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Hepatitis, Viral, Human clinical trials

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NCT ID: NCT03410953 Completed - Hepatitis B Clinical Trials

Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines

Start date: April 13, 2018
Phase: Phase 4
Study type: Interventional

Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.

NCT ID: NCT01804829 Completed - Clinical trials for Hepatocellular Carcinoma

Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.

Start date: June 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.

NCT ID: NCT01532973 Completed - Clinical trials for Hepatitis, Viral, Human

Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)

Start date: February 16, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered. Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated). Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants, the mean maximum reduction in HCV viral load is greater following multiple dose oral administration of elbasvir as compared to placebo. Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

NCT ID: NCT01170741 Completed - Clinical trials for Human Immunodeficiency Virus

Computer-Assisted Tailored Cue-card Health [CATCH] Study

CATCH
Start date: June 2010
Phase: Phase 1
Study type: Interventional

This study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with HIV/STI testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. The specific aims of the proposed study are: 1. To refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and herpes). 2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition. 3. To assess the feasibility and acceptability of the tailored intervention in a rural setting.

NCT ID: NCT01163240 Completed - Hepatitis B Clinical Trials

Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

EPIC B
Start date: June 2009
Phase: N/A
Study type: Observational

The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric population. Family history and history of HBV transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment This information will be used to assist with the feasibility and design of studies for the Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB is not accurately known in Western countries or the rest of the world making pediatric studies difficult to plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.

NCT ID: NCT00915057 Completed - Clinical trials for Hepatitis, Viral, Human

Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC.

NCT ID: NCT00913757 Completed - Clinical trials for Carcinoma, Hepatocellular

A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area

Start date: July 1, 2009
Phase:
Study type: Observational

Background: - Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States. - More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives: - To identify genetic factors that may help to explain the aggressiveness of liver cancer. - To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility: - Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C. - Participants will reside in Baltimore City and the surrounding areas. Design: - Participants will complete a questionnaire and provide blood and urine samples for testing: - The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer. - Blood and urine samples will be collected from all participants after the questionnaire. - Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease. - No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.

NCT ID: NCT00608192 Completed - HIV Infections Clinical Trials

HIV and Hepatitis Care Coordination in Methadone Treatment

Start date: January 2008
Phase: N/A
Study type: Interventional

This randomized clinical trial will examine the effectiveness of a strategy of HIV and Hepatitis Care Coordination (HCC) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard Testing, Education, and Counseling (TEC).

NCT ID: NCT00564811 Completed - Hepatitis C Clinical Trials

Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)

Start date: March 2003
Phase: N/A
Study type: Interventional

The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.

NCT ID: NCT00342186 Completed - Clinical trials for Hepatitis, Viral, Human

Genes Involved in Resistance or Susceptibility to Hepatitis B Virus

Start date: September 27, 2002
Phase:
Study type: Observational

This study, conducted by the Beijing University First Hospital of China and the National Cancer (NCI), will try to identify genes associated with either susceptibility or resistance to chronic infection by the hepatitis B virus (HBV). Some people recover from HBV infection; others become chronically infected and may go on to develop severe liver disease such as cirrhosis or liver cancer. About 350 million people worldwide have chronic HBV infection. Of 120 million infected Chinese, 90 percent of children infected at less than 5 years of age and 10 percent of infected adults develop persistent infection. HBV-infected and non-infected healthy persons of Han ethnicity born before 1963 may be eligible for this study. Offspring of infected candidates (born in any year) may also be enrolled. Infected adults must have at least one infected parent or sibling. Persons who resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months before 1986 may not participate. All participants (except offspring of the study subjects) will fill out a health questionnaire (providing information about eating, drinking, and smoking habits and a personal and family health history) and will donate no more than 20 milliliters of blood. The blood will be tested for antibodies, antigens, and other substances that may indicate infection with hepatitis viruses. Some of the blood will be sent to the NCI for DNA analysis to identify genetic factors that may influence clearance of the hepatitis virus after infection or progression to liver diseases associated with HBV infection. Infected patients who have had a liver biopsy in the past will be asked permission to examine tissue from the biopsy and to review laboratory results of any tests done for diagnostic and treatment purposes. When the study is completed, specimens sent to the NCI will have identifiers linking the material to the donor removed. The anonymous samples may then be used for other genetic studies. Specimens remaining in China will continue to have identifiers linked to them and may be used for future studies designed to identify who is at greatest risk of developing serious liver diseases. Participants who do not want their blood used for future studies may request that the samples be destroyed. Because children inherit one-half of their DNA from each parent, DNA samples from HBV infected study participants may provide additional information about the parent s DNA structure. Offspring who participate in this study will provide a DNA sample. The sample is obtained by swishing a mouthwash in the mouth for 30 seconds and then spitting the mouth wash into a cup. The DNA is then isolated from the mouth cells.