title: REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

summary: The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.

location_country:
Croatia
Poland
Saudi Arabia
Spain
Thailand
Indonesia
Sweden
Hungary
Korea, Republic of
France
Malaysia
China
Singapore
South Africa
Germany


status: Completed

primary_purpose: Treatment

acronym: CLARINET LT

intervention_type: Drug

title: Long Term Safety Study in Patients Included in the CLARINET Study With Cyanotic Congenital Heart Disease Palliated With a Systemic-to-pulmonary Artery Shunt and for Whom the Shunt is Still in Place at One Year of Age

study_completion_date_type: Actual

lead_sponsor: Sanofi

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Avlonitis VS, Planas S, Hayes AM, Parry A. Occlusion of modified Blalock-Taussig shunt after clopidogrel cessation. Ann Thorac Surg. 2012 Feb;93(2):656-8. doi: 10.1016/j.athoracsur.2011.07.071.

enrollment_type: Actual

location_country:
Poland
Taiwan
Brazil
Portugal
Spain
Italy
Russian Federation
United Kingdom
Hungary
United States
France
India
Malaysia
Mexico
Germany

summary:
This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension

acronym: ACCELERATE

summary: This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

primary_purpose: Diagnostic

ReferenceCitation: Brown MJ, Williams B, Morant SV, Webb DJ, Caulfield MJ, Cruickshank JK, Ford I, McInnes G, Sever P, Salsbury J, Mackenzie IS, Padmanabhan S, MacDonald TM; British Hypertension Society's Prevention and Treatment of Hypertension with Algorithm-based Therapy (PATHWAY) Studies Group. Effect of amiloride, or amiloride plus hydrochlorothiazide, versus hydrochlorothiazide on glucose tolerance and blood pressure (PATHWAY-3): a parallel-group, double-blind randomised phase 4 trial. Lancet Diabetes Endocrinol. 2016 Feb;4(2):136-47. doi: 10.1016/S2213-8587(15)00377-0. Epub 2015 Oct 18.

ReferenceCitation: Brown MJ, McInnes GT, Papst CC, Zhang J, MacDonald TM. Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet. 2011 Jan 22;377(9762):312-20. doi: 10.1016/S0140-6736(10)62003-X. Epub 2011 Jan 12.

lead_sponsor: Novartis

location_country:
United Kingdom
Greece
Canada
Switzerland
Guatemala
Venezuela
Costa Rica
France
South Africa
Germany


title: 28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.

acronym: LAPTOP

summary: To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

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

location_facility:
Sanofi-Aventis Administrative Office
Sanofi aventis administrative office
Sanofi-aventis administrative office


title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

ReferenceCitation: Branco JC, Cherin P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011 Jul;38(7):1403-12. doi: 10.3899/jrheum.101025. Epub 2011 Apr 1.

lead_sponsor: Pierre Fabre Medicament

location_country:
Portugal
Spain
Italy
Finland
Czech Republic
Sweden
France
Romania
Norway
Germany

location_facility: KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care


title: Efficacy and Safety of Dronedarone for the Control of Ventricular Rate During Atrial Fibrillation (ERATO)

acronym: ERATO

summary: The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population.

ReferenceType: result

ReferenceCitation: Davy JM, Herold M, Hoglund C, Timmermans A, Alings A, Radzik D, Van Kempen L; ERATO Study Investigators. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008 Sep;156(3):527.e1-9. doi: 10.1016/j.ahj.2008.06.010.

location_country:
Poland
Spain
Italy
Czech Republic
Switzerland
Sweden
France
Belgium
Netherlands


acronym: HIP

title: An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: a Long Term Study

lead_sponsor: AstraZeneca

location_country: Poland Italy Ukraine France Belgium Germany

summary: The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.


title: Comparison Trial Evaluating Efficacy and Safety of Single i.v. Bolus Tenecteplase Plus Standard Anticoagulation as Compared With Standard Anticoagulation in Normotensive Patients

acronym: PEITHO

summary: Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.

study_start_date_type: Actual

ReferenceCitation: Wan S, Quinlan DJ, Agnelli G, Eikelboom JW. Thrombolysis compared with heparin for the initial treatment of pulmonary embolism: a meta-analysis of the randomized controlled trials. Circulation. 2004 Aug 10;110(6):744-9. Epub 2004 Jul 19.

ReferenceCitation: Zuo Z, Yue J, Dong BR, Wu T, Liu GJ, Hao Q. Thrombolytic therapy for pulmonary embolism. Cochrane Database Syst Rev. 2021 Apr 15;4:CD004437. doi: 10.1002/14651858.CD004437.pub6.

ReferenceCitation: Konstantinides SV, Vicaut E, Danays T, Becattini C, Bertoletti L, Beyer-Westendorf J, Bouvaist H, Couturaud F, Dellas C, Duerschmied D, Empen K, Ferrari E, Galiè N, Jiménez D, Kostrubiec M, Kozak M, Kupatt C, Lang IM, Lankeit M, Meneveau N, Palazzini M, Pruszczyk P, Rugolotto M, Salvi A, Sanchez O, Schellong S, Sobkowicz B, Meyer G. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. J Am Coll Cardiol. 2017 Mar 28;69(12):1536-1544. doi: 10.1016/j.jacc.2016.12.039.

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galiè N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

ReferenceCitation: Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012 Jan;163(1):33-38.e1. doi: 10.1016/j.ahj.2011.10.003.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Poland Portugal Slovenia Greece Austria Italy Spain Hungary France Israel Belgium Germany

location_facility: Istituto di Cardiologia, Policlinico S.Orsola-MaBologna

lead_sponsor_type: academique


title: CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months

summary: Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10.

ReferenceCitation: Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljański J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.

location_country: Denmark Greece France Sweden Germany

location_facility:
Research Site
Research


title: A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer

acronym: XENON

summary:
Primary objective:

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer.

