View clinical trials related to Chronic Hepatitis C.
Filter by:Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
The XN-20, is a full blood count (FBC) analyser with an extended differential counting and flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses a two stage process to classify the white blood count (WBC) sub-populations and detect the presence of abnormal reactive and malignant cells. In regards to lymphocytes in the peripheral blood, the machine has the capacity to distinguish activated from non-activated T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from a standard full blood count) with results available in 1.5 minutes. It is a fully automated process and can be considered as an alternative rapid flow cytometry method. Objective of the SASA study: to investigate the signal pattern of white blood cells assessed using the XN-20 full blood count platform in patients with untreated viral infections i.e. HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's demographic and clinical disease characteristics with the aim of detecting characteristic cell populations that can be used in the development of system flags for future studies.
The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab, India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC) patients. The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016 to provide free treatment to all CHC aiming to eliminate HCV from Punjab. The study assessed the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC patients in a public health care setting.
HCV infection is treated with oral drugs, termed as 'direct-acting anti-viral agents' (DAAs). In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]). Globally, DAA based regimens have obtained excellent rates of cure. Cure of HCV infection is defined as undetectable HCV RNA 12 weeks after stopping drugs, also referred to as sustained virological response at week 12 (SVR12). Using these DAA based treatment regimens, a small number (up to 5%) of people fail to achieve SVR12 and HCV RNA reappear after a few weeks of stopping the drugs (virological relapse). Data on management of virological relapse are extremely limited, especially in genotype 3, and no guidelines exist regarding re-treatment options for such group. Hence, we plan to re-treat such people using what appear to be the best combination treatment in each situation and to review our experience over time. Participants with chronic HCV infection who relapsed following standard DAA-based treatment regimen will be invited to participate. We propose to re-treat them with the anti-HCV drug combination which appears to be the most suited to his/her clinical profile, based on the current empiric knowledge - the choice of drugs will be based on HCV genotype, the previous treatment regimen and the presence/absence of liver cirrhosis, etc. During anti-HCV treatment, participants will be given expected standard of care and HCV RNA will be tested at 4-week intervals starting from week 4 and till RNA becomes undetectable, and then at the end of treatment and 12 weeks after the treatment was stopped - as is the usual practice during such treatment. Relevant clinical, laboratory and treatment details will be recorded in a pre-defined data collection form. Treatment outcome will be categorized as success (SVR12), treatment failure (any detectable HCV RNA at the end of 24 weeks treatment duration) or relapse (HCV RNA negative at the end of treatment, but positive at 12 weeks after stopping treatment). If possible, a 5-ml blood specimen will be collected before starting re-treatment from all participants; in addition, another similar specimen will be collected following the treatment in those in whom the re-treatment is unsuccessful. These will be stored and may be used in future for virological studies to look for drug-resistance variations.
The Mukh-Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) is a public health initiative for prevention and control of hepatitis C in the Punjab state, India. The efficacy of decentralised public health services and safety of 12- or 24-weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) with or without ribavirin (RBV) in the treatment of pediatric chronic hepatitis C will be assessed
The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.
The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.
The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment
The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.