8 results
Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…
The objective of the study is to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitized recipients of living donor kidney transplants requiring desensitization therapy.
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
Primary Objective: To evaluate the immunogenicity of N9-GPKey Secondary Objectives:* To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis (…
Primary Objective: To evaluate the immunogenicity of N9-GP.Key Secondary Objectives: * To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP.* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis…
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.