Secondary objective:

To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
To assess the effect of xaliproden on the rate of at least partial recovery of grade > 2 PSN at 6 months
To assess the effects of xaliproden on the time to complete recovery from PSN
To evaluate the safety profile of xaliproden

status: Terminated

location_country:
Spain
Greece
Italy
United Kingdom
Canada
United States
France
Germany

status_simplified: Unknown


title: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy

summary: The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Poland
Spain
Ireland
Italy
Australia
New Zealand
Canada
United Kingdom
Puerto Rico
United States
France
Israel
Belgium

location_facility: Complejo Hospitalario Universitario A Coruña- Hospital A Coruña

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Sandwell & West Birmingham Hospitals NHS Trust

location_facility: Az. Ospedaliera Universitaria S. Orsola Malpighi

location_facility: Auckland City Hospital / Auckland University

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: NHS Greater Glasgow and Clyde Western Infirmary

location_facility: UHCW (University Hospital Coventry and Warwickshire)

location_facility: Poole Hospital NHS Foundation Trust, Poole General Hospital

location_facility: Complejo Hospitalario de Navarra, Servicio de Hematologia


title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

acronym: STATURE

summary: The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
Canada
United States
France
India
Japan
Germany
Slovakia


title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week Follow-up

acronym: STRATUS-EU

summary:
The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

location_country:
Denmark
Spain
United Kingdom
Switzerland
France
Belgium
Sweden


title: Stroke in Young Fabry Patients (sifap2): Characterization of the Stroke Rehabilitation in Young Patients With Fabry Disease: An Epidemiological, International, Multicenter Prognosis Study

summary:
New studies indicate that in about 1 - 2 percent of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. In this case certain fat molecules are not digested and broken down by the body - but remain in the cells. These fat molecules build up to dangerous levels, which start to damage the body, because they accumulate e.g. in the walls of the blood vessels. This accumulation in the blood vessels of the whole body may cause life-threatening malfunctions in the brain, inducing a stroke.

The purpose of this study is to investigate the stroke rehabilitation of Fabry patients during different therapeutic standard approaches for stroke and for Fabry disease (if any). During this study, stroke patients with Fabry disease will be monitored in greater detail to determine whether the differences in treatment are significant for patient recovery and on what they depend.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Rolfs A, Böttcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Löhr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. Erratum in: Lancet. 2006 Dec 23;368(9554):2210.

ipd_sharing: Undecided

lead_sponsor: CENTOGENE GmbH Rostock

location_country: Croatia Poland Portugal Austria Georgia France Germany

location_facility: Department of Neurology, University Hospital Sestre Milosrdnice

location_facility: Heinrich-Heine-University Duesseldorf, Dept. of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Leipzig

location_facility: Charite Campus Benjamin Franklin, Dept. of Neurology

location_facility: Department of Neurology, University Tuebingen

location_facility: Institute of Psychiatry and Neurology, Dept. of Neurology

location_facility: Department of Neurology, Klinikum Chemnitz gGmbH

location_facility: Ludwig-Maximilians-University of Munich, Klinikum München-Großhadern, Dept. of Neurology

location_facility: Centro Hospitalar de Lisboa Central, Servico de Neurologia

location_facility: Department of Neurology, Universitaetsklinikum Carl Gustav Carus

location_facility: Department of Neurology, Universitaetsklinikum Jena

location_facility: University of Ulm, Department of Neurology

location_facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

location_facility: Department of Neurology, Klinikum Hohe Warte

location_facility: University of Giessen-Marburg Dept. of Neurology

location_facility: Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

location_facility: Department of Neurology, Universitaetsklinikum Hamburg-Eppendorf

location_facility: Department of Neurology, Allgemeines Krankenhaus Celle

location_facility: Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

intervention_type: Other


title: A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.

acronym: VEGA

summary:
The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A.

The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period.

The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.

location_country:
Spain
Italy
Russian Federation
Australia
Hungary
France
Chile
Mexico
Germany


title: A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

summary:
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

To establish the safety profile.
To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
To assess the Overall Survival (OS)

ReferenceCitation: Van Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496.

location_country:
Portugal
Spain
Italy
Russian Federation
United Kingdom
Switzerland
Hungary
United States
France
Turkey
Belgium
Germany


type: Other Identifier

title: Investigating Bone Density and Bone Loss Without Baseline Information

summary:
RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.

PURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.

ReferenceCitation: Decensi A, Sun Z, Guerrieri-Gonzaga A, Thürlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schönenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Spain
Italy
New Zealand
Australia
Switzerland
France
Peru
South Africa

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Institute of Oncology at Prince of Wales Hospital


title: 2-Weekly CHOP Chemotherapy With Dose-Dense Rituximab for the Treatment of Patients Aged 61 to 80 Years With Aggressive CD-20 Positive B-Cell Lymphomas: A Phase-II/Pharmacokinetic Study (CHOP-R-ESC)

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with previously untreated B-cell lymphoma.

lead_sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group

location_country:
Poland
United Kingdom
Italy
Netherlands
Switzerland
Sweden
France
Germany
Czechia

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Staedtisches Krankenhaus Muenchen - Harlaching

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Klinikum Schwaebisch Gmuend Stauferklinik

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Praxis Internistischer Onkologie und Haematologie - Koeln

location_facility: Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

location_facility: Gemeinschaftspraxis fuer Haematologie und Internist - Schweinfurt

location_facility: Onkologische Gemeinschaftspraxis - Kaiserslautern

location_facility: Krankenhaus Hohe Warte Mediziniche Klinik

location_facility: Gemeinschaftspraxis fuer Onkologie - Nordhorn

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Haematologische / Onkologische Schwerpunktpraxis

location_facility: Praxis fuer Haematologie und Onkologie - Burgwedel

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie - Flensburg

location_facility: Krankenhaus Barmherzige Brueder Regensburg

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Klinik fuer Onkologie - Katharinenhospital Stuttgart

location_facility: Helios Kliniken Wuppertal University Hospital

location_facility: Internistische Gemeinschaftspraxis - Halle

location_facility: St. Marienkrankenhaus - Frankfurt am Main

location_facility: Evangelisches Krankenhaus - Lutherstadt Wittenberg

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Gemeinschaftspraxis Dres. med. Ellbrueck/Goeller/Kraenzle/Niedermeier/Jocham

location_facility: Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

location_facility: Schwerpunktpraxis Haematologie/Onkologie - Hannover

location_facility: Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

location_facility: University Leipzig Clinic of Internal Medicine

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie - Luebeck

location_facility: Gastroenterologische und Haematologisch-Onkologische Praxis E. M. Dr. Hoering von Ehr Respondek

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Klinikum Barnim GmbH, Werner Forssmann Krankenhaus

location_facility: Internistische Gemeinschaftspraxis - Magdeburg

location_facility: Gemeinschaftspraxis fuer Haematologie - Northeim

location_facility: Praxis fur Innere Medizin - Schmiedeberg

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Gemeinschaftspraxis fuer Dres. Aldaoud und Schwarzer

location_facility: Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

location_facility: Praxis fuer Haematologie und Interne Onkologie

location_facility: Medizinische Klinik am Lukas - Krankenhaus

location_facility: Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

location_facility: Haematologie und Internistische Onkologie Praxis

location_facility: Praxis Dr. Rheinhold Siegmund - Dr. Matthias Penke

location_facility: Onkologische Schwerpunktpraxis - Villingen

location_facility: Praxis fuer Haematologie und Internistische Onkologie - Borken

location_facility: St. Marien Hospital - Muelheim an der Ruhr

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: Burkhard and Reimann Gemeinschaftspraxis

location_facility: Praxis Internistischer Onkologie und Haematologie - Frechen

location_facility: Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

location_facility: Onkologische Schwerwpunktpraxis Dr. Ladda

location_facility: Praxis fuer Innere Medizin am Krankenhaus Siloah - Pforzheim

location_facility: Praxis Fuer Internistische Haematologie / Onkologie

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Internistische Gemeinschaftspraxis - Jena

location_facility: Haematologische Praxis - Moenchengladbach

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Onkologische Schwerpunktpraxis Dr. med. Verpoort, PD Dr. med. Zeller and Dr. med. Wierecky

