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Hepatitis clinical trials

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NCT ID: NCT02578693 Recruiting - Clinical trials for Chronic Hepatitis C Infection

Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

Start date: May 2015
Phase:
Study type: Observational

The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.

NCT ID: NCT02577029 Terminated - Hepatitis B Clinical Trials

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

MONARCH
Start date: December 2015
Phase: Phase 2
Study type: Interventional

Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be evaluated for safety and efficacy.

NCT ID: NCT02576314 Completed - Clinical trials for Chronic Hepatitis C Infection

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

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

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

NCT ID: NCT02574884 Completed - Hepatitis C Clinical Trials

Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins

VINTAGE VHC
Start date: August 2011
Phase: N/A
Study type: Interventional

The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).

NCT ID: NCT02573376 Completed - HEPATITIS C Clinical Trials

Antiviral Pharmacology and Adherence in Drug Users

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

Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.

NCT ID: NCT02570191 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Start date: November 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

NCT ID: NCT02569710 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

Start date: October 31, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

NCT ID: NCT02569372 Completed - Chronic Hepatitis B Clinical Trials

A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Start date: November 9, 2015
Phase: Phase 1
Study type: Interventional

This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in Chronic Hepatitis B Patients.

NCT ID: NCT02568540 Terminated - Hepatitis C Clinical Trials

C Tracker, Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study

CTracker
Start date: October 2015
Phase:
Study type: Observational

Today's mobile devices (especially smartphones) are powerful ways to communicate new information to medical researchers. For this study, researchers at Boston Children's Hospital are asking people with hepatitis C to make use of their smartphones to help report information about themselves that may improve how hepatitis C is treated. This study uses a free app called C Tracker that can be installed from the Apple App Store onto the participants iPhone. The main goal of this research study is to use this app to report hepatitis C related health information to the researchers who are conducting this study. The investigators will ask participants about their health,activities, medications, and ways in which hepatitis C has impacted you. This information will be reported anonymously, which means that the researchers doing the study won't know who the participants are.

NCT ID: NCT02566148 Completed - HIV Infection Clinical Trials

Life Course, HIV and Hepatitis B Among African Migrants Living in Ile-de-France

PARCOURS
Start date: February 2012
Phase: N/A
Study type: Observational

Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in France and are among the most exposed to HIV infection and hepatitis B. The Parcours study aims to understand, among sub-Saharan African migrants, how social and individual factors combine in the course of migration and settlement in France, and influence the risk of infection, access to prevention and care, and the effectiveness of care for both HIV and hepatitis B diseases. The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants reside. It consists in a cross-sectional observational survey, using a life-event history approach that reproduces the sequence of different life and health events, and contributes to explain the present situation (type of disease management, patient's quality of life) in light of all the elements of the past trajectory (administrative, familial, socio-economic, professionals). A representative survey was conducted between February 2012 and May 2013 in health care facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group living with HIV, a group living with chronic hepatitis B and a group who has neither of these diseases. For each group, stratified random sampling was used. The survey was conducted in 24 hospital services providing HIV care, 20 health care facilities providing hepatitis B care, and 30 primary health care facilities. Were eligible all patients attending these health care facilities, born in a Sub-Saharan African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group). Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by hepatitis B, and 763 patients without these two diseases participated in the study. For all participants, detailed information on socio-demographic characteristics; migration and life conditions in France; social, sexual and reproductive life history; and screening and care history were collected using a life-event history questionnaire administered face-to-face by a specialized interviewer. Health care professionals documented clinical information from the medical records. Data was collected anonymously.