title: A Phase 1/2 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-cell Non-hodgkin's Lymphoma

summary: The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin [CMC-544] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

ReferenceCitation: Fayad L, Offner F, Smith MR, Verhoef G, Johnson P, Kaufman JL, Rohatiner A, Advani A, Foran J, Hess G, Coiffier B, Czuczman M, Giné E, Durrant S, Kneissl M, Luu KT, Hua SY, Boni J, Vandendries E, Dang NH. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol. 2013 Feb 10;31(5):573-83. doi: 10.1200/JCO.2012.42.7211. Epub 2013 Jan 7.

name: Luis Fayad, MD Anderson Cancer Center, Houston, TX; Fritz Offner, Ghent University Hospital, Ghent; Gregor Verhoef, University Hospitals, Leuven, Belgium; Mitchell R. Smith, Fox Chase Cancer Center, Philadelphia; Joseph Boni, Pfizer, Collegeville, PA; Peter Johnson, University of Southampton, Southhampton; Ama Rohatiner, St. Bartholomew's Hospital, London, United Kingdom; Jonathan L. Kaufman, Emory University, Atlanta, GA; Anjali Advani, Taussig Cancer Institute, The Cleveland Clinic, Cleveland, OH;...

family: Fayad

full_name: Luis Fayad

given: Luis

family: Offner

full_name: Fritz Offner

given: Fritz

family: Smith

full_name: Mitchell R. Smith

given: Mitchell R.

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Johnson

full_name: Peter Johnson

given: Peter

family: Kaufman

full_name: Jonathan L. Kaufman

given: Jonathan L.

family: Rohatiner

full_name: Ama Rohatiner

given: Ama

family: Advani

full_name: Anjali Advani

given: Anjali

family: Foran

full_name: James Foran

given: James

family: Hess

full_name: Georg Hess

given: Georg

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Czuczman

full_name: Myron Czuczman

given: Myron

family: Giné

full_name: Eva Giné

given: Eva

family: Durrant

full_name: Simon Durrant

family: Kneissl

full_name: Michelle Kneissl

given: Michelle

family: Luu

full_name: Kenneth T. Luu

given: Kenneth T.

family: Hua

full_name: Steven Y. Hua

given: Steven Y.

family: Boni

full_name: Joseph Boni

given: Joseph

family: Vandendries

full_name: Erik Vandendries

given: Erik

family: Dang

full_name: Nam H. Dang

given: Nam H.

publisher_group: American Society of Clinical Oncology (ASCO)

title: Safety and Clinical Activity of a Combination Therapy Comprising Two Antibody-Based Targeting Agents for the Treatment of Non-Hodgkin Lymphoma: Results of a Phase I/II Study Evaluating the Immunoconjugate Inotuzumab Ozogamicin With Rituximab

location_country:
Italy
Hong Kong
Netherlands
Switzerland
Germany
France
Poland
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

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

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University Hospital Gent - Department of Hematology

location_facility: Bart's Cancer Institute; Queen Mary University of London

location_facility: Universitaetsklinik Bonn, Medizinische Klinik und Poliklinik III

location_facility: Universita La Sapienza Cattedra di Ematologia

location_facility: Emory University Investigational Drug Service

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet, III. medizinische klinik und Poliklinik

location_facility: The University of Texas M.D. Anderson Cancer Center


title: A 12-Week, Double-Blind, Placebo-Controlled, Multicenter Study With A 40 Week Follow Up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 Milligram (Mg) Twice Daily (BID) for Smoking Cessation in Subjects With Cardiovascular Disease

summary: The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4.

name: From the Tobacco Research and Treatment Center, General Medicine Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Mass (N.A.R.); University of Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada (A.L.P.); Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine and Bioengineering & Therapeutic Sciences, University of California, San Francisco (N.L.B.); Pfizer Inc, New York, NY (C.A., D.G.); and...

family: Rigotti

full_name: Nancy A. Rigotti

given: Nancy A.

sequence: first

family: Pipe

full_name: Andrew L. Pipe

given: Andrew L.

sequence: additional

family: Benowitz

full_name: Neal L. Benowitz

given: Neal L.

family: Arteaga

full_name: Carmen Arteaga

given: Carmen

family: Garza

full_name: Dahlia Garza

given: Dahlia

family: Tonstad

full_name: Serena Tonstad

given: Serena

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Cardiovascular Disease

lead_sponsor: Pfizer

location_country:
Brazil
United States
United Kingdom
Mexico
Netherlands
Germany
France
Greece
Argentina
Australia
Denmark
Canada
Czech Republic
Korea, Republic of
Taiwan

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures

summary: The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

ReferenceCitation: Kwan P, Brodie MJ, Kälviäinen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.

family: Kwan

full_name: Patrick Kwan

given: Patrick

family: Brodie

full_name: Martin J Brodie

given: Martin J

family: Kälviäinen

full_name: Reetta Kälviäinen

given: Reetta

family: Yurkewicz

full_name: Lorraine Yurkewicz

given: Lorraine

family: Weaver

full_name: Jerry Weaver

given: Jerry

family: Knapp

full_name: Lloyd E Knapp

given: Lloyd E

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Finland
Romania
Belgium
Taiwan
India
France
Thailand
Lithuania
Slovakia
Norway
Korea, Republic of
Colombia
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
Ireland
Portugal
China
Germany
United Kingdom
Italy
Mexico
Czechia
Spain
Estonia
Latvia


title: A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

summary: The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

status: Terminated

lead_sponsor: Facet Biotech

location_country:
Italy
Austria
United States
Netherlands
Germany
Croatia
France
Israel
Norway
Hungary
Australia
Belgium
Canada
Czech Republic
Ukraine

status_simplified: Unknown


title: A Phase 1 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

summary: Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.

study_start_date_type: Actual

design_allocation: Non-Randomized

ipd_sharing: Yes

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

lead_sponsor: Amgen

location_country:
Italy
France
Japan
Greece
Australia
United States

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII


title: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

summary: The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Zaidat OO, Fifi JT, Nanda A, Atchie B, Woodward K, Doerfler A, Tomasello A, Tekle W, Singh IP, Matouk C, Thalwitzer J, Jargiełło T, Skrypnik D, Beuing O, Berge J, Katz JM, Biondi A, Bonovich D, Sheth SA, Yoo AJ, Hassan AE; COMPLETE Registry Investigators*. Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results. Stroke. 2021 Sep 22:STROKEAHA121034268. doi: 10.1161/STROKEAHA.121.034268. [Epub ahead of print]

name: Mercy Health St. Vincent Medical Center, Toledo, OH (O.O.Z.).

family: Zaidat

full_name: Osama O. Zaidat

given: Osama O.

name: Icahn School of Medicine at Mount Sinai, New York, NY (J.T.F.).

family: Fifi

full_name: Johanna T. Fifi

given: Johanna T.

name: SSM St. Clare Healthcare, Fenton, MO (A.N.).

family: Nanda

full_name: Ashish Nanda

given: Ashish

name: RIA Neurovascular, Englewood, CO (B.A.).

family: Atchie

full_name: Benjamin Atchie

given: Benjamin

name: Fort Sanders Regional Medical Center, Knoxville, TN (K.W.).

family: Woodward

full_name: Keith Woodward

given: Keith

name: Universitätsklinikum Erlangen, Germany (A.D.).

family: Doerfler

full_name: Arnd Doerfler

given: Arnd

name: Hospital Universitari Vall d’Hebron, Barcelona, Spain (A.T.).

family: Tomasello

full_name: Alejandro Tomasello

given: Alejandro

name: University of Texas Rio Grande Valley - Valley Baptist Health System, Harlingen (W.T.).

family: Tekle

full_name: Wondwossen Tekle

given: Wondwossen

name: Mount Sinai Health System, New York, NY (I.P.S.).

family: Singh

full_name: Inder Paul Singh

given: Inder Paul

name: Yale New Haven Hospital, New Haven, CT (C.M.).

family: Matouk

full_name: Charles Matouk

given: Charles

name: Klinikum Chemnitz GmbH, Chemnitz, Germany (J.T.).

family: Thalwitzer

full_name: Jörg Thalwitzer

given: Jörg

name: Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin, Poland (T.J.).

family: Jargiełło

full_name: Tomasz Jargiełło

given: Tomasz

name: Moscow City Clinical Hospital named after Davydovsky, Russia (D.S.).

family: Skrypnik

full_name: Dmitry Skrypnik

given: Dmitry

name: Universitätsklinikum Magdeburg, Germany (O.B.).

family: Beuing

full_name: Oliver Beuing

given: Oliver

name: CHU de Bordeaux- Hôpital Pellegrin, Bordeaux, France (J.B.).

family: Berge

full_name: Jérôme Berge

given: Jérôme

name: North Shore University Hospital, Northwell Health, Manhasset, NY (J.M.K.).

family: Katz

full_name: Jeffrey M. Katz

given: Jeffrey M.

name: J Minjoz University Hospital, Besançon, France (A.B.).

family: Biondi

full_name: Alessandra Biondi

given: Alessandra

name: Eden Medical Center, Castro Valley, CA (D.B.).

family: Bonovich

full_name: David Bonovich

given: David

name: Department of Neurology, UTHealth McGovern Medical School, Houston, TX (S.A.S.).

family: Sheth

full_name: Sunil A. Sheth

given: Sunil A.

name: Texas Stroke Institute, Dallas-Fort Worth (A.J.Y.).

family: Yoo

full_name: Albert J. Yoo

given: Albert J.

name: University of Texas Rio Grande Valley - Valley Baptist Medical Center, Harlingen (A.E.H.).

family: Hassan

full_name: Ameer E. Hassan

given: Ameer E.

family: Piotin

full_name: Michel Piotin

given: Michel

family: Blanc

full_name: Raphaël Blanc

given: Raphaël

family: Desilles

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

repository_institution: The University of Texas Rio Grande Valley - ScholarWorks @ UTRGV

location_country:
United States
France
Poland
Russian Federation
Spain
Germany

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Foundation Ophthalmic Adolphe De Rothschild


title: A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

summary:
This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects.

Pediatric subjects (<18 years of age) requiring an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure, wherein a target bleeding site (TBS) is identified, and a topical hemostatic agent is indicated, will be eligible to participate in the clinical trial.

The study treatments will be applied on the cut parenchymous surface of a solid organ (ie, liver) and in soft tissue (ie, fat, muscle, or connective tissue).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Grifols Therapeutics LLC

location_country:
United States
Sweden
Serbia
France
Bulgaria
Romania
Hungary
Germany
United Kingdom
Canada

location_facility: Semmelweis University, 2nd Dpt of Paediatrics

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Spitalul Clinic de Urgenta pentru Copii "Grigore Alexandrescu"

location_facility: Insititute for Health Protection of Children and Youth

location_facility: Petz Aladár County Teaching Hospital, Department of Pediatric Surgery

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu"

location_facility: Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria"

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: University of Pécs Clinical Centre, Pediatric Clinic

location_facility: University of Debrecen Clinical Center, Pediatric Clinic No. I.

location_facility: The Urological Institute of Northeastern New York

location_facility: Spitalul Clinic de Urgenta pentru Copii "Maria Sklodowska Curie"

location_facility: Mother and Child Healthcare Institute of Serbia "Dr Vukan Cupic"

location_facility: Clinical Centre Nis, Clinic for Pediatric Surgery and Orthopedics

location_facility: Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

intervention_type: Biological

status_simplified: Ongoing


ReferenceType: background

ReferenceCitation: Inubushi T, Lemire I, Irie F, Yamaguchi Y. Palovarotene Inhibits Osteochondroma Formation in a Mouse Model of Multiple Hereditary Exostoses. J Bone Miner Res. 2018 Apr;33(4):658-666. doi: 10.1002/jbmr.3341. Epub 2017 Nov 30.

intervention_type: Other

lead_sponsor: Clementia Pharmaceuticals Inc.

location_country:
Italy
United States
Netherlands
Spain
France
Japan
Belgium
Australia
Portugal
Turkey
Canada
United Kingdom

acronym: MO-Ped

location_facility: Hôpital universitaire Necker - Enfants Malades

location_facility: Shriners Hospital for Children - Chicago

location_facility: Shriners Hospital for Children - Philadelphia

location_facility: The Children's Hospital of Philadelphia (CHOP)

location_facility: Bezmialem Vakif University Medical Faculty Hospital

location_facility: Shriners Hospital for Children - Sacramento

location_facility: Shriners Hospitals for Children - Portland

location_facility: Centre Hospitalier Universitaire Sainte-Justine

type: EudraCT Number

source: euctr

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Palovarotene in Subjects With Multiple Osteochondromas

summary: This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).


title: An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

summary: this study extension objective is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with active systemic lupus erythematosus (SLE) who had participated in the main study IP-005.

lead_sponsor: ImmuPharma

location_country:
United States
France
Czechia
Hungary
Puerto Rico
Germany
Mauritius

location_facility: Clinic for Rheumatology and Internal Medicine

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Arthritis and Rheumatic Disease Specialties


title: Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

acronym: KNOCOUT PE

summary: This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

time_perspective: Other

lead_sponsor: EKOS Corporation

location_country:
Austria
Switzerland
Netherlands
Germany
France
Turkey
United States
United Kingdom

location_facility: Cardiology Associates of Northern Mississippi

location_facility: West Virginia University Heart & Vascular Institute

location_facility: AdventHealth Tampa Pepin Heart Institute

location_facility: St. Vincent Hospital, Allegheny Health Network

location_facility: Healthfinity, PLLC Advanced Cardiac & Vascular Clinic

location_facility: Temple University Hospital, Department of Thoracic Medicine & Surgery

location_facility: Metro Health - University of Michigan Health

location_facility: St. Vincent Hospital/Reliant Medical Group

intervention_type: Device


title: A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Efavaleukin Alfa in Adult Subjects With Steroid Refractory Chronic Graft Versus Host Disease

summary:
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD).

Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

status: Active, not recruiting

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

location_country:
United States
Belgium
France
Japan

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: The Ohio State University Wexner Medical Center Arthur G James Cancer Hospital and Solove Research


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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
United States
South Africa
India
Spain
Germany
France
Japan
Malaysia
Australia
China
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

acronym: ATLAS-INH

location_facility:
Investigational Site Number 9105
Investigational Site Number 0135
Investigational Site Number 0136
Investigational Site Number 4906
Investigational Site Number 4905
Investigational Site Number 9102
Investigational Site Number 4407
Investigational Site Number 8003
Investigational Site Number 0128
Investigational Site Number 3303
Investigational Site Number 0103
Investigational Site Number 8805
Investigational Site Number 0119
Investigational Site Number 9006
Investigational Site Number 8202
Investigational Site Number 3904
Investigational Site Number 9002
Investigational Site Number 8001
Investigational Site Number 8804
Investigational Site Number 0111
Investigational Site Number 9003
Investigational Site Number 9104
Investigational Site Number 8803
Investigational Site Number 8602
Investigational Site Number 9004
Investigational Site Number 0105
Investigational Site Number 0117
Investigational Site Number 8604
Investigational Site Number 6004
Investigational Site Number 2703
Investigational Site Number 8603
Investigational Site Number 9103
Investigational Site Number 1102
Investigational Site Number 3402
Investigational Site Number 9106
Investigational Site Number 2702
Investigational Site Number 0115
Investigational Site Number 0137
Investigational Site Number 6104
Investigational Site Number 9108
Investigational Site Number 3901
Investigational Site Number 8204
Investigational Site Number 9111
Investigational Site Number 9001
Investigational Site Number 6101
Investigational Site Number 8110
Investigational Site Number 2701
Investigational Site Number 8002
Investigational Site Number 8103
Investigational Site Number 8801
Investigational Site Number 9005
Investigational Site Number 0139
Investigational Site Number 0104
Investigational Site Number 8203
Investigational Site Number 3301
Investigational Site Number 8605
Investigational Site Number 6003
Investigational Site Number 8601

type: Other Identifier

title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX

summary: The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).


title: A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older With an Extension Period of Up To 60 Months

summary: The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Singapore
Hungary
United States
Germany
United Kingdom
Austria
Serbia
Czechia
Israel
New Zealand
Spain
Turkey


ReferenceCitation: Raal FJ, Rosenson RS, Reeskamp LF, Hovingh GK, Kastelein JJP, Rubba P, Ali S, Banerjee P, Chan KC, Gipe DA, Khilla N, Pordy R, Weinreich DM, Yancopoulos GD, Zhang Y, Gaudet D; ELIPSE HoFH Investigators. Evinacumab for Homozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Aug 20;383(8):711-720. doi: 10.1056/NEJMoa2004215.

name: From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) — both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H....

family: Raal

full_name: Frederick J. Raal

given: Frederick J.

family: Rosenson

full_name: Robert S. Rosenson

given: Robert S.

family: Reeskamp

full_name: Laurens F. Reeskamp

given: Laurens F.

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

family: Rubba

full_name: Paolo Rubba

given: Paolo

family: Ali

full_name: Shazia Ali

given: Shazia

family: Banerjee

full_name: Poulabi Banerjee

given: Poulabi

family: Chan

full_name: Kuo-Chen Chan

given: Kuo-Chen

family: Gipe

full_name: Daniel A. Gipe

given: Daniel A.

family: Khilla

full_name: Nagwa Khilla

given: Nagwa

family: Pordy

full_name: Robert Pordy

given: Robert

family: Weinreich

full_name: David M. Weinreich

given: David M.

family: Yancopoulos

full_name: George D. Yancopoulos

given: George D.

family: Zhang

full_name: Yi Zhang

given: Yi

family: Gaudet

full_name: Daniel Gaudet

given: Daniel

journal_name: New England Journal of Medicine

oa_host_type: publisher

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Italy
Austria
United States
South Africa
Netherlands
France
Japan
Greece
Australia
Canada
Ukraine

location_facility:
Regeneron Research Site #2
Regeneron Research Site
Regeneron Research Site #3
Regeneron Research Site # 2

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

summary: The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.


title: FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

acronym: FAST Registry

summary: The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

lead_sponsor: The Hospital for Sick Children

location_country:
Brazil
United States
Sweden
Hong Kong
Netherlands
Switzerland
Finland
France
Czechia
Australia
Russian Federation
Spain
Canada
United Kingdom

location_facility: Cohen Children's Medical Centre/Northwell Health - Lake Success

location_facility: Karolinska University Hospital, Astrid Lindgen Childrens Hospital

location_facility: Cincinnati Children's Hospital Medical Centre

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Associação Beneficente Síria - Hospital do Coração

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Inc Pediatric Cardiology of Austin Practice

location_facility: West Virginia University Research Corporation

location_facility: National medical research center for obstetrics, gynecology and perinatology

location_facility: Queen Elizabeth University Hospital, Glasgow

location_facility: St George's University Hospital Foundation Trust

lead_sponsor_type: academique


title: Open Label, Long-term Safety, Tolerability, and Efficacy Study of GIVINOSTAT in All DMD Patients Who Have Been Previously Treated in One of the GIVINOSTAT Studies

summary: This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.

status: Enrolling by invitation

ipd_sharing: Undecided

lead_sponsor: Italfarmaco

location_country:
Italy
United States
Serbia
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Holland Bloorview Kids Rehabilitation Hospital

location_facility: Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN)

location_facility: U.O.S.D. Centro Traslazionale di Miologia e Patologie Neurodegenerative, Building 16 - ground floor IRCCS Istituto Giannina Gaslini,

location_facility: Rady Children's Hospital center - UCSD Department of Neuroscience

location_facility: Klinik- und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum HamburgEppendorf, Martinistr. 52

location_facility: A.O.U. Policlinico G. Martino, U.O.C. Neurologia e Malattie Neuromuscolari

location_facility: Fondazione Policlinico Universitario "A.Gemelli", UOC Neuropsichiatria Infantile

location_facility: The John Walton Muscular Dystrophy Research Centre

location_facility: Klinikum der Universitat Munchen, Campus Innenstadt, Lindwurmstr. 4

location_facility: Hospital Universitari i Politècnic La Fe - Servicio Neurologia

location_facility: Centro Clinico NeMO Fondazione Serena ONLUS Area SUD

location_facility: University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation

location_facility: Kinsmen Research Centre - Alberta Children's Hospital

location_facility: Hôpital Armand Trousseau I-Motion - Plateforme d'essais cliniques pédiatriques Bâtiment Lemariey - Porte 20 * 2ème étage 26 Avenue du Dr Arnold Nette

location_facility: University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology

location_facility: CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest

location_facility: The University of British Columbia, Children's and Womens Health Centre of BC Branch

location_facility: Neuromuscular Pathology Unit - Hospital Sant Joan de Déu

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD

location_facility: Leiden University Medical Center LUMC, Albinusdreef 2

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

location_facility: Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111

location_facility: Universitätsklinikum Essen - Kinder-und Jugendmedizin Neuropadiatrie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica

location_facility: The Children's Hospital of Philadelphia Colket Translational Research Building

location_facility: Virginia Commonwealth University Childrens Hospital of Richmond at

location_facility: Connecticut Children's Medical Center, Neurology Division

location_facility: Clinic of Neurology and Psychiatry for Children and Youth - Neurology Department Dr. Subotic 6a,

location_facility: Ospedale Pediatrico Bambino Gesù, Malattie Neuromuscolari e Neurodegenerative