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Onkologische Schwerpunktpraxis Dr. Schmidt

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Internistische Praxis Dres. Hempel und Hochdorfer

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: Krankenhaus St. Elisabeth und St. Barbara

location_facility: Internistisch-Haematologische Gemeinschaftspraxis - Gustrow

location_facility: Onkologische Schwerpunktpraxis - Straubing

location_facility: Gemeinschaftspraxis feur Haemotologie und Onkologie - Weilheim

location_facility: St. Johannes Hospital - Medical Klinik II

location_facility: Onkologische Schwerpunktpraxis und Tagesklinik Dres

location_facility: Praxis fuer Onkologie am Diakonissenhaus

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Praxisklinik fuer Innere Medizin - Nuernberg

location_facility: Marienhospital at Ruhr University Bochum

location_facility: Medizinische Klinik III - Universitaetsklinikum Erlangen

location_facility: Gemeinschaftspraxis fuer Internistische - Frankenthal

location_facility: Haematologische/Onkologische Schwerpunktpraxis - Rostock

location_facility: Sophien - und Hufeland - Klinikum Weimar gGmbH

location_facility: Ruprecht - Karls - Universitaet Heidelberg

location_facility: Clinic for Bone Marrow Transplantation and Hematology and Oncology

location_facility: Schwerpunktpraxis Internist Onkologie - Marburg

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Regional Hospital Am Plattenwald Bad Friedrichshall

intervention_type: Biological


acronym: paradigm™ 3

title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

lead_sponsor: Novo Nordisk A/S

design_allocation: Non-Randomized

ReferenceCitation: Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]

location_country: Macedonia, The Former Yugoslav Republic of

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.


title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

summary: This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.

ReferenceCitation: Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51.

ReferenceCitation: Krusenstjerna-Hafstrøm T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.

location_country:
Poland
Spain
Finland
Hungary
Israel
France
South Africa
Norway
Germany


acronym: Rollover study

title: MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia

location_country:
Taiwan
Canada
Korea, Republic of
United States
France
Netherlands

summary: This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.


title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis

summary:
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.

The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

lead_sponsor: LEO Pharma

location_country:
Denmark
Portugal
Spain
United Kingdom
Canada
France
Norway
Sweden

location_facility: Hôpital de l'Archet, Service de Dermatologie

location_facility: Hospitais da Universidade de Coimbra, Servico de dermatologia

location_facility: FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: Hospital Virgen de la Macarena, Servicio de Dermatología

location_facility: Roskilde Hospital, Division of Dermatology

location_facility: Western Infirmary, Dermatology Department


title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Woodhouse L, Gandhi R, Warden SJ, Poiraudeau S, Myers SL, Benson CT, Hu L, Ahmad QI, Linnemeier P, Gomez EV, Benichou O; STUDY INVESTIGATORS. A Phase 2 Randomized Study Investigating the Efficacy and Safety of Myostatin Antibody LY2495655 versus Placebo in Patients Undergoing Elective Total Hip Arthroplasty. J Frailty Aging. 2016;5(1):62-70. doi: 10.14283/jfa.2016.81.

location_country:
Denmark
Spain
Austria
Estonia
Canada
Finland
United States
France
Belgium
Japan
Sweden

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.

summary: The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older participants undergoing elective total hip arthroplasty (eTHA).


title: Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

lead_sponsor: UCB Pharma SA

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

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

summary: This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.


title: A Randomized and Controlled Clinical Study to Evaluate the Efficacy and Safety of Fibrin Sealant VH S/D (FS VH S/D) in Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites

summary: This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing lumpectomy and level I and II axillary lymph node dissection with two separate incisions.

lead_sponsor: Baxter Healthcare Corporation

location_country: Austria Germany France Italy

location_facility: Istituto Nationale per la Ricerca sul Cancro

location_facility: Allgemeines Krankenhaus der Stadt Wien, University Clinic for Gynecology

location_facility: Centre Régional de Lutte Contre le Cancer, Centre Eugène Marquis

location_facility: S. Luigi - S. Curro, Presidi Ospedalieri Unificati

intervention_type: Procedure


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X Syndrome

ReferenceCitation: Bailey DB Jr, Berry-Kravis E, Wheeler A, Raspa M, Merrien F, Ricart J, Koumaras B, Rosenkranz G, Tomlinson M, von Raison F, Apostol G. Mavoglurant in adolescents with fragile X syndrome: analysis of Clinical Global Impression-Improvement source data from a double-blind therapeutic study followed by an open-label, long-term extension study. J Neurodev Disord. 2016;8:1. doi: 10.1186/s11689-015-9134-5. Epub 2015 Dec 15.

ReferenceCitation: Berry-Kravis E, Des Portes V, Hagerman R, Jacquemont S, Charles P, Visootsak J, Brinkman M, Rerat K, Koumaras B, Zhu L, Barth GM, Jaecklin T, Apostol G, von Raison F. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials. Sci Transl Med. 2016 Jan 13;8(321):321ra5. doi: 10.1126/scitranslmed.aab4109.

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Indonesia
Switzerland
Sweden
United States
France
Israel
Turkey
Belgium
Germany

summary: This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.


title: An Open-label, Randomized, Multicenter, Clinical Study to Compare the Effects of Telithromycin, Azithromycin and Cefuroxime Axetil on the Penicillin or Macrolide Resistance of Streptococcus Pneumoniae in Patients With Acute Exacerbation of Chronic Bronchitis

summary:
Primary Objective:

The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae (Sp) strains resistant to beta-lactams or macrolides at the Test of Cure (TOC) visit in the sputum of patients with Sp detected at the start of the study (Visit 1).

Secondary Objectives:

The secondary objectives of the study are:

To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1);
To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at the End of Therapy (EOT) and Test of Cure visits;
To compare the effect of telithromycin, azithromycin and cefuroxime axetil at the End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1);
To compare the clinical efficacy at the End of Therapy visit and safety at the Test of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the "global" randomized population.

location_country:
Spain
Tunisia
Hungary
United States
France
Turkey
Belgium
Morocco


title: Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

summary: This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

ReferenceCitation: Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A. Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2011 Mar;26(2):75-83. doi: 10.1097/YIC.0b013e328341bb5f.

