A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
Hepatitis BChronicThe purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment...
Hepatitis CChronicThe purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.
Study on the Prevalence of Hepatitis C In a psychiatRic Population
Hepatitis CViral hepatitis, especially hepatitis C, is a major public health issue. Nowadays, very few studies in France have evaluated the prevalence of hepatitis C in a psychiatric environment. In 2019, at the time of new treatments for HCV, it therefore seems essential to update the available data by estimating the prevalence of chronic active hepatitis C in psychiatric population. In addition to an update of epidemiological data, it is of high importance to assess the effectiveness of the care pathway for patients in whom chronic active hepatitis C is diagnosed, including the cascade of care, currently too inefficient despite treatments that are themselves ultra-efficient. Indeed, it is essential that once hepatitis is detected, it is formally diagnosed, then that the patient actually starts care and is adherent to treatment (take his treatment according to the prescription and until the end: this implies that the patient accepts his or her illness and understands the value of the prescribed treatments), to hope to cure the infection. In this context, the SaPHIR study will allow to test a systematic screening of patients in an adult psychiatric environment, through rapid diagnostic tests (RDT). The objective is to promote the adherence of patients, and to assess possible obstacles in order to optimize the screening (RDTs), diagnosis (confirmation of only positive RDTs by venous sampling) and care management circuits in routine practice. In addition, the study envisages a combined HCV-HBV-HIV screening, taking into account the cross-infection risk (same mode of contamination, same risk population, frequent co-infections, more severe liver pathology in case of co-infection, etc.), thus making it possible to take care of the patient as a whole. The results of the SaPHIR study can ultimately be sent to the French health authorities to improve screening and care circuits, and their coverage by social security.
Improving Inpatient Screening for Hepatitis C
Hepatitis CThis study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.
A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis...
Hepatitis BThe purpose of this study is to generate an exploratory training set of data and to identify predictive biomarkers (a measurable biological response that predicts something) of innate and adaptive responses to immunisation of two vaccines utilizing different adjuvant technology given according to approved schedules to healthy adult volunteers. The vaccines are model agents selected as they match antigens but have discordant adjuvants, have a known immunogenicity profile, assays are freely available to measure responses, and they are safe to administer to healthy adults at the doses and schedules proposed. This study will strive to correlate biomarker activity with observed immunological responses to vaccination and if successful, these biomarkers could be used in early stage clinical trials to optimize selection of vaccine candidates with a profile that will be most likely to be effective once they are in generalized use.
The Impact of Everolimus Based Immunosuppression in the Evolution of Hepatitis C Fibrosis After...
Hepatitis C Recurrence After Liver TransplantBackground: Hepatitis C recurrence, which invariably occurs in viremic liver transplant (LT) recipients, associated with accelerated liver fibrosis leading to established graft cirrhosis in 40-20% of patients in 5 years with another 5% experiencing an aggressive form with cirrhosis and graft loss in 1 year. Since treatment after LT has a low efficacy, the overall survival of HCV-infected LT recipients is shorter than that of uninfected LT patients. New immunosuppressive agents such as mTOR inhibitors (Everolimus/Sirolimus) reduce the risk of liver graft rejection, have antifibrotic properties and do not worsen HCV recurrence. Moreover new directly-acting antiviral agents have increased efficacy of interferon-based treatment but their use in LT recipients may be limited by side effects. Hypothesis: Use of individualized immunosuppressive regimen and early personalized anti-viral treatment based on recipient and viral factors would improve outcome of HCV infected liver transplant recipients. Objectives: To evaluate safety and efficacy of two steroid-free immunosuppressive regimens to reduce hepatitis C recurrence associated to fibrosis progression (F≥2 under ISHAK score) at one year post-transplant. To identify viral and recipient factors associated with liver fibrosis progression using ultra-deep pyrosequencing (UDPS).
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection...
HBeAg Positive Chronic Hepatitis B InfectionDuring hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation:...
Hepatitis COxidative StressThe objective of the present study is to evaluate the antioxidant status in the blood of HCV patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800 mg,500 mg and 40 mg; respectively) during six months.
Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed...
Hepatitis CHIVThis research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.
A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
Hepatitis CTo evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.