status: Active, not recruiting

acronym: CATNON

intervention_type: Procedure

title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

study_completion_date_type: Anticipated

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

ReferenceCitation: Tesileanu CMS, Sanson M, Wick W, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Rudà R, Weller M, McBain C, van Linde ME, Aldape K, Jenkins RB, Kros JM, Wesseling P, von Deimling A, Hoogstrate Y, de Heer I, Atmodimedjo PN, Dubbink HJ, Brouwer RWW, van IJcken WFJ, Cheung KJ, Golfinopoulos V, Baumert BG, Gorlia T, French PJ, van den Bent MJ. Temozolomide and Radiotherapy versus Radiotherapy Alone in Patients with Glioblastoma, IDH-wildtype: Post Hoc Analysis of the EORTC Randomized Phase III CATNON Trial. Clin Cancer Res. 2022 Jun 13;28(12):2527-2535. doi: 10.1158/1078-0432.CCR-21-4283.

ReferenceCitation: van den Bent MJ, Tesileanu CMS, Wick W, Sanson M, Brandes AA, Clement PM, Erridge S, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Rogers L, Taal W, Rudà R, Weller M, McBain C, Reijneveld J, Enting RH, Caparrotti F, Lesimple T, Clenton S, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, de Heer I, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, French P, Baumert BG. Adjuvant and concurrent temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): second interim analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2021 Jun;22(6):813-823. doi: 10.1016/S1470-2045(21)00090-5. Epub 2021 May 14.

ReferenceCitation: van den Bent MJ, Baumert B, Erridge SC, Vogelbaum MA, Nowak AK, Sanson M, Brandes AA, Clement PM, Baurain JF, Mason WP, Wheeler H, Chinot OL, Gill S, Griffin M, Brachman DG, Taal W, Rudà R, Weller M, McBain C, Reijneveld J, Enting RH, Weber DC, Lesimple T, Clenton S, Gijtenbeek A, Pascoe S, Herrlinger U, Hau P, Dhermain F, van Heuvel I, Stupp R, Aldape K, Jenkins RB, Dubbink HJ, Dinjens WNM, Wesseling P, Nuyens S, Golfinopoulos V, Gorlia T, Wick W, Kros JM. Interim results from the CATNON trial (EORTC study 26053-22054) of treatment with concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma: a phase 3, randomised, open-label intergroup study. Lancet. 2017 Oct 7;390(10103):1645-1653. doi: 10.1016/S0140-6736(17)31442-3. Epub 2017 Aug 8. Erratum in: Lancet. 2017 Oct 7;390(10103):1644.

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
United States
France
Israel
Belgium
Germany

location_facility: University Health Network - Oci / Princess Margaret Hospital

location_facility: UPMC - Heritage Valley Health System - The Medical Center

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Memorial Health University Medical Center

location_facility: State University of New York Upstate Medical University

location_facility: Erasmus MC - Daniel den Hoed Cancer Center

location_facility: Cancer Centers of the Carolinas - Eastside

location_facility: University of Rochester - James P. Wilmot Cancer Center

location_facility: Akron City Hospital - Summa Health System

location_facility: Assistance Publique - Hôpitaux de Marseille - C.H.U. De La Timone

location_facility: Dixie Medical Center Regional Cancer Center

location_facility: Cancer Centers of the Carolinas - Faris Road

location_facility: Massachussets General Hospital Cancer Center

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: UCSF University of California San Francisco Medical Center-Mount Zion

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: University Of Wisconsin Comprehensive Cancer Center

location_facility: Azienda Ospedaliera San Giovanni Battista Di Torino-Universita Di Torino

location_facility: Southwest General Health Center Ireland Cancer Center

location_facility: University Of Utah - Huntsman Cancer Institute

location_facility: Maastro Clinic - Maastricht Radiation Oncology

location_facility: ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

location_facility: Cancer Centers of the Carolinas - Greer Radiation Oncology

location_facility: Cancer Centers of the Carolinas - Seneca

location_facility: Froedtert and the Medical College of Wisconsin

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.

status_simplified: Ongoing


title: PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils

acronym: PRET

summary: The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
United Kingdom
Canada
United States
Chile
France
Japan

location_facility: Stony Brook University Medical Center (SUNY)

location_facility: Centre Hospitalier de l'Université de Montréal - Notre Dame Hospital

location_facility: University of Wisconsin Hospital and Clinics

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: University of Oklahoma Health Sciences Center

location_facility: CHU de Nantes - Hôpital Guillaume et René Laennec

location_facility: Kobe City Medical Center General Hospital

lead_sponsor_type: academique

status_simplified: Completed


title: A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

acronym: APRIL-SLE

summary: This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

ReferenceCitation: Isenberg D, Gordon C, Licu D, Copt S, Rossi CP, Wofsy D. Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial). Ann Rheum Dis. 2015 Nov;74(11):2006-15. doi: 10.1136/annrheumdis-2013-205067. Epub 2014 Jun 20. Erratum in: Ann Rheum Dis. 2016 May;75(5):946.

lead_sponsor: EMD Serono

location_country:
Croatia
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
South Africa
Philippines
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Malaysia
Lebanon
Switzerland
Germany
Bulgaria
Taiwan
Greece
Latvia
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: Feinstein Institute for Medical Research

location_facility: University of Cincinnati Medical Center, Division of Immunology

location_facility: Division of Clinical Immunology and Rheumatology - UAB

intervention_type: Other

lead_sponsor_type: industriel


type: Other Identifier

title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

summary: This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

ReferenceCitation: Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Austria
Puerto Rico
United States
France
Germany