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center, Exploratory Dose-response Study to Assess the Efficacy and Safety of Different Oral Doses of BAY1128688 in Women With Symptomatic Endometriosis Over a 12-week Treatment Period

summary: Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

lead_sponsor: Bayer

location_country:
Italy
Austria
Netherlands
Finland
France
Czechia
Poland
Hungary
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Casa di Cura Privata Malzoni - Villa dei Platani

location_facility: Hospital General Universitario de Valencia

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro

location_facility: Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: NZOZ NOVITA, Specjalistyczne Gabinety Lekarskie


ReferenceCitation: Rosen S, Tiefenbacher S, Robinson M, Huang M, Srimani J, Mackenzie D, Christianson T, Pasi KJ, Rangarajan S, Symington E, Giermasz A, Pierce GF, Kim B, Zoog SJ, Vettermann C. Activity of transgene-produced B-domain-deleted factor VIII in human plasma following AAV5 gene therapy. Blood. 2020 Nov 26;136(22):2524-2534. doi: 10.1182/blood.2020005683.

family: Rosen

full_name: Steffen Rosen

given: Steffen

name: Colorado Coagulation, Laboratory Corporation of America Holdings, Englewood, CO;

family: Tiefenbacher

full_name: Stefan Tiefenbacher

given: Stefan

family: Robinson

full_name: Mary Robinson

given: Mary

name: BioMarin Pharmaceutical Inc, Novato, CA;

family: Huang

full_name: Mei Huang

given: Mei

family: Srimani

full_name: Jaydeep Srimani

given: Jaydeep

family: Mackenzie

full_name: Donnie Mackenzie

given: Donnie

family: Christianson

full_name: Terri Christianson

given: Terri

name: Royal London Haemophilia Centre, Barts Health, National Health Service (NHS) Trust, London, United Kingdom;

family: Pasi

full_name: K. John Pasi

given: K. John

name: University Hospital Southampton, Southampton, United Kingdom;

family: Rangarajan

full_name: Savita Rangarajan

given: Savita

name: Cambridge University Hospitals, NHS Foundation Trust, Cambridge, United Kingdom;

family: Symington

full_name: Emily Symington

given: Emily

name: Division of Hematology/Oncology, Department of Medicine, University of California at Davis, Sacramento, CA; and

family: Giermasz

full_name: Adam Giermasz

given: Adam

family: Pierce

full_name: Glenn F. Pierce

given: Glenn F.

family: Kim

full_name: Benjamin Kim

given: Benjamin

family: Zoog

full_name: Stephen J. Zoog

given: Stephen J.

family: Vettermann

full_name: Christian Vettermann

given: Christian

journal_name: Blood

repository_institution: University of Southampton - ePrints Soton

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

title: Activity of transgene-produced B-domain–deleted factor VIII in human plasma following AAV5 gene therapy

lead_sponsor: BioMarin Pharmaceutical

location_country:
Italy
Brazil
South Africa
Germany
France
Israel
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Department of Pediatrics, Kyung Hee University Hospital at Gangdong

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: University of California San Diego, Hematology and Oncology, Hemophilia &Thrombosis Treatment Center

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda, Center for Hemophilia and Thrombosis Angelo Bianchi Bonomi

location_facility: Wayne State University, Detroit Medical Center

location_facility: University of Michigan, Pediatric Hematology and Oncology

location_facility: Hopital de la Timone Marseille - Assistance Publique des Hopitaux de Marseille

location_facility: Vivantes Clinic im Friedrichshain- Landsberger Allee

location_facility: Parana's Hematology And Hemotherapy Center (HEMEPAR)

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Barts and The London School of Medicine and Dentistry, Haemophilia Centre

location_facility: Regional University Hospital of Lille (CHRU de Lille)

location_facility: Los Angeles Orthopedic Hospital, Orthopedic Hemophilia Treatment Center

location_facility: Campinas Estadual University (UNICAMP) / Campinas Hemocentro / Hematologia E Hemoterapia Center

location_facility: Washington University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology

location_facility: Holy Spirit Hematology and Hemotherapy Center

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Arthur De Siqueira Cavalcanti Hematology State Institute

location_facility: Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center

location_facility: Churchill Hospital, Oxford Hemophilia and Thrombosis Center

location_facility: Glasgow Royal Infirmary, Department of Hematology

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Hematology

location_facility: St. Joseph's Children's Hospital, Center for Bleeding and Clotting Disorders

title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients With Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions

summary: This Phase III clinical study will assess the efficacy of BMN 270 defined as FVIII activity, during weeks 49-52 following intravenous infusion of BMN 270 and assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy and the number of bleeding episodes from week 5 to last visit by data cutoff.


title: Onyx ONE Study; A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

acronym: Onyx ONE

summary: The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

ReferenceCitation: Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW; ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020 Mar 26;382(13):1208-1218. doi: 10.1056/NEJMoa1910021. Epub 2020 Feb 12.

name: From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (S.W.); Montefiore Medical Center (A.L.), Columbia University Irving Medical Center–New York–Presbyterian Hospital (A.J.K., S.O.M.), the Cardiovascular Research Foundation (A.J.K., S.O.M., I.J., G.W.S.), Mount Sinai Medical Center (R. Mehran), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.) — all in New York; Isala Zwolle, Zwolle, the Netherlands (E.K.); Medical...

family: Windecker

full_name: Stephan Windecker

given: Stephan

family: Latib

full_name: Azeem Latib

given: Azeem

family: Kedhi

full_name: Elvin Kedhi

given: Elvin

family: Kirtane

full_name: Ajay J. Kirtane

given: Ajay J.

family: Kandzari

full_name: David E. Kandzari

given: David E.

