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Hepatitis, Chronic clinical trials

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NCT ID: NCT03212833 Recruiting - Hepatitis C Clinical Trials

Impact of Insulin Resistance on Therapeutic Response for Oral Treatment of Chronic Hepatitis C Virus Infection

Start date: May 1, 2017
Phase: N/A
Study type: Observational

Globally, approximately 170 million people are infected with hepatitis C virus (HCV); 350,000 deaths each year are caused by HCV infection (Perz,et al, 2006).The Egyptian Demographic Health Survey (EDHS), across sectional survey including hepatitis C virus (HCV)biomarkers, was conducted in 2008 on a large nationally representative sample (El-Zanaty F, et al 2009). It estimated HCV prevalence among the 15-59 years age group to be 14.7% (El-Zanaty F, et al 2009).Accordingly, Egypt has the highest HCV prevalence in the world (Lavanchy D, 2011), ( Shepard CW,et al 2005)..Interferon (INF)-free regimens of combined directly acting antivirals (DAAs) have shown improved efficacy and tolerability compared with interferon (IFN)-containing regimens, and they have become the standard of care for treatment of HCV genotype-1 (HCV-1)(Afdhal, et al, 2014).Insulin resistance is a state in which a given concentration of insulin produces a less-than-expected biological effect. The prevalence of type 2 diabetes mellitus in hepatitis C in cirrhotic patients is 27.3% which is higher than among non-cirrhotic hepatitis C patients (17.5%)(Romero-Gómez, 2006). HCV promotes insulin resistance and insulin resistance induces interferon resistance, steatosis and fibrosis progression in a genotype-dependent manner.In HCV-1, insulin resistance decreases sustained response rate, and increase the risk for the development of steatosis and fibrosis progression, However, the impact of insulin resistance in other genotypes seems not achieve enough importance to impair sustained response, probably due to the high sensitivity to peginterferon. The treatment of insulin resistance, decreasing hyperinsulinemia, could improve sustained response rate in patients with chronic HCV-1 infection when treated with peginterferon plus ribavirin(Romero-Gómez,2006). Objectives: we aim to determine the prevalence of insulin resistance among the patients with chronic hepatitis C virus( HCV) infection and to explore the association between insulin resistance and therapeutic response by comparing the insulin resistance among responders and non-responders to oral treatment of chronic hepatitis C virus infection Patients and methods: The study is intended to include patients of chronic hepatitis C virus infection receiving oral treatment for one year period. All patients will have clinical evaluation, ultrasonographic examination, and laboratory investigations which include complete blood count, liver function tests, estimation of fasting serum glucose, fasting serum insulin, and determination of insulin resistance index.The patients will be selected according the selection criteria determined by the National Committee for Control of Viral Hepatitis (NCCVH).

NCT ID: NCT03210506 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Cytokines During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.

NCT ID: NCT03210493 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

NCT ID: NCT03210467 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: N/A
Study type: Observational

Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication. In hepatitis B infection, Plasmacytoid Dendritic Cells(pDCs) are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV) therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus.

NCT ID: NCT03209908 Recruiting - Chronic Hepatitis B Clinical Trials

The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Start date: January 1, 2017
Phase: N/A
Study type: Observational

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

NCT ID: NCT03209037 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.

NCT ID: NCT03209011 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.

NCT ID: NCT03208998 Recruiting - Clinical trials for Chronic Hepatitis B Infection

The Changes of Natural Killer Cells Frequency and Function During Antiviral Therapy

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, NKs are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of NKs frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of NKs function, or Peg IFN - alpha enhanced NKs function which gave rise to the decline of the virus.

NCT ID: NCT03108794 Recruiting - Chronic Hepatitis B Clinical Trials

A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B

Start date: June 30, 2012
Phase: N/A
Study type: Observational [Patient Registry]

CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. The main criteria for registration is HBsAg-positivity more than 6 months, and these patients will receive followed-up visits every three to six months.

NCT ID: NCT03099278 Recruiting - Chronic Hepatitis D Clinical Trials

Ezetimibe for Patients With Chronic Hepatitis D

Start date: January 2017
Phase: Phase 2
Study type: Interventional

Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection