View clinical trials related to Hepatitis C.
Filter by:The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3 direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325 75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter probe substrates.
The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.
Liver fibrosis is an important public health problem, with a substantial morbidity and mortality due to progression to cirrhosis and hepatocellular carcinoma. All causes of chronic liver disease may lead to fibrosis. The traditional diagnostic approach requires a biopsy for assessing the severity of liver disease prior to therapy. However, liver biopsy has several limitations: cost, sampling error, and procedure-related morbidity and mortality. Considering the high prevalence of viral hepatitis and nonalcoholic fatty liver disease, a condition often associated with obesity and type 2 diabetes, there is an urgent need for noninvasive screening, diagnosis and monitoring strategies of chronic liver disease severity. Our team has the expertise to investigate ultrasound-based and magnetic resonance-based elastographic methods for the noninvasive staging of liver fibrosis. The primary objective of this cross-sectional study is to compare the sensitivity of elastographic methods for detecting histology-determined significant fibrosis. The secondary objectives are to compare the diagnostic accuracy of these elastographic methods and the influence of potential confounders (inflammation, steatosis and iron deposition) on their diagnostic accuracy.
Vertical HCV Transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). Spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.
Chronic hepatitis C virus (HCV) infection and nonalcoholic fatty liver disease (NAFLD) are characterized by a spectrum of pathological conditions ranging from an early stage of inflammation and fibrosis up to more advanced disease conditions, such as hepatocellular carcinoma. The prevalence of NAFLD is between 10 and 25% of the population, with large differences in age and ethnic groups, while it is well known that HCV infection is a major cause of chronic liver disease in Western countries. For both diseases the progression of liver damage is in close correlation with the lifestyle of patients (eg., nutrition, physical activity, ingestion of alcohol, etc.). In fact, it was shown that feeding imbalances may have implications in altering the normal immune functions of the subjects, suggesting that the metabolic and the immune systems are closely related to each other. Although it is well known the negative role of obesity on the progression of NAFLD and HCV liver diseases, the pathogenic mechanism underlying the alterations related to the immune response is not yet fully understood. Insulin resistance, altered lipid metabolism, lipid peroxidation, oxidative stress and mitochondrial alterations are pathogenic mechanisms that induce liver damage and its progression, both in NAFLD and in HCV infection. Recent studies suggest that the evolution of viral infections and chronic inflammation in NAFLD are deeply influenced by CD4+ T helper cells expressing IL-17 , defined as T helper 17 (Th17) cells. Broadening the knowledge on the role of diet in the course of NAFLD and HCV infection in the activation of Th17 cells and in the alteration of some of their functions, will allow to shed light on the pathogenic mechanisms underlying the progression of immune-mediated diseases. Moreover, this investigation will allow to understand whether Th17 cells may have a role in the diminished response to therapy in patients who have high cholesterol levels. If the results will confirm our hypothesis, this study will provide useful informations for the clinical management of patients with both steatosis and chronic HCV infection. The data obtained can also be used for the development of new therapeutic strategies directed to modulate the antiviral immune response. All patients will undergo clinical and instrumental assessment depending on the type of pathology. Patients will be required to follow a normocaloric low cholesterol diet for a period of 30 days. The prospective clinical study does not present any form of additional risk for the patients and will be conducted in accordance with the principles established by the Declaration of Helsinki and with the standards of Good Clinical Practice (GCP). The study does not require any additional costs.
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
This trial is open to participants with cirrhosis due to chronic hepatitis C virus (HCV), and to participants who have already received a liver transplant for chronic HCV. All subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain conditions, the treatment duration may be extended for cirrhotic participants . The study will test how well this combination of investigational drugs works to treat chronic HCV.
Study SPC3649-207E is designed as an extension study to the prior protocol to provide additional long-term safety and efficacy information for subjects participating in Study SPC3649-207.
Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or -2b and ribavirin have been used in small numbers of hepatitis C virus-infected children with sustained virological response being higher in genotypes 2 and 3 than in genotypes 1 and 4. Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to modify treatment protocols have been tried in adults in an attempt to achieve higher rates of sustained virological response. Shortening injection interval and/or treatment duration prolongation have been tried with variable outcome reports. A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard) has been used over the last 4 years in the Egyptian market. We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers. Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction (PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during treatment and 6 months after stoppage of treatment. All patients were assigned to receive a weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2 groups. Group I: Patients who continued treatment on weekly basis: this group included patients who had negative PCR at week 12 as well those who had positive PCR without any change in viremia. Group II: Patients who continued treatment on a 5- days schedule: this group included patients who had any decrease in viremia at week 12. Patients who were PCR-negative at week 48 and had at least one PCR-positive test during therapy were assigned to have an extended treatment course of 6 months duration. The occurrence of adverse effects was assessed during treatment and follow up