Yuan Yuan

given: Yuan

family: Takas

full_name: Therese Takas

given: Therese

family: Domachowske

full_name: Joseph B. Domachowske

given: Joseph B.

family: Madhi

full_name: Shabir A. Madhi

given: Shabir A.

family: Manzoni

full_name: Paolo Manzoni

given: Paolo

family: Simões

full_name: Eric A.F. Simões

given: Eric A.F.

family: Esser

full_name: Mark T. Esser

given: Mark T.

family: Khan

full_name: Anis A. Khan

given: Anis A.

family: Dubovsky

full_name: Filip Dubovsky

given: Filip

family: Villafana

full_name: Tonya Villafana

given: Tonya

family: DeVincenzo

full_name: John P. DeVincenzo

given: John P.

journal_name: New England Journal of Medicine

oa_host_type: publisher

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: MedImmune LLC

primary_purpose: Prevention

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

acronym: MEDI8897 Ph2b

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

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


ReferenceCitation: Debruyne FM, Gittelman M, Sperling H, Börner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.

family: Debruyne

full_name: Frans M.J. Debruyne

given: Frans M.J.

family: Gittelman

full_name: Marc Gittelman

given: Marc

family: Sperling

full_name: Herbert Sperling

given: Herbert

family: Börner

full_name: Matthias Börner

given: Matthias

family: Beneke

full_name: Manfred Beneke

given: Manfred

journal_name: The Journal of Sexual Medicine

title: Time to Onset of Action of Vardenafil: A Retrospective Analysis of the Pivotal Trials for the Orodispersible and Film‐Coated Tablet Formulations

ReferenceCitation: Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.

full_name: Frans Debruyne

given: Frans

family: Boermans

full_name: Antonius Boermans

given: Antonius

family: Ulbrich

full_name: Ernst Ulbrich

given: Ernst

family: Ewald

full_name: Silke Ewald

given: Silke

title: The POTENT I Randomized Trial: Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction

ReferenceCitation: Heinig R, Weimann B, Dietrich H, Böttcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.

family: Heinig

full_name: Roland Heinig

given: Roland

family: Weimann

full_name: Boris Weimann

given: Boris

family: Dietrich

full_name: Hartmut Dietrich

given: Hartmut

family: Böttcher

full_name: Michael-Friedrich Böttcher

given: Michael-Friedrich

journal_name: Clinical Drug Investigation

publisher_dissemination: Springer

publisher_group: Springer

title: Pharmacokinetics of a New Orodispersible Tablet Formulation of Vardenafil

ReferenceCitation: Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.

family: Norenberg

title: Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction in Elderly Men and Those with Underlying Conditions: An Integrated Analysis of Two Pivotal Trials

location_country:
South Africa
Netherlands
France
Belgium
Spain
Germany

title: Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I

summary: This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.


ReferenceCitation: Charlton M, Rinella M, Patel D, McCague K, Heimbach J, Watt K. Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study. Transplantation. 2017 Dec;101(12):2873-2882. doi: 10.1097/TP.0000000000001913.

family: Charlton

full_name: Michael Charlton

given: Michael

family: Rinella

full_name: Mary Rinella

given: Mary

family: Patel

full_name: Dharmesh Patel

given: Dharmesh

family: McCague

full_name: Kevin McCague

given: Kevin

family: Heimbach

full_name: Julie Heimbach

given: Julie

family: Watt

full_name: Kymberly Watt

given: Kymberly

journal_name: Transplantation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Fischer L, Saliba F, Kaiser GM, De Carlis L, Metselaar HJ, De Simone P, Duvoux C, Nevens F, Fung JJ, Dong G, Rauer B, Junge G; H2304 Study Group. Three-year Outcomes in De Novo Liver Transplant Patients Receiving Everolimus With Reduced Tacrolimus: Follow-Up Results From a Randomized, Multicenter Study. Transplantation. 2015 Jul;99(7):1455-62. doi: 10.1097/TP.0000000000000555.

family: Fischer

full_name: Lutz Fischer

given: Lutz

family: Saliba

full_name: Faouzi Saliba

given: Faouzi

family: Kaiser

full_name: Gernot M. Kaiser

given: Gernot M.

family: De Carlis

full_name: Luciano De Carlis

given: Luciano

family: Metselaar

full_name: Herold J. Metselaar

given: Herold J.

family: De Simone

full_name: Paolo De Simone

given: Paolo

family: Duvoux

full_name: Christophe Duvoux

given: Christophe

family: Nevens

full_name: Frederik Nevens

given: Frederik

family: Fung

full_name: John J. Fung

given: John J.

