7 results
The primary objective of this study is to evaluate the efficacy of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC.The secondary objective is to evaluate the safety of EN3348 as compared with…
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…
To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.
The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…
Main Study Objective• To confirm the dose and assess response to single agent 177Lutetium-DOTATATE treatmentin patients with relapsed or refractory high-risk neuroblastomaSecondary Study Objectives:• To assess long term survival and response• To…
Primary objective(s): To assess the effect of LysaKare® administration on serum potassium concentration in GEP-NET patients eligible for Lutathera® treatmentSecondary objective(s): To confirm the safety profile of LysaKare® infusion in GEP-NET…