ReferenceCitation: Sheehan DV, Meyers AL, Prakash A, Robinson MJ, Swindle RW, Russell JM, Mallinckrodt CH. The relationship between functional outcomes and the treatment of anxious and painful somatic symptoms in patients with generalized anxiety disorder. Curr Med Res Opin. 2008 Sep;24(9):2457-66. doi: 10.1185/03007990802293643 . Epub 2008 Jul 24.

ReferenceCitation: Hartford JT, Endicott J, Kornstein SG, Allgulander C, Wohlreich MM, Russell JM, Perahia DG, Erickson JS. Implications of pain in generalized anxiety disorder: efficacy of duloxetine. Prim Care Companion J Clin Psychiatry. 2008;10(3):197-204.

ReferenceCitation: Koponen H, Allgulander C, Erickson J, Dunayevich E, Pritchett Y, Detke MJ, Ball SG, Russell JM. Efficacy of duloxetine for the treatment of generalized anxiety disorder: implications for primary care physicians. Prim Care Companion J Clin Psychiatry. 2007;9(2):100-7.

ReferenceCitation: Allgulander C, Hartford J, Russell J, Ball S, Erickson J, Raskin J, Rynn M. Pharmacotherapy of generalized anxiety disorder: results of duloxetine treatment from a pooled analysis of three clinical trials. Curr Med Res Opin. 2007 Jun;23(6):1245-52. Epub 2007 Apr 25.

ReferenceCitation: Endicott J, Russell JM, Raskin J, Detke MJ, Erickson J, Ball SG, Marciniak M, Swindle RW. Duloxetine treatment for role functioning improvement in generalized anxiety disorder: three independent studies. J Clin Psychiatry. 2007 Apr;68(4):518-24. Erratum in: J Clin Psychiatry. 2007 Apr;68(4):518. J Clin Psychiatry. 2007 May;68(5):806.

location_country:
Spain
Finland
Sweden
United States
France
South Africa
Germany

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


title: Phase II Clinical Trial On Taxol As Single Agent In Locally Advanced And/Or Metastatic Or Recurrent Vulva Cancer Not Amenable For Surgery And/Or Radiotherapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva.

ReferenceCitation: Witteveen PO, van der Velden J, Vergote I, Guerra C, Scarabeli C, Coens C, Demonty G, Reed N. Phase II study on paclitaxel in patients with recurrent, metastatic or locally advanced vulvar cancer not amenable to surgery or radiotherapy: a study of the EORTC-GCG (European Organisation for Research and Treatment of Cancer--Gynaecological Cancer Group). Ann Oncol. 2009 Sep;20(9):1511-1516. doi: 10.1093/annonc/mdp043. Epub 2009 Jun 1.

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

location_country:
Portugal
United Kingdom
Italy
France
Belgium
Netherlands

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Hospitais da Universidade de Coimbra (HUC)


title: An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
United States
France
Germany

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).


title: Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

summary:
RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

ReferenceCitation: Wittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82.

ReferenceCitation: Verbakel WF, Hideghety K, Morrissey J, Sauerwein W, Stecher-Rasmussen F. Towards in vivo monitoring of neutron distributions for quality control of BNCT. Phys Med Biol. 2002 Apr 7;47(7):1059-72.

ReferenceCitation: Hüsing J, Sauerwein W, Hideghéty K, Jöckel KH. A scheme for a dose-escalation study when the event is lagged. Stat Med. 2001 Nov 30;20(22):3323-34.

ReferenceCitation: Rassow J, Stecher-Rasmussen F, Voorbraak W, Moss R, Vroegindeweij C, Hideghéty K, Sauerwein W. Comparison of quality assurance for performance and safety characteristics of the facility for Boron Neutron Capture therapy in Petten/NL with medical electron accelerators. Radiother Oncol. 2001 Apr;59(1):99-108. Review.

ReferenceCitation: Sauerwein W, Moss R, Rassow J, Stecher-Rasmussen F, Hideghéty K, Wolbers JG, Sack H. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group. Strahlenther Onkol. 1999 Jun;175 Suppl 2:108-11.

ReferenceCitation: Gabel D, Philipp KH, Wheeler FJ, Huiskamp R. The compound factor of the 10B(n,alpha)7Li reaction from borocaptate sodium and the relative biological effectiveness of recoil protons for induction of brain damage in boron neutron capture therapy. Radiat Res. 1998 Apr;149(4):378-86.

ReferenceCitation: Pignol JP, Oudart H, Chauvel P, Sauerwein W, Gabel D, Prevot G. Selective delivery of 10B to soft tissue sarcoma using 10B-L-borophenylalanine for boron neutron capture therapy. Br J Radiol. 1998 Mar;71(843):320-3.

ReferenceCitation: Verbakel WF, Sauerwein W, Hideghety K, Stecher-Rasmussen F. Boron concentrations in brain during boron neutron capture therapy: in vivo measurements from the phase I trial EORTC 11961 using a gamma-ray telescope. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):743-56.

ReferenceCitation: Hideghéty K, Sauerwein W, Haselsberger K, Grochulla F, Fankhauser H, Moss R, Huiskamp R, Gabel D, de Vries M. Postoperative treatment of glioblastoma with BNCT at the petten irradiation facility (EORTC protocol 11,961). Strahlenther Onkol. 1999 Jun;175 Suppl 2:111-4.

ReferenceCitation: Gabel D, Touw D, Stecher-Rasmussen F, et al.: Quality control of Na2B12H11SH, a drug boron neutron capture therapy in EORTC trial 11961. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Hideghéty K, Sauerwein W, Wittig A, Götz C, Paquis P, Grochulla F, Haselsberger K, Wolbers J, Moss R, Huiskamp R, Fankhauser H, de Vries M, Gabel D. Tissue uptake of BSH in patients with glioblastoma in the EORTC 11961 phase I BNCT trial. J Neurooncol. 2003 Mar-Apr;62(1-2):145-56.

ReferenceCitation: Hideghety W, Sauerwein W, DeVries M, et al.: Post-operative treatment of glioblastoma with boron neutron capture therapy at the European High Flux Reactor Petten (EORTC protocol 11961). [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Sauerwein W, Hideghety K, De Vries M, et al.: Boron neutron capture therapy (BNCT) for the treatment of glioblastoma (EORTC protocol 11961). [Abstract] Radiother Oncol 48(suppl 1): s157, 1998.

ReferenceCitation: Sauerwein W, Hideghety K, De Vries M, et al.: Conducting phase I clinical trial in binary treatment modality: methodical questions for the evaluation of boron neutron capture therapy. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.

