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Hepatitis A clinical trials

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NCT ID: NCT03575208 Withdrawn - Chronic Hepatitis B Clinical Trials

Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B

Start date: February 13, 2019
Phase: Phase 2
Study type: Interventional

Background: Hepatitis B is a viral infection of the liver. When the immune system tries to clear hepatitis B, it damages the liver. Eventually, the immune system gets exhausted fighting the virus. Researchers want to see if giving large doses of an antibody (HBIg) with the drug peginterferon will boost the immune system in people with this disease. Objectives: To observe the effect of large doses of antibody against the hepatitis B surface antigen on the immune response to the virus. To see if removing hepatitis B surface antigen from the blood enhances the action of peginterferon. Eligibility: Adults ages 18 and older with hepatitis B Design: Participants will be screened twice with a medical history, physical exam, and blood and urine tests. Participants will be randomly put in one of two groups. All participants will get peginterferon for 24 weeks. One group will first get HBIg for 12 weeks. Participants in the combination group will have a 4-day clinic stay. They will have: Repeats of screening tests Eye exam Liver ultrasound The first dose of HBIg by IV over 2 hours These participants will get HBIg at the clinic up to 8 times over 12 weeks then start the peginterferon. All participants will get peginterferon for 24 weeks. They will get it by injection under the skin once a week. They may do this themselves. They will keep a drug diary. They will have 5 visits to assess response and monitoring for safety.. After stopping the study drug, participants will have 4 follow-up visits over 36 weeks. They will repeat screening tests and have 1 liver ultrasound.

NCT ID: NCT03570112 Completed - Hepatitis C Clinical Trials

Transmission of Chronic Hepatitis C in Pregnancy

Start date: June 8, 2018
Phase:
Study type: Observational

This is a multicenter, non-comparative, observational study that will recruit women with singleton pregnancy and chronic HCV infection to determine the natural history of chronic HCV in pregnancy and the rate of vertical transmission to their infants. All participants will be offered curative therapy with sofosbuvir/velpatasvir (Epclusa ®) after delivery and the cessation of breastfeeding. Subjects may be enrolled at any time after conception up through 36 weeks gestation. The management of subjects in pregnancy will be in accordance with ACOG guidelines and individual clinical judgment, however testing will include, but not be limited to, testing for HCV infection, HIV infection, HBV infection, HSV infection, group B Streptococcal colonization, HCV genotype, HCV viral load, as well as assessment of hepatic and renal function. Subjects will be followed on a schedule that is determined by their obstetric care providers throughout their pregnancy. Following delivery, infants will be evaluated at 12, 24 and 48 weeks of age, with testing for HCV RNA to be obtained at each evaluation. Vertical transmission is defined as two positive HCV RNA PCR tests, at least one before the 48 week infant visit, and again at the 12-month follow-up infant visit.

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: NCT03567382 Completed - Hepatitis B Clinical Trials

Arresting Vertical Transmission of Hepatitis B Virus

AVERT-HBV
Start date: September 24, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

NCT ID: NCT03566966 Completed - Viral Hepatitis C Clinical Trials

Autoantibodies and Direct-acting Antivirals

BIOEPA
Start date: July 1, 2015
Phase:
Study type: Observational [Patient Registry]

The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value. To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.

NCT ID: NCT03566563 Completed - Hepatitis C Clinical Trials

Epidemiology of Chronic Hepatitis C and Disease Modelling

EPIC
Start date: February 21, 2017
Phase:
Study type: Observational

Hepatitis C (HCV) is a major health problem amongst people who inject drugs (PWID) and have limited contact with health care services. Halfway houses (HH) serve to reintegrate former drug users into society. Strategies to eliminate HCV must focus on screening for HCV amongst HH. Linkage to care for PWID population is an issue globally. The aim is to determine the sero-prevalence, demographics, disease distribution and factors associated with the risk of HCV transmission amongst former drug users at Halfway Houses. The secondary aim would be to determine the best models of care that can be used to link these individuals to existing healthcare services in a pragmatic, randomised fashion Halfway Houses are invited to participate in a program of HCV education, point-of-care screening using Oraquick test and staging with Fibroscan® by a small mobile team of healthcare workers. A detailed survey regarding illicit drug injecting practices is performed. Those who are tested positive are referred to medical care. It is anticipated that the prevalence of Hepatitis C within the drug injecting population along with the stages of liver disease such that models for disease burden can be determined.

NCT ID: NCT03566030 Not yet recruiting - Hepatitis B Clinical Trials

Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance

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

- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48 - To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48

NCT ID: NCT03564639 Completed - Hepatitis C Clinical Trials

Examining Hepatitis C Reinfection Rates in Kenya

Start date: October 1, 2019
Phase:
Study type: Observational

The goal of this research project is to build upon the Testing and Linkage to Care for Injecting Drug Users (TLC-IDU) parent study and describe post-cure HCV reinfection in a population of people who inject drugs (PWIDs) in Kenya.

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.

NCT ID: NCT03551002 Recruiting - Hepatitis C Clinical Trials

Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego

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

A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.