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Price

full_name: Matthew J. Price

given: Matthew J.

family: Abizaid

full_name: Alexandre Abizaid

given: Alexandre

family: Simon

full_name: Daniel I. Simon

given: Daniel I.

family: Worthley

full_name: Stephen G. Worthley

given: Stephen G.

family: Zaman

full_name: Azfar Zaman

given: Azfar

family: Hudec

full_name: Martin Hudec

given: Martin

family: Poliacikova

full_name: Petra Poliacikova

given: Petra

family: Abdul Ghapar

full_name: A. Kahar bin Abdul Ghapar

given: A. Kahar bin

family: Selvaraj

full_name: Kamaraj Selvaraj

given: Kamaraj

family: Petrov

full_name: Ivo Petrov

given: Ivo

family: Mylotte

full_name: Darren Mylotte

given: Darren

family: Pinar

full_name: Eduardo Pinar

given: Eduardo

family: Moreno

full_name: Raul Moreno

given: Raul

family: Fabbiocchi

full_name: Franco Fabbiocchi

given: Franco

family: Pasupati

full_name: Sanjeevan Pasupati

given: Sanjeevan

full_name: Hyo-Soo Kim

given: Hyo-Soo

family: Aminian

full_name: Adel Aminian

given: Adel

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Kedhi E, Latib A, Abizaid A, Kandzari D, Kirtane AJ, Mehran R, Price MJ, Simon D, Worthley S, Zaman A, Brar S, Liu M, Stone GW, Windecker S. Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy. Am Heart J. 2019 Aug;214:134-141. doi: 10.1016/j.ahj.2019.04.017. Epub 2019 May 6.

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: Newcastle Univesity - Newcastle University ePrints

location_country:
Malaysia
Australia
Belgium
France
Poland
Lithuania
Slovakia
Thailand
Norway
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Singapore
Ireland
United Kingdom
Italy
Austria
New Zealand
Spain
Latvia

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Golden Jubilee National Hospital - NHS Trust

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Stavanger Universitetssjukehus - Helse Stavanger HF

location_facility: Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Galway University Hospitals - University Hospital Galway (UHG)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Paula Stradina Kliniska universitates slimnica

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: Cardiff and Vale University Health Board - University Hospital of Wales (UHW)

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Bundaberg Cardiology - Friendly Society Private Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

location_facility: Royal Devon and Exeter NHS Foundation Trust

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

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Keimyung University Dongsan Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach


title: A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy

summary: The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.

primary_purpose: Basic Science

lead_sponsor: Hoffmann-La Roche

location_country:
France
Spain
United States
United Kingdom
Korea, Republic of

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Yale Cancer Center; Barbara Ann Karmanos Cancer Institute

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

location_facility: Seoul National University Hospital; Department of Oncology

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

location_facility: Centre Leon Berard; Service Oncologie Medicale

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

intervention_type: Procedure


ReferenceCitation: Tariot PN, Cummings JL, Soto-Martin ME, Ballard C, Erten-Lyons D, Sultzer DL, Devanand DP, Weintraub D, McEvoy B, Youakim JM, Stankovic S, Foff EP. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021 Jul 22;385(4):309-319. doi: 10.1056/NEJMoa2034634.

name: From Banner Alzheimer’s Institute and University of Arizona College of Medicine, Phoenix (P.N.T.); Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada, Las Vegas, Las Vegas (J.L.C.); Gérontopôle Alzheimer Clinical and Research Center, Centre Hospitalier Universitaire de Toulouse, Geriatric Department, Maintain Functions and Intrinsic Capacities with Aging Research Team, Center for Epidemiology and Population Health...

family: Tariot

full_name: Pierre N. Tariot

given: Pierre N.

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

family: Soto-Martin

full_name: Maria E. Soto-Martin

given: Maria E.

family: Ballard

full_name: Clive Ballard

given: Clive

family: Erten-Lyons

full_name: Deniz Erten-Lyons

given: Deniz

family: Sultzer

full_name: David L. Sultzer

given: David L.

family: Devanand

full_name: Davangere P. Devanand

given: Davangere P.

family: Weintraub

full_name: Daniel Weintraub

given: Daniel

family: McEvoy

full_name: Bradley McEvoy

given: Bradley

family: Youakim

full_name: James M. Youakim

given: James M.

family: Stankovic

full_name: Srdjan Stankovic

given: Srdjan

family: Foff

full_name: Erin P. Foff

given: Erin P.

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
Italy
Chile
Serbia
Germany
France
Czechia
Bulgaria
Poland
Slovakia
Spain
United States
United Kingdom
Ukraine

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Premier Clinical Research Institute, Inc.

location_facility: Klinik für Psychiatrie und Psychotherapie der Universität Tübingen

location_facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council"

location_facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone - Service de Neurologie et Pathologie du Mouvement du Pr Azulay

location_facility: Visionary Investigators Network (First Choice Neurology Group)

location_facility: Municipal Institution "Odesa Regional Psychiatric Hospital #2", Female Gerontological Department # 5, Male Gerontological Department #1

location_facility: MUDr. Beata Dupejova, neurologicka ambulancia s.r.o

location_facility: Visionary Investigators Network (Aventura Neurologic Associates)

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute a della Scienza di Torino - c/o Presidio Ospedaliero Molinette Clinica Neurologica I

location_facility: Municipal Institution of Health Care "Kharkiv Regional Clinical Psychiatric Hospital #3"

location_facility: IRCCS Fondazione Santa Lucia, Dipartimento di Neurologia e Psichiatria

location_facility: Neuro-Behavioral Clinical Research, Inc.

location_facility: Millennium Psychiatric Associates, LLC; DBA Millennium Center for Clinical Research

location_facility: Azienda Ospedaliera di Padova Clinica Neurologica

location_facility: Royal United Hospital - The Research Institute for the Care of Older People (RICE) Centre

location_facility: State Institution "Institute of Neurology, Psychiatry, and Narcology of the National Academy of Medical Sciences of Ukraine", Department of Clinical, Social, and Paediatric Psychiatry

location_facility: Clinical Hospital Center Dr Dragisa Misovic-Dedinje

location_facility: Psychiatric Clinic, Military Medical Academy

location_facility: Centre de Recherche du Gerontopole - CHU de Toulouse

location_facility: Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I. I. Mechnikov"

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

location_facility: Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic

location_facility: Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev

location_facility: Military Medical Academy, Clinic for Neurology

location_facility: Lviv Regional State Clinical Psychiatric Hospital

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy

location_facility: Municipal Institution "Odesa Regional Medical Center of Mental Health", Department #18

location_facility: Universita degli Studi di ROMA "La Sapienza" Dipartimento di NEUROLOGIA E PSICHIATRIA

location_facility: Clinical center of Serbia, Clinic for Neurology

location_facility: Department of addictive disorders of the Clinic for Psychiatry, Clinical center Kragujevac

location_facility: Clinic for Psychiatry, Clinical Center Kragujevac

title: A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

summary: The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who responded to 12 weeks of open label pimavanserin treatment.


title: A Phase 2 Study of Poziotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, With EGFR or HER2 Exon 20 Insertion Mutation (ZENITH20)

summary: This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
United States
Netherlands
France
Israel
Belgium
Spain
Canada

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University Hospital Germans Trias i Pujol, Department of Medical Oncology

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: The Bond & Steele Clinic, P.A. dba Bond Clinic, P.A.

