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,
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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
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Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

• Pays Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States,
• Organes Aucun
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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
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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
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XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

• Pays Belgium, Canada, France, Germany, Hungary, Italy, Poland, Russian Federation, Spain, United Kingdom, United States,
• Organes Aucun
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Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.

• Pays Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Netherlands, Norway, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun