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Hepatitis B clinical trials

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NCT ID: NCT00168194 Completed - HIV Infections Clinical Trials

Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History

Start date: December 2004
Phase: N/A
Study type: Observational

It remains unclear why some individuals are able to clear HBV from their bodies while in others HBV is a persistent infection. We plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the HBV virus. We will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with HBV and also in individuals who are also infected with HIV. The primary aims are therefore: 1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals. 2. To determine the effect of HIV infection on HBV-specific T-cell responses

NCT ID: NCT00160940 Recruiting - Hepatitis C Clinical Trials

Differential Gene Expression of Liver Tissue and Blood From Individuals With Chronic Viral Hepatitis

Start date: February 2002
Phase: N/A
Study type: Observational

The purpose of this research is to study body materials like blood proteins as well as white blood cell and liver cellular RNA in individuals with liver diseases such as chronic viral hepatitis with or without hepatoma and autoimmune liver disease. Presently it is not understood how infection with chronic viral hepatitis or autoimmune liver disease damages the liver. This research study enroll patients with either chronic viral hepatitis with or without hepatoma or autoimmune liver disease. The purpose of this study is to find the genes that are expressed in both the circulating white blood cells and the liver of patients with varying degrees of liver damage of different causes. Genes are biological messengers some of which determine how the body responds to injury. We anticipate that results from Differential Gene Expression (DGE) analysis will allow us to make predictions about likelihood of disease progression and/or response to treatment. In addition we will test the blood for markers of injury. The blood collected will be prepared differently from the liver tissue. We will use technologies to express pure proteins and then we will investigate the functions of these proteins. Nearly all drugs act on proteins, not genes, so understanding proteins is the key to really effective new medicines. Similarly the first signs of ill health appear in changes to the body’s blood proteins, making them the most sensitive diagnostic indicators. The studies we plan are called proteomics. We will later correlate the patterns of gene expression in both circulating white blood cells and the liver tissue with clinical outcome and patterns of proteins measured in blood and we hope to gain an understanding of how the disease process occurs, which may in turn help us to make more precise diagnoses and develop new forms of treatment. These techniques that we use are still experimental and so we do not yet know if they will be helpful in monitoring changes which may help us to predict the potential severity of your liver disease or even if they can be used to indicate who will best respond to treatment.

NCT ID: NCT00158808 Completed - Hepatitis B Clinical Trials

Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths

Start date: January 2005
Phase: Phase 2
Study type: Interventional

To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine

NCT ID: NCT00158756 Completed - Hepatitis B Clinical Trials

Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Start date: September 12, 2005
Phase: Phase 3
Study type: Interventional

To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.

NCT ID: NCT00158717 Completed - Hepatitis B Clinical Trials

Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.

Start date: April 2003
Phase: N/A
Study type: Observational

To investigate the durability of HBeAg seroconversion in patients with chronic hepatitis B virus infection (HBV) who have seroconverted while participating in a previous Gilead-sponsored study of adefovir dipivoxil.

NCT ID: NCT00158704 Terminated - Hepatitis B Clinical Trials

Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

Start date: January 2002
Phase: N/A
Study type: Interventional

Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.

NCT ID: NCT00155155 Completed - Hepatitis B Clinical Trials

Studies of Immune Responses in Patients With Chronic Hepatitis B

Start date: May 2005
Phase: Phase 1
Study type: Observational

Taiwan is a hyperendemic area of hepatitis B virus (HBV) infection. Previous studies demonstrated vigorous T cell responses to HBV-encoded antigens developed in patients with self-limited acute hepatitis B. In contrast, weak or no T cell responses could be detected in chronic hepatitis B (CH-B) patients. However, these immune responses are still not well known in patients with acute exacerbation (AE) of CH-B and in patients with advanced liver diseases, such as liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The CD4+CD25+ regulatory T cells might suppress immune responses against foreign antigens and pathogens. The roles of CD4+CD25+ regulatory T cells in patients chronically infected with HBV remain to be clarified. The high percentage of HBV carriers in Taiwan are related to the vertical transmissions. High maternal HBV viral load may make the newborns tolerant to the HBV. However, the HBV-specific CD8+ T cells responses in the cord bloods of newborns are still unknown. Thus, we want to resolve these issues in this study. We will enroll the HBsAg (+) patients from NTUH. Blood samples will be collected. We will then analyze the HBV-specific CD8+ T cell responses and the clarify the roles of regulatory T cells.

NCT ID: NCT00155103 Recruiting - Hepatitis B Clinical Trials

Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma

Start date: August 2004
Phase: N/A
Study type: Observational

The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.

NCT ID: NCT00154869 Recruiting - Clinical trials for Hepatitis C, Chronic

Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C

Start date: June 2004
Phase: Phase 3
Study type: Interventional

The investigators' pilot study indicates that hepatitis C virus (HCV)- and hepatitis B virus (HBV)-coinfected patients with predominantly active hepatitis C and those with predominantly active hepatitis B may need different anti-viral regimens. Since in the majority of these coinfected patients the hepatitis activity is more likely due to HCV than to HBV, the optimal therapeutic regimen for HCV- and HBV-coinfected patients with predominantly active hepatitis C will first be investigated. The combination therapy using pegylated interferons (IFNs) such as PEG-IFN alfa-2a has been shown to have a superior efficacy than that using conventional IFN in the treatment of monoinfected chronic hepatitis C. This new combination therapy might also further enhance the treatment efficacy in HCV- and HBV- coinfected patients. The investigators therefore propose to initiate a trial comparing the efficacy of pegylated IFN plus ribavirin (RBV) in dual chronic hepatitis B and C versus that in chronic hepatitis C only, for both HCV genotype 1 and 2/3 patients. The efficacy using a 24-week combination therapy in the sustained clearance of serum HCV RNA is equivalent to that using a 48-week combination therapy in patients with HCV genotype non-1 [Hadziyannis et al, EASL 2002]. A 48-week course of pegylated IFN and RBV combination therapy, in contrast, has been shown to yield a better efficacy in the sustained clearance of serum HCV RNA in patients with HCV genotype 1 than a 24-week combination therapy in western countries [Hadziyannis et al, EASL 2002; Poynard et al, 1998]. The primary objective of the current proposal is to investigate and compare the efficacy of combination therapy using pegylated IFN plus RBV on the clearance of serum HCV RNA in both dually infected patients with a dominant HCV infection and HCV monoinfected patients. Therefore, in this proposal, the treatment duration will be 24 weeks for HCV genotype 2/3 in patients with dual chronic hepatitis C and B and in patients with monoinfected HCV, and will be 48 weeks for HCV genotype 1 in patients with dual chronic hepatitis C and B and in patients with monoinfected HCV.

NCT ID: NCT00154531 Recruiting - Clinical trials for Hepatocellular Carcinoma

Identification of Biomarkers Associated With Human Hepatocellular Carcinoma by SELDI

Start date: August 2004
Phase: N/A
Study type: Observational

Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin(DCP) are used as the tumor markers for diagnosis of HCCs. Thus, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed. SELDI is a proteomic profiling techniques in biomarker discovery. Its approach has been successfully used to identify biomarkers of various cancers, such as prostate cancer, bladder cancer, ovarian cancer, lung cancer, colon cancer, breast cancer and pancreatic cancer. In this current project we will apply the SELDI technique to identify the HCC biomarkers. Sera samples from the HCC patients and relevant controls will be collected. We hope that we can find the new HCC biomarkers. If biomarkers of HCC are identified, this can be used to clinical application for the possible early detection of HCCs.