location_facility: North Shore Hematology Oncology Associates P.C. DBA NY Cancer and Blood Specialists

location_facility: Montefiore Einstein Medical Center for Cancer Care

location_facility: Yale University, Yale Cancer Center Smilow Cancer Hospital at Yale

location_facility: Hopital Larrey, CHU Toulouse, Unité d'Oncologie des Voies Respiratoires

location_facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: North Shore Hematology Oncology Associates DBA New York Cancer and Blood Specialists

location_facility: Ambroise Pare University Hospital Center

location_facility: Oncology Physician's Network Inc./OPN Healthcare

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Gustave Roussy Oncology Institute, Department of Medical Oncology

location_facility: National Cancer Institute Regina Elena, IRCCS, Operative Unit of Medical Oncology A 1

location_facility: CTCA - Southeastern Regional Medical Center

location_facility: National Cancer Institute, IRCCS, Department of Medical Oncology

location_facility: UCSF Helen Diller Comprehensive Cancer Center at Mt Zion

location_facility: CTCA - Midwestern Regional Medical Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute


title: An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of AZD1775 for Patients Enrolled in AZD1775 Clinical Pharmacology Studies

summary: Open-label, non-randomised study to provide continued access to AZD1775 for patients with advanced solid tumours who have previously completed an AZD1775 clinical pharmacology study and to investigate the safety of AZD1775.

lead_sponsor: AstraZeneca

location_country:
United States
United Kingdom
France
Netherlands


title: A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) Versus IV Decitabine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML)

summary: Multicenter, randomized, open-label, crossover PK study of ASTX727 versus IV decitabine. Adult subjects who are candidates to receive IV decitabine will be randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, subjects will continue to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the subject discontinues treatment or withdraws from the study.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Italy
Austria
Germany
France
Czechia
Hungary
Spain
United States
United Kingdom
Canada

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Compassionate Cancer Care Research Group

location_facility: University of Pittsburgh Hillman Cancer Center

location_facility: Baylor Scott & White University Medical Center

location_facility: Hospital Universitari I Politècnic La Fe

location_facility: Charleston Hematology Oncology Associates

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi

location_facility: Centre de lutte contre le Cancer Leon Berard

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Princess Margaret Cancer Center - University Health Network

location_facility: Centre Intégré Universitaire de Santé et de Services Sociaux (CIUSSS) de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve Rosemont

location_facility: ULSS 8 Vicenza - Ospedale San Bortolo di Vicenza

location_facility: Fondazione IRCCS C Granda OM Policlinico

location_facility: University of Pecs, 1st Department of Internal Medicine

location_facility: Hospital Universitario Central de Asturias

location_facility: Fakultni Nemocnice Kralovske Vinohrady FNKV

location_facility: Oberärztin für Innere Medizin, Hämato-/Onkologie und Palliativmedizin

location_facility: Indiana Blood and Marrow Transplantation

location_facility: University of Texas Southwestern Medical Center

location_facility: Queen Elizabeth II (QEII) Health Sciences Center

location_facility: Philipps-Universität Marburg, Klinik für Innere medizin, Hämatologie, Onkologie und Immunologie

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità Novara


lead_sponsor: Amgen

primary_purpose: Supportive Care

location_country:
Italy
Sweden
France
Poland
Australia
Spain
United States
United Kingdom

location_facility: Abramson Cancer Center at Pennsylvania Hospital

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy

location_facility: University of Minnesota Medical Center Fairview

location_facility: Washington Cancer Institute at MedStar Washington Hospital

title: Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

summary: Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.


title: A Randomized, Subject- and Investigator-blinded, Placebo Controlled, Multi-center, Multiple Dose Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Moderate to Severe Asthma

summary: An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
France
Israel
Slovakia
Belgium
Argentina
Denmark
United States


lead_sponsor: Allergan

location_country:
India
Philippines
France
Bulgaria
Malaysia
Israel
Poland
Singapore
Thailand
Australia
Spain
United States
Korea, Republic of
Ukraine

acronym:
Diabetic Gastroparesis Study 1

 Étude de la gastroparésie diabétique 1

location_facility: Family Medical Associates, Research Department

location_facility: Frederick Gastroenterology Associates, PA an Elligo Health Research Site

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia

location_facility: University of Iowa Hospitals and Clinics

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Kyiv municipal clinical endocrinological center

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: NZOZ Vita Diabetica - Malgorzata Buraczyk

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Premier Clinical Research d.b.a. STAT Research

location_facility: L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

location_facility: Kyiv Railway hospital on the railway transport #2 of the branch "health

location_facility: Centrum Medyczne Pratia S.A. Warsaw, Poland

location_facility: Indiana University Health University Hospital

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Regional Public Organization Chernivtsi Regional Endocrinology Center

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Municipal Institution City Hospital No. 7

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Municipal nonprofit entity of Kharkiv municipal council

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Synexus Clinical Research, US, Santa Rosa

location_facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi

location_facility: Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

location_facility: S R Kalla (SRK) Memorial Gastro & General Hospital

location_facility: Synexus Polska sp.z.o.o oddzial Czestochowa

location_facility: Cotton-O'Neil Clinical Research Center - Digestive Health

location_facility: University of North Carolina at Chapel Hill

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: West Visayas State University Medical Center

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: Hospital Universitario Principe de Asturias

location_facility: Connecticut Clinical Research Foundation

location_facility: Limited Liability Company "Medical Center "Salutem"

location_facility: Private Small-Scale Enterprise Medical Centre Pulse

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

location_facility: Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Diacon Hospital and research Center - Diabetology

location_facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Digestive Health Specialist of the South East

location_facility: Family Practice Center of Wadsworth, Inc.

location_facility: Synexus Polska Sp. z o.o.Oddzial w Poznaniu

location_facility: Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

location_facility: Ivano-Frankivsk National Medical University

title: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

summary: This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.


title: A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

summary: The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

lead_sponsor: Shire

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Ukraine
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Lebanon
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Elite Clinical Studies - Phoenix - Clinedge - PPDS

location_facility: Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: Multiprofile Hospital for Active Treatment Eurohospital

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Midwest Biomedical Research Foundation - NAVREF

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: A.ö. Krankenhaus der Barmherzigen Brüder

location_facility: St. Elizabeth Municipal Clinical Hospital

location_facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS

location_facility: Atria Clinical Research - Clinedge - PPDS

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Azienda Ospedaliera Mater Domini Di Catanzaro

location_facility: Shiga University of Medical Science Hospital

location_facility: Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

location_facility: General County Hospital Vukovar and Croatian Veterans Hospital

location_facility: Twoja Przychodnia - Szczecińskie Centrum Medyczne

location_facility: Alliance Clinical Research-(Vestavia Hills)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Centro de Investigacion Clinica Acelerada, S.C.

