title: REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

acronym: REDUCE LAP-HF

summary: The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

ReferenceCitation: Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hünlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.

ReferenceCitation: Hasenfuß G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.

family: Hasenfuß

full_name: Gerd Hasenfuß

given: Gerd

family: Hayward

full_name: Chris Hayward

given: Chris

family: Burkhoff

full_name: Dan Burkhoff

given: Dan

family: Silvestry

full_name: Frank E Silvestry

given: Frank E

family: McKenzie

full_name: Scott McKenzie

given: Scott

family: Gustafsson

full_name: Finn Gustafsson

given: Finn

family: Malek

full_name: Filip Malek

given: Filip

family: Van der Heyden

full_name: Jan Van der Heyden

given: Jan

family: Lang

full_name: Irene Lang

given: Irene

family: Petrie

full_name: Mark C Petrie

given: Mark C

family: Cleland

full_name: John G F Cleland

given: John G F

family: Leon

full_name: Martin Leon

given: Martin

family: Kaye

full_name: David M Kaye

given: David M

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

ReferenceCitation: Kaye DM, Hasenfuß G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12). pii: e003662.

ReferenceCitation: Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.

name: Department of Cardiology, Rigshospitalet; Copenhagen Denmark

family: Wolsk

full_name: Emil Wolsk

given: Emil

name: Baker IDI Heart and Diabetes Research Institute; Melbourne Australia

full_name: David Kaye

given: David

name: Division of Cardiovascular Diseases, Mayo Clinic and Foundation; Rochester MN USA

family: Borlaug

full_name: Barry A. Borlaug

given: Barry A.

name: Cardiovascular Research Foundation; Orangeburg NY USA

full_name: Daniel Burkhoff

given: Daniel

name: Department of Internal Medicine, School of Medicine, Wake Forest School of Medicine; Winston-Salem NC USA

family: Kitzman

full_name: Dalane W. Kitzman

name: National Heart Centre Singapore; Singapore and Duke-National University of Singapore; Singapore

name: Department of Heart Diseases; Medical University and Centre for Heart Diseases, Military Hospital; Wrocław Poland

name: Division of Cardiology, Department of Medicine; Northwestern University Feinberg School of Medicine; Chicago IL USA

ReferenceCitation: Kaye DM, Petrie MC, McKenzie S, Hasenfuβ G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.

name: Department of Cardiology; Alfred Hospital; Commercial Rd Melbourne Victoria 3004 Australia

name: Department of Cardiology; Prince Charles Hospital; Brisbane Australia

name: Georg-August-Universität Göttingen; Göttingen Germany

name: Na Homolce Hospital; Prague Czech Republic

name: St Antonius Ziekenhuis Nieuwegein; Nieuwegein The Netherlands

name: University of Auckland; Auckland New Zealand

name: Department of Cardiology; Rigshospitalet; Copenhagen Denmark

name: Allgemeines Krankenhaus Universitätskliniken; Vienna Austria

name: Fourth Military Hospital; Wrocław Poland

name: Universitätklinikum Düsseldorf; Düsseldorf Germany

name: Cardiovascular Center Aalst; Aalst Belgium

name: University Medical Center Schleswig-Holstein; Kiel Germany

name: Department of Internal Medicine; University of Heidelberg; Heidelberg Germany

name: Bichat AP-HP Hospital, INSERM; Paris France

name: Wrocław Medical University; Wrocław Poland

name: Department of Cardiology; St Vincent's Hospital; Sydney Australia

name: on behalf of the REDUCE LAP-HF study investigators

repository_normalized: University of Melbourne - Minerva Access

ReferenceCitation: Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfuβ G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.

name: Division of Cardiology, Columbia University, New York, NY (J.W., D.B.).

name: Heart Failure Research Group, Baker Heart and Diabetes Institute, Melbourne, Australia (D.K.).

name: Department of Cardiology, Rigshospitalet, Copenhagen, Denmark (F.G.).

name: British Heart Foundation Institute of Cardiovascular and Medical Sciences, Glasgow University, United Kingdom (M.C.P.).

name: Heart Centre, Georg-August Universität, Gottingen, Germany (G.H.).

name: National Heart Centre Singapore and Duke-National University of Singapore (C.S.P.L.).

name: Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (B.A.B.).

name: Corvia Medical Incorporated, Tewksbury, MA (J.K.).

name: Cardiology Division, Evanston Hospital, NorthShore University Health System, IL (T.F.).

name: Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (S.J.S.).

name: on behalf of the REDUCE-LAP-HF Trial Investigators and Advisors

ReferenceCitation: Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfuβ G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.

ReferenceCitation: Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfuβ G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.

journal_name: Journal of the American College of Cardiology

location_country:
Austria
Netherlands
France
Czechia
Poland
Australia
Belgium
New Zealand
Denmark
Germany
United Kingdom

location_facility: Allgemeines Krankenhaus Univesitäts Kliniken


type: Other Identifier

type: EudraCT Number

title: A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib (Velcade) in Patients With Multiple Myeloma in First or Second Relapse.

acronym: OPTIMRETREAT

summary: The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Terpos E, Gobbi M, Potamianou A, Lahaye M, Couturier C, Cavo M. Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study. Eur J Haematol. 2018 Jan;100(1):10-19. doi: 10.1111/ejh.12937. Epub 2017 Oct 30.

name: Department of Clinical Therapeutics; School of Medicine; University of Athens; Athens Greece

family: Terpos

full_name: Evangelos Terpos

given: Evangelos

sequence: first

name: Clinical Hematology; IRCCS AOU San Martino-IST; Genova Italy

family: Gobbi

full_name: Marco Gobbi

given: Marco

sequence: additional

name: EMEA Medical Affairs; Janssen-Cilag; Neuss Germany

family: Potamianou

full_name: Anna Potamianou

given: Anna

name: Biometrics; Janssen-Cilag; Tilburg Netherlands

family: Lahaye

full_name: Marjolein Lahaye

given: Marjolein

name: EMEA Medical Affairs; Janssen-Cilag; Issy-les-Moulineaux Cedex France

family: Couturier

full_name: Catherine Couturier

given: Catherine

name: Seràgnoli Institute of Hematology; University of Bologna; Bologna Italy

family: Cavo

full_name: Michele Cavo

given: Michele

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Haematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Janssen-Cilag International NV

location_country: Sweden Netherlands Finland France Poland Israel Norway Belgium Portugal Turkey Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

acronym: L-MIND

summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: result

ReferenceCitation: Duell J, Maddocks KJ, González-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, André M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Aug 19. doi: 10.3324/haematol.2021.279802. [Epub ahead of print]

family: Duell

full_name: Johannes Duell

given: Johannes

family: Maddocks

full_name: Kami J. Maddocks

given: Kami J.

family: González-Barca

full_name: Eva González-Barca

given: Eva

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Liberati

full_name: Anna Marina Liberati

given: Anna Marina

family: De Vos

full_name: Sven De Vos

given: Sven

family: Nagy

full_name: Zsolt Nagy

given: Zsolt

family: Obr

full_name: Aleš Obr

given: Aleš

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

family: Abrisqueta

full_name: Pau Abrisqueta

given: Pau

family: Kalakonda

full_name: Nagesh Kalakonda

given: Nagesh

family: André

full_name: Marc André

given: Marc

family: Dreyling

full_name: Martin Dreyling

family: Menne

full_name: Tobias Menne

given: Tobias

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Augustin

full_name: Marinela Augustin

given: Marinela

family: Rosenwald

full_name: Andreas Rosenwald

given: Andreas

family: Dirnberger-Hertweck

full_name: Maren Dirnberger-Hertweck

given: Maren

family: Weirather

full_name: Johannes Weirather

family: Ambarkhane

full_name: Sumeet Ambarkhane

given: Sumeet

family: Salles

full_name: Gilles Salles

given: Gilles

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Duell J, Maddocks KJ, González-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, André M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958.

ReferenceCitation: Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.

location_country:
Italy
United States
France
Czechia
Poland
Hungary
Belgium
Spain
Germany
United Kingdom


title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations

summary: Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open

design_allocation: Non-Randomized

ReferenceCitation: Ho AL, Brana I, Haddad R, Bauman J, Bible K, Oosting S, Wong DJ, Ahn MJ, Boni V, Even C, Fayette J, Flor MJ, Harrington K, Kim SB, Licitra L, Nixon I, Saba NF, Hackenberg S, Specenier P, Worden F, Balsara B, Leoni M, Martell B, Scholz C, Gualberto A. Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations. J Clin Oncol. 2021 Jun 10;39(17):1856-1864. doi: 10.1200/JCO.20.02903. Epub 2021 Mar 22. Erratum in: J Clin Oncol. 2021 Oct 1;39(28):3192.

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

name: Department of Medicine, Weill Cornell Medical College, New York City, NY

family: Ho

full_name: Alan L. Ho

given: Alan L.

name: Vall D'Hebron Institute of Oncology, Barcelona, Spain

family: Brana

full_name: Irene Brana

given: Irene

name: Dana-Farber Cancer Institute, Boston, MA

family: Haddad

full_name: Robert Haddad

given: Robert

name: Fox Chase Cancer Center, Philadelphia, PA

family: Bauman

full_name: Jessica Bauman

given: Jessica

family: Bible

full_name: Keith Bible

given: Keith

name: University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

family: Oosting

full_name: Sjoukje Oosting

given: Sjoukje

family: Wong

full_name: Deborah J. Wong

given: Deborah J.

family: Ahn

full_name: Myung-Ju Ahn

given: Myung-Ju

family: Boni

full_name: Valentina Boni

given: Valentina

family: Even

full_name: Caroline Even

given: Caroline

family: Fayette

full_name: Jerome Fayette

given: Jerome

name: Hospital Virgen del Rocio, Sevilla, Spain

family: Flor

full_name: Maria José Flor

given: Maria José

name: The Institute of Cancer Research, London, England

family: Harrington

full_name: Kevin Harrington

given: Kevin

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

family: Hong

full_name: David S. Hong

given: David S.

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

name: Fondazione IRCCS Istituto Nazionale Tumori Milano and University of Milan, Italy

family: Licitra

full_name: Lisa Licitra

given: Lisa

name: Beatson West of Scotland Cancer Centre, Glasgow, Scotland

family: Nixon

full_name: Ioanna Nixon

given: Ioanna

name: Winship Cancer Institute of Emory University, Atlanta, GA

family: Saba

full_name: Nabil F. Saba

given: Nabil F.

name: Universitätsklinikum Würzburg, ENT Department and Early Clinical Trial Unit, Würzburg, Germany

family: Hackenberg

full_name: Stephan Hackenberg

given: Stephan

name: University Hospital Antwerp, Edegem, Belgium

family: Specenier

full_name: Pol Specenier

given: Pol

name: University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

family: Worden

full_name: Francis Worden

given: Francis

family: Balsara

full_name: Binaifer Balsara

given: Binaifer

family: Leoni

full_name: Mollie Leoni

given: Mollie

family: Martell

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Italy
United States
Netherlands
France
Greece
Belgium
Spain
Germany
United Kingdom
Korea, Republic of

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Virgen de la Rocio

location_facility: Oklahoma University Health Sciences Center

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: START, Centro Integral Oncologico Clara Campal

location_facility: Wihship Cancer Institute of Emory University


status: Terminated

study_start_date_type: Actual

lead_sponsor: Celgene

location_country:
Italy
United States
France
Belgium
Spain
Germany

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Centre Regional de lutte contre le cancer Paul Papin

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

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Hamatologisch Onkologische Praxis Eppendorf

location_facility: Clinique Sainte Elisabeth - Service d'Oncologie

source: euctr

title: A Phase 2, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women With ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor

summary: The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).

status_simplified: Unknown


title: AN OPEN-LABEL PHASE 1B STUDY OF PF-04449913 (GLASDEGIB) IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH PREVIOUSLY UNTREATED HIGHER-RISK MYELODYSPLASTIC SYNDROME, ACUTE MYELOID LEUKEMIA, OR CHRONIC MYELOMONOCYTIC LEUKEMIA

acronym: BRIGHT 1012

summary: This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

ipd_sharing: No

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

lead_sponsor: Pfizer

location_country:
United States
Germany
France
Belgium
Canada
United Kingdom

location_facility: CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Duke University Health System, Duke University Hospital

location_facility: Stony Brook University Hospital Cancer Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Washington Medical Center (UWMC)

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: Duke University Health System: Adult Bone Marrow Transplant Clinic

