6 results
The primary objective of this study is to evaluate the efficacy of TDF plus Peginterferon *-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined…
ObjectivesPrimary Efficacy Objective• To assess the sustained clinical effect of BM32 during 2 consecutive treatment years compared to placebo. The clinical effect of BM32 is evaluated by a combined Symptom-Medication-Score (SMS) which is recorded…
The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…
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…
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 (…
1. To explore the pharmacokinetics (PK) of intra-vaginal delivery of gonadorelin and oxybutynin. 2. To assess the safety and tolerability of gonadorelin and oxybutynin delivery with a prototype intra-vaginal ring.