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Hepatitis A clinical trials

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NCT ID: NCT01829347 Terminated - Clinical trials for Severe Acute Alcoholic Hepatitis

To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure

Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).

NCT ID: NCT01826760 Completed - Clinical trials for Acute-on-chronic Hepatitis B Liver Failure

Study of the Model to Predict 3-month Mortality Risk of Acute-on-chronic Hepatitis B Liver Failure

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

This study was to predict 3-month mortality risk of acute-on-chronic hepatitis B liver failure (ACHBLF) on an individual patient level using artificial neural network (ANN) system. The area under the curve of receiver operating characteristic (AUROC) were calculated for ANN and MELD-based scoring systems to evaluate the performances of the ANN prediction.

NCT ID: NCT01825980 Completed - Hepatitis C Clinical Trials

Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients

CBZF961X2201
Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.

NCT ID: NCT01821794 Active, not recruiting - Clinical trials for Chronic Hepatitis B e Antigen Positive

Tenofovir DF With or Without Peginterferon for Chronic Hepatitis B

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

Background: - There are two forms of chronic hepatitis B. The difference between the forms is whether or not a viral protein called hepatitis B e antigen is present in the blood. Standard approaches to treating both forms of chronic hepatitis B involve different drugs. One drug is called peginterferon, another is called tenofovir DF. These drugs are often given separately and used for different forms of the disease. However, researchers want to see if combining peginterferon and tenofovir DF will be a more effective treatment than tenofovir DF alone. Objectives: - To see whether combining tenofovir DF and peginterferon, or using tenofovir DF alone, is a more effective treatment of chronic hepatitis B. Eligibility: - Individuals at least 18 years of age who have chronic hepatitis B and are in the Hepatitis B Research Network Cohort study. Design: - Participants will be screened with a physical exam and medical history. Blood, urine, and liver tissue samples will be collected. Bone and liver imaging studies will also be performed. - Participants will be divided into two groups. One group will have tenofovir DF alone for 192 weeks (about 4 years). The other group will have tenofovir DF and peginterferon for 24 weeks (about 6 months), and then tenofovir DF alone for 168 weeks (about 3.5 years). - Participants will take the study drugs on the schedule determined by their study doctors. They will keep a diary to record their doses and any side effects. - Participants will have three study visits 4 weeks apart after the starting the treatment. At these visits, they will have a physical exam and provide blood samples. They may also provide urine samples and have imaging studies. - After the first three study visits, participants will continue to have study visits every 12 weeks until the treatment ends at week 192. These visits will have many of the same tests as the first three visits. At some of these visits, they may fill out questionnaires about their quality of life. - Participants who do not respond to the study drugs may have their medications changed. They may also be asked to stop treatment.

NCT ID: NCT01821625 Terminated - Hepatitis C Clinical Trials

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

SQUELCH-C
Start date: April 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This study will provide chronic hepatitis C patients with low platelets (less than 75x10^9/L) the opportunity to undergo treatment and possible cure of their virus. The main hepatitis C drugs will be administered as standard of care, with the addition of the study drug eltrombopag. The investigators hypothesize that providing eltrombopag to chronic hepatitis C patients with low platelets (less than 75x10^9/L) will permit the initiation and completion of antiviral triple therapy with boceprevir, ribavirin, and pegylated-interferon.

NCT ID: NCT01821547 Completed - Hepatitis B Clinical Trials

New Methods to Measure the Immune Response to Hepatitis B Vaccine

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.

NCT ID: NCT01820208 Completed - Clinical trials for Severe Alcoholic Hepatitis

Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.

NCT ID: NCT01813266 Withdrawn - Clinical trials for Chronic Hepatitis C Virus Infection

Prospective Cohort Study: To Provide Evidence & Guidance in Hepatitis C Virus Screening, Comparing the New Birth Cohort Recommendations From the CDC, Versus Classical Traditional Strategies With Established Risk Factors

TPEGHCVS
Start date: May 2013
Phase:
Study type: Observational [Patient Registry]

Although infection with the hepatitis C virus (HCV) can result in acute hepatitis; it more commonly progresses to chronic hepatitis. The acute process is most often asymptomatic. Acute HCV typically leads to chronic infection. Chronic HCV infection is usually slowly progressive. Approximately 5 to 20 percent of chronically infected individuals develop cirrhosis over a 20-30 year period of time. Chronic HCV is the most common cause of chronic liver disease, cirrhosis, hepatocellular carcinoma, and the most frequent indication for liver transplantation in the United States. Screening for chronic HCV infection is crucial because chronic HCV infection is often asymptomatic, effective treatment is available, and untreated disease carries a high risk of morbidity and mortality. Expert opinion, recommendations, and guidelines for HCV screening do not all agree. All guidelines recommend screening patients at increased risk for HCV (ie: typical risk factors). In 2012, the Centers for Disease Control and Prevention (CDC) recommended screening all persons born between 1945 and 1965. At least two studies suggest that screening persons born between 1945 and 1964 or 1946 to 1970, respectively, is cost-effective. The studies estimated that if patients found to be HCV positive were treated with pegylated interferon, ribavirin, and direct acting antiviral therapy (for patients with HCV genotype 1), it would cost $35,700 to 37,700 per quality adjusted life-year. Screening based upon a birth cohort in patients without risk factors may lead to more false positive results. Currently only 1 % of patients in the birth cohort of 1945-1965 who cared for by Intermountain Healthcare providers have been screened. Ambulatory care physicians are not effectively screening patients. It is unclear whether screening based on risk factors alone versus screening based upon risk factors and birth cohort most effectively manages the burden of chronic HCV infection for patients managed by Intermountain Healthcare providers. It is possible that the Intermountain Healthcare population differs in risk from the U.S. population,making guideline application less certain. A well-designed prospective cohort study is needed to understand the risks and benefits of different HCV screening strategies on diagnostic yield and clinical outcomes. The investigators hypothesize that screening based on a person's history of risk factors will detect chronic HCV infection in 2.7 % of the population tested; this would be according to national average. The investigators further hypothesize that screening based on birth cohort and risk factors will identify roughly the same percentage in the tested population. The investigators anticipate usable data within three months which should give us data to describe and publish the effectiveness of different screening strategies. The investigators will identify patients with chronic HCV infection through this initial study who now require treatment and management. The investigators believe this group could be followed inexpensively for clinical endpoints for many years. This would then definitively define the effectiveness of screening strategies based on good evidence. No study has evaluated clinical outcomes associated with the different screening strategies for chronic hepatitis c virus infection.

NCT ID: NCT01810835 Completed - Hepatitis B Clinical Trials

Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.

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

The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.

NCT ID: NCT01809132 Completed - Clinical trials for Acute Alcoholic Hepatitis

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6 months and the two treatment groups will be compared for differences in death rates and laboratory tests that measure liver and gut function.