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Hepatitis clinical trials

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NCT ID: NCT02444611 Completed - Clinical trials for Innate Immune Response

A Trial Investigating the Influence of BCG and Hepatitis B Immunisation at Birth on Neonatal Immune Responses: The Early Life Vaccines and Immunity Study

ELVIS
Start date: March 2015
Phase: N/A
Study type: Interventional

Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood disease-specific immunisation is irrefutably linked to the decline in deaths from these targeted infections over the last century. However, neonatal immunisation is limited, in part, by the impaired adaptive immune function in this age group. There is now an expanding body of evidence for heterologous ('non-specific') effects of various vaccines used in childhood. This refers to the immunomodulatory capabilities of vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The underlying immunological mechanisms responsible for these effects are incompletely understood, but evidence is mounting that the innate immune system is central to these observed effects. This study is a randomised controlled trial designed to determine the influence of two commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth, on the neonatal immune responses to non-specific antigens. The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne, Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups, receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1 week post randomisation) A blood sample will be taken at 1-week post randomisation for in vitro immunological analyses. This study will improve current understanding of the influence of vaccines on neonatal immunity and will help develop strategies exploiting beneficial heterologous ('non-specific') effects to improve protection against infection in the very young.

NCT ID: NCT02443233 Completed - Clinical trials for Hepatitis B Infection

Evaluation of Paternal, Maternal and Obstetric Factors Leading to the Hepatitis B Immunization Failure in Hong Kong

Start date: January 2014
Phase: N/A
Study type: Observational

Globally, hepatitis B virus (HBV) infection is the most common form of chronic hepatitis. There are still a lot of uncertainties on how infants acquired HBV leading to the development of chronic HBV infection despite active and passive immunoprophylaxis. The investigators would like to carry out a prospective study to answer the following questions: 1. the paternal, maternal and obstetric factors leading to immunoprophylaxis failure 2. the prevalence of immunoprophylaxis failure in Hong Kong

NCT ID: NCT02442284 Completed - Cirrhosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

Start date: May 13, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

NCT ID: NCT02442271 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

Start date: April 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3b, open-label, multicenter study to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12), in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin.

NCT ID: NCT02441283 Completed - Hepatitis C Clinical Trials

A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Start date: June 22, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

NCT ID: NCT02439567 Completed - Cirrhosis Clinical Trials

Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)

SPLEEN-C
Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.

NCT ID: NCT02434848 Completed - HIV Clinical Trials

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Start date: July 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

NCT ID: NCT02431312 Completed - Hepatitis B Clinical Trials

Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects

Start date: January 12, 2015
Phase: Phase 1
Study type: Interventional

This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.

NCT ID: NCT02430194 Completed - Clinical trials for Chronic Hepatitis D Infection

Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)

LOWR-2
Start date: December 2014
Phase: Phase 2
Study type: Interventional

An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta Hepatitis (HDV) (LOWR-2).

NCT ID: NCT02430181 Completed - Clinical trials for Chronic Hepatitis D Infection

Lonafarnib With and Without Ritonavir in HDV (LOWR-1)

LOWR-1
Start date: November 2014
Phase: Phase 2
Study type: Interventional

To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).