24 results
The primary objective is to study the effect of a 16-week treatment with a PPAR-* agonist versus placebo on effectiveness of subsequent standard treatment with PEG-IFN and RBV, measured as SVR, in previously non-responders or relapsers with CHC…
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 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…
This trial will determine the relative incidence of CV outcomes compared to placebo forthe TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to thetherapeutic regimen of a person with type 2 diabetes who has additional…
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…
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: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-…
To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).
The primary objectives of this study are as follows:• To determine the efficacy of treatment with GS-7977+ribavirin (RBV) compared as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (…
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…
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 ObjectiveTo assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNAgenotype 1 who are prior non-responders to pegIFNα-2a/RBV.Secondary Objectives• To assess efficacy, as determined by the proportion of subjects…
The primary objectives of this study are to evaluate the safety of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV, and to show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week…
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 (…
Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…
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…
Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?
The objective of the study is to evaluate the efficacy of the addition of SYR-322 (25 mg) to subjects who are inadequately controlled on pioglitazone HCl (30 mg) and metformin (*1500 mg or MTD).
The primary objective of this study is to evaluate the effects of SYR-322 and SYR-322coadministered with pioglitazone HC1 versus placebo on postprandial triglycerides in subjectswith type 2 diabetes.