Kusajili – Centralise les essais cliniques mondiaux

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1) The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

• Pays Austria, Belgium, France, Germany, Japan, Portugal, Romania, Russian Federation, Spain, Switzerland, United Kingdom,
• 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
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Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

• Pays Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain,
• Organes Aucun
• Spécialités Aucun

FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

• Pays Australia, Belgium, Canada, Denmark, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

• Pays Australia, Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

• Pays Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain,
• Organes Aucun
• Spécialités Aucun

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

• Pays Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
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Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

• Pays Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russian Federation, Slovenia, Spain, Switzerland, Turkey, United Kingdom,
• Organes Aucun
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Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

• Pays Argentina, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, Hungary, Iceland, India, Italy, Korea, Republic of, Philippines, Poland, Romania, Singapore, Spain, Sweden, United Kingdom, United States,
• Organes Aucun
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A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.

• Pays Belgium, France, Germany, Italy, Poland, Romania, Spain,
• Organes Aucun
• Spécialités Aucun