Kusajili – Centralise les essais cliniques mondiaux

Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

• Pays Australia, Belgium, Canada, France, Germany, Italy, United States,
• Organes Aucun
• Spécialités Aucun

Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse. The secondary objectives were to : - evaluate the efficacy of rasburicase in terms of renal protection, - evaluate the safety of rasburicase in the two cohorts of patients, - correlate efficacy and safety results with antibodies generation/level.

• Pays Belgium, France, Germany, Italy,
• Organes Aucun
• Spécialités Aucun

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Pays Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Province of China, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

• Pays France, Germany, Italy, Spain, United States,
• Organes Aucun
• Spécialités Aucun

Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658

• Pays Austria, Canada, France, Germany, Italy, Poland, United States,
• Organes Aucun
• Spécialités Aucun

Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder 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.

• Pays Australia, Chile, France, Germany, Hungary, Italy, Mexico, Russian Federation, Spain,
• Organes Aucun
• Spécialités Aucun

Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

• Pays Australia, Belgium, Canada, France, Greece, Hungary, Italy, Latvia, Poland, Russian Federation, United States,
• Organes Aucun
• Spécialités Aucun

SonoVue Guided Prostate Biopsy This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.

• Pays Austria, Belgium, France, Germany, Italy, Netherlands, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.

• Pays Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

• Pays Austria, Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland,
• Organes Aucun
• Spécialités Aucun