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Hepatitis clinical trials

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NCT ID: NCT03692897 Recruiting - Hepatitis B Clinical Trials

An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Start date: October 11, 2018
Phase:
Study type: Observational

The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.

NCT ID: NCT03685045 Recruiting - Hepatitis C Clinical Trials

ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings

ETHOS II
Start date: May 28, 2018
Phase: N/A
Study type: Interventional

The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for subsequent establishment of HCV screening and treatment programs in drug treatment clinics and NSPs across NSW and nationally.

NCT ID: NCT03680183 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

Start date: May 22, 2018
Phase:
Study type: Observational [Patient Registry]

The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.

NCT ID: NCT03643172 Recruiting - Clinical trials for Chronic Hepatitis B, HBeAg Negative

Terminator 2 Register

Start date: September 1, 2018
Phase:
Study type: Observational

All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.

NCT ID: NCT03640728 Recruiting - Hepatitis B Clinical Trials

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Start date: January 25, 2019
Phase:
Study type: Observational

HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet. In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, the drug metabolism characteristics of TAF will be explored in such severe liver injury population of HBV-ACLF.

NCT ID: NCT03627819 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Plant Sterols and Plant Stanols and Liver Inflammation

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

As the prevalence of obesity is reaching epidemic proportions, the prevalence of non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH), increases concomitantly and becomes a major global health hazard. Successful pharmacological interventions to treat or prevent NASH are not available and so far only weight loss has clear benefits, but sustained weight-loss is difficult to achieve on the longer-term. We recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation, which needs to be validated in humans in a translational approach. In the current proposed pilot study, the effect of consuming plant sterol or plant stanol esters on biopsy proven liver inflammation will be investigated in NAFLD patients. The objective is to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 12 months on biopsy proven liver inflammation in NAFLD patients. This study is a randomized, placebo-controlled, double blinded pilot study with a run-period of 2 weeks, an intervention period of 12 months and a wash-out period of 1 month. The study population consists of 15 patients with biopsy-proven liver inflammation, aged 18-75 years. All subjects will start a run-in period of two weeks during which they consume daily 20 grams of control margarine after which they will be randomly allocated to consume 20 grams control margarine or plant sterol or plant stanol enriched margarine on a daily basis for a period of 12 months. The primary outcome parameter in this study is biopsy proven liver inflammation.

NCT ID: NCT03601546 Recruiting - Clinical trials for Hepatitis C Infection

Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam

CoViet-C
Start date: September 13, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies

NCT ID: NCT03587467 Recruiting - Healthy Clinical Trials

Study on Gut Microbiota in Chronic HBV Infected Patients

HBV
Start date: December 1, 2017
Phase:
Study type: Observational

Hepatitis B Virus(HBV) infection is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. Age is the main factor affecting the chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in perinatal and infant period will develop into chronic infection respectively. Whereas the proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an important role in maintaining nomal physiological function of the intestine and the immune function of the body. It has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. Recently, the relationship between immune response and intestinal microbiota has been claimed. In a previous study using IMT to treat HBeAg positive chronic hepatits B patients combined with antiviral theraopy, 80% of them has reached HBeAg clearance. Increasing evidence suggests that the gut microbiota has evolved as a new important player in the pathogenesis of hepatitis B virus-induced chronic liver disease. However, the composition and structure alteration of the gut microbiota associated with the stage and progression of HBV infection remains unknown. Hence, we proposed a trial to detected gut microbiota of chronic HBV infected patients high-throughput 16S rRNA gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.

NCT ID: NCT03568578 Recruiting - Hepatitis B Clinical Trials

A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

Start date: January 28, 2018
Phase: N/A
Study type: Interventional

The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.

NCT ID: NCT03559790 Recruiting - Chronic Hepatitis b Clinical Trials

Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

Start date: July 18, 2018
Phase:
Study type: Observational

Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.