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: University of Alabama at Birmingham the Kirklin Clinic

location_facility: Hopital Saint-Louis (AP-HP) - Service Hematologie Senior

status_simplified: Ongoing


title: A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

acronym: ALT GIST

summary: An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Australasian Gastro-Intestinal Trials Group

location_country:
Sweden
Netherlands
Finland
France
Slovakia
Norway
Singapore
Australia
Spain
United Kingdom

location_facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Netherlands Cancer Institute -Antoni Van Leeuwenhoek

location_facility: University Hospital Birmingham - Queen Elizabeth Hospital

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

ReferenceCitation: Li CSW, Sweeney K, Cronenberger C. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(®)) in patients with advanced non-squamous non-small cell lung cancer. Cancer Chemother Pharmacol. 2020 Mar;85(3):487-499. doi: 10.1007/s00280-019-03946-8. Epub 2019 Nov 26.

family: Li

full_name: Cheryl S. W. Li

given: Cheryl S. W.

family: Sweeney

full_name: Kevin Sweeney

family: Cronenberger

full_name: Carol Cronenberger

given: Carol

journal_name: Cancer Chemotherapy and Pharmacology

oa_colors: green hybrid

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

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: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer

ReferenceCitation: Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin(®)), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study. BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

family: Bryl

full_name: Maciej Bryl

given: Maciej

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Syrigos

full_name: Kostas Syrigos

given: Kostas

family: Vladimirov

full_name: Vladimir Vladimirov

given: Vladimir

family: Zereu

full_name: Manuela Zereu

given: Manuela

family: Bair

full_name: Angel H. Bair

given: Angel H.

family: Hilton

full_name: Fiona Hilton

given: Fiona

family: Liau

full_name: Katherine Liau

given: Katherine

family: Kasahara

full_name: Kazuo Kasahara

given: Kazuo

journal_name: BioDrugs

title: PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study

location_country:
Malaysia
Greece
Romania
Australia
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Japan
Poland
Thailand
Korea, Republic of
South Africa
Chile
Netherlands
Philippines
Bulgaria
Hungary
Germany
United States
Italy
Brazil
Czechia
Spain
Turkey

location_facility: National Hospital Organization Disaster Medical Center

location_facility: S.G. Primushko Republican Clinical Oncology Dispensary

location_facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.

location_facility: FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,

location_facility: SBHI of Stavropol Region "Essentuki Central City Hospital"

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

location_facility: COT - Centro Oncologico do Triangulo Ltda

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;

location_facility: SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

location_facility: Institut fuer Diagnostische und Interventionelle Radiologie

location_facility: Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

location_facility: SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region

location_facility: FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO

location_facility: Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: Consorcio Hospital Universitario General De Valencia

location_facility: Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

location_facility: Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

location_facility: Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: Centro Internacional de Estudios Clinicos (CIEC)

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

location_facility: POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

location_facility: Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont

location_facility: NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario La Paz, Servicio de Oncologia

location_facility: P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: National Hospital Organization Mito Medical Center

location_facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

location_facility: lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -

location_facility: SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

location_facility: Institute of Respiratory Diseases, SMS Medical College & Hospital

location_facility: "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,

location_facility: Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University

location_facility: Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

location_facility: Centre Hospitalier General De Mont De Marsan

location_facility: Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

location_facility: Mahatma Gandhi Cancer Hospital And Research Institute

location_facility: Federal State Budgetary Institution of Healthcare "Clinical Hospital #

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

location_facility: "SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""

location_facility: S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

location_facility: Matrai Gyogyintezet Pulmonologiai Osztaly

location_facility: UOSD Pneumologia Oncologica - Padiglione Flaiani

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: State Budget Healthcare Institution of Arkhangelsk Region

location_facility: Medizinische Hochschule Hannover Zentralapotheke

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,

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

location_facility: Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.

location_facility: General Oncology Hospital of Kifissia "Ag. Anargiroi"

location_facility: Hospital da Cidade de Passo Fundo - HCPF

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology",

location_facility: Staedtisches Klinikum Braunschweig gGmbH Apotheke

location_facility: SBHI "Chelyabinsk Regional Clinical Hospital"

location_facility: Vivantes GmbH Apotheke des Humboldt-Klinikums

location_facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

location_facility: Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

location_facility: Cardiac Services, John Flynn Private Hospital -

location_facility: Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

location_facility: National Hospital Organization Oita Medical Center

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Seoul National University Bundang Hospital

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

location_facility: National Hospital Organization Mie Chuo Medical Center

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

location_facility: "Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""

location_facility: Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

location_facility: Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

location_facility: "RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: National Hospital Organization Kochi National Hospital

location_facility: National Hospital Organization Himeji Medical Center

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

location_facility: Institut Fuer Versorgungsforschung In Der Onkologie

location_facility: MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie

location_facility: Austin Health - Olivia Newton - John Cancer & Wellness Centre

location_facility: SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

location_facility: Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"

location_facility: Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -

location_facility: Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''

location_facility: Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

location_facility: Saratov scientific research institute of traumatology and orthopedics

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Hopital d'instruction des armees Sainte Anne

location_facility: Semmelweis Egyetem, Pulmonologiai Klinika

location_facility: SPb SBHI "City Clinical Oncology Dispensary"

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Limited Liability Company "Common health"

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Clinical hospital n.a. S.R. Mirotvortseva of SSMU

location_facility: Universitaetsklinikum des Saarlandes, Apotheke

location_facility: SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

location_facility: Klinisch Chemisch en Hematologisch Laboratorium (KCHL)

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: "SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""

location_facility: SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region

location_facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita

location_facility: Instituto Clínico Oncológico del Sur (ICOS)

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

location_facility: Clinical Research Center, Phramongkutklao Hospital

location_facility: Hiperdia Timisoara, Radiologie si imagistica medicala

location_facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

location_facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

location_facility: Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

location_facility: Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

location_facility: Baskent Universitesi Tip Fakultesi Adana Hastanesi

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: LLC "Medical clinic "INNOVACIA", chemotherapy department

location_facility: Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala

location_facility: South Coast Radiology, John Flynn Private Hospital


title: A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)

summary: This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

ReferenceCitation: Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hästbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.

name: Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Victoria, Australia

name: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

name: Intensive Care Unit, Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom

name: Department of Clinical & Experimental Medicine, School of Biosciences & Medicine, University of Surrey, Guildford, United Kingdom

family: Forni

full_name: Lui G. Forni

given: Lui G.

name: Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, and

family: Busse

full_name: Laurence W. Busse

given: Laurence W.