location_facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

location_facility: Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

location_facility: Medical Center of LLC Medical Center Dopomoga-Plus

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

location_facility: Research Institute of Physiology and Basic Medicine

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: First St. Petersburg State Medical University n.a. I.P Pavlov

location_facility: ENCORE Borland-Groover Clinical Research - ERN - PPDS

location_facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council

location_facility: Colo-Proctology Center Matsushima Clinic

location_facility: Chiinkai Dojima General & Gastroenterology Clinic

location_facility: Fundación Cardioinfantil Instituto Cardiológico

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway

location_facility: Omega Research Consultants LLC - Clinedge - PPDS

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Institut Klinicke A Experimentalni Mediciny

location_facility: Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: DelRicht Clinical Research, LLC - ClinEdge - PPDS

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council

location_facility: Centro Medico Teknon - Grupo Quironsalud

location_facility: Laporte County Institute For Clinical Research

location_facility: Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Western General Hospital Edinburgh - PPDS

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Dr.Carol Davila Emergency University Central Military Hospital

location_facility: Washington University School of Medicine

location_facility: Centro Hospitalar do Algarve - Hospital de Portimao

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: La Sapienza-Università di Roma-Policlinico Umberto I

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: CHI Franciscan Digestive Care Associates

location_facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

location_facility: University of Miami Miller School of Medicine

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Gastroenterologische Facharztpraxis am Mexikoplatz

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Russian Medical Military Academy n.a. S.M. Kirov

location_facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

location_facility: Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

location_facility: CATS Research Center - University of Arizona

location_facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

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

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Hakodate Koseiin Hakodate Goryoukaku Hospital

location_facility: MNPE of Kharkiv Regional Council Regional Clinical Specialised Dispensary of Radiation Protection

location_facility: Asthma and Allergy Associates PC - CRN - PPDS

location_facility: University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

location_facility: Regional Consulting and Diagnostics Centre

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

location_facility: OM Research LLC - Lancaster - ClinEdge - PPDS

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

location_facility: SI "Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station" of SE "Prydniprovska Zaliznytsia"

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Bayside Clinical Research - New Port Richey

location_facility: Toronto Digestive Disease Associates Inc

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska

location_facility: Gastroenterology Associates of Western Michigan, PLC

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach

location_facility: Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Hammoud Hospital University Medical Center

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Hospital Universitario Juan Ramon Jimenez

location_facility: Second Multiprofile Hospital for Active Treatment Sofia

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Medical Center OK!Clinic+LLC International Institute of Clinical Research

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

location_facility: Medical Center of LLC Medical Clinic Blagomed

location_facility: University General Hospital of Heraklion

location_facility: VA Long Beach Healthcare System - NAVREF - PPDS

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Diagnostic Consultative Centre Mladost - M OOD

location_facility: Centrum Medyczne Czestochowa - PRATIA - PPDS

location_facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

location_facility: Veteran's Research and Education Foundation - NAVREF - PPDS

location_facility: Accel Research Sites - St. Petersburg - ERN - PPDS

location_facility: Cluj-Napoca Emergency Clinical County Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Friedrich, Rubin, Panella, Sapienza, and Kaplounov, LLP

location_facility: Centro de Investigación Médica Aguascalientes

location_facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

location_facility: Edward Hines Jr VA Hospital - NAVREF - PPDS

location_facility: Hospital Privado Centro Médico de Córdoba

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

location_facility: Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

location_facility: Centrum Medyczne Warszawa - PRATIA - PPDS

location_facility: University Multiprofile Hospital for Active Treatment Sveta Anna

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Moscow Regional Research Clinical Institute Na Mfvladimirskiy

location_facility: Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine

location_facility: Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino

location_facility: Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

location_facility: Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

location_facility: Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council

location_facility: Clinica de Higado y Gastroenterologia Integral, S.C.

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: MNPE Central City Clinical Hospital of Uzhhorod City Council

location_facility: Diagnostic and Consulting Center Aleksandrovska EOOD

location_facility: Health Pharma Professional Research S.A de C.V.

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Unidad de Atencion Medica e Investigacion en Salud

location_facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Kitasato University Kitasato Institute Hospital


title: International BPA Registry

summary: The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).

lead_sponsor: International CTEPH Association

location_country:
Austria
Netherlands
Germany
France
Czechia
Japan
Poland
Belgium
United States
United Kingdom

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Centre Hospitalier Universitaire Grenoble-Alpes

location_facility: National Cerebral and Cardiovascular Center


title: Multiple Cardiac Sensors for the Management of Heart Failure

acronym: MANAGE-HF

summary: The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

primary_purpose: Diagnostic

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
United States
France

location_facility: University of Southern California Hospital

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: Strong Memorial Hospital of the University of Rochester

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Southeast Texas Clinical Research Center

location_facility: Penn State Milton S Hershey Medical Center


title: A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications

summary: This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of derazantinib by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) or FGFR2 gene mutations or amplifications (based on NGS testing performed or commissioned by the respective study center) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of derazantinib capsules.

ReferenceCitation: Mazzaferro V, El-Rayes BF, Droz Dit Busset M, Cotsoglou C, Harris WP, Damjanov N, Masi G, Rimassa L, Personeni N, Braiteh F, Zagonel V, Papadopoulos KP, Hall T, Wang Y, Schwartz B, Kazakin J, Bhoori S, de Braud F, Shaib WL. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. Br J Cancer. 2019 Jan;120(2):165-171. doi: 10.1038/s41416-018-0334-0. Epub 2018 Nov 13.

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: El-Rayes

full_name: Bassel F. El-Rayes

given: Bassel F.

family: Droz dit Busset

full_name: Michele Droz dit Busset

given: Michele

family: Cotsoglou

full_name: Christian Cotsoglou

given: Christian

family: Harris

full_name: William P. Harris

given: William P.

family: Damjanov

full_name: Nevena Damjanov

given: Nevena

family: Masi

full_name: Gianluca Masi

given: Gianluca

family: Rimassa

full_name: Lorenza Rimassa

given: Lorenza

family: Personeni

full_name: Nicola Personeni

given: Nicola

family: Braiteh

full_name: Fadi Braiteh

given: Fadi

family: Zagonel

full_name: Vittorina Zagonel

given: Vittorina

family: Papadopoulos

full_name: Kyriakos P. Papadopoulos

given: Kyriakos P.

family: Hall

full_name: Terence Hall

given: Terence

family: Wang

full_name: Yunxia Wang

given: Yunxia

family: Schwartz

full_name: Brian Schwartz

given: Brian

family: Kazakin

full_name: Julia Kazakin

given: Julia

family: Bhoori

full_name: Sherrie Bhoori

given: Sherrie

family: de Braud

full_name: Filippo de Braud

given: Filippo

family: Shaib

full_name: Walid L. Shaib

given: Walid L.

journal_name: British Journal of Cancer

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

location_country:
Italy
United States
Switzerland
Germany
France
Ireland
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Sant'Orsola-Malpighi Hospital, University of Bologna

location_facility: Humanitas Cancer Center, Istituto Clinico Humanitas IRCCS

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

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Winship Cancer Institute of Emory University

location_facility: The University of Texas Southwestern Medical Center


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington's Disease

summary: PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).

