View clinical trials related to Hepatitis C.
Filter by:The objective of the present study is to evaluate the antioxidant status in the blood of HCV patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800 mg,500 mg and 40 mg; respectively) during six months.
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.
To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
Combination therapy with peginterferon plus ribavirin has become the current standard of care for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63%. Based on the ample evidence, a 48-week course of peginterferon plus weight-based ribavirin therapy is widely recommended to treat HCV genotype 1 infection in different parts of the world. Despite the increased SVR rates with the improved medical therapies, about 25-50% and 10-20% of HCV genotype 1 and HCV genotype 2/3 patients may experience relapse after the cessation of therapy with undetectable HCV viremia at the end of treatment. Moreover, combination therapy is costly and may cause various adverse events. Therefore, individualized therapy based on outcome analysis should be adopted to save medical cost as well as to lessen inadequate treatment. Few studies are aimed to evaluate the host responses of micro RNA regulation during interferon-based therapy and its relationships to the overall treatment responses. Micro RNA (miRNA) is a single-stand RNA composed of 21-23 nucleotides, which may regulate the function of messenger RNA (mRNA). The regulating mechanisms involving micro RNA between the hosts and the HCV virus include (1) auto-regulation of HCV mRNA by HCV miRNA; (2) regulation of host mRNA by HCV miRNA; and (3) regulation of HCV mRNA by host miRNA. MiR-122 is the abundant liver-specific miRNA which is crucial for efficient HCV replication in culture Huh7 cells stably expressing HCV replicons. Recently, an in vivo study for hepatic miR-122 of 42 patients with CHC who received IFN-based therapy showed that patients who did not respond to IFN therapy had markedly decreased pretreatment miR-122 levels. Although miR-122 is abundant in the liver, liver biopsy is still considered an invasive procedure, which prevents its widespread use in routine clinical practice. The miRNA can be detected in the sera and is stable after 24 hours of room temperature store or repeated freezing and de-freezing. The serum miR-122 levels can reflect the severity of liver injuries in a rat acetaminophen toxicity model. Because miR-122 is liver specific and the miRNA is stable in the sera, the investigators aimed to evaluate the role of serum and hepatic miR-122 on the viral kinetics and the treatment responses and in HCV patients receiving peginterferon and ribavirin combination therapy.
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. Combination of peginterferon plus ribavirin therapy has become the current standard of care for chronic hepatitis C (CHC) patients, with an overall sustained virologic response (SVR) rate of 54-63% and more favorable response rates in patients with genotype 2/3 infection than those with genotype 1/4 infection. Therefore, accurate pre-treatment HCV genotype evaluation is of paramount importance to facilitate individualized therapy in the era of response guide therapy and specific-targeted antiviral therapy for HCV (STAT-C). Currently, direct HCV genetic sequencing for both the 5' untranslated terminal region (5'UTR) and non-structural 5B (NS5B) regions with subsequent phylogenetic tree analysis is considered the gold standard for determining HCV genotype and subtype. However, it is time-consuming and need special laboratory settings. Several commercial available reverse hybridization with type-specific probing assay (Inno-LiPA II) or simplified direct sequencing of the 5'UTR region were used to replace the two region sequencing method (Trugene HCV 5' NC genotyping kit). Nonetheless, data on the overall diagnostic accuracy varied. The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for determining the genotype(s) of HCV in plasma and serum from HCV-infected individuals. Based on genetic similarity, HCV has been classified into six major genotypes (1-6) and numerous subtypes. HCV genotype is predictive of the response of HCV-infected patients to peginterferon plus ribavirin combination therapy. The Abbott RealTime HCV Genotype II assay uses the Abbott m2000sp instrument for processing samples and the Abbott m2000rt instrument for amplification and detection. Furthermore, the Abbott m2000sp provides automated sample transfer and reaction assembly of the assay reagents in the Abbott 96-Well Optical Reaction Plate. The investigators aimed to evaluate the overall diagnostic accuracy of the currently available commercial HCV genotype kits (Abbott RealTime HCV Genotype II) by using 5'UTR and NS5A gene amplification and direct sequencing as the gold standard.
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide. The prevention of HCV transmission and early intervention of HCV infection are urgently needed to reduce or halt the liver-related morbidity and mortality. Double filtration plasmapheresis (DFPP) has been with widespread use in clinical practice for several indications with plasma filters optimized for the respective elimination targets with excellent safety. By way of the plasma separator, the blood is separated into plasma and cell components. Separated plasma is then led into the plasma component separator where the pores of the plasma component separator further fractionate the plasma into large and small molecular components. The large molecular components, including pathogenic substances, is removed and discarded and the small molecular components, including proteins such as albumin and gamma-globulin, are returned to the patient and mixed with the cell components. After the initiation of pegylated interferon plus ribavirin (Peg-IFN+RBV) therapy, the rapid first phase relates to a significant reduction in virus production and the degradation of free virus particles, which is followed by a second much slower one reflecting the elimination and clearance of infected cells. In HCV patients, high baseline viral load at the initiation of therapy is considered to be a negative predictor for systemic vascular resistance (SVR) for HCV genotype 1 patients. Reduction of baseline viral load by means of therapeutic double filtration plasmapheresis (DFPP) may represent a plausible adjunct for improved antiviral therapy to reduce the virus load with the initiation of treatment in synergy with Peg-IFN and RBV combination therapy. Recently, several clinical studies in evaluating the therapeutic efficacy and safety of DFPP in conjunction with IFN-based therapy were conducted for treatment-naïve genotype 1 high viral load CHC patients, and CHC patients who underwent liver transplantation. These studies showed that patients with DFPP treatment had more favorable HCV early viral kinetics to those without DFPP treatment. Furthermore, all these studies showed excellent safety after DFPP treatment. Therefore, the investigators aimed to conduct a large-scaled randomized controlled trial to evaluate the overall response of DFPP for HCV genotype 1 patients with high viral load.
The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C infected patients so that interventions can be targeted to address these problem areas in order to optimize care of these patients.
The purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection.