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Hepatitis B clinical trials

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NCT ID: NCT02782247 Completed - Hepatitis C Clinical Trials

Dynamic Liver Tests in Liver Disease

Start date: May 2016
Phase:
Study type: Observational

Chronic viral hepatitis often leads to liver scarring - cirrhosis. If the virus is eradicated from the liver, the liver scarring and liver function often recovers. In some patients the damage is too severe and recovery does not take place. It is not yet known which patients have liver disease that is too advanced to benefit from therapy nor is it known how fast the recovery occurs. Non-intrusive dynamic liver testing (DLT) may allow us to predict the functionality of the liver post treatment and may guide us in treatment choices - for example patients who are predicted not to recover may be prioritised for transplantation. Indocyanine green (ICG) is a dye solely excreted by the liver into bile and used to measure its dynamic function. Transient elastography is similar to ultrasound and measures the degree of fibrosis within the liver. The investigators hypothesise that the use of non-intrusive dynamic liver testing pre-treatment, will allow us to delineate patients before therapy who will have functional liver recovery following viral eradication. The investigators hypothesise that monitoring changes in liver fibrosis and liver function in patients with historical viral clearance will allow an assessment of the likely speed of recovery of liver fibrosis and function - for example if all patients 5 years after treatment for viral hepatitis induced cirrhosis have 'normal' fibrosis and liver function scores the investigators will be able to conclude that recovery is complete within 5 years. The investigators will perform a study pre and post-treatment assessing liver function using non-intrusive dynamic liver testing in addition to currently-used 'liver function' scoring systems, in a multivariate analysis, to determine whether or not the investigators can identify patients who are will have functional liver recovery post therapy.

NCT ID: NCT02760537 Completed - Hepatitis B Clinical Trials

Lay Health Worker Model to Reduce Liver Cancer Disparities in Asian Americans

LHWAA
Start date: April 2013
Phase: N/A
Study type: Interventional

The study was conducted between April 2013 and October 2014. In the parent study, 600 foreign-born Asian American adults 18 years of age and older were drawn from the community in the Baltimore Washington Metropolitan Area. Using a non-probability sampling method, foreign-born Asian American adults, 18 years of age and older, were recruited from the community. After providing informed consent, all the participants were asked to complete a self-administered questionnaire in English, Chinese, Korean, or Vietnamese with the assistance of a bilingual interviewer when necessary. Then, all of the participants were instructed and given 5 to 10 to minutes to read culturally integrated and linguistically appropriate educational material (e.g., Photo novel) developed and validated for efficacy from a prior study. All participants received hepatitis B testing: HBsAg (hepatitis B surface antigen), HBsAb (hepatitis B surface antibody) and, HBcAb (hepatitis B core antibody). A total of 600 completed the survey and screening. A week later, they received the results of the screening test. Based on the screening results, all participants were categorized into three groups: (1) infected (HbsAg+), (2) unprotected (HbsAg-/HbsAb-), or (3) protected (HbsAg-/HbsAb+). We sent the results by mail to participants who were unprotected and protected. Among those 600 screened participants, 33(5.5%) had chronic hepatitis B virus (HBV) infection and 335 (55.8%) had evidence of resolved HBV infection (protected). A total of 232 (38.7%) were susceptible to HBV infection (unprotected). LHW (lay health worker) Intervention for those unprotected: Those unprotected (n=232) were randomly assigned to either the intervention (n=124) or the control (n=108) groups by computer-automated random assignment. Randomization was used to assure equivalence between groups on key factors that may potentially influence the outcome of HBV vaccinations: gender, age, education, length of stay in the U.S. LHWs conducted phone interventions by reminding participants of a series of vaccinations at months 1, 2, and 5 among those assigned to the intervention group. Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments. Seven months after mailing the results, those unprotected were followed up by phone to ask about their status of the series of vaccinations and about promoters or barriers to vaccinations.

NCT ID: NCT02759354 Completed - Hepatitis B Clinical Trials

Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)

Start date: April 26, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa

NCT ID: NCT02752152 Completed - Clinical trials for HIV, Hepatitis B, Hepatitis C and Syphilis Infections

Counseling and Reminders for Regular HIV and STIs Screening

Napneung-1
Start date: December 9, 2015
Phase: N/A
Study type: Interventional

Counseling intervention: Primary objective: to evaluate and compare, in at-risk populations, the efficacy of three different counseling methods in terms of propensity to come back for a HIV re-test. Secondary objectives: to evaluate and compare the efficacy of the counseling methods in terms of reported risk behavior and HIV knowledge as well as their acceptability and cost-effectiveness; describe the distribution of duration from HIV primary infection to detection; and estimate the prevalence of chronic hepatitis B and C, and syphilis in HIV-uninfected participants of targeted populations. Reminder intervention Primary objective: to evaluate and compare, in at-risk individuals who require frequent testing, the efficacy of reminders in terms of propensity to come back for a HIV re-test within 7 months. Secondary objective: to assess the cost-effectiveness of reminders. The interim analyses have shown that that some strategies are better than the others and the Advisory Committee recommended to use only the most efficient strategies (Computer assisted counseling and Scheduling an appointment and sending reminder to clients). In addition, CD4 cell count normal ranges in 30 HIV uninfected individuals in Thailand will be assessed. Transient elastometry (FibroScan) will be used to assess liver fibrosis in participants with and without viral hepatitis.

NCT ID: NCT02751996 Completed - Hepatitis B Clinical Trials

A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV

ACHIEVE
Start date: May 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus

NCT ID: NCT02749864 Completed - Hepatitis C Clinical Trials

Study to Evaluate the Prevalence of Hepatitis C in Spain in 2015 (PREVHEP)

PREVHEP
Start date: July 1, 2015
Phase:
Study type: Observational

The hypothesis of this investigation stresses that the current understanding of the prevalence of HCV infection in the general population and in different subgroups will serve to lay out medium- and long-term measures for action geared toward reducing the disease burden through preventive, research, screening and therapeutic measures. Aim: To determine the prevalence of seropositivity and chronic infection with the HCV and to analyze the associated factors. To analyze and infer different screening strategies for HCV infection based on the at-risk groups/cohorts of elevated prevalence detected. to assess the efficiency of screening strategies and the subsequent cost-effectiveness of treatment in the general population

NCT ID: NCT02743182 Completed - Clinical trials for Chronic Hepatitis B (HBeAg-negative)

HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

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

Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.

NCT ID: NCT02738554 Completed - Chronic Hepatitis B Clinical Trials

Off Treatment Durability in Chronic Hepatitis B With Good Immune Control

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

Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse. However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05 IU/mL) show good off-treatment durability after treatment cessation. Through the quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be before once can achieve successful disease control after treatment cessation.

NCT ID: NCT02732054 Completed - Hepatitis B Clinical Trials

Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts

Start date: March 2015
Phase: Phase 4
Study type: Interventional

This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.

NCT ID: NCT02726789 Completed - Clinical trials for Hepatitis B, Chronic

Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already receiving entecavir and continuing entecavir with treatment.