Active clinical trials for "Hepatitis C"

This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.

Hepatitis C is the leading cause of chronic liver disease and cirrhosis in United States veterans. Cirrhosis is associated with impaired antibody responses and increased risk of bacterial infections. We have recently identified that cirrhosis is associated with abnormalities of memory B-cells, cells that make antibodies and help protect against bacterial infections. We have identified that chemicals associated with gut bacteria might play a role in causing these B-cell abnormalities. It is well known that gut bacteria have increased access to the blood in individuals with cirrhosis, a process called bacterial translocation. We hypothesize that reducing bacteria counts in the gut by using poorly-absorbed antibiotics (also known as selective gut decontamination) will partially reverse losses of memory B-cells in cirrhosis by reducing bacterial translocation.

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks. hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.

The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® ) versus Triple therapy regimen (Reiferon Retard® , Ribavirin and Nitazoxanide) versus the standard of care regimen(Reiferon Retard® and Ribavirin) in the treatment of Naïve chronic hepatitis C among the Egyptian population. Effectiveness will be evaluated based on Sustained Virological Response (SVR) . PRIMARY OBJECTIVE(S): The primary objectives of this trial are as follows: To compare the efficacy of the three treatment arms in naïve Chronic Hepatitis C Virus (HCV) genotype 4 patients by evaluating the sustained virological response ( SVR) at week 60 ( 3 months after end of treatment period) Identify optimum treatment protocol for HCV genotype 4 in respect to used combination of medications Whether adding vitamin D, a potent immunomodulator, could improve viral response. STUDY DESIGN: This is a phase IV, single center, open labeled, randomized (1:1:1) controlled study. NUMBER OF EVALUABLE SUBJECTS: 300 NUMBER OF CENTER/S: 1 Country:Egypt DURATION OF THE STUDY: 94 weeks TREATMENT: randomized 1:1:1 ratio into 3 Arms SUBJECT POPULATION: male or female subjects assessed by BMI less than 35, between the ages of 20 and 50 years. Subjects have to be diagnosed as Naïve Chronic Hepatitis C genotype 4 patients with compensated liver disease assessed by hematological and biochemical tests. - DURATION OF THE STUDY: 94 weeks as follows: Estimated Enrollment Duration: 16 weeks Collection of last Case Report Form (CRF) : 2 weeks from Last patient out. Queries Resolution: 4 weeks from Collection of last CRF. Database lock planned date: 2 weeks from Quires resolution. Final Study Report: 8 weeks from Database lock. Estimated duration of subject participation: 62 weeks as follows; Screening period per subject = 2 weeks Treatment phase per subject = 48 weeks Follow-up phase per subject = 12 weeks N.B : Each patient will receive medications for Maximum 48 weeks if his/her Polymerase Chain Reaction (PCR) -ve at weeks 12 and 24 , and if his/her PCR +ve at week 12 or week 24 the treatment will be stopped .

The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.

The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV). Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)

The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.