View clinical trials related to Hepatitis C, Chronic.
Filter by:This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid [RNA] 12 weeks after completing study treatment (SVR12) will be evaluated.
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in adult subjects with CHC infection. Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state. The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile. Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study. Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies
Metformin treatment during 36 months could be associated with decreased risk of HCC occurrence and liver related death in patients with compensated HCV cirrhosis and insulinoresistance. This study is an ancillary of the observational study from the CIRVIR cohort in which more than 1200 patients with compensated HCV cirrhosis are currently included. participating centers : 26
Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3
The primary objective of this study is to assess changes in alanine aminotransferase (ALT) in hepatitis C virus (HCV)-infected subjects given daily doses of JKB-122 for 3 months who have been nonresponsive to, intolerable to, or relapsed from prior interferon-based therapies (pegylated or standard) either alone or in combination with ribavirin or other anti-HCV therapies including direct-acting anti-viral agents.
The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.