ReferenceCitation: Vos MJ, Turowski B, Zanella FE, Paquis P, Siefert A, Hideghéty K, Haselsberger K, Grochulla F, Postma TJ, Wittig A, Heimans JJ, Slotman BJ, Vandertop WP, Sauerwein W. Radiologic findings in patients treated with boron neutron capture therapy for glioblastoma multiforme within EORTC trial 11961. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):392-9.

ReferenceCitation: Haselsberger K, Pendl G, Sauerwein W, et al.: BNCT for glioblastoma in Europe: design of the EORTC protocol 11961 and clinical course of the first patient. [Abstract] J Neurooncol 39 (2): A-P155, 147, 1998.

location_country: Italy Austria Netherlands Canada France Germany

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

location_facility: EC Joint Research Centre - Institute for Energy


title: A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.

ReferenceCitation: Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. Epub 2006 Nov 3.

location_country:
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

intervention_type: Radiation


title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

ReferenceCitation: Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Czech Republic
United States
France
Mexico
Germany

location_facility:
Site Reference ID/Investigator# 51271
Site Reference ID/Investigator# 51269
Site Reference ID/Investigator# 51504
Site Reference ID/Investigator# 51506
Site Reference ID/Investigator# 52743
Site Reference ID/Investigator# 51804
Site Reference ID/Investigator# 51925
Site Reference ID/Investigator# 51468
Site Reference ID/Investigator# 51076
Site Reference ID/Investigator# 51077
Site Reference ID/Investigator# 51079
Site Reference ID/Investigator# 51265
Site Reference ID/Investigator# 51946
Site Reference ID/Investigator# 52346
Site Reference ID/Investigator# 51522
Site Reference ID/Investigator# 51924
Site Reference ID/Investigator# 51807
Site Reference ID/Investigator# 51424
Site Reference ID/Investigator# 51945
Site Reference ID/Investigator# 51268
Site Reference ID/Investigator# 51426
Site Reference ID/Investigator# 51427
Site Reference ID/Investigator# 51503
Site Reference ID/Investigator# 51548
Site Reference ID/Investigator# 52744
Site Reference ID/Investigator# 51806
Site Reference ID/Investigator# 51642
Site Reference ID/Investigator# 51263
Site Reference ID/Investigator# 51502
Site Reference ID/Investigator# 51302
Site Reference ID/Investigator# 51505
Site Reference ID/Investigator# 51425
Site Reference ID/Investigator# 51078
Site Reference ID/Investigator# 51428
Site Reference ID/Investigator# 51423


acronym: BRITE™

title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

lead_sponsor: UCB BIOSCIENCES, Inc.

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Russian Federation
Puerto Rico
India
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Latvia
Estonia
Finland
Korea, Republic of
France
Netherlands

summary: This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).


acronym: FUTURE 3 Ext

title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

lead_sponsor: Actelion

location_country:
Poland
Belarus
Serbia
Italy
Russian Federation
Australia
Mexico
Spain
Ukraine
Hungary
United States
France
China
India
Israel
South Africa
Germany
Czechia

location_facility: State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801

location_facility: Children's National Medical Center - Site 9104

location_facility: Shanghai Children's Medical Center - Site 5102

location_facility: Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101

location_facility: Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802

location_facility: Deutsches Herzzentrum Kinderkardiologie - Site 1401

location_facility: Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907

location_facility: Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404

location_facility: RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805

location_facility: Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103

location_facility: The Republican Scientific-Practical Center "Cardiology" - Site 3001

location_facility: Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101

location_facility: Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002

location_facility: Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502

location_facility: Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804

location_facility: Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906

location_facility: Royal Children's Hospital Melbourne, Cardiology - Site 5001

location_facility: Department of Paediatric Cardiology University of the Free State - Site 6001

location_facility: Cardiovascular Institute and Fuwai Hospital

location_facility: Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101

location_facility: Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403

location_facility: Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501

location_facility: CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202

location_facility: Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102

location_facility: Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301

location_facility: Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803

location_facility: Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605

location_facility: CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402

location_facility: Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604

location_facility: Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201

location_facility: Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401

summary: The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).


title: Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

acronym: HA-SAFE

summary: In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

ipd_sharing_description:
Availability of this study's data will later 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.vivli.org 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 member section of the portal.

lead_sponsor: Bayer

location_country:
Denmark
Luxembourg
Slovenia
Greece
Austria
Italy
Netherlands
Russian Federation
Spain
United Kingdom
Sweden
France
Belgium
Norway
Germany

status_simplified: Ongoing


type: Other Grant/Funding Number

title: A Phase I Open Label Followed by a Phase II Randomized, Controlled Study to Assess the Efficacy and Safety of ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic

acronym: PanC-ASAP

summary: A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

ReferenceCitation: Erazo T, Lorente M, López-Plana A, Muñoz-Guardiola P, Fernández-Nogueira P, García-Martínez JA, Bragado P, Fuster G, Salazar M, Espadaler J, Hernández-Losa J, Bayascas JR, Cortal M, Vidal L, Gascón P, Gómez-Ferreria M, Alfón J, Velasco G, Domènech C, Lizcano JM. The New Antitumor Drug ABTL0812 Inhibits the Akt/mTORC1 Axis by Upregulating Tribbles-3 Pseudokinase. Clin Cancer Res. 2016 May 15;22(10):2508-19. doi: 10.1158/1078-0432.CCR-15-1808. Epub 2015 Dec 15.

ReferenceCitation: Muñoz-Guardiola P, Casas J, Megías-Roda E, Solé S, Perez-Montoyo H, Yeste-Velasco M, Erazo T, Diéguez-Martínez N, Espinosa-Gil S, Muñoz-Pinedo C, Yoldi G, Abad JL, Segura MF, Moran T, Romeo M, Bosch-Barrera J, Oaknin A, Alfón J, Domènech C, Fabriàs G, Velasco G, Lizcano JM. The anti-cancer drug ABTL0812 induces ER stress-mediated cytotoxic autophagy by increasing dihydroceramide levels in cancer cells. Autophagy. 2021 Jun;17(6):1349-1366. doi: 10.1080/15548627.2020.1761651. Epub 2020 May 25.

ReferenceCitation: Felip I, Moiola CP, Megino-Luque C, Lopez-Gil C, Cabrera S, Solé-Sánchez S, Muñoz-Guardiola P, Megias-Roda E, Pérez-Montoyo H, Alfon J, Yeste-Velasco M, Santacana M, Dolcet X, Reques A, Oaknin A, Rodríguez-Freixinos V, Lizcano JM, Domènech C, Gil-Moreno A, Matias-Guiu X, Colas E, Eritja N. Therapeutic potential of the new TRIB3-mediated cell autophagy anticancer drug ABTL0812 in endometrial cancer. Gynecol Oncol. 2019 May;153(2):425-435. doi: 10.1016/j.ygyno.2019.03.002. Epub 2019 Mar 7.