name: Division of Pulmonary & Critical Care Medicine, School of Medicine, University of Maryland, Baltimore, Maryland

family: McCurdy

full_name: Michael T. McCurdy

given: Michael T.

name: Department of Critical Care, Regions Hospital, University of Minnesota, St. Paul, Minnesota

family: Ham

full_name: Kealy R. Ham

given: Kealy R.

name: Division of Critical Care, Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California

family: Boldt

full_name: David W. Boldt

given: David W.

name: Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland

family: Hästbacka

full_name: Johanna Hästbacka

given: Johanna

name: Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

name: Outcomes Research Consortium, Cleveland, Ohio

family: Khanna

full_name: Ashish K. Khanna

given: Ashish K.

name: Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, School of Medicine, University of California-Davis, Northern California Health System, Mather, California

family: Albertson

full_name: Timothy E. Albertson

given: Timothy E.

name: Renal Division, Department of Medicine, Emory University Medical Center, Emory University, Atlanta, Georgia

family: Tumlin

full_name: James Tumlin

given: James

name: La Jolla Pharmaceutical Company, San Diego, California

family: Storey

full_name: Kristine Storey

given: Kristine

family: Handisides

full_name: Damian Handisides

given: Damian

name: Stanford University, Palo Alto, California

family: Tidmarsh

full_name: George F. Tidmarsh

given: George F.

name: Department of Medicine, Veterans Affairs Medical Center, San Diego, California; and

family: Chawla

full_name: Lakhmir S. Chawla

given: Lakhmir S.

name: Department of Critical Care, Guy’s & St. Thomas’ Hospital, King’s College London, London, United Kingdom

family: Ostermann

full_name: Marlies Ostermann

given: Marlies

journal_name: American Journal of Respiratory and Critical Care Medicine

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories: University of Melbourne - Minerva Access

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

ReferenceCitation: Bellomo R, Wunderink RG, Szerlip H, English SW, Busse LW, Deane AM, Khanna AK, McCurdy MT, Ostermann M, Young PJ, Handisides DR, Chawla LS, Tidmarsh GF, Albertson TE. Angiotensin I and angiotensin II concentrations and their ratio in catecholamine-resistant vasodilatory shock. Crit Care. 2020 Feb 6;24(1):43. doi: 10.1186/s13054-020-2733-x.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Senatore F, Jagadeesh G, Rose M, Pillai VC, Hariharan S, Liu Q, McDowell TY, Sapru MK, Southworth MR, Stockbridge N. FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock. Am J Cardiovasc Drugs. 2019 Feb;19(1):11-20. doi: 10.1007/s40256-018-0297-9. Erratum in: Am J Cardiovasc Drugs. 2019 Apr;19(2):227.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hästbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: University of Newcastle, Australia - NOVA

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

ReferenceCitation: Schmull S, Wang Z, Gao L, Lv J, Li J, Xue S. Angiotensins and Their Receptors in Cardiac and Vascular Injury. Curr Hypertens Rev. 2016;12(3):170-180. doi: 10.2174/1573402112666160302101545. Review.

location_country:
United States
Switzerland
Germany
Finland
France
Belgium
Australia
New Zealand
Canada
United Kingdom

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: John Peter Smith Hospital - JPS Health Network

location_facility: Methodist Hospital, Indiana University Health Physicians

location_facility: Virginia Commonwealth University Medical Center

location_facility: Rutgers Robert Wood Johnson Medical Center

location_facility: Los Angeles County + University of Southern California Medical Center

location_facility: Norfolk and Norwich University Hospitals

location_facility: Montefiore Medical Center, Weiler Division

location_facility: South Health Campus & Rockyview General Hospital

location_facility: University of California, Irvine Medical Center


title: A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

summary: The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

ReferenceCitation: Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.

name: Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, Massachusetts

family: Rooks

full_name: Daniel Rooks

given: Daniel

family: Swan

full_name: Therese Swan

given: Therese

family: Goswami

full_name: Budhaditya Goswami

given: Budhaditya

family: Filosa

full_name: Lee Anne Filosa

given: Lee Anne

name: Translational Medicine and Musculoskeletal Diseases Research, Novartis Institutes for BioMedical Research, Basel, Switzerland

family: Bunte

full_name: Ola Bunte

given: Ola

family: Panchaud

full_name: Nicolas Panchaud

given: Nicolas

family: Coleman

full_name: Laura A. Coleman

given: Laura A.

family: Miller

full_name: Ram R. Miller

given: Ram R.

family: Garcia Garayoa

full_name: Elisa Garcia Garayoa

given: Elisa

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

family: Praestgaard

full_name: Jens Praestgaard

given: Jens

name: Panax Clinical Research, Miami Lakes, Florida

family: Perry

full_name: Robert G. Perry

given: Robert G.

name: Center for Advanced Research and Education, Gainesville, Georgia

family: Recknor

full_name: Chris Recknor

given: Chris

name: Spartanburg Medical Research, Spartanburg, South Carolina

family: Fogarty

full_name: Charles M. Fogarty

given: Charles M.

name: National Center for Geriatrics and Gerontology, Obu, Japan

family: Arai

full_name: Hidenori Arai

given: Hidenori

name: Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan

family: Chen

full_name: Liang-Kung Chen

given: Liang-Kung

name: National Hospital Organization, Osaka Minami Medical Center, Osaka, Japan

family: Hashimoto

full_name: Jun Hashimoto

given: Jun

name: Ajou University School of Medicine, Suwon, South Korea

family: Chung

full_name: Yoon-Sok Chung

given: Yoon-Sok

name: Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

family: Vissing

full_name: John Vissing

given: John

family: Laurent

full_name: Didier Laurent

given: Didier

family: Petricoul

full_name: Olivier Petricoul

given: Olivier

family: Hemsley

full_name: Sarah Hemsley

given: Sarah

family: Lach-Trifilieff

full_name: Estelle Lach-Trifilieff

given: Estelle

family: Papanicolaou

full_name: Dimitris A. Papanicolaou

given: Dimitris A.

