View clinical trials related to Hepatitis C.
Filter by:The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment. PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.
This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy. It is likely that the synergistic effect of the host's immune response and antiviral therapy when given during the first 6 months of HCV infection makes antiviral therapy during acute HCV infection more effective. In this study the investigators would like to document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss in efficacy. Study design and intervention: Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4 patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily combination tablet). Study population: 80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV treatment centers in the Netherlands and Belgium will be included. Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT study population (=genotype 1 and 4).
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.
There are now several licensed drug treatments for patients with HCV infection. These medications have been shown to be very effective in getting rid of the virus in patients with HCV infection including those with early stages of cirrhosis without complications known as compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little data to show that treating patients with HCV infection and decompensated cirrhosis will give the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B infection who received treatment to control their virus show improvement of their overall liver condition, and the liver complications of many of these patients disappeared. Also, patients with cirrhosis due to excess alcohol and who stopped drinking also showed improvement in liver function and their complications of cirrhosis coming under control. Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected to show the same positive effects, because the underlying cause of cirrhosis is coming under control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir) that prevents the hepatitis C virus from copying and multiplying themselves, allowing the body to clear the virus from their systems and be cured of HCV infection. This study is being conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in patients with decompensated cirrhosis giving rise to improvement in liver function, together with improvement of quality of life and survival.
The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.
Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.