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

intervention_type: Drug


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group Polysomnography Study to Assess the Efficacy and Safety of a 16-day Oral Administration of ACT-078573 in Adult Subjects With Chronic Primary Insomnia

acronym: RESTORA 1

summary: A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

ReferenceCitation: Black J, Pillar G, Hedner J, Polo O, Berkani O, Mangialaio S, Hmissi A, Zammit G, Hajak G. Efficacy and safety of almorexant in adult chronic insomnia: a randomized placebo-controlled trial with an active reference. Sleep Med. 2017 Aug;36:86-94. doi: 10.1016/j.sleep.2017.05.009. Epub 2017 May 29.

lead_sponsor: Midnight Pharma, LLC

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
United Kingdom
Finland
Czech Republic
Switzerland
Ukraine
Sweden
Hungary
France
Israel
South Africa
Belgium
Germany
Bulgaria
Slovakia

location_facility: Hospital La Fe, Unidad de Neurofisiologi

location_facility: CH Jolimont / Sleep Disorders Center, Hospital de Jolimont

location_facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych ACK, Szpital AMG

location_facility: Hospital Son Dureta, Unidad de Psicologia

location_facility: IRCCS Fondazione San Raffaele del Monte Tabor, Centro per i Disturbi del Sonno

location_facility: Centre pour l'Etude et le Traitement des Troubles du Sommeil Hopital Bell Idee

location_facility: Neurologicka klinika, FN L. Pasteura Kosice

location_facility: Somnocentrum Trutnov-spankova laborator, Oddeleni neurologie

location_facility: Hospital de la Santa Creu i Sant Pau, Unidad Framacologia Clinica

location_facility: The Woolcock Institute of Medical Research

location_facility: WITS Sleep Laboratory School of Physiology

location_facility: Burnside Hospital Clinical Trials Centre

location_facility: Fakultni nemocnice Ostrava/Klinika detske neurologie SLEEP LABORATORY

location_facility: Sleep Disorder Centre, State Health Centre

location_facility: Instytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej

location_facility: National Medical University n.a. O.O. BohomoletsChair of Diseases of Nervous System, City Clinical Hospital No.4, Neurological Departments I and II

location_facility: Service de Neurologie B, Hopital Gui de Chauliac

location_facility: Institute for Breathing and Sleep (IBAS)

location_facility: Monash Adult Sleep Center, Monash Medical Centre

location_facility: Psychiatric University Clinics (UPK) Basel, Sleep Medicine and Neurophysiology

location_facility: Westmead Hospital, Department of Respiratory

location_facility: Centre du Sommeil et de la Vigilance, Hopital Hotel Dieu de Paris

location_facility: University of Turku, Sleep Research Unit

location_facility: Laboratorium Diagnostyka Snu, Pro-Medica

location_facility: Medical University of Innsbruck, Department of Neurology

location_facility: Örebro University Hospital, Neurology department Sleep Unit

location_facility: Oddeleni nasledne pece, Nemocnice Ceske Budejovice

location_facility: Centro del Sonno, Dipartimento di Neuroscienze, Clinica Neuroligica, Università di Pisa

location_facility: Australian Clinical Research Organisation

location_facility: Interdisziplinäres Schlafmedizinisches Zentrum, Universitätsklinikum Giesen und Marburg GmbH

location_facility: Soroka University Medical Center, Unit for Sleep Research

location_facility: Centrum pro poruchy spanku a bdeni, Neurologicka klinika

location_facility: University Hospital Zurich (USZ) Neurology Polyclinic, Center for Sleep Medicine

location_facility: Hospital MAZ, Unidad de Neurofisiologia y Sueno

location_facility: Technion Sleep Medicine Center, Rambam Medical Center

location_facility: Sleep Disorders Laboratory, Royal Adelaide Hospital

location_facility: Poradna pro porchy spanku a spankova, Laborator Unimeds s.r.o.

location_facility: IRCCS Neurologico Casimiro Mondino, Centro Multidisciplinare di Medicina del Sonno, Servizio di Neurofisiopatologia

location_facility: Department of Psychiatry and Psychotherapy of the University Hospital of Freiburg

location_facility: Charite Campus Benjamin Franklin, Klinik und Hochschulambulanz fur Psychiatrie und Psychotherapie

location_facility: University of Vienna - Department of Neurology

location_facility: KSM Luzern Klinik fur Schlafmedizin, c/o Klinik St. Anna

location_facility: Department of Neurology , University of Debrecen

location_facility: I. Neurologická klinika FNsP Bratislava Nemocnica Staré Mesto

location_facility: Osrodek Diagnostyki i Leczenia Zaburzen Snu i Chorob Ukladu


title: A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies

summary: This is a phase III, double-blind, randomized, multicenter, and parallel group trial with a duration of 24 weeks, followed by a 120 week Open-label Period. The primary purpose of the study is to demonstrate the efficacy and safety of ofatumumab in reducing clinical signs and symptoms in adult RA patients who had an inadequate response to TNF-α antagonist therapy.

status: Terminated

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Argentina
Sweden
Korea, Republic of
France
Peru
Norway
Germany

status_simplified: Unknown


ipd_sharing: Yes

title: A Randomized Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter, Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

source: euctr

ReferenceType: background

ReferenceCitation: Bateman ED, Bleecker ER, Lötvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.

