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NCT ID: NCT01360879 Recruiting - Chronic Hepatitis B Clinical Trials

Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

FIBROELAST
Start date: September 2010
Phase: N/A
Study type: Observational

This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.

NCT ID: NCT01341275 Recruiting - Hepatitis B Clinical Trials

Adolescents' Response to Hepatitis B Vaccine Booster Dose

REACH
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The aims of this study are to determine: 1. the degree of immunity against hepatitis B, 2. factors associated with immunity against hepatitis B, 3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and 4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents. Study subjects eligible for enrollment will: - have blood drawn for baseline serologies - receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose) - have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine) The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.

NCT ID: NCT01335711 Recruiting - Chronic Hepatitis C Clinical Trials

CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects

Start date: April 2011
Phase: Phase 2
Study type: Interventional

To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.

NCT ID: NCT01327729 Recruiting - Hepatitis C Clinical Trials

Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C

Start date: November 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus (HCV). Methods: Randomized, Open-label trial, in 3 parallel groups (each of 100 patients)

NCT ID: NCT01312012 Recruiting - Clinical trials for Hepatitis B Virus Infection, Pregnancy

The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment. A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.

NCT ID: NCT01310062 Recruiting - Hepatitis B,Chronic Clinical Trials

The Development of Diagnostic Biomarker Panels for Hepatitis and Liver Cancer

Start date: August 2010
Phase: N/A
Study type: Observational

More recent studies have shown that the HBV-infected population has a greater risk of development of hepatocellular carcinoma. Nevertheless, there are still a significant number of people chronically infected by HBV who do not develop the complication. Hence, there exist biological markers that could be indicator for the disease-inducing and carcinogenic potential of the virus.

NCT ID: NCT01306071 Recruiting - Clinical trials for Chronic Hepatitis B e Antigen Positive

Observational Study of Persons With Hepatitis B Virus Infection in North America

Start date: February 26, 2011
Phase: N/A
Study type: Observational

Background: - Chronic hepatitis B virus infection is a leading cause of morbidity and mortality from end stage liver disease and liver cancer. Although significant progress has been made recently in hepatitis B therapy, current knowledge about how to manage the infection is limited because most treatment trials involve 1 to 2 years of therapy at most, even though most patients require treatment of much longer duration for optimal long-term outcome. To improve current knowledge on the disease and long-term disease progression, the Hepatitis B Research Network is collecting health and disease information from individuals who have been diagnosed with hepatitis B. Objectives: - To study individuals with hepatitis B and identify factors that affect the way the disease progresses. Eligibility: - Individuals at least 18 years of age who have been diagnosed with hepatitis B. Design: - Participants will be screened with a physical examination and medical history. Health information will be collected through questionnaires and surveys on health behaviors, and family history of liver disease. Participants will also provide blood samples, and those who have had a liver biopsy within the past 2 years or have one during the course of the study will provide biopsy material for further study. - Information will be collected during a series of study visits. Each visit will take approximately 1 hour. During the first year, participants will have study visits 12 weeks, 24 weeks, and 48 weeks after entering the study. In subsequent years, participants will have a study visit approximately every 24 weeks (6 months) until the end of the study. - Additional visits will be required of women who are pregnant when enrolled in the study or become pregnant during the course of the study. - Participants whose hepatitis B status changes during the course of the study (for example, a flare of disease activity) may be asked to return for more frequent visits.

NCT ID: NCT01289652 Recruiting - HIV Clinical Trials

The Natural History and Treatment of Acute Hepatitis C Virus (HCV) in HIV-positive Individuals

PROBE-C
Start date: May 2011
Phase: N/A
Study type: Observational

The aim of the study is to investigate the epidemiology, natural history and treatment outcomes of acute hepatitis C (HCV) infection. Given the current pattern of case reporting, the cohort will be largely made up of human immunodeficiency virus (HIV)-positive patients, but HIV-negative patients with acute hepatitis C (AHC) will also be enrolled to enable comparisons to be made as appropriate and possible.

NCT ID: NCT01274208 Recruiting - Hepatitis C Clinical Trials

Examining the Immune Response in Patients With Gaucher Disease and Hepatitis C

Start date: January 2011
Phase: N/A
Study type: Observational

Study objectives: - Investigate the anti-HCV response in patients with Gaucher disease(GD) - Define the potential role of high levels of Glucocerebroside in the immune system Study hypothesis: High levels of Glucocerebroside can be used as a tool in the antiviral treatment of hepatitis C by potentiating the immune response of natural killer T cells and dendritic cells

NCT ID: NCT01270165 Recruiting - Chronic Hepatitis B Clinical Trials

Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

Start date: June 2010
Phase: Phase 3
Study type: Interventional

No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.