family: Dong

full_name: Gaohong Dong

given: Gaohong

family: Rauer

full_name: Barbara Rauer

given: Barbara

family: Junge

full_name: Guido Junge

given: Guido

ReferenceCitation: Saliba F, De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Jonas S, Sudan D, Fischer L, Duvoux C, Chavin KD, Koneru B, Huang MA, Chapman WC, Foltys D, Dong G, Lopez PM, Fung J, Junge G; H2304 Study Group. Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study. Am J Transplant. 2013 Jul;13(7):1734-45. doi: 10.1111/ajt.12280. Epub 2013 May 28.

name: Hepatobiliary Center, AP-HP Hôpital Paul Brousse; Université Paris-Sud; Villejuif; France

name: General Surgery and Liver Transplantation; Azienda Ospedaliero-Universitaria Pisana; Pisa; Italy

name: Department of Hepatology; University Hospital KU Leuven; Leuven; Belgium

name: Department of General Surgery and Transplantation; Azienda Ospedaliera Niguarda Cà Granda; Milan; Italy

name: Department of Gastroenterology and Hepatology; Erasmus MC, University Hospital Rotterdam; Rotterdam; the Netherlands

name: Department of Visceral, Transplantation, Thoracic and Vascular Surgery; University Medical Center Leipzig; Leipzig; Germany

name: Division of Transplant Surgery, Department of General Surgery; Duke University Medical Center; Durham; NC

name: Department of Hepatobiliary Surgery and Transplantation; University Medical Center Eppendorf; Hamburg; Germany

name: Liver Transplant Unit; AP-HP Hôpital Henri Mondor; Créteil; France

name: Division of Transplant Surgery; Medical University of South Carolina; Charleston; SC

name: Department of Surgery; University of Medicine and Dentistry-New Jersey Medical School; Newark; NJ

name: Division of Gastroenterology, Department of Internal Medicine; Henry Ford Hospital; Detroit; MI

name: Department of Surgery; Washington University School of Medicine; St Louis; MO

name: Department of Transplant Surgery; University Medical Center, Johannes Gutenberg University; Mainz; Germany

name: Novartis Pharmaceuticals; East Hanover; NJ

name: Transplantation Center, Cleveland Clinic; Cleveland; OH

title: Renal Function at Two Years in Liver Transplant Patients Receiving Everolimus: Results of a Randomized, Multicenter Study

location_country:
Italy
Brazil
Sweden
United Kingdom
Netherlands
Spain
Germany
France
Israel
Hungary
Belgium
Argentina
Australia
Ireland
Russian Federation
United States
Czech Republic
Canada
Colombia

title: A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

summary: This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.


lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Romania
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
India
France
Poland
Norway
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Georgia
Spain

acronym: RE-DEEM

location_facility: 1160.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.10002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303C Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303D Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11018 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49019 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82013 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3303A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3305B Boehringer Ingelheim Investigational Site

location_facility: 1160.67.3301A Boehringer Ingelheim Investigational Site

location_facility: 1160.67.95001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11016 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49015 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82012 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11014 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11020 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70010 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.45001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.34001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.59002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.47004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.11003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.46005 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32011 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.91007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.32001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.40004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70004 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.39003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.53001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.48003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.58001 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.82006 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70008 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.31003 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.44002 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.70009 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.49017 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.36007 Boehringer Ingelheim Investigational Site

location_facility: 1160.67.38004 Boehringer Ingelheim Investigational Site

type: Other Identifier

title: RandomizEd Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi-centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study (RE-DEEM)

summary: The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.


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

acronym: TULIP SLE LTE

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

lead_sponsor: AstraZeneca

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


title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer

acronym: ENTHUSE M1C

summary:
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

ReferenceCitation: Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8. Erratum in: J Clin Oncol. 2014 Oct 20;32(30):3461. Fizazi, Karim S [Corrected to Fizazi, Karim].

name: Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Celestia S. Higano, University of Washington, Seattle, WA; Joel B. Nelson, University of Pittsburgh, Pittsburgh, PA; Martin Gleave, University of British Columbia, Vancouver, British Columbia, Canada; Kurt Miller, Charité Berlin, Berlin, Germany; Thomas Morris, Stuart McIntosh, and Kristine Pemberton, AstraZeneca, Alderley Park, Macclesfield, United Kingdom; Faith E. Nathan, AstraZeneca, Wilmington, DE; and Judd W. Moul,...

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Higano

full_name: Celestia S. Higano

given: Celestia S.

family: Nelson

full_name: Joel B. Nelson

given: Joel B.

family: Gleave

full_name: Martin Gleave

given: Martin

family: Miller

full_name: Kurt Miller

given: Kurt

family: Morris

full_name: Thomas Morris

given: Thomas

family: Nathan

full_name: Faith E. Nathan

given: Faith E.

family: McIntosh

full_name: Stuart McIntosh

given: Stuart

family: Pemberton

full_name: Kristine Pemberton

given: Kristine

family: Moul

full_name: Judd W. Moul

given: Judd W.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III, Randomized, Placebo-Controlled Study of Docetaxel in Combination With Zibotentan in Patients With Metastatic Castration-Resistant Prostate Cancer

location_country:
Peru
Finland
Romania
Australia
Russian Federation
Czech Republic
Taiwan
India
France
Poland
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Serbia
Spain


lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Sweden
United Kingdom
Netherlands
France
Poland
Hungary
Belgium
Spain
Germany
Czech Republic

title: Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

summary: The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.


ReferenceCitation: Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Reséndiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.

family: Bronstein

full_name: Marcello D. Bronstein

given: Marcello D.

name: on behalf of the Pasireotide C2305 Study Group

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

family: Neggers

full_name: Sebastian Neggers

given: Sebastian

family: Colao

full_name: Annamaria Colao

given: Annamaria

family: Sheppard

full_name: Michael Sheppard

given: Michael

family: Gu

full_name: Feng Gu

given: Feng

family: Shen

full_name: Chiung-Chyi Shen

given: Chiung-Chyi

family: Gadelha

full_name: Mônica Gadelha

given: Mônica

family: Farrall

full_name: Andrew J. Farrall

given: Andrew J.

family: Hermosillo Reséndiz

full_name: Karina Hermosillo Reséndiz

given: Karina

family: Ruffin

full_name: Matthieu Ruffin

given: Matthieu

family: Chen

full_name: YinMiao Chen

given: YinMiao

family: Freda

full_name: Pamela Freda

given: Pamela

journal_name: BMC Endocrine Disorders

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5. Review.

family: Shanik

full_name: Michael H. Shanik

given: Michael H.

family: Cao

full_name: Paul D. Cao

title: Historical Response Rates Of Somatostatin Analogues In The Treatment Of Acromegaly: A Systematic Review

ReferenceCitation: Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Reséndiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6. Erratum in: Pituitary. 2015 Jun;18(3):395-6.

location_country:
Greece
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Switzerland
Netherlands
Hungary
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur

location_facility: Cedars Sinai Medical Center The Pituitary Center

location_facility: University of Texas/MD Anderson Cancer Center Regulatory -12

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)

location_facility: Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.

location_facility: University of Texas Southwestern Medical Center Danziger Research Bldg.

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)

location_facility: Stanford University Medical Center Stanford Cancer Center (3)

location_facility: University of California at Los Angeles Division of Endocrinology

location_facility: Northport VA Medical Center CSOM230C2305

location_facility: University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

summary:
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.


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

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

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

name: Medical Oncology Department; St John of God Midland; Perth Australia

name: Medical Oncology Department; Sir Charles Gairdner Hospital; Perth Australia

family: Hoon

full_name: Siao-Nge Hoon

given: Siao-Nge

name: Medical Oncology Department; Peter MacCallum Cancer Centre; Melbourne Australia

family: Lau

full_name: Peter K H Lau

given: Peter K H

name: Murdoch Community Hospice; St John of God Hospital Murdoch; Perth Australia

name: Palliative Care Department; Royal Perth Hospital; Perth Australia

family: White

full_name: Alison M White

given: Alison M

name: Institute for Health Research; University of Notre Dame Australia; Fremantle Australia

name: School of Population and Global Health; The University of Western Australia; Perth Australia

name: Division of Surgery and Interventional Science; University College London; London UK

family: Bulsara

full_name: Max K Bulsara

given: Max K

name: Medical Oncology Department; University Hospital Geelong; Geelong Australia

family: Banks

full_name: Patricia D Banks

given: Patricia D

name: School of Medicine; University of Western Australia; Perth Australia

name: Medical Oncology Department; Fiona Stanley Hospital; Perth Australia

family: Redfern

full_name: Andrew D Redfern

given: Andrew D

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hoffmann-La Roche

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


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

family: Niederwieser

full_name: Dietger Niederwieser

given: Dietger

family: Hamm

full_name: Caroline Hamm

given: Caroline

family: Cobb

full_name: Patrick Cobb

given: Patrick

family: Mo

full_name: Mindy Mo

given: Mindy

family: Forsyth

full_name: Cecily Forsyth

given: Cecily

family: Tucci

full_name: Alessandra Tucci

given: Alessandra

family: Hanes

full_name: Vladimir Hanes

given: Vladimir

family: Delwail

full_name: Vincent Delwail

given: Vincent

family: Hajek

full_name: Roman Hajek

given: Roman

family: Chien

full_name: David Chien

given: David

journal_name: Targeted Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

intervention_type: Biological

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

lead_sponsor: Amgen

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

acronym: JASMINE

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

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

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