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Switzerland
Germany
France
Czechia
Japan
Belgium
Australia
Russian Federation
Spain
Denmark
United States
Korea, Republic of
Taiwan


ReferenceCitation: Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

name: Chelsea and Westminster Hospital, London, United Kingdom.

family: Nelson

full_name: Mark Nelson

given: Mark

name: Hospital Universitario 12 Octubre, Centro de Actividades Ambulatorias, Madrid, Spain.

family: Rubio

full_name: Rafael Rubio

given: Rafael

name: Scientific Institute Ospedale, San Raffaele, Milan, Italy.

family: Lazzarin

full_name: Adriano Lazzarin

given: Adriano

name: State Research Center-Institute of Biophysics, Russian Ministry of Health, Moscow, Russia.

family: Romanova

full_name: Svetlana Romanova

given: Svetlana

name: Zuckerberg San Francisco General, University of California, San Francisco, San Francisco, California.

family: Luetkemeyer

full_name: Annie Luetkemeyer

given: Annie

name: Vancouver Infectious Diseases Centre, Vancouver, Canada.

family: Conway

full_name: Brian Conway

given: Brian

name: Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, University of Paris Diderot, Paris, France.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

name: Bristol-Myers Squibb, Wallingford, Connecticut.

family: Xu

full_name: Dong Xu

given: Dong

family: Srinivasan

full_name: Subasree Srinivasan

given: Subasree

name: Shionogi Inc., Florham Park, New Jersey.

family: Portsmouth

full_name: Simon Portsmouth

given: Simon

journal_name: Journal of Interferon & Cytokine Research

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Mexico
Germany
France
Poland
Belgium
Argentina
Russian Federation
Spain
Canada
United Kingdom

acronym: DIMENSION

location_facility: Vancouver Id Reserach & Care Centre Society

location_facility: Mcgill University Health Centre (Muhc) Montreal Chest Institute

location_facility: Emory Hospital Midtown Infectious Disease Clinic

title: Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

summary: To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1


ReferenceCitation: McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.

family: McInnes

full_name: Iain B McInnes

given: Iain B

family: Ferraccioli

full_name: Gianfranco Ferraccioli

given: Gianfranco

family: D'Agostino

full_name: Maria-Antonietta D'Agostino

given: Maria-Antonietta

family: Le Bars

full_name: Manuela Le Bars

given: Manuela

family: Banerjee

full_name: Subhashis Banerjee

given: Subhashis

family: Ahmad

full_name: Harris A Ahmad

given: Harris A

family: Elbez

full_name: Yedid Elbez

given: Yedid

family: Mease

full_name: Philip J Mease

given: Philip J

currency_apc_doaj: GBP

journal_name: RMD Open

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_institution: The University of Glasgow - Enlighten: Publications

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.

family: Strand

full_name: Vibeke Strand

given: Vibeke

family: Alemao

full_name: Evo Alemao

given: Evo

family: Lehman

full_name: Thomas Lehman

given: Thomas

family: Johnsen

full_name: Alyssa Johnsen

given: Alyssa

full_name: Harris A. Ahmad

given: Harris A.

full_name: Philip J. Mease

given: Philip J.

ReferenceCitation: Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Italy
Brazil
United States
Chile
Peru
South Africa
Mexico
Germany
France
Czechia
Greece
Israel
Poland
Argentina
Spain
Canada
Colombia

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Toronto Western Hospital, University Health Network

location_facility: Groupe De Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Arthritis Asso & Osteo Ctr Of Colorado Springs

location_facility: Clinical Research Center Of Reading, Llc

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc

title: A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis

summary: The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis


ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

family: Brunner

full_name: Hermine I. Brunner

given: Hermine I.

family: Tzaribachev

full_name: Nikolay Tzaribachev

given: Nikolay

family: Vega-Cornejo

full_name: Gabriel Vega-Cornejo

given: Gabriel

family: Louw

full_name: Ingrid Louw

given: Ingrid

family: Cimaz

full_name: Rolando Cimaz

given: Rolando

family: Dare

full_name: Jason Dare

given: Jason

family: Espada

full_name: Graciela Espada

given: Graciela

family: Faugier

full_name: Enrique Faugier

given: Enrique

family: Ferrandiz

full_name: Manuel Ferrandiz

given: Manuel

family: Gerloni

full_name: Valeria Gerloni

given: Valeria

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Silva

full_name: Clovis Artur Silva

given: Clovis Artur

family: Wagner-Weiner

full_name: Linda Wagner-Weiner

given: Linda

family: Gandhi

full_name: Yash Gandhi

given: Yash

family: Passarell

full_name: Julie Passarell

given: Julie

family: Nys

full_name: Marleen Nys

given: Marleen

family: Wong

full_name: Robert Wong

given: Robert

family: Martini

full_name: Alberto Martini

given: Alberto

family: Lovell

full_name: Daniel J. Lovell

given: Daniel J.

journal_name: The Journal of Rheumatology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

ReferenceCitation: Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penadés I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

name: for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

title: Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2–5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept

ReferenceCitation: Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penadés I, Antón J, Ávila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastañaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Pérez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study. Arthritis Rheumatol. 2018 Jul;70(7):1144-1154. doi: 10.1002/art.40466. Epub 2018 May 20.

name: Cincinnati Children's Hospital Medical Center; Cincinnati Ohio

name: Pediatric Rheumatology Research Institute; Bad Bramstedt Germany

name: Hospital México Americano; Guadalajara Mexico

name: Panorama Medical Centre; Cape Town South Africa

name: Hospital Angel C. Padilla; Tucumán Argentina

name: Hospital Universitario y Politécnico de La Fe; Valencia Spain

name: Hospital Sant Joan de Déu; Barcelona Spain

name: Hospital General de Niños Pedro de Elizalde; Buenos Aires Argentina

name: Asklepios Clinic Sankt Augustin; Sankt Augustin Germany

name: Hamburg Centre for Pediatric and Adolescent Rheumatology; Hamburg Germany

name: Togliatti City Clinical Hospital No.5; Togliatti Russia

name: Randall Children's Hospital at Legacy Emanuel; Portland Oregon

name: Universitair Ziekenhuis Gent; Ghent Belgium

name: Université catholique de Louvain; Brussels Belgium

name: Hospital de Niños de la Santísima Trinidad; Córdoba Argentina

name: University Hospital Gasthuisberg; Leuven Belgium

name: University of Utah School of Medicine; Salt Lake City

name: Steve Biko Academic Hospital, University of Pretoria; Pretoria South Africa

name: Pédiatrie 1, CHU Hautepierre; Strasbourg France

name: German Rheumatism Research Center and Charité University Medicine; Berlin Germany

