42 results
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 (…
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with propofol and daily sedation stops, in maintaining a target depth of sedation in ventilated…
To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…
The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…
To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
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.
1. To quantify the influence of propofol on the distribution, redistribution and elimination of ketamine and to evaluate the importance of hemodynamic parameters on the pharmacokinetics of ketamine.2. To quantify the influence of ketamine on the…
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…
Primary objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.Secondary:• To evaluate how many patients need a dose adjustment to achieve adequate…
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…
Determining the effectiveness of commonly used premedicating agents in reducing subclinical stress responses in newborns during intubation.
Primary: To determine the safety and tolerability of TCAD administered orally to immunocompromised patients diagnosed with influenza ASecondary: To assess the antiviral effect, the speed of symptom resolution, and the influenza complication rate of…
The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be…
Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?
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…
1) Compare a group of bilateral users to a unilateral control group (between-subject design)2) Compare unilateral use to bilateral use after sequential implantation (within-subject design)3) Compare simultaneous bilateral implantation to sequential…
The primary objective is: To evaluate the efficacy, safety and tolerability of NIM811 administered in combination with SOC in an interferon-relapser population of patients infected with chronic hepatitis C genotype-1.Secundary objectives are: * To…
The primary objectives of this trial are the following:- to determine the dose dependency of the antiviral effect of TMC435350 during 1 week ofmonotherapy in treatment-naïve HCV-infected subjects;- to determine the dose dependency of the antiviral…
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 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.…