ReferenceCitation: Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, PT, Portugal

name: Instituto de Medicina Molecular, Lisbon, PT, Portugal

family: Rodrigues

full_name: Filipe B. Rodrigues

given: Filipe B.

family: Wild

full_name: Edward J. Wild

given: Edward J.

journal_name: Journal of Huntington's Disease

oa_colors: green other

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Huntington’s Disease Clinical Trials Corner: April 2020

ReferenceCitation: Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001. Review.

name: Huntington’s Disease Centre, University College London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Portugal

name: Clinical Pharmacology Unit, Instituto de Medicina Molecular, Lisbon, Portugal

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
UCL Discovery
pdfs.semanticscholar.org

title: Huntington’s Disease Clinical Trials Corner: February 2018

lead_sponsor: Wave Life Sciences Ltd.

location_country:
Germany
France
Poland
Australia
Denmark
Canada
United Kingdom

location_facility: Royal Devon and Exeter Hospital NHS Trust

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Odense University Hospital and University of Southern Denmark

location_facility: Institut du Cerveau et de la Moelle Epinière


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease

summary: PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).

repositories_institution: University College London - UCL Discovery

location_facility: Center Hospitalier de l'Universite de Montreal


ReferenceCitation: O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.

family: O’Reilly

full_name: E.M. O’Reilly

family: Hechtman

full_name: J.F. Hechtman

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Italy
Germany
France
Singapore
Ireland
Belgium
Australia
Spain
Denmark
United States

location_facility: Univ.of California-San Diego Moores Cancer Center

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

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: UCLA Jonsson Comprehensive Cancer Center

title: A Phase 1/2 Study of the TRK Inhibitor Selitrectinib in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

summary: This research study is done to test the safety of the new drug selitrectinib in children and adults with cancer having a change in a particular gene (NTRK1, NTRK2 or NTRK3). The drug may treat cancer by interfering with the effect of the NTRK genes on cancer growth. The study also investigates how the drug is absorbed and processed in the human body, and how well and for how long the cancer responds to the drug. This is the first study to test selitrectinib in humans with cancer, for whom no other effective therapy exists.


title: Longitudinal Study of Young Patients With Embolic Stroke of Undetermined Source (ESUS)

acronym: Y-ESUS

summary: This study seeks to determine the clinical characteristics of young ESUS patients using diagnostic criteria of the Cryptogenic Stroke / ESUS International Working Group, and to determine the rates of stroke recurrence, death, and hospital readmission in a contemporary cohort of young ESUS patients during follow-up of up to 18 months.

lead_sponsor: Population Health Research Institute

location_country:
United States
Chile
South Africa
Switzerland
Mexico
Germany
France
Poland
Argentina
Australia
Spain
Canada
United Kingdom

location_facility: Stroke Center Inselspital University Hospital Bern

location_facility: Texas Tech University Health Sciences Center El Paso

location_facility: Institute Psychiatry and Neurology, 2 Department of Neurology

location_facility: Fundacion para la Lucha vs. Enf. Neurologicas de la Infancia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: East Kent Hospitals - Queen Elizabeth the Queen Mother Hospital

location_facility: University of Calgary/Foothills Medical Center

location_facility: Complejo Médico de la PFA Churruca Visca

location_facility: Szpital Specjalistyczny im. Sw. Lukasza, Oddzial Neurologii z Oddzialem Udarowym

location_facility: Cambridge University Foundation Trust Hospitals, Addenbrookes site

location_facility: Vancouver Stroke Program - Research Offices at Vancouver General Hospital

location_facility: Yoevil District Hospital Foundation Trust

location_facility: Asklepios Klinik Nord, Department of Neurology

location_facility: University of South Carolina - School of Medicine - Neurology

location_facility: Royal Stoke University Hospital, University Hospital of North Midlands NHS Trust

location_facility: National Institute of Neurology and Neurosurgery

location_facility: University of Texas Health Center - San Antonio

location_facility: Southend University Hospital NHS Foundation Trust


title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

summary: The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

ReferenceCitation: Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.

name: From the Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., N.K., R.H., R.P., Y.D., V.S.) — both in New York; TREAD Research, Cardiology Unit, Department of Internal Medicine and Tygerberg Hospital, Parow, South Africa (L.J.B.); the Department of Internal Medicine I, Medical University Innsbruck, Innsbruck, Austria (C.F.E.); Excel Medical Clinical Trials, Department of Integrated Medical Sciences, Charles E. Schmidt College of Medicine, Florida...

family: Rosenson

full_name: Robert S. Rosenson

given: Robert S.

family: Burgess

full_name: Lesley J. Burgess

given: Lesley J.

family: Ebenbichler

full_name: Christoph F. Ebenbichler

given: Christoph F.

family: Baum

full_name: Seth J. Baum

given: Seth J.

family: Stroes

full_name: Erik S.G. Stroes

given: Erik S.G.

family: Ali

full_name: Shazia Ali

given: Shazia

family: Khilla

full_name: Nagwa Khilla

given: Nagwa

family: Hamlin

full_name: Robert Hamlin

given: Robert

family: Pordy

full_name: Robert Pordy

family: Dong

full_name: Yuping Dong

given: Yuping

family: Son

full_name: Vladimir Son

given: Vladimir

family: Gaudet

full_name: Daniel Gaudet

given: Daniel

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Italy
Austria
United States
South Africa
Jordan
Sweden
Netherlands
France
Czechia
Japan
Israel
Poland
Norway
Australia
Russian Federation
New Zealand
Spain
Denmark
Canada
United Kingdom

location_facility: Samara Regional Clinical Cardiologic Dispensary

location_facility: Univerzita Karlova v Praze 1 Lekarska Fakulta

location_facility: National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid

location_facility: Ausl Della Romagna-Ospedale Degli Infermi

location_facility: Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic

location_facility: Federal State Budget Institution Out-patient Clinic 3

location_facility: Ikem Institut Klinicke A Experimentalni Mediciny

location_facility: Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Universitair Medisch Centrum Utrech - Locatie AZU

location_facility: The Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Clinique des maladies lipidiques de Quebec

location_facility: The University Of Texas Health Science Center Houston

location_facility: Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di

location_facility: University of Maryland School of Medicine

location_facility: Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease

location_facility: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica

location_facility: Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov

location_facility: Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED

location_facility: University Hospital Innsbruck - Tyrolean Hospital

location_facility: Sourasky Medical Center, Cardiovascular Research Center

location_facility: Hospital Universitario Virgen de las Nieves (HUVN)

location_facility: Royal Free Hospital-Royal Free London NHS Foundation Trust

location_facility: Limmited Liability Company International Medical Centre SOGAZ

location_facility: Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn


title: A Multi-centre, Double-blind, Parallel-group, Randomised, Placebo Controlled Phase II a Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Different Doses of Orally Administered BI 1467335 During a 12-week Treatment Period Compared to Placebo in Patients With Clinical Evidence of NASH.

summary:
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.

To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH.

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Netherlands
Germany
France
Ireland
Belgium
Spain
Canada
United Kingdom

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: American Research Corporation at the Texas Liver Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: The University of North Carolina at Chapel Hill