View clinical trials related to Hepatitis, Chronic.
Filter by:Objective: To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options. Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.
The CHB subjects who are cirrhosis, will be randomized to two groups. The subjects who go into group A will be treated by nucleotide analogue (NA) combination with peginterferon alfa-2a,180μg/week for 48 weeks. The subjects who go into group B will be treated by nucleotide analogue (NA) only for 48 weeks.
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
To evaluate efficacy and safety of Ombitasvir, paritaprevir, and ritonavir plus ribavirin based therapy for chronic hepatitis C with or without compensated cirrhosis in haemodialysis patients.
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to < 12 years.
Recently,surprisingly and unexpectedly increased aggressiveness and high rates of HCC recurrence (28%(16/58) and 29%(17/59), respectively) have been reported in patients who cleared HCV with DAAs after achieving a complete response to resection or local ablation within only 6 months of therapy. The authors hypothesized that the rapid eradication of HCV and control of liver inflammation would impact anti-tumoral immune control, which in turn might contribute to the neoplastic cells proliferation. Conversely, three independent prospective French cohorts failed to reveal an increased risk of HCC recurrence after DAAs treatment in CHC patients after receiving curative cancer treatments.Although the impact of DAAs treatment on the rate of HCC occurrence or recurrence still remain unclear, it would be more important to pay attention to the immunological changes of CHC patients treated with DAAs.Up to now, little was known about the immunological changes of chronic hepatitis C (CHC) patients treated with direct-acting antiviral agents (DAAs), here we try to explore the effect of antiviral treatment of CHC patients with DAAs on the frequency of monocytes, NK cells and cytokines that promote their activation.
This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA [direct-acting antiviral agent] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.
HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution. Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment. The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002. A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated. AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population. 3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b. Study Design: .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.
Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of having a potent antiviral effect, and good tolerance without side effect. The long-term safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients treated with lamivudine. A recent study investigating the post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been identified, there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently. Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy response are also still uncertain. The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy, and to identify the predictive factors of relapse.