ReferenceCitation: López-Plana A, Fernández-Nogueira P, Muñoz-Guardiola P, Solé-Sánchez S, Megías-Roda E, Pérez-Montoyo H, Jauregui P, Yeste-Velasco M, Gómez-Ferreria M, Erazo T, Ametller E, Recalde-Percaz L, Moragas-Garcia N, Noguera-Castells A, Mancino M, Morán T, Nadal E, Alfón J, Domènech C, Gascon P, Lizcano JM, Fuster G, Bragado P. The novel proautophagy anticancer drug ABTL0812 potentiates chemotherapy in adenocarcinoma and squamous nonsmall cell lung cancer. Int J Cancer. 2020 Aug 15;147(4):1163-1179. doi: 10.1002/ijc.32865. Epub 2020 Feb 6.

ReferenceCitation: Vidal L, Victoria I, Gaba L, Martín MG, Brunet M, Colom H, Cortal M, Gómez-Ferrería M, Yeste-Velasco M, Perez A, Rodon J, Sohal DPS, Lizcano JM, Domènech C, Alfón J, Gascón P. A first-in-human phase I/Ib dose-escalation clinical trial of the autophagy inducer ABTL0812 in patients with advanced solid tumours. Eur J Cancer. 2021 Mar;146:87-94. doi: 10.1016/j.ejca.2020.12.019. Epub 2021 Feb 12.

ReferenceCitation: París-Coderch L, Soriano A, Jiménez C, Erazo T, Muñoz-Guardiola P, Masanas M, Antonelli R, Boloix A, Alfón J, Pérez-Montoyo H, Yeste-Velasco M, Domènech C, Roma J, Sánchez de Toledo J, Moreno L, Lizcano JM, Gallego S, Segura MF. The antitumour drug ABTL0812 impairs neuroblastoma growth through endoplasmic reticulum stress-mediated autophagy and apoptosis. Cell Death Dis. 2020 Sep 17;11(9):773. doi: 10.1038/s41419-020-02986-w.

ReferenceCitation: Polonio-Alcalá E, Solé-Sánchez S, Muñoz-Guardiola P, Megías-Roda E, Perez-Montoyo H, Yeste-Velasco M, Alfón J, Lizcano JM, Domènech C, Ruiz-Martínez S, Puig T. ABTL0812 enhances antitumor effect of paclitaxel and reverts chemoresistance in triple-negative breast cancer models. Cancer Commun (Lond). 2022 Jun;42(6):567-571. doi: 10.1002/cac2.12282. Epub 2022 Mar 16.

lead_sponsor: Ability Pharmaceuticals SL

location_country:
United States
Spain
France

location_facility: Hospital General Universitario Dr. Balmis

location_facility: Hospital General Universitario Morales Meseguer


title: Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

lead_sponsor: Insmed Incorporated

ReferenceCitation: Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW; CLEAR-110 Study Group. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Nov;20(6):1010-1017. doi: 10.1016/j.jcf.2021.05.013. Epub 2021 Jun 16.

location_country:
Denmark
Poland
Serbia
Spain
Greece
Austria
Ireland
Italy
Canada
Netherlands
United Kingdom
Hungary
France
Belgium
Germany
Bulgaria
Slovakia

summary: The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.


primary_purpose: Other

title: A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols

lead_sponsor: Sumitomo Pharma Oncology, Inc.

location_country:
Japan
United States
Taiwan
France

location_facility: Winship Cancer Institute, Emory University

summary: This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.


title: SYMBIOSIS Post-Market Registry

acronym: SYMBIOSIS

summary: The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

lead_sponsor: Medtronic Cardiac Surgery

location_country: Spain Greece Austria Netherlands France Belgium Norway Germany

location_facility: Maastricht University Medical Center (MUMC+)


title: Observational Study, for Quality Assessment, of Sarcoma as a Model to Improve Diagnosis and Clinical Care of Rare Tumors Through a European and Latin American Multidisciplinary NETWORK

acronym: (SELNET)

summary:
Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc.

Expert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis.

Tumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.

time_perspective: Other

ipd_sharing_description: Data could be shared receiving an application to the Study Main contact indicating reason and objectives.

lead_sponsor: Grupo Espanol de Investigacion en Sarcomas

location_country:
Brazil
Spain
Italy
Argentina
France
Costa Rica
Peru
Mexico

location_facility: Instituo Nacional de enfermedades Neoplásicas


title: A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

acronym: CHERISH

summary: The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

status: Active, not recruiting

primary_purpose: Basic Science

ipd_sharing_description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

lead_sponsor: UCB Biopharma S.P.R.L.

location_country:
Spain
Switzerland
United States
France
Germany


ipd_sharing: Yes

intervention_type: Genetic

title: A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects ≤17 Years of Age With Cerebral Adrenoleukodystrophy (CALD)

lead_sponsor: bluebird bio

ipd_sharing_description: Bluebird bio is committed to transparency and appropriately de-identified patient-level datasets and supporting documents may be shared following attainment of applicable marketing approvals associated with this study and consistent with criteria established by bluebird bio and/or industry best practices to maintain the privacy of study participants. For enquiries, please contact us at datasharing@bluebirdbio.com.

location_country:
United Kingdom
Italy
Netherlands
United States
France
Germany

location_facility: Boston Children's Hospital/Massachusetts General Hospital

summary:
Study ALD-104 is an international, non-randomized, open-label, multi-site study in male participants (Less than or equal to [< or =] 17 years of age at enrollment) with cerebral adrenoleukodystrophy (CALD). Approximately 35 participants will be infused with Lenti-D Drug Product after myeloablative conditioning with busulfan and fludarabine.

This trial will evaluate the efficacy and safety of autologous cluster of differentiation 34 (CD34+) hematopoietic stem cells, transduced ex-vivo with Lenti-D lentiviral vector, for the treatment of CALD. A participant's blood stem cells will be collected and modified (transduced) using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After modification (transduction) with the Lenti-D lentiviral vector, the cells will be transplanted back into the participant following myeloablative conditioning.