name: Hospital Nacional Edgardo Rebagliati Martins; Lima Peru

name: Universidad Autónoma de Nuevo León, Hospital Universitario Dr. J. E. González; Monterrey Mexico

name: CHU de Poitiers, Rheumatology; Poitiers France

name: University of the Free State; Bloemfontein South Africa

name: Bristol-Myers Squibb; Princeton New Jersey

name: Bristol-Myers Squibb; Braine-L'Alleud Belgium

name: the Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

repository_institution: Universidad Autónoma de Nuevo León - El Repositorio Academico Digital de la UANL

location_country:
Italy
Brazil
Peru
South Africa
Mexico
Germany
France
Belgium
Argentina
Russian Federation
Spain
United States

location_facility: Cincinnati Children'S Hospital Medical Center

location_facility: Hospital General De Niqos Pedro De Elizalde

title: A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

summary: The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA


lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
Peru
Costa Rica
Mexico
Spain
France
Japan
Poland
Russian Federation
China
Germany
Korea, Republic of
Portugal
Ukraine

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Gifu University Hospital; Digestive Surgery

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Hospital de Basurto; Servicio de Oncologia

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

location_facility: Cancerologia de Queretaro; Oncologia; Investigación

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Zhejiang Cancer Hospital; Breast Surgery

location_facility: Harbin Medical University Cancer Hospital

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: West China Hospital, Sichuan University; Department of Breast

title: A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study

summary: This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.


location_country: Australia France

title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)

summary: The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.


title: A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

summary: The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.

ReferenceCitation: Judge DP, Kristen AV, Grogan M, Maurer MS, Falk RH, Hanna M, Gillmore J, Garg P, Vaishnaw AK, Harrop J, Powell C, Karsten V, Zhang X, Sweetser MT, Vest J, Hawkins PN. Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR). Cardiovasc Drugs Ther. 2020 Jun;34(3):357-370. doi: 10.1007/s10557-019-06919-4. Erratum in: Cardiovasc Drugs Ther. 2020 Jun 16;:.

family: Judge

full_name: Daniel P. Judge

given: Daniel P.

family: Kristen

full_name: Arnt V. Kristen

given: Arnt V.

family: Grogan

full_name: Martha Grogan

given: Martha

family: Maurer

full_name: Mathew S. Maurer

given: Mathew S.

family: Falk

full_name: Rodney H. Falk

given: Rodney H.

family: Hanna

full_name: Mazen Hanna

given: Mazen

family: Gillmore

full_name: Julian Gillmore

given: Julian

family: Garg

full_name: Pushkal Garg

given: Pushkal

family: Vaishnaw

full_name: Akshay K. Vaishnaw

given: Akshay K.

family: Harrop

full_name: Jamie Harrop

given: Jamie

family: Powell

full_name: Christine Powell

given: Christine

family: Karsten

full_name: Verena Karsten

given: Verena

family: Zhang

full_name: Xiaoping Zhang

given: Xiaoping

family: Sweetser

full_name: Marianne T. Sweetser

given: Marianne T.

family: Vest

full_name: John Vest

given: John

family: Hawkins

full_name: Philip N. Hawkins

given: Philip N.

journal_name: Cardiovascular Drugs and Therapy

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

location_country:
Italy
United States
Sweden
Germany
France
Belgium
Spain
Canada
United Kingdom


title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

acronym: POSITIVE

summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

ReferenceType: background

ReferenceCitation: Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.

ReferenceCitation: Leclère B, Molinié F, Trétarre B, Stracci F, Daubisse-Marliac L, Colonna M; GRELL Working Group. Trends in incidence of breast cancer among women under 40 in seven European countries: a GRELL cooperative study. Cancer Epidemiol. 2013 Oct;37(5):544-9. doi: 10.1016/j.canep.2013.05.001. Epub 2013 Jun 12. Erratum in: Cancer Epidemiol. 2014 Feb;38(1):106. GRELL Working Group [added]; multiple investigator names added.

ReferenceCitation: Bentzon N, Düring M, Rasmussen BB, Mouridsen H, Kroman N. Prognostic effect of estrogen receptor status across age in primary breast cancer. Int J Cancer. 2008 Mar 1;122(5):1089-94.

ReferenceCitation: Anders CK, Hsu DS, Broadwater G, Acharya CR, Foekens JA, Zhang Y, Wang Y, Marcom PK, Marks JR, Febbo PG, Nevins JR, Potti A, Blackwell KL. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008 Jul 10;26(20):3324-30. doi: 10.1200/JCO.2007.14.2471. Erratum in: J Clin Oncol. 2011 Sep 20;29(27):3721.

lead_sponsor: International Breast Cancer Study Group

location_country:
Greece
Australia
Belgium
Denmark
France
Japan
Norway
Canada
Slovenia
Korea, Republic of
Switzerland
Netherlands
Hungary
Ireland
Portugal
United States
Italy
Austria
Serbia
Lebanon
Israel
Spain

location_facility: Institute of Oncology Ljubljana - Medical Oncology Department

location_facility: Salvatore Maugeri Foundation - Medical Oncology Unit

location_facility: Bon Secours Memorial Regional Medical Centre

location_facility: Greenville Health System Cancer Institute-Spartanburg

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: Huntsman Cancer Institute / University of Utah

location_facility: Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

location_facility: Norwegian Radium Hospital (Oslo University)

location_facility: Montefiore Medical Center - Moses Campus, 111 East 210th Street

location_facility: Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

location_facility: IHA Hematology Oncology Consultants-Ann Arbor

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Sanford USD Medical Centre - Sioux Falls

location_facility: NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi

location_facility: Laso General Hospital, First Department of Medical Oncology

location_facility: University of Colorado Cancer Centre - Anschutz Cancer Pavilion

location_facility: Greenville Health System Cancer Institute-Faris

location_facility: Institute of Oncology & Radiology of Serbia

location_facility: Smilow Cancer Hospital Care Center at Saint Francis

location_facility: Univ. Klinik f. Frauenheilkunde Innsbruck

location_facility: CHUM - Centre Hospitalier de l'Universite de Montreal

location_facility: Greenville Health System Cancer Institute-Seneca

location_facility: Hennepin County Medical Center - Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: Cliniques Universitaires Saint-Luc Brussels

location_facility: Spital STS AG Onkologiezentrum Thun-Berner Oberland

location_facility: Smilow Cancer Hospital-Waterbury Care Center

location_facility: University Hospital of Lausanne (CHUV) BH06 - Oncology Department