ReferenceCitation: Psaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

ReferenceCitation: Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Poland
Russian Federation
Estonia
Canada
Sweden
Korea, Republic of
United States
France
Peru
Mexico
Philippines
Germany
Bulgaria
Slovakia

summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.


title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

summary: Adult Patients with Severe Sepsis

ReferenceCitation: Laterre PF, Macias WL, Janes J, Williams MD, Nelson DR, Girbes AR, Dhainaut JF, Abraham E. Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis. Crit Care. 2008;12(5):R117. doi: 10.1186/cc7011. Epub 2008 Sep 11.

location_country:
Denmark
Brazil
Austria
Australia
Argentina
Canada
Czech Republic
Finland
France
Chile
Belgium
Egypt

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


acronym: CATZ

title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures

lead_sponsor: Eisai Inc.

location_country: Poland Spain Italy Latvia Estonia Ukraine Hungary France Belgium

summary: The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.


title: An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis

summary: This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Hong Kong
Spain
Greece
Italy
Australia
Russian Federation
Canada
Thailand
Hungary
Korea, Republic of
France
Israel
Belgium
Germany


title: A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD

summary: This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

lead_sponsor: Novartis

location_country:
Poland
Romania
United Kingdom
Ireland
Italy
Latvia
Argentina
Lithuania
Hungary
France
Chile
Peru
South Africa
Belgium
Norway
Germany
Turkey

location_facility:
Novartis Investigator site
Novartis investigator site
Novartis Investigator Site - 2 sites
novartis Investigator site
Novartis Investigator Site


type: EudraCT Number

title: Randomized Phase II Study to Investigate the Efficacy, Safety and Tolerability of ZK 230211 (25 mg vs. 100 mg) as Second-line Endocrine Therapy for Postmenopausal Women With Hormone Receptor-positive Metastatic Breast Cancer

summary: Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once the cancer has spread beyond the lymph nodes to areas such as e.g. the skin, soft tissues, lung, and liver it is called metastatic breast cancer. Patients who have been diagnosed with metastatic breast cancer that has progressed since their previous cancer treatment and that cannot be removed completely by surgery are eligible to be treated within this trial.Treatment with a new drug called Progesterone Receptor Antagonist ZK 230211 (ZK PRA) targets the progesterone receptor which may be expressed on breast cancer tumour cells. Therefore only patients with this progesterone receptor on their tumour cells can be included in this study.Progesterone receptor antagonists (including onapristone) have already shown efficacy in postmenopausal women with advanced breast cancer (Klijn et al. 2000). This phase II study investigates the efficacy (proof of concept), safety and tolerability of ZK PRA at two dose levels (25 mg and 100 mg) before initiating pivotal phase III trials.

ReferenceCitation: Jonat W, Bachelot T, Ruhstaller T, Kuss I, Reimann U, Robertson JFR. Randomized phase II study of lonaprisan as second-line therapy for progesterone receptor-positive breast cancer. Ann Oncol. 2013 Oct;24(10):2543-2548. doi: 10.1093/annonc/mdt216. Epub 2013 Jun 20.

lead_sponsor: Bayer

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Finland
Switzerland
Sweden
France
Germany


title: Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients

summary: The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

primary_purpose: Prevention

ReferenceCitation: Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S, Brown KA, Nashan B, Rostaing L, Meadows-Shropshire S, Agarwal M, Harler MB, Garcia-Valdecasas JC. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. Am J Transplant. 2014 Aug;14(8):1817-27.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Spain
Italy
Austria
Argentina
Canada
United States
France
Germany

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Washington University School Of Medicine

location_facility: Hospital Of The University Of Pennsylvania

location_facility: University Of California San Francisco Medical Center


acronym: ENTHUSE M1

title: A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.

lead_sponsor: AstraZeneca

location_country:
Serbia
United Kingdom
Italy
United States
Belgium
Japan
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Finland
Czech Republic
Korea, Republic of
France
Netherlands

summary:
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.


acronym: CARE-MS II

intervention_type: Biological

title: A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

lead_sponsor: Genzyme, a Sanofi Company

type: Registry Identifier

ReferenceCitation: Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernández Ó, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9. Review.

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernández Ó, Havrdová EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

ReferenceCitation: Horáková D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

ReferenceCitation: Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernández Ó, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernández Ó, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

ReferenceCitation: Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.

ReferenceCitation: Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.

ReferenceCitation: Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.

ReferenceCitation: Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Brazil
Canada
Germany
Denmark
Czech Republic
France
Netherlands

location_facility: Department of Neurology, Keck School of Medicine, University of Southern California

location_facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

location_facility: University of Louisville Research Foundation

location_facility: Neurology Consultants of Kansas City, Inc.

location_facility: Moscow State Public Medical Institution, City Clinical Hospital #11

location_facility: Klinikum Ingolstadt, Neurologische Klinik

location_facility: General Hospital Varazdin, Department of neurology

location_facility: General Hospital " Sveti Duh", Department of neurology

location_facility: Hôpital Civil, Departement de Neurologie

location_facility: East Bay Physicians Medical Group/Sutter East Bay Medical Foundation

location_facility: London Health Sciences Centre- University Hospital

location_facility: Ospedale Civile di Brescia c/o Ospedale Richiedei, Centro di riferimento per la Sclerosi Multiple

location_facility: Università di Genova Dipartimento di Neuroscienze Oftalmologia e Genetica

location_facility: Multiple Sclerosis Clinic, Connell 7, Kingston General Hospital