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

summary: The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

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

location_country:
Ukraine
United States
Peru
Belgium
Philippines
Romania
South Africa
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Malaysia
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Greece
New Zealand
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Teva Investigational Site 227
Teva Investigational Site 341
Teva Investigational Site 11
Teva Investigational Site 64
Teva Investigational Site 642
Teva Investigational Site 763
Teva Investigational Site 47
Teva Investigational Site 26
Teva Investigational Site 44
Teva Investigational Site 582
Teva Investigational Site 428
Teva Investigational Site 505
Teva Investigational Site 207
Teva Investigational Site 643
Teva Investigational Site 724
Teva Investigational Site 15
Teva Investigational Site 780
Teva Investigational Site 743
Teva Investigational Site 25
Teva Investigational Site 629
Teva Investigational Site 260
Teva Investigational Site 380
Teva Investigational Site 702
Teva Investigational Site 403
Teva Investigational Site 105
Teva Investigational Site 624
Teva Investigational Site 720
Teva Investigational Site 603
Teva Investigational Site 600
Teva Investigational Site 229
Teva Investigational Site 543
Teva Investigational Site 286
Teva Investigational Site 626
Teva Investigational Site 504
Teva Investigational Site 741
Teva Investigational Site 143
Teva Investigational Site 512
Teva Investigational Site 589
Teva Investigational Site 221
Teva Investigational Site 69
Teva Investigational Site 280
Teva Investigational Site 162
Teva Investigational Site 43
Teva Investigational Site 621
Teva Investigational Site 142
Teva Investigational Site 630
Teva Investigational Site 203
Teva Investigational Site 17
Teva Investigational Site 625
Teva Investigational Site 12
Teva Investigational Site 372
Teva Investigational Site 363
Teva Investigational Site 52
Teva Investigational Site 182
Teva Investigational Site 30
Teva Investigational Site 74
Teva Investigational Site 369
Teva Investigational Site 164
Teva Investigational Site 542
Teva Investigational Site 700
Teva Investigational Site 554
Teva Investigational Site 563
Teva Investigational Site 150
Teva Investigational Site 366
Teva Investigational Site 632
Teva Investigational Site 122
Teva Investigational Site 681
Teva Investigational Site 161
Teva Investigational Site 580
Teva Investigational Site 58
Teva Investigational Site 540
Teva Investigational Site 125
Teva Investigational Site 509
Teva Investigational Site 705
Teva Investigational Site 740
Teva Investigational Site 544
Teva Investigational Site 123
Teva Investigational Site 223
Teva Investigational Site 549
Teva Investigational Site 546
Teva Investigational Site 587
Teva Investigational Site 144
Teva Investigational Site 742
Teva Investigational Site 3
Teva Investigational Site 222
Teva Investigational Site 523
Teva Investigational Site 19
Teva Investigational Site 225
Teva Investigational Site 24
Teva Investigational Site 645
Teva Investigational Site 583
Teva Investigational Site 727
Teva Investigational Site 200
Teva Investigational Site 420
Teva Investigational Site 685
Teva Investigational Site 545
Teva Investigational Site 404
Teva Investigational Site 6
Teva Investigational Site 261
Teva Investigational Site 41
Teva Investigational Site 140
Teva Investigational Site 633
Teva Investigational Site 281
Teva Investigational Site 264
Teva Investigational Site 4
Teva Investigational Site 128
Teva Investigational Site 723
Teva Investigational Site 226
Teva Investigational Site 16
Teva Investigational Site 287
Teva Investigational Site 55
Teva Investigational Site 300
Teva Investigational Site 507
Teva Investigational Site 500
Teva Investigational Site 631
Teva Investigational Site 623
Teva Investigational Site 557
Teva Investigational Site 432
Teva Investigational Site 602
Teva Investigational Site 367
Teva Investigational Site 422
Teva Investigational Site 704
Teva Investigational Site 521
Teva Investigational Site 27
Teva Investigational Site 701
Teva Investigational Site 559
Teva Investigational Site 166
Teva Investigational Site 181
Teva Investigational Site 641
Teva Investigational Site 585
Teva Investigational Site 784
Teva Investigational Site 101
Teva Investigational Site 45
Teva Investigational Site 147
Teva Investigational Site 63
Teva Investigational Site 524
Teva Investigational Site 433
Teva Investigational Site 33
Teva Investigational Site 46
Teva Investigational Site 209
Teva Investigational Site 202
Teva Investigational Site 146
Teva Investigational Site 53
Teva Investigational Site 285
Teva Investigational Site 204
Teva Investigational Site 8
Teva Investigational Site 400
Teva Investigational Site 32
Teva Investigational Site 425
Teva Investigational Site 541
Teva Investigational Site 588
Teva Investigational Site 423
Teva Investigational Site 426
Teva Investigational Site 160
Teva Investigational Site 552
Teva Investigational Site 371
Teva Investigational Site 59
Teva Investigational Site 28
Teva Investigational Site 180
Teva Investigational Site 555
Teva Investigational Site 520
Teva Investigational Site 562
Teva Investigational Site 49
Teva Investigational Site 421
Teva Investigational Site 66
Teva Investigational Site 622
Teva Investigational Site 680
Teva Investigational Site 761
Teva Investigational Site 782
Teva Investigational Site 522
Teva Investigational Site 283
Teva Investigational Site 104
Teva Investigational Site 284
Teva Investigational Site 686
Teva Investigational Site 560
Teva Investigational Site 721
Teva Investigational Site 126
Teva Investigational Site 18
Teva Investigational Site 14
Teva Investigational Site 601
Teva Investigational Site 2
Teva Investigational Site 683
Teva Investigational Site 584
Teva Investigational Site 745
Teva Investigational Site 34
Teva Investigational Site 262
Teva Investigational Site 1
Teva Investigational Site 682
Teva Investigational Site 342
Teva Investigational Site 220
Teva Investigational Site 407
Teva Investigational Site 121
Teva Investigational Site 73
Teva Investigational Site 103
Teva Investigational Site 9
Teva Investigational Site 361
Teva Investigational Site 513
Teva Investigational Site 185
Teva Investigational Site 370
Teva Investigational Site 127
Teva Investigational Site 40
Teva Investigational Site 401
Teva Investigational Site 5
Teva Investigational Site 586
Teva Investigational Site 263
Teva Investigational Site 402
Teva Investigational Site 558
Teva Investigational Site 561
Teva Investigational Site 21
Teva Investigational Site 31
Teva Investigational Site 120
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Teva Investigational Site 405
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Teva Investigational Site 604
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Teva Investigational Site 205
Teva Investigational Site 50
Teva Investigational Site 511


title: International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery

acronym: VENICE

summary: The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

study_start_date_type: Anticipated

status: Unknown status

ReferenceCitation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

ReferenceCitation: Lellouche F, Delorme M, Bussières J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4. Review.