location_facility: Champalimaud Cancer Center - Breast Cancer Unit

location_facility: Social Medical Corporation Hakuaikai Sagara Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: U.O Medicina Oncologica Ospedale di Carpi

location_facility: Regional Hematology Oncology Practice Associates

location_facility: Instituto Catalán de Oncología de Gerona Hospital

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Hospital General Universitario de Valencia - Servico Oncologia

location_facility: Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

location_facility: Bon Secours Saint Francis Medical Centre

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: St Marianna University School of Medicine Hospital

location_facility: NorthShore Unversity Health System - Highland Park Hospital

location_facility: Smilow Cancer Hospital Care Center-Fairfield

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

location_facility: National Cancer Center for Global Medicine

location_facility: Greenville Health System Cancer Institute-Butternut

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione

location_facility: Medical Oncology Hematology Consultants PA

location_facility: Ospedale degli Infermi - S. C. Oncologia Medica

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: Weill Medical College of Cornell University

location_facility: Smilow Cancer Hospital-Orange Care Center

location_facility: Brustzentrum Thurgau - Obstetrics and Gynecology

location_facility: Montefiore Medical Center-Weiler Hospital

location_facility: Greenville Health System Cancer Institute-Eastside

location_facility: Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

location_facility: Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: American University of Beirut Medical Center

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Smilow Cancer Hospital-Derby Care Center

location_facility: Abbott-Northwestern Hospital, 800 East 28th Street

location_facility: NorthShore University Health System - Glenbrook Hospital

location_facility: Greenville Health System Cancer Institute-Greer

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: Yale-New Haven Hospital North Haven Medical Center

location_facility: University General Hospital of Heraklion

location_facility: Smilow Cancer Hospital-Torrington Care Center

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Women and Infants Hospital of Rhode Island

intervention_type: Other


title: The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

summary: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia

ReferenceCitation: Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.

family: Gouni-Berthold

full_name: Ioanna Gouni-Berthold

given: Ioanna

family: Alexander

full_name: Veronica J Alexander

given: Veronica J

family: Yang

full_name: Qingqing Yang

given: Qingqing

family: Hurh

full_name: Eunju Hurh

given: Eunju

family: Steinhagen-Thiessen

full_name: Elisabeth Steinhagen-Thiessen

given: Elisabeth

family: Moriarty

full_name: Patrick M Moriarty

given: Patrick M

family: Hughes

full_name: Stephen G Hughes

given: Stephen G

family: Gaudet

full_name: Daniel Gaudet

given: Daniel

family: Hegele

full_name: Robert A Hegele

given: Robert A

family: O'Dea

full_name: Louis St L O'Dea

given: Louis St L

family: Stroes

full_name: Erik S G Stroes

given: Erik S G

family: Tsimikas

full_name: Sotirios Tsimikas

given: Sotirios

family: Witztum

full_name: Joseph L Witztum

given: Joseph L

family: Agarwal

full_name: Abhay Agarwal

given: Abhay

family: Ballantyne

full_name: Christie Ballantyne

given: Christie

family: Baum

full_name: Seth Baum

given: Seth

family: Bergeron

full_name: Jean Bergeron

given: Jean

family: Bruckert

full_name: Eric Bruckert

given: Eric

family: Burdick

full_name: Richard Burdick

given: Richard

family: Castro-Cabezas

full_name: Manuel Castro-Cabezas

given: Manuel

family: Cervi

full_name: Mark Cervi

given: Mark

family: Corder

full_name: Clinton Corder

given: Clinton

family: DuFour

full_name: Robert DuFour

given: Robert

location_country:
United States
Netherlands
France
Germany
United Kingdom
Canada


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:
United States
Brazil
South Africa
Switzerland
Mexico
France
Czechia
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom

ipd_sharing: Yes

title: A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

summary: This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.


title: BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III

summary: BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mwipatayi BP, Barry IP, Brodmann M, Zeller T, Varcoe RL, Moscovic M, Chian JWC, Christensen JK, Yahaya SA, Oshin OA, Tepe G; BIOLUX P-III Global Registry Investigators. Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis. Ann Vasc Surg. 2021 Aug;75:237-252. doi: 10.1016/j.avsg.2021.02.050. Epub 2021 Apr 5.

family: Mwipatayi

full_name: Bibombe Patrice Mwipatayi

given: Bibombe Patrice

family: Barry

full_name: Ian Patrick Barry

given: Ian Patrick

family: Brodmann

full_name: Marianne Brodmann

given: Marianne

family: Zeller

full_name: Thomas Zeller

given: Thomas

family: Varcoe

full_name: Ramon L. Varcoe

given: Ramon L.

family: Moscovic

full_name: Matej Moscovic

given: Matej

family: Chian

full_name: John Wang Chaw Chian

given: John Wang Chaw

family: Christensen

full_name: Johnny Kent Christensen

given: Johnny Kent

family: Yahaya

full_name: Shaiful Azmi Yahaya

given: Shaiful Azmi

family: Oshin

full_name: Olufemi Ayoadeleke Oshin

given: Olufemi Ayoadeleke

family: Tepe

full_name: Gunnar Tepe

given: Gunnar

journal_name: Annals of Vascular Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol. 2021 Feb;44(2):207-217. doi: 10.1007/s00270-020-02663-7. Epub 2020 Oct 20. Erratum in: Cardiovasc Intervent Radiol. 2021 Jul;44(7):1155-1156.

family: Corpataux

full_name: Jean-Marc Corpataux

given: Jean-Marc

family: Keirse

full_name: Koen Keirse

given: Koen

family: Nano

full_name: Giovanni Nano

given: Giovanni

family: Schroeder

full_name: Henrik Schroeder

given: Henrik

family: Binkert

full_name: Christoph A. Binkert

given: Christoph A.

journal_name: CardioVascular and Interventional Radiology

ReferenceCitation: Tepe G, Wang J, Corpataux JM, Pua U, Binkert CA, Moscovic M, Ghotbi R, Keirse K, Robertson D, Brodmann M. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol. 2021 Jan;44(1):10-18. doi: 10.1007/s00270-020-02586-3. Epub 2020 Sep 22. Erratum in: Cardiovasc Intervent Radiol. 2021 Aug;44(8):1307.