location_facility: AKH Wien, Universitätsklinikum für Neurologie

location_facility: University of California, Davis Medical Center

location_facility: Concord Repatriation General Hospital, Neurosciences Department

location_facility: Hospital Angeles del Pedregal; Camino a Santa Teresa

location_facility: Mayo Clinic Arizona, Department of Neurology

location_facility: George Washington University Medical Faculty Associates

location_facility: University of Michigan Department of Neurology

location_facility: Servicio de Neurología Hospital Virgen de la Macarena

location_facility: Municipal Treatment and Prevention Institution, "City Hospital #33"

location_facility: Kyiv Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System

location_facility: Indiana University School of Medicine, Department of Neurology

location_facility: Griffith School of Medicine, Gold Coast Campus, Griffith University

location_facility: Servicio de Neurología Hospital Clínico San Carlos

location_facility: Servicio de Neurología Hospital Carlos Haya

location_facility: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Rockstock

location_facility: University of Florida Neuroscience Institute

location_facility: Louisiana State University Health Sciences Center

location_facility: Renown Institute for Neurosciences / Renown regional Medical Center

location_facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic

location_facility: Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center

location_facility: Salford Royal NHS Foundation Trust, Clinical Trials Unit

location_facility: CHU Clermont-Ferrand, Hôpital Gabriel Montpied

location_facility: Wayne State University, School of Medicine, Department of Neurology

location_facility: Ruan Neurology Clinic and Research Center

location_facility: Institution of the Russian Academy of Sciences, "Institute of the Human Brain n.a. N.P. Bekhtereva within the Russian Academy of Sciences"

location_facility: Independent Public Teaching Hospital No. 4 in Lublin

location_facility: Liverpool Hospital, Neurology Department

location_facility: St.Petersburg State Medical Institution, "City Multispecialty Hospital #2"

location_facility: St. Vincent's Hospital, MS Education & Research, Department of Clinical Neurosciences

location_facility: Spectrum Health Medical Group, Neurology (Previously known as Michigan Medical P.C., Neurology)

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilioin

location_facility: Danylo Halytsky Lviv National Medical University, Department of Neurology

location_facility: Clinical Centre Vojvodina Institute of Neurology

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: Krankenhaus Hohe Warte, Betriebsstätte der Bayreuth

location_facility: St.Petersburg State Medical Institution, "Nikolayevskaya Hospital"

location_facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

location_facility: University Hospital Leuven, Campus Gasthuisberg, Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: Clinic of Neurology, Clinical Centre of Serbia

location_facility: Clinical Cognitive Research Unit/Clinical Trials, The Queen Elizabeth Hospital, Neurology Department

location_facility: Servicio de Neurología Hospital Vall d'Hebron Paseo de Vall d'Hebron

location_facility: Unidad de Investigación en Salud de Chihuahua, S.C.

location_facility: SUNY Upstate Medical University, Department of Neurology

location_facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science Barts and The London School of Medicine and Dentistry

location_facility: Århus Universitetshospital, Scleroseklinikken, Århus Sygehus

location_facility: Krajska zdravotni a.s. - Hospital Teplice

location_facility: Federal State Institution: Siberian District Medical Center

location_facility: Azienda Ospedaliera Sant'Andrea Neurologia

location_facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine

location_facility: Cleveland Clinic Foundation, Mellen Center

location_facility: Wake Forest University Health Science, Department of Neurology

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Ospedale Binaghi - Centro Sclerosi Multipla

location_facility: Emory University, Department of Neurology

location_facility: Royal Melbourne Hospital, Department of Neurology

location_facility: University of Kansas Medical Center, Department of Neurology

location_facility: University of North Carolina-Chapel Hill, Department of Neurology

location_facility: Clinical Hospital Centre Rijeka, Clinic for Neurology

location_facility: North Central Neurology Associates, P.C.

location_facility: Moscow State Medical Institution City Clinical Hospital #11, Moscow City Center for Multiple Sclerosis

location_facility: Negroski, Stein, Sutherland and Hanes Neurology

location_facility: Orbis Medisch Centrum, Department of Neurology

location_facility: Hôpital Pitié Salpétrière, Service de Neurologie

location_facility: Department of Neurology 1st Faculty of Medicine and General Teaching Hospital, MS Center

location_facility: Partners Multiple Sclerosis Center/Brigham and Women's Hospital

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: St. Petersburg Pavlov State Medical University, Department of Neurology and Neurosurgery with a Clinic

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Klinikum Rechts der Isar, Klinik für Neurologie

location_facility: Centre de Sante et de Services Sociaux de Gatineau-Hull Hospital

location_facility: Institution of the Russian Academy of Medical Sciences, "Neurology Scientific Center under RAMS"

location_facility: Cliniques Universitaires Saint-Luc, Neurology

location_facility: Tel Aviv Sourasky Medical Center, Department of Neurology

location_facility: University of Chicago Medical Center, Department of Neurology

location_facility: State Medical Institution, "Samara Regional Clinical Hospital n.a. M.I. Kalinin"

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: Sahlgrenska University Hospital, Neurologkliniken

location_facility: Lehigh Valley Hospital, Neuroscience and Pain Research

location_facility: Department of Neurology Glossop Road, Royal Hallamshire Hospital

location_facility: University of Pittsburgh, Kaufmann Medical Building

location_facility: Heliodor Swiecicki Teaching Hospital of the Poznan, University of Medical Sciences

location_facility: Clinique Neuro rive-sud, Recherche sepmus inc

location_facility: University of South Florida, Department of Neurology

location_facility: Multiple Sklerose Zentrum am, Zentrum für klinische Neurowissenschaften, Neurologische Uniklinik Dresden

location_facility: Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis

summary: The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.