ReferenceCitation: Güldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754. Review.

lead_sponsor: University Hospital, Caen

location_country: Poland Brazil Italy Netherlands France Norway Belgium Japan Germany Czechia

location_facility: Klinik für Anästhesiologie und Intensivmedizin

location_facility: Universidade Federal de São Paulo (UNIFESP)

location_facility: Osaka city University Graduate school of Medecine

location_facility: CUB Erasm, Université libre de Bruxelles


title: A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter Study With Open-label Treatment Extension to Assess the Effect of MIN-102 (IMP) on the Progression of Adrenomyeloneuropathy in Male Patients With X-linked Adrenoleukodystrophy

acronym: Advance

summary: This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter, two parallel-group study in male patients with the AMN phenotype of X-linked adrenoleukodystrophy (X-ALD) to assess the efficacy and safety of MIN-102 treatment. Study sites will consist of specialist referral centers experienced in the management of adrenoleukodystrophy (ALD).

lead_sponsor: Minoryx Therapeutics, S.L.

location_country:
Spain
Italy
United Kingdom
Netherlands
Hungary
United States
France
Germany

location_facility: Universitat Leipzig Klinik and Poliklinik für Neurologie

location_facility: National hospital for Neurology and Neurosurgery Charles Dent Metabolic Unit)

location_facility: Institute of Genomic Medicine and Rare Disorders


title: A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects With Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral βA-T87Q-Globin Vector in Subjects ≤50 Years of Age

summary: This is a single-arm, multi-site, single-dose, Phase 3 study in approximately 18 participants less than or equal to (<=) 50 years of age with transfusion-dependent β-thalassemia (TDT), who have a β0/β0, β0/IVS-I-110, or IVS-I-110/IVS-I-110 genotype. The study will evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product.

location_country:
United Kingdom
Italy
Greece
United States
France
Germany

location_facility: General Hospital of Thessaloniki 'G.Papanikolaou'

location_facility: UCSF Benioff Children's Hospital Oakland

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


title: Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

lead_sponsor: H. Lundbeck A/S

location_country:
Poland
Serbia
Spain
Italy
Latvia
Estonia
Russian Federation
United Kingdom
Hungary
France
South Africa
Germany
Bulgaria

location_facility: Prywatne Gabinety Lekarskie ¿Promedicus¿ Anna Agnieszka Tomczak

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

location_facility: Nizhny Novgorod Region State Institution Of Healthcare

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Universita degli Studi di Messina - Facolta di Medicina e Chirurgia

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Medicorehabilitation Research Center "Phoenix"

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Guz "Saratov Regional Psychiatric Hospital St. Sofii"

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: Specialized Clinical Psychiatric Hospital 1 of the Ministry of Health

location_facility: Lipetsk Regional Psychoneurological Hospital

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: Clinic of Neurology and Psychiatry for Children and Adolescents

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej (SPZOZ) - Centrum Neuropsychiatrii "NEUROMED"

location_facility: Marienthal Center of Psychiatry and Psychology

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: SPECTRUM Centrum Neurologii i Psychiatrii

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry

summary: Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD


title: An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Denmark
Spain
Italy
Canada
Korea, Republic of
United States
France
Singapore
Germany

location_facility: Massachusetts General Hospital MGH Cancer Center

summary: The purpose of this study is to assess long-term safety and provide continued study treatment access to eligible participants who are judged by the Investigator to benefit from continued treatment with capmatinib monotherapy or in combination with other treatments or with the combination treatment alone in a Novartis sponsored study


title: Paediatric Hepatic International Tumour Trial

acronym: PHITT

summary:
The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB.

Children with HCC will be included as a separate cohort.

lead_sponsor: University of Birmingham

location_country:
Poland
Spain
Ireland
Austria
Netherlands
United Kingdom
Switzerland
France
Israel
Belgium
Norway
Germany
Czechia

location_facility: Noah's Ark Children's Hospital for Wales

location_facility: Royal Belfast Hospital for Sick Children


title: A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in Patients With HER2+ Early Breast Cancer

acronym: TROIKA

summary: In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

ReferenceCitation: Pivot X, Georgievich MA, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, Petrelli F, Villanueva C, Nikolaevich LO, Hii J, Kim J, Pradhan S, Jaison L, Feyaerts P, Kaufman L, Derde MP, Bonamy GMC, Deforce F, Cox DG. Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):698-705. doi: 10.1001/jamaoncol.2021.8171. Erratum in: JAMA Oncol. 2022 May 1;8(5):784.

lead_sponsor: Prestige Biopharma Limited

location_country:
Poland
Belarus
Spain
Italy
Georgia
Estonia
Russian Federation
Thailand
Ukraine
Hungary
France
Malaysia
Bulgaria

location_facility: GI "V. T. Zaycev Institute General and Urgent Surgery of NAMS of Ukraine "


title: A Phase I, Open-label, Multi-center Dose Escalation Study of FAZ053 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies

summary:
The purpose of this "first-in-human" study of FAZ053 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of FAZ053 administered Intravenously (i.v.)as a single agent or in combination with PDR001 in adult patients with advanced solid tumors.

By blocking the interaction between Programmed Death Ligand-1 (PD-L1) and its receptors, Programmed Death-1 (PD-1) and B7.1, FAZ053 inhibits the PD-L1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.

This study has been designed as a Phase I, open-label, multi-center study with a dose escalation part of FAZ053 as single agent and in combination with PDR001, followed by a dose expansion part of FAZ053 as single agent.

FAZ053 will initially be dosed every three weeks. A less frequent dosing regimen such as every 6 weeks may be evaluated in parallel.

A patient may continue treatment with FAZ053 single agent or in combination with PDR001 until the patient experiences unacceptable toxicity, confirmed disease progression per immune related Response Criteria and/or treatment is discontinued at the discretion of the investigator or the patient.

location_country:
Taiwan
Spain
Italy
Canada
United States
Israel
France
Japan
Singapore

location_facility:
UT MD Anderson Cancer Center
Novartis Investigative Site
Memorial Sloan Kettering Cancer Center


title: A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ReferenceCitation: Rowe SM, McColley SA, Rietschel E, Li X, Bell SC, Konstan MW, Marigowda G, Waltz D, Boyle MP; VX09-809-102 Study Group. Lumacaftor/Ivacaftor Treatment of Patients with Cystic Fibrosis Heterozygous for F508del-CFTR. Ann Am Thorac Soc. 2017 Feb;14(2):213-219. doi: 10.1513/AnnalsATS.201609-689OC.

ReferenceCitation: Boyle MP, Bell SC, Konstan MW, McColley SA, Rowe SM, Rietschel E, Huang X, Waltz D, Patel NR, Rodman D; VX09-809-102 study group. A CFTR corrector (lumacaftor) and a CFTR potentiator (ivacaftor) for treatment of patients with cystic fibrosis who have a phe508del CFTR mutation: a phase 2 randomised controlled trial. Lancet Respir Med. 2014 Jul;2(7):527-38. doi: 10.1016/S2213-2600(14)70132-8. Epub 2014 Jun 24.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United Kingdom
Australia
New Zealand
United States
France
Belgium
Germany