View clinical trials related to Hepatitis C, Chronic.
Filter by: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 primary objective of this pilot trial is to compare the efficacy, measured as sustained virologic response (SVR) at least 12 weeks after completion of therapy, across three study regimens/delivery modalities: Arm 1 - 4 weeks of sofosbuvir (SOF) + daclatasvir (DAC) + pegylated interferon alfa-2a (PEG) delivered using directly observed therapy (DOT); Arm 2 - 12 weeks of SOF+DAC delivered using DOT; and Arm 3 - 12 weeks of SOF+DAC delivered as per standard of care (monthly dispensation with no DOT). Secondary objectives are 1)To compare the cost per SVR for each of the three study arms; 2) To compare adherence among persons across the three study arms; 3) To evaluate the safety, tolerability and acceptability of treatment in the three arms.
Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.
The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.
This is an observational study of cases of chronic hepatitis C and negative HCV controls in adults receiving chronic hemodialysis at the National Renal Health Center (NRHC) -EsSalud in Lima - Peru.The NRHC provides specialized health care, including hemodialysis, to people with advanced kidney disease from all the districts of Lima. Study population: By December 2017, there were 293 adults receiving chronic hemodialysis at the NRHC-EsSalud. All adult patients receiving chronic hemodialysis at the NRHC-EsSalud will be invited to participate. Primary objective: Characterize HCV disease in patients receiving chronic hemodialysis at the NRHC-EsSalud. Secondary objective: Identify factors associated with an increased risk of HCV infection. Inclusion criteria: Age > 18 years Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC. Exclusion criteria: • Inability to provide informed consent. To comply with the primary objective of the study, samples from volunteers with HCV serology confirmed in Roe Clinic Laboratory (cases) will be subjected to additional tests: HCV viral load followed by determination of the HCV genotype by using the Abbott m2000 real-time PCR system capable of identifying genotypes 1 (1a and 1b), 2, 3, 4 , 5 and 6, using fluorescent probes of oligonucleotides specific for each genotype . In addition to these lab tests, volunteers will have a Fibroscan test performed at a local provider, with the Fibroscan Model 402 with E and XL probes. The information will be collected in a Case Report Form (CRF), which will be filled out by study staff. The source of clinical information will be primarily the clinical history of the NRHC - EsSalud. The source of information on the results of the auxiliary tests will be obtained from the results issued by Roe Clinic Laboratory and by the image center of the Delgado Clínic. Protection of Human Subjects: The protocol and informed consent will be reviewed and approved by the Ethics Committee of the NRHC. No study procedure will be carried out if the volunteer has not given his or her written consent. All reasonable precautions will be taken to protect the privacy of the volunteer's information, whose data will be identified only through a code. Researchers will keep the study folders in a locked cabinet in a safe place
The main purpose of the CoDISEN cohort study is to propose a model of prevention and care for HIV and viral hepatitis adapted to the needs of people who inject drugs (PWID) in Dakar, Senegal.
This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.
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 investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated. The investigators hypothesize that patients receiving DAAs do not experience higher rates of adverse events compared to patients who have not received DAAs. The study population is adults between the ages of 18 and 88 with any indication of a diagnosis of HCV. An intervention group (those receiving a DAA) and comparison group (those who are not treated) will be created using medication dispensing data. Eligibility for the study will be determined from January 1, 2011 through December 31, 2017. Covariates will be collected from January 1, 2011 through December 31, 2017. Individual study sites may have access to historical data prior to 2011 that can be used as covariates or to identify individuals with HCV. The primary outcomes of interest include acute myocardial infarction, neurological outcomes (e.g. acute stroke, intracranial bleed), acute kidney failure, acute on chronic liver failure, hepatic decompensation, multiple organ dysfunction syndrome, cancer, bradyarrhythmia, and death. The secondary outcomes include decompensated cirrhosis, hospitalization, emergency department visit, and arrhythmia. Outcomes will be assessed from January 1, 2011 through December 31, 2017. The investigators will use two different analytic approaches to answer the question of interest: a Poisson regression model and marginal structural modeling (MSM). The simpler Poisson model is an extension of tabular rate of event analysis. The more complicated MSM model incorporates modeling of the treatment decision to more flexibly control for confounding by indication. For each outcome, the investigators will only record the first date an outcome occurs. Each outcome will be modeled separately.
This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.