title: A Double-Blind, Randomized, Stratified Multi-Center Trial Evaluating Conventional and Double Dose Oseltamivir in the Treatment of Immunocompromised Patients With Influenza

study_start_date_type: Actual

ReferenceCitation: Mitha E, Krivan G, Jacobs F, Nagler A, Alrabaa S, Mykietiuk A, Kenwright A, Le Pogam S, Clinch B, Vareikiene L. Safety, Resistance, and Efficacy Results from a Phase IIIb Study of Conventional- and Double-Dose Oseltamivir Regimens for Treatment of Influenza in Immunocompromised Patients. Infect Dis Ther. 2019 Dec;8(4):613-626. doi: 10.1007/s40121-019-00271-8. Epub 2019 Oct 30.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Belgium
South Africa
Czechia
Poland
Argentina
Israel
Mexico
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Latvia
Estonia
France
Chile
Colombia

location_facility: University of Alabama at Birmingham; Pediatric Nephrology

location_facility: Scott and White Division of Nephrology Dept of Medicine

location_facility: UNI-Klinikum Heidelberg Chirurgische Klinik

location_facility: Charite - Campus Virchow Klinikum; Abteilung fuer Chirurgie

location_facility: Hopital Saint Louis; Service de Nephrologie - Transplantation

location_facility: Novant Health Pulmonary and Critical Care

location_facility: Institutul de Urologie Si Transplant Renal Fundeni

location_facility: Our Lady of Lourdes Medical Center; Transplant Dept

location_facility: North Estonia medical Centre; Hematology

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; Infectología piso 7

location_facility: Ukrainian Pediatric Specialized Hospital of Ministry of Health of Ukraine Dept of BMT

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Fov.Onk.Egyesitett Szt. Istvan es Szt Laszlo Korh.-Rend.Int.

location_facility: Zaporozhye State Medical University; Dept of Transplantology

location_facility: Tartu Uni Clinics; Clinic of Surgery & Internal Medicine Dept of Nephrology

location_facility: Texas Tech University Health Sciences Center; Department of Urology

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: The Institute of Hematology and Blood Transfusion Transplantation Unit; Hematology and Blood Transf

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Universitätsspital Zürich; Klinik für Nephrologie

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Hospital Universitario 12 de Octubre; HIV Unit

location_facility: All Children'S Hospital; Pediatric Blood & Marrow Transplant Program

location_facility: Mhat Alexandrovska Ead ; Clinic of Nephrology & Transplantation, Uni Hospital

location_facility: Universitaetsklinikum Muenster; Paedriatrische Haematologie und Onkologie

location_facility: Nottingham City Hospital; Transplant Unit

location_facility: UT Southwestern Medical Center; Pediatrics Dept.

location_facility: Uni of Michigan Medical Center; Internal Medicine/ Infectious Disease

location_facility: Hospital General de Agudos Dr. Ignacio Pirovano

location_facility: Rabin Medical Center-Golda Campus - Hasharon; Department of Transplantation

location_facility: Sammons Cancer Center-Baylor University; Blood & Marrow Transplantation

location_facility: Republican Tuberculosis and Infectious Diseases University H

location_facility: Hospital General de Agudos Juan Antonio Fernandez; infectología

location_facility: Hospital Universitario la Paz; Servicio de Enfermedades Infecciosas - HIV unit

location_facility: SPZOZ Uniwersytecki Szp Klin; nr1 im.N.Barlickiego UM

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; Clinica Pediatica De Macchi

location_facility: University of California Davis Health System

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Universitario La Paz; Hepatología y Trasplantes

location_facility: Children'S Hospital of Pittsburgh; Infectious Disease

location_facility: Fundacion Cardiovascular de Colombia - Instituto del Corazón

location_facility: Hopital Europeen Georges Pompidou; Service de Nephrologie

location_facility: Institute of Nephrology AMS; Dept of Nephrology & dialysis

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: Uni of Cincinnati Medical Center; Nephrology & Hypertension

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: University of Szeged; Transplantation Department

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Medical College of Georgia; Medicine/ Nephrology

location_facility: Mount Sinai Medical Center; Division of Liver Diseases

location_facility: M.D Anderson Cancer Center; Infectious Diseases, Infection Control, and Employee Health

location_facility: Wayne State University School of Medicine

location_facility: UMHAT Sv. Georgi, EAD; Clinic of Infectious Diseases

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: ASST DI MONZA; Divisione Malattie Infettive

location_facility: Cleveland Clinic Foundation; Infectious Disease

location_facility: Hospital Universitario de Monterrey; Infectologia

location_facility: Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Dipartimento Malattie Infettive

location_facility: Kaunas Clinics Public Institution; Clinic of Nephrology

location_facility: University of Maryland School of Medicine

location_facility: Lugansk Regional Clinical Hospital; Chair of Therapy Faculty of Postgr.Ed

location_facility: University of Colorado; Kidney Transplant Center Office of Dr. Laurence Chan

location_facility: Hospital Roosevelt Guatemala; Clinica de Infecciosas

location_facility: KASMED, s.r.o.; Alergologie a klinicka imunologie

location_facility: Hospital de Especialidades del Centro Medico Puerta de Hierr

location_facility: Latvia Transplantation Center P. Stradina Hospital; Transplantation

location_facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Debreceni Egyetem, Orvos- és Egészségtudományi Centrum;

