32 results
Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…
The aim of the present study is to investigate the differences in patient and endoscopist satisfaction and experiences and patient*s safety with different sedation protocols.
Study aims (see page 2 of the protocol)a. To assess the dose-response relationship of propofol on breathing.b. To assess the interaction of propofol and remifentanil on breathing.c. To qunatify the data under closed-loop conditions using an emprical…
The aim of this study is to determine the patients* and endoscopists experiences and patients* safety with different sedation protocols.
- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…
1.To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol.2.To evaluate the influence of epidural blockade with ropivacaine on the pharmacodynamics of propofol. This includes both the sedative and the…
To investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with NA enhances the degree of HBsAg decline
To determine effective and safe age specific propofol dosing guidelines for neonates of different age groups (both gestational age and postnatal age). Secondary objective is to determine a new age specific PK/PD (pharmacokinetic/pharmacodynamic),…
to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary Objective:The primary objective for this study is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection:* SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…
1. To determine the safety and tolerability of TMC649128/TMC619688 during multiple dosing in treatmentnaïve and treatment-experienced genotype 1 HCV-infected subjects at different dose regimens as 10-days and 14-days monotherapy.2. To determine the…
Inhibition of CYP2D6 enzymes by SSRIs may lead to reduced endoxifen plasma concentrations and thereby possibly influence tamoxifen treatment outcome. Paroxetine is a potent CYP2D6 inhibitor and strongly reduces endoxifen plasma concentrations.…
The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…
Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…
Previous investigations in our lab have provided insight in the requirements for development of such a system and shown the feasibility of the paradigm (Blokland et al., 2011, Blokland et al., 2012). We have been able to optimize the settings of our…
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…
The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…