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry. J Endovasc Ther. 2020 Apr;27(2):304-315. doi: 10.1177/1526602819898804. Epub 2020 Jan 28. Erratum in: J Endovasc Ther. 2021 Jun;28(3):489.

name: Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany

name: Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany

name: Angiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia

name: Department of Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland

name: Department of Radiology, Kolding Hospital, Kolding, Denmark

name: Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium

name: 1st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy

name: Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany

name: Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland

name: Division of Angiology, Department of Internal Medicine, Medical University Graz, Austria

location_country: Italy Austria Switzerland Netherlands Spain Finland France Malaysia Slovakia Singapore Australia Belgium Portugal Denmark Germany Latvia

location_facility: Department Radiologie, Universitätsklinik für Radiodiagnostik

location_facility: Hospital. Universitario Germans Trias i Pujol

location_facility: P.Stradins Clinical University Hospital, Institute of Diagnostic

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Centre Hopsitalier Universitaire Vaudois

location_facility: Institute of Cardiovascular diseases Kosice, Dpt. of Angiology

location_facility: Department of Angiology at Universitats- Herzzentrum Freiburg


title: Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

summary:
Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.

To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

ReferenceCitation: Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Diabetes Technol Ther. 2017 Sep;19(9):516-526. doi: 10.1089/dia.2017.0117. Epub 2017 Aug 30. Erratum in: Diabetes Technol Ther. 2017 Dec;19(12):753.

lead_sponsor: Sanofi

location_country:
United States
France
Japan
Poland
Hungary
Russian Federation
Spain
Germany

location_facility:
Investigational Site Number 840061
Investigational Site Number 250005
Investigational Site Number 840016
Investigational Site Number 616002
Investigational Site Number 840031
Investigational Site Number 724001
Investigational Site Number 840038
Investigational Site Number 276006
Investigational Site Number 840011
Investigational Site Number 840033
Investigational Site Number 348007
Investigational Site Number 643006
Investigational Site Number 392004
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Investigational Site Number 840060
Investigational Site Number 840028
Investigational Site Number 392003
Investigational Site Number 840043
Investigational Site Number 840007
Investigational Site Number 276003
Investigational Site Number 724002
Investigational Site Number 840049
Investigational Site Number 840045
Investigational Site Number 840042
Investigational Site Number 250002
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 840009
Investigational Site Number 250001
Investigational Site Number 840020
Investigational Site Number 643007
Investigational Site Number 840023
Investigational Site Number 348011
Investigational Site Number 392001
Investigational Site Number 840059
Investigational Site Number 840040
Investigational Site Number 643002
Investigational Site Number 250003
Investigational Site Number 840036
Investigational Site Number 840018
Investigational Site Number 724003
Investigational Site Number 348010
Investigational Site Number 840034
Investigational Site Number 724005
Investigational Site Number 348003
Investigational Site Number 840013
Investigational Site Number 392006
Investigational Site Number 348005
Investigational Site Number 840019
Investigational Site Number 840048
Investigational Site Number 276002
Investigational Site Number 840041
Investigational Site Number 840046
Investigational Site Number 840037
Investigational Site Number 392005
Investigational Site Number 840021
Investigational Site Number 840050
Investigational Site Number 643001
Investigational Site Number 840015
Investigational Site Number 276004
Investigational Site Number 840054
Investigational Site Number 840051
Investigational Site Number 840039
Investigational Site Number 840002
Investigational Site Number 643004
Investigational Site Number 276008
Investigational Site Number 840022
Investigational Site Number 276007
Investigational Site Number 276001
Investigational Site Number 840027
Investigational Site Number 840004
Investigational Site Number 840030
Investigational Site Number 840026
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 348001
Investigational Site Number 840029
Investigational Site Number 392002
Investigational Site Number 840006
Investigational Site Number 616001
Investigational Site Number 724004
Investigational Site Number 276005
Investigational Site Number 643005
Investigational Site Number 643003
Investigational Site Number 840062
Investigational Site Number 348002
Investigational Site Number 840012
Investigational Site Number 616004


title: A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

summary: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

ReferenceCitation: Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Samoilova O, Novak J, Ben-Yehuda D, Strugov V, Gill D, Gribben JG, Hsu E, Lih CJ, Zhou C, Clow F, James DF, Styles L, Flinn IW. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):43-56. doi: 10.1016/S1470-2045(18)30788-5. Epub 2018 Dec 3. Erratum in: Lancet Oncol. 2019 Jan;20(1):e10.

family: Moreno

full_name: Carol Moreno

given: Carol

family: Greil

full_name: Richard Greil

given: Richard

family: Demirkan

full_name: Fatih Demirkan

given: Fatih

family: Tedeschi

full_name: Alessandra Tedeschi

given: Alessandra

family: Anz

full_name: Bertrand Anz

given: Bertrand

family: Larratt

full_name: Loree Larratt

given: Loree

family: Simkovic

full_name: Martin Simkovic

given: Martin

family: Samoilova

full_name: Olga Samoilova

given: Olga

family: Novak

full_name: Jan Novak

given: Jan

family: Ben-Yehuda

full_name: Dina Ben-Yehuda

given: Dina

family: Strugov

full_name: Vladimir Strugov

given: Vladimir

family: Gill

full_name: Devinder Gill

given: Devinder

family: Gribben

full_name: John G Gribben

given: John G

family: Hsu

full_name: Emily Hsu

given: Emily

family: Lih

full_name: Chih-Jian Lih

given: Chih-Jian

family: Zhou

full_name: Cathy Zhou

given: Cathy

family: Clow

full_name: Fong Clow

given: Fong

family: James

full_name: Danelle F James

given: Danelle F

family: Styles

full_name: Lori Styles

given: Lori

family: Flinn

full_name: Ian W Flinn

given: Ian W

journal_name: The Lancet Oncology

ReferenceCitation: Greil R, Tedeschi A, Moreno C, Anz B, Larratt L, Simkovic M, Gill D, Gribben JG, Flinn IW, Wang Z, Cheung LWK, Nguyen AN, Zhou C, Styles L, Demirkan F. Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study. Ann Hematol. 2021 Jul;100(7):1733-1742. doi: 10.1007/s00277-021-04536-6. Epub 2021 May 20.

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

location_country:
Italy
Austria
United States
Sweden
Spain
France
Czechia
Poland
Israel
Australia
Belgium
New Zealand
Russian Federation
Turkey
Canada
United Kingdom

location_facility:
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