location_facility: Northwestern Memorial Hospital; Divison of Infectious Diseases/ Dept of Medicine

location_facility: West Tallinn Central Hospital; Nephrology

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University of Pennsylvania Health System

location_facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building

location_facility: Nazih Zuhdi Transplant Inst. ; Integris Baptist Medical Center

location_facility: UMHA - Sv. Georgi; Clinic of Nephrology & Haemodialysis

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador; Infectologia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Uni of Pennsylvania; Infectious Diseases

location_facility: Fakultni nemocnice v Motole; Klinika detske hematologie a onkologie UK 2.LF

location_facility: Tartu University Hospital; Department of Infectious Diseases

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Uni of Alabama At Birmingham; Division of Nephrology

location_facility: University of Utah Health Science Center Gastroenterology

location_facility: Phylaxis Clinical Research S de RL de CV

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Medical University of South Carolina; Pediatric Cardiology

location_facility: Tygerberg Hospital Pediatrics and Child Health

location_facility: Wake Forest University Baptist Medical Center

location_facility: Rush Uni Medical Center; Medicine/ Section of Infectious Diseases

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Henry Ford Health System; Gastroenterology

location_facility: Baylor University Medical Center Transplant Administration

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Enfermedades Infecciosas

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hospital Universitario 12 de Octubre; Servicio de Pediatria

location_facility: Western New England Renal & Transplant Associates, P.C.

location_facility: University of Texas Health Science Center Transplant center

location_facility: Hospital Luis Calvo Mackenna; Unidad de Investigacion

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: Wojewodzki Szp.Specjalistyczny im.K.Dluskiego w Bialymstoku

location_facility: Synexus Clinical Research Centres SA Stanza Bopape

location_facility: Ludwig-Maximilians-Universitaet; Medizinische Klinik und Poliklinik IV

location_facility: University of Chicago; Infectious Disease

location_facility: Centro de Investigaciones Clinicas S.A.S

location_facility: Szpital Dzieciatka Jezus-Centrum Lecezenia Obrazen; Dpt of Transplantation Medicine & Nephrology

location_facility: Hadassah University Hospital - Ein Kerem; BMT & Cancer Immunotherapy Dept.

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: CALIFORNIA PACIFIC MEDICAL CENTER; Office of Dr. Venkat Peddi

location_facility: Siauliai Republican Hospital Public Institution

location_facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

location_facility: Specialized Hospital for children with oncohaematologica Diseases; Dept. Of Transplantations

location_facility: Azienda Ospedaliera; Divisione Malattie Infettive E Tropicali

location_facility: Hopital Robert Debre; Pediatric Hematology Dept

summary: This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.


title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

summary: To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

design_allocation: Non-Randomized

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United Kingdom
Austria
Netherlands
Canada
Puerto Rico
United States
France
Germany

location_facility: Virology Treatment Center, Maine Medical Center

location_facility: Columbia Gastroenterology Associates, PA

location_facility: University of British Columbia Vancouver General Hospital

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of Miami Center for Liver Diseases

location_facility: University of Colorado Health Sciences Center


title: A 26-week Treatment, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study to Assess the Safety of Indacaterol (300 and 600 µg o.d.) in Patients With Moderate to Severe Persistent Asthma, Using Salmeterol (50 µg b.i.d.) as an Active Control

summary: This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily [od]), compared with salmeterol (50 μg twice a day [b.i.d.]), over 26 weeks, in patients with moderate to severe persistent asthma.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Argentina
Czech Republic
Canada
Hungary
United States
France
Peru
Turkey
Germany
Slovakia

location_facility:
Novartis Investigator site
Novartis Investigative Site
Novartis Investigator Site x 2 sites
Novartis Investigator Site


title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With RRMS

acronym: ALLEGRO

summary: Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).

ReferenceCitation: Kolb-Sobieraj C, Gupta S, Weinstock-Guttman B. Laquinimod therapy in multiple sclerosis: a comprehensive review. Neurol Ther. 2014 May 6;3(1):29-39. doi: 10.1007/s40120-014-0017-6. eCollection 2014 Jun. Review.

ReferenceCitation: Filippi M, Rocca MA, Pagani E, De Stefano N, Jeffery D, Kappos L, Montalban X, Boyko AN, Comi G; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage. J Neurol Neurosurg Psychiatry. 2014 Aug;85(8):851-8. doi: 10.1136/jnnp-2013-306132. Epub 2013 Sep 12.

ReferenceCitation: Comi G, Jeffery D, Kappos L, Montalban X, Boyko A, Rocca MA, Filippi M; ALLEGRO Study Group. Placebo-controlled trial of oral laquinimod for multiple sclerosis. N Engl J Med. 2012 Mar 15;366(11):1000-9. doi: 10.1056/NEJMoa1104318.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Czechia
Poland
Austria
Russian Federation
Israel
Turkey
Sweden
Canada
Hungary
Germany
Bulgaria
Latvia
Georgia
Estonia
France
Netherlands

