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Showing 1-20 of 45 trials
NCT05975216
Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up. Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.
NCT06718530
Hepatitis C virus (HCV), which infects more than 185 million people, is a major risk factor. Direct-acting antiviral (DAA) therapy has significantly improved the eradication of the virus, but has not completely eliminated the risk of HCC, so careful surveillance is necessary. The genetic diversity of the natural killer receptor, histocompatibility antigens (HLA) and interferon lambda 4 (INFL4) activity, among other factors, have been found to be crucial in directing disease progression. Importantly, these markers are detectable years before the diagnosis of HCC. In addition, polymorphic variants attributable to the expression of genes involved in innate-type immune response, such as IFNL4 and HLA-E, have been shown to be predictive for the development of HCC and have not yet been extensively studied. The aim of the study is to evaluate novel circulating biomarkers, including the presence of antibodies to specific HCV proteome peptides, IFNL4 expression, and the interaction of specific HLA receptors/ligands in a large cohort of HCV-positive subjects in order to create a screening strategy for the early diagnosis of HCV-associated HCC. Part of the study will be devoted to describing the immune microenvironment associated with the expression of IFNL4 and HLAE, evaluating them as potential prognostic indicators for HCC in HCV-infected subjects undergoing surgery for HCC, as well as in those with advanced/metastatic HCC.
NCT05071261
The aim of this study is to assess the HCV screening rate in Arizona by identification of potential HCV patients/subjects through different methods of communication - text message, email, social media, radio, newspaper ads, and flyers.
NCT05906459
The present study aims to establish a " one-sample testing platform " and assess the prevalence of hepatitis C in individuals taking routine physical examination or outpatient visit in mainland China.
NCT04980157
The purpose of the study is to examine the efficacy of educational materials to promote hepatitis C virus (HCV) screening and colorectal cancer (CRC) screening uptake among adults born between 1945-1965.
NCT04852614
This is a prospective, observational, open-label, pharmacokinetic study will evaluate PK of SOF/DAC in lactating HCV-infected females at weaning or women who voluntarily decided to forego breastfeeding to initiate HCV infection treatment. Therefore, drug concentrations can be determined in maternal plasma and milk without risk to the children. HCV infected women at weaning after various durations of breastfeeding and HCV infected women who wish to initiate treatment immediately after delivery and forego breastfeeding will be recruited to start treatment under the guidance of their physician with SOF/DAC to determine M/P ratios of each of SOF, GS-331007 and DAC.
NCT04596475
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).
NCT05361603
The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.
NCT02939989
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.
NCT04251572
The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population. Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.
NCT04136405
This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.
NCT04732832
Among the hemodialysis units, the global incidence of HCV infection ranges from 1.2% to 2.9%. Data regarding the long-term risk of reinfection among hemodialysis patients achieving SVR are limited. To our best knowledge, only one study assessed the long-term negativity of serum HCV RNA in hemodialysis patients who achieved SVR after IFN-based therapies. With a median follow-up of 48 months following SVR, the life-time cumulative survival for HCV RNA negativity was 86% among the 121 participants who were on maintenance dialysis. Furthermore, the life-time cumulative survival for HCV RNA negativity was 95% among the 45 participants who underwent renal transplantation from HCV-negative donors. Because the literatures regarding the long-term follow-up of viral outcome, the patient numbers to be recruited are still limited, and all studies are focused on IFN-based treatment, we aim to assess the long-term risk of HCV reinfection in hemodialysis patients attaining SVR by IFN-based or IFN-free therapies.
NCT03820258
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
NCT02185794
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
NCT04391985
enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
NCT04387539
Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
NCT04378608
The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients
NCT04385407
A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).
NCT04382339
This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
NCT03381859
Primary Efficacy Objective -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification \[LLOQ\] for 12 weeks (SVR12) after completion of the study treatment course Secondary Objectives * To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 \[End of Treatment - EOT\]) and 24 (SVR12) * To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC. * To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12 Clinical hypotheses. Primary Efficacy Hypothesis \- A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12. Secondary hypotheses * A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12) * Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations. * In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12