Kusajili – Clinical trials directory

Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

• Country Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, United Kingdom, United States,
• organs None
• Specialty None

Predictive Markers in GHD and TS Children Treated With SAIZEN® The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children. The study will recruit approximately 360 children in several countries worldwide. The study lasts for about the first one month of daily growth hormone treatment. There will be three clinic visits during the month of the study. There is an initial visit, then a visit before growth hormone treatment starts and finally a visit at the fourth week of treatment. The study requires two additional blood tests to a regular Saizen treatment follow-up. One sample is taken before growth hormone injections start and one additional blood sample is taken at the fourth week of treatment.

• Country Argentina, Australia, Austria, Canada, France, Germany, Italy, Norway, Russian Federation, Singapore, Spain, Sweden, United Kingdom,
• organs None
• Specialty None

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

• Country Argentina, Australia, Canada, Chile, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, Sweden, Switzerland, United States,
• organs None
• Specialty None

Satavaptan Dose-Ranging Study in the Prevention of Ascites The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

• Country Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Italy, Spain, Taiwan, Province of China,
• organs None
• Specialty None

A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.

• Country Australia, Canada, France, Germany, Italy, United States,
• organs None
• Specialty None

A Study in Men With Benign Prostatic Hyperplasia The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

• Country Australia, Canada, France, Germany, Greece, Italy, Russian Federation, United States,
• organs None
• Specialty None

BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

• Country Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States,
• organs None
• Specialty None

A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.

• Country Australia, Canada, Denmark, France, Germany, Italy, Sweden, Switzerland, United Kingdom, United States,
• organs None
• Specialty None

Repinotan in Patients With Acute Ischemic Stroke The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.

• Country Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States,
• organs None
• Specialty None

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary objectives were: - To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population. - To document Celivarone plasma levels during the study.

• Country Argentina, Australia, Belgium, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United States,
• organs None
• Specialty None