location_facility:
Teva Investigational Site 3240
Teva Investigational Site 1088
Teva Investigational Site 3140
Teva Investigational Site 3146
Teva Investigational Site 3133
Teva Investigational Site 5704
Teva Investigational Site 3137
Teva Investigational Site 3139
Teva Investigational Site 1076
Teva Investigational Site 5316
Teva Investigational Site 5026
Teva Investigational Site 1073
Teva Investigational Site 3251
Teva Investigational Site 1079
Teva Investigational Site 1131
Teva Investigational Site 5029
Teva Investigational Site 1081
Teva Investigational Site 5705
Teva Investigational Site 5027
Teva Investigational Site 3242
Teva Investigational Site 5504
Teva Investigational Site 5315
Teva Investigational Site 1090
Teva Investigational Site 1075
Teva Investigational Site 5802
Teva Investigational Site 5208
Teva Investigational Site 5210
Teva Investigational Site 4204
Teva Investigational Site 3422
Teva Investigational Site 5318
Teva Investigational Site 1128
Teva Investigational Site 1130
Teva Investigational Site 3809
Teva Investigational Site 3239
Teva Investigational Site 5322
Teva Investigational Site 4206
Teva Investigational Site 5116
Teva Investigational Site 3247
Teva Investigational Site 1083
Teva Investigational Site 5021
Teva Investigational Site 1098
Teva Investigational Site 3144
Teva Investigational Site 5211
Teva Investigational Site 1092
Teva Investigational Site 5804
Teva Investigational Site 3039
Teva Investigational Site 3243
Teva Investigational Site 1093
Teva Investigational Site 5505
Teva Investigational Site 8030
Teva Investigational Site 1086
Teva Investigational Site 5114
Teva Investigational Site 5900
Teva Investigational Site 5902
Teva Investigational Site 3245
Teva Investigational Site 3810
Teva Investigational Site 1100
Teva Investigational Site 1129
Teva Investigational Site 8100
Teva Investigational Site 1085
Teva Investigational Site 3244
Teva Investigational Site 1102
Teva Investigational Site 6100
Teva Investigational Site 3246
Teva Investigational Site 5115
Teva Investigational Site 3044
Teva Investigational Site 1087
Teva Investigational Site 5320
Teva Investigational Site 5022
Teva Investigational Site 3524
Teva Investigational Site 5325
Teva Investigational Site 8033
Teva Investigational Site 3525
Teva Investigational Site 1094
Teva Investigational Site 3138
Teva Investigational Site 5904
Teva Investigational Site 3303
Teva Investigational Site 3238
Teva Investigational Site 3046
Teva Investigational Site 5903
Teva Investigational Site 3135
Teva Investigational Site 5317
Teva Investigational Site 1126
Teva Investigational Site 3250
Teva Investigational Site 3040
Teva Investigational Site 3038
Teva Investigational Site 3424
Teva Investigational Site 3237
Teva Investigational Site 5416
Teva Investigational Site 8101
Teva Investigational Site 1082
Teva Investigational Site 3248
Teva Investigational Site 5800
Teva Investigational Site 3301
Teva Investigational Site 3047
Teva Investigational Site 1096
Teva Investigational Site 3300
Teva Investigational Site 3236
Teva Investigational Site 8032
Teva Investigational Site 5801
Teva Investigational Site 3045
Teva Investigational Site 3132
Teva Investigational Site 5031
Teva Investigational Site 1097
Teva Investigational Site 1084
Teva Investigational Site 5024
Teva Investigational Site 1101
Teva Investigational Site 3241
Teva Investigational Site 555
Teva Investigational Site 5030
Teva Investigational Site 6102
Teva Investigational Site 1132
Teva Investigational Site 3528
Teva Investigational Site 5212
Teva Investigational Site 3142
Teva Investigational Site 3143
Teva Investigational Site 5417
Teva Investigational Site 5023
Teva Investigational Site 5209
Teva Investigational Site 8031
Teva Investigational Site 3527
Teva Investigational Site 3526
Teva Investigational Site 3134
Teva Investigational Site 5117
Teva Investigational Site 3041
Teva Investigational Site 5319
Teva Investigational Site 5803
Teva Investigational Site 4205
Teva Investigational Site 3136
Teva Investigational Site 3529
Teva Investigational Site 5028
Teva Investigational Site 5905
Teva Investigational Site 8201
Teva Investigational Site 3811
Teva Investigational Site 5604
Teva Investigational Site 8034
Teva Investigational Site 3302
Teva Investigational Site 5901
Teva Investigational Site 3042
Teva Investigational Site 1134
Teva Investigational Site 5025
Teva Investigational Site 3425
Teva Investigational Site 3249
Teva Investigational Site 1078


title: Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma

summary: This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) [complete response (CR) or partial response (PR)] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.

ReferenceCitation: Dummer R, Duvic M, Scarisbrick J, Olsen EA, Rozati S, Eggmann N, Goldinger SM, Hutchinson K, Geskin L, Illidge TM, Giuliano E, Elder J, Kim YH. Final results of a multicenter phase II study of the purine nucleoside phosphorylase (PNP) inhibitor forodesine in patients with advanced cutaneous T-cell lymphomas (CTCL) (Mycosis fungoides and Sézary syndrome). Ann Oncol. 2014 Sep;25(9):1807-1812. doi: 10.1093/annonc/mdu231. Epub 2014 Jun 19.

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Spain
Italy
Austria
Australia
United Kingdom
Finland
Switzerland
United States
France
Germany

location_facility: University Hospitals Case Medical Center, Dept. of Dermatology

location_facility: Washington University School of Medicine

location_facility: Wake Forest University Health Sceinces, Dept. of Dermatology

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Ctr

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Hospital at the University of Pennsylvania

location_facility: University of Wisconsin-Madison, Dept of Dermatology

location_facility: Hillman Cancer Ctr., University of Pittsburgh

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie

location_facility: M.D. Anderson Cancer Center - Dermatology


title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

summary: This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

ipd_sharing: No

lead_sponsor: ACADIA Pharmaceuticals Inc.

location_country:
United Kingdom
Russian Federation
Ukraine
India
United States
France
Bulgaria


title: A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.

summary: Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

ReferenceCitation: Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11:10. doi: 10.1186/1465-9921-11-10. Erratum in: Respir Res. 2010;11:88.

location_country:
Brazil
Spain
Greece
Ireland
Italy
United Kingdom
Argentina
Andorra
United States
Chile
France
Israel
Mexico
South Africa
Germany


acronym: iINHALE 7

title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

lead_sponsor: Novo Nordisk A/S

location_country: Poland Austria Mexico Argentina Canada France India Israel Turkey Belgium Bulgaria

summary: This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).


title: A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

ReferenceType: result

ReferenceCitation: Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelová A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.

ReferenceCitation: Kalra S, Plata-Que T, Kumar D, Mumtaz M, Søndergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.

location_country:
Poland
Romania
Spain
Austria
Netherlands
Argentina
Czech Republic
Former Serbia and Montenegro
Sweden
France
India
South Africa
Mexico
Philippines
Malaysia

summary:
This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.


title: European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

summary: The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Spain
Greece
Ireland
Italy
Czech Republic
Sweden
France
Belgium
Germany
Slovakia
Cyprus


title: A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

summary: The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16. Review.

ReferenceCitation: Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109.

ReferenceCitation: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.

location_country:
Spain
Italy
United Kingdom
Ukraine
Belgium
Philippines
South Africa
Poland
Austria
Russian Federation
India
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Hungary
China
Germany
Denmark
Czech Republic
Korea, Republic of
France
Chile
Colombia


title: A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.

summary: This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

ReferenceCitation: Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.

location_country:
Taiwan
Brazil
Hong Kong
Russian Federation
Australia
New Zealand
Thailand
Korea, Republic of
United States
France
China
Singapore
Germany


title: A Phase II, Open-Label Trial Using Velcade for ReTreatment of Multiple Myeloma Subjects Following an Initial Response to Velcade

summary: The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.

lead_sponsor: Janssen-Cilag International NV

location_country: Portugal Luxembourg Spain Greece Austria France Belgium Germany


title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

ReferenceCitation: Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.

ReferenceCitation: Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3. Erratum in: Obstet Gynecol. 2008 Dec;112(6):1392.

location_country:
Denmark
Finland
Czech Republic
Hungary
France
Norway
Sweden

summary: This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.


title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen

summary: This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

ReferenceCitation: Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.

ReferenceCitation: Monk BJ, Pandite LN. Survival data from a phase II, open-label study of pazopanib or lapatinib monotherapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2011 Dec 20;29(36):4845. doi: 10.1200/JCO.2011.38.8777. Epub 2011 Nov 14.

ReferenceCitation: de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

location_country:
Spain
Ireland
Italy
Estonia
Mexico
Argentina
Canada
Thailand
United States
France
India
Belgium
Germany


title: A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

ReferenceCitation: Spaeth M, Russell IJ, Perrot S, Alvarez-Horine S, Guinta D, Wang YG, Bennett R. Durability of Response in a 38-Week Open-Label Study of Sodium Oxybate in Patients With Fibromyalgia [ACR/ARHP abstract 2356]. Arthritis Rheum. 2010;62(suppl 10):97.

ReferenceCitation: Spaeth M, Alegre C, Perrot S, Wang Y, Guinta DR, Alvarez-Horine S, Russell I; Sodium Oxybate Fibromyalgia Study Group. Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia. Arthritis Res Ther. 2013 Nov 11;15(6):R185. doi: 10.1186/ar4375.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Netherlands
United States
France
Germany

location_facility: Praxis fur Innere Medizin und Rheumatologie

location_facility: Professional Clinical Research, Inc. at Crystal Lake Health Center

location_facility: Clinical Research Group of St. Petersburg, Inc

location_facility: Hill Top Physicians Inc./Hightop Medical Research Center

location_facility: Azienda Ospedaliera universitaria Pisana-Ospedale Santa Chiara

location_facility: Centre Catherine de Sienne unite d evaluation et de traitement de la douleur

location_facility: Hopital Hotel Dieu service de medicine interne

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Anderson & Collins Clinical Research, Inc.

location_facility: Hopital Claude Huriez Service de medecine interne

location_facility: Gemeinschaftspraxis fur anasthesie und spezielle Schmerztherapie

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Professional Clinical Research at Crystal Lake Health Center


title: A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery (The Advance-3 Study Apixaban Dosed Orally Versus Anticoagulation With Injectable Enoxaparin to Prevent Venous Thromboembolism)

summary: The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

ReferenceCitation: Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.

location_country:
Spain
United Kingdom
Ukraine
United States
Romania
Belgium
Poland
Russian Federation
Australia
Argentina
India
Israel
Mexico
Norway
Sweden
Canada
Hungary
China
Germany
Denmark
France

location_facility: Advanced Orthopedic And Sports Medicine Specilists


title: A Ten-week, Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled, Paralleled-Group, Flexible-Dose Study Evaluating the Efficacy, Safety and Tolerability of GSK372475 or Paroxetine Compared to Placebo in Adult Subjects Diagnosed With Major Depressive Disorder

summary: To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

ReferenceCitation: Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.

lead_sponsor: GlaxoSmithKline

location_country:
Croatia
Poland
Italy
Canada
Costa Rica
Chile